2024 & Beyond: Navigating Promising Frontiers in 3D Printed Medical Applications

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In a time when technological advances and healthcare innovations intersect, the domain of 3D printed medical applications stands at the forefront of a transformative wave. While some of the most anticipated advances in 2024 promise the widespread use of custom-designed implants and prosthetics, advanced drug delivery systems, 3D printed models of patient-specific anatomies, bioresorbable devices, and wearable sensors, the field of 3D printing is rapidly evolving elsewhere, too.

The potential for unforeseen breakthroughs in the next decade is on the rise, promising to further expand the capabilities and applications of this technology in healthcare. As the industry grapples with challenges like an aging population, rising healthcare costs, and the need for personalized treatments, 3D printing stands out as an innovative force. Today, 3D printing extends beyond its initial novelty in healthcare practices, offering applications with the potential to broaden the scope of patient care. While this field’s expansion is remarkable, it’s not without challenges, such as regulatory hurdles, technological constraints, and ethical debates. However, the ongoing drive towards medical advances and enhancing patient outcomes strengthens the momentum in 3D printing.

Here, we delve into three innovations in 3D printed medical applications that could turn the tables for patients this decade, paving the way for a new chapter in medical science.

Tiny Titans

When it comes to minimally invasive surgery, 3D printed microbots are a strong innovation. Leading the charge in this revolutionary field is Brad Nelson of ETH Zurich , a robotics and intelligent systems veteran who recently elucidated his two-decade-long journey in a December 2023 paper in the journal Science . His microrobots have the potential to redefine the delivery of drugs within the human body, targeting illnesses with unprecedented precision. These microrobots, ranging in size from a micron to a few millimeters, can consist of synthetic, biological, or biohybrid materials. They would potentially “navigate to disease sites” – such as tumors or thrombi – to release drugs directly, reducing the systemic toxicity commonly associated with drug treatments. According to Nelson, “biomedical microrobots could overcome current challenges in targeted therapies.”

However, this pioneering work is not isolated. Other institutes worldwide are contributing to this niche. For example, Tufts University and Harvard’s Wyss Institute are looking into 3D printed microrobots that can autonomously move and stimulate neuron growth. University Of California, Berkeley , and Johns Hopkins University are all part of this global pursuit, each exploring unique elements of microrobotics in medicine. Seoul National University’s work on microrobots capable of navigating bodily fluids underlines the international collaborative effort towards revolutionizing this niche within minimally invasive surgeries.

Nelson points out that when translating microrobots from the lab to clinics, “It is important to focus on simplicity, at least for the first attempts.” The medical microrobots field has progressed in preclinical settings after researchers in South Korea demonstrated 3D printed minirobot’s capability to navigate autonomously through blood vessels and perform surgical tasks in pigs. Published in IEEE Robotics and Automation Letters , this development addressed challenges in treating occlusive vascular diseases, major causes of death.

However, despite these promising developments, technical and regulatory challenges line the path to widespread clinical use. As medical devices and drug delivery systems, microrobots face a unique regulatory landscape, requiring further studies to meet the U.S. Food and Drug Administration (FDA) standards and other bodies, mainly due to their novel drug-device combination nature.

Neural Nexus

Current research in neural 3D printed bioelectronic interfaces shows tangible progress, particularly in developing implants for the nervous system. Bioelectronic interfaces, designed as devices, link electronic systems with biological functions, thereby bridging the gap between technology and the human body. Teams from the University of Oxford and the University of Sheffield are pioneering this area. Oxford’s team has successfully 3D printed human stem cells to create tissue structures that integrate with mouse brain tissue. This suggests potential for repairing brain injuries and enhancing understanding of the human brain.

Instead, Sheffield’s team focuses on customizing implants for spinal cord stimulation in animal models, which indicates possible future applications in treating paralysis. These developments, primarily in preclinical stages, are steps towards more personalized and effective treatments for neurological conditions. However, the transition from laboratory to clinical application remains a work in progress, with ongoing efforts to refine these technologies for practical use in human patients.

Another specific example of this technological innovation is evident in the work carried out at Lancaster University , also in the U.K. Here, researchers, under the guidance of John Hardy, have developed an advanced 3D printing method to integrate flexible electronics into biocompatible materials. Published in Advanced Materials Technologies , this project represents a leap in manufacturing complex 3D electronics for surgical implants and medical device repairs. The team’s success in embedding an electrical circuit within a silicone-based flexible matrix and attaching it to a mouse brain slice to stimulate neuronal responses shows the potential of this technology. The researchers have even extended this to printing conducting structures directly into worms, demonstrating compatibility with living organisms.

Although further progress in laser technology and ink formulation is needed for clinical application, Lancaster University’s pioneering work opens new avenues for creating tailor-made bioelectronic devices for neural monitoring and personalized medical treatments. This indicates a promising future for bioelectronic interfaces in medicine.

It’s a Heart Thing

Heart diseases, among the leading causes of mortality worldwide, could see transformative treatments thanks to 3D printing technologies in bioengineering. Customized 3D printed heart valves are at the forefront of this revolution. A beacon of hope for over 30 million people suffering from valvular heart diseases, this innovation represents a significant stride in tackling some of the most pressing health challenges of our times. Although the FDA approval status for these valves is still pending, and their clinical application is in the developmental stages, their potential is immense.

With over 182,000 valve replacements performed annually in the United States alone, it’s clear why the market is moving towards minimally invasive solutions. By 2026, the number of heart valve replacements in the U.S. will exceed 240,000. Tailored to individual patient anatomy, 3D printed valves can improve surgical outcomes and reduce the need for future surgeries, especially in pediatric patients.

Current heart valves are typically permanent devices with critical limitations. In pediatric patients who grow at rapid rates, they quickly become too small, which increases the need for replacements. Although 3D printed heart valves exist and bioresorbable materials have been used for implants, the two have not been combined.

Researchers at the Georgia Institute of Technology spearhead patient-specific, bioresorbable heart valves designed to reduce complications and reinterventions. Unlike permanent devices, these 3D printed valves are designed to be absorbed and replaced by the body’s tissue over time. This technology is particularly beneficial for children, as the valves can adapt and grow with the patient, potentially reducing the need for multiple surgeries. The valves are crafted using a combination of polymeric and metallic materials, each selected to match the specific mechanical behavior of the patient’s tissue. The design process involves detailed consideration of the patient’s anatomy, age, condition, and the required delivery mechanism.

case study 3d printing medical

An iteration of the prototype (left). The valve can be seen closing (center) and opening (right) under physiological aortic flow conditions via a pulse duplicator. Image courtesy of Georgia Tech.

In addition to functional benefits, manufacturers can customize these valves at the surface level to enhance integration with surrounding tissues and promote cell growth. Researchers at Canada’s Sainte-Justine Hospital are exploring using hydrogels and patient-derived stem cells in these valves to create a fully personalized solution less prone to rejection. This “personalized medicine” approach could revolutionize the treatment of various cardiovascular diseases and conditions.

These 3D printed heart valves are still in the experimental phase, with ongoing animal studies and human trials expected to begin in about a decade. This breakthrough could significantly improve the quality of life and treatment outcomes for millions of heart disease patients worldwide. The ability to tailor these valves to individual patient anatomy and conditions enhances the success rate of surgeries. It opens up new possibilities for treating a wide range of cardiovascular diseases, including congenital heart defects and valve stenosis.

case study 3d printing medical

Researchers at Canada’s Sainte-Justine Hospital produce 3D printed heart valves. Image courtesy of Sainte-Justine Hospital.

Together, this progress in 3D printed medical applications illustrates the potential of 3D printing in medicine and the collaborative and dynamic nature of research that spans continents and institutes, heralding a new era in medical treatments and patient care.

Featured image courtesy of Stratasys. 

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  • Published: 02 October 2020

Clinical applications of custom 3D printed implants in complex lower extremity reconstruction

  • Rishin J. Kadakia   ORCID: orcid.org/0000-0001-6124-5069 1 ,
  • Colleen M. Wixted 1 ,
  • Nicholas B. Allen 1 ,
  • Andrew E. Hanselman 1 &
  • Samuel B. Adams 1  

3D Printing in Medicine volume  6 , Article number:  29 ( 2020 ) Cite this article

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Three dimensional printing has greatly advanced over the past decade and has made an impact in several industries. Within the field of orthopaedic surgery, this technology has vastly improved education and advanced patient care by providing innovating tools to complex clinical problems. Anatomic models are frequently used for physician education and preoperative planning, and custom instrumentation can assist in complex surgical cases. Foot and ankle reconstruction is often complicated by multiplanar deformity and bone loss. 3D printing technology offers solutions to these complex cases with customized implants that conform to anatomy and patient specific instrumentation that enables precise deformity correction.

Case presentation

The authors present four cases of complex lower extremity reconstruction involving segmental bone loss and deformity – failed total ankle arthroplasty, talus avascular necrosis, ballistic trauma, and nonunion of a tibial osteotomy. Traditional operative management is challenging in these cases and there are high complication rates. Each case presents a unique clinical scenario for which 3D printing technology allows for innovative solutions.

Conclusions

3D printing is becoming more widespread within orthopaedic surgery. This technology provides surgeons with tools to better tackle some of the more challenging clinical cases especially within the field of foot and ankle surgery.

Introduction

The use of 3D printing has revolutionized the manufacturing process across various industries and enabled the creation of precise customized products. The origin of this technology can be traced back to 1984 when Charles Hull filed a patent for the stereolithography fabrication system and eventually began selling 3D printers for commercial use in 1988 [ 1 , 2 ]. This technology has drastically changed over the years and is currently being employed in almost every major manufacturing sector. Three dimensional printing technology has recently been more utilized in medicine and specifically in the field of orthopaedic surgery. Within orthopaedic surgery, 3D printing has allowed for the development of anatomical models that can be used for preoperative planning and education and more revolutionary, the development of patient specific instruments and implants that can be used intraoperatively. This technology can be helpful in cases of complex lower extremity reconstruction as deformity and bony defects can be challenging to manage. The ability to customize surgical instruments and implants to match the complex three dimensional deformity that is frequently seen with foot and ankle pathology has made 3D printing a novel tool when tackling these challenging problems. The applications of 3D printing within foot and ankle surgery are endless and as the technology continues to progress, the clinical utility will become more evident.

3D printing within orthopaedic surgery

3D printing technology is already being utilized within other subspecialties in orthopaedic surgery. Takeyasu et al. reported on a series of 30 patients who underwent correction of cubitus varus deformity – a complex deformity of the elbow - with custom made 3D printed surgical guides. They found statistically significant improvements in alignment and 90% of patients reported excellent results [ 3 ]. For total knee arthroplasty (TKA) and total hip arthroplasty (THA) cases in patients with complex or unique anatomy, 3D printed patient specific instrumentation and implants have become a viable alternative. Compared to standard implants, patients with custom implants reported fewer adverse events, decreased intraoperative blood loss, and were less likely to be discharged to an acute care facility or rehabilitation center in a recently published study [ 4 ]. 3D printing technology has also allowed engineers to improve upon standard implant designs through the manufacturing process. Patients who underwent revision hip arthroplasty with 3D printed acetabular cups demonstrated improved stability, better hip scores, and decreased pain [ 5 ]. While a majority of the products of 3D printing technology provides direct patient benefit, surgical trainees can develop, practice, and refine their technical skills with realistic 3D patient models as well. A survey of resident surgeons regarding the clinical utility of 3D models of posterior column fractures reported high overall satisfaction with these models when planning their surgical approach [ 6 ]. There are many applications of 3D printing already in place within orthopaedic surgery and the applications will continue to grow as technology advances and access to 3D printers improves.

3D printing in foot and ankle surgery

Foot and ankle pathology can be challenging to manage given the complexity of the three dimensional anatomy and interactions between the several articulations. Deformity correction requires an appreciation for normal anatomy but also an understanding of the deformity in multiple planes. 3D printing technology can assist in the preoperative planning of these complex cases by providing precise anatomical models to plan out hardware placement and osteotomies. Jastifer et al. reported on using a 3D model to help plan for deformity correction for an ankle fracture malunion. The authors used the model to template their fibular lengthening osteotomy and fixation construct [ 7 ]. 3D printing has also been shown to be effective in the management of acute foot and ankle trauma. High energy trauma to the foot and ankle can be challenging as anatomical reduction of the articular is crucial for long term success. Zhang et al. presented a cohort of patients who underwent surgical management of high energy ankle fracture dislocations with the assistance of 3D printed models for preoperative planning. They compared this to a cohort of similar patients who did not have preoperative 3D models and found that the patients who underwent fixation with the models had shorter operative times and less intraoperative fluoroscopy and blood loss [ 8 ]. Yao et al. similarly created 3D models of calcaneus fractures to assist with preoperative planning but also used the models to pre-countour hardware to ensure it fits appropriately. They found that this technique improved accuracy of hardware positioning and placement and allowed for minimally invasive surgical approaches [ 9 ]. 3D printed patient specific cutting guides can be used to ensure precision and accuracy when making bone cuts and osteotomies for deformity correction. Several studies have demonstrated that patient specific instrumentation is accurate and reproducible performing total ankle arthroplasty [ 10 , 11 ]. 3D printed custom guides have also been designed for subtalar joint arthrodesis, and a recently published study found that these guides reduced operative time and radiation exposure from fluoroscopy [ 12 ].

Complex foot and ankle reconstruction is frequently complicated by large osseous defects that require structural bone grafting. Structural grafts typically require significant contouring and can be difficult to mold to the patient’s native anatomy. The graft can also collapse over time which compromises its mechanical integrity. 3D printing has allowed for the development of custom metal implants that provide superior mechanical stability while also conforming to the patient’s anatomy. These custom implants can also be designed with surfaces that promote bone growth and can have areas to pack bone graft. Dekker et al. reported on a cohort of 15 patients who underwent complex lower extremity reconstruction augmented with a 3D printed titanium cage and demonstrated an 87% success rate with 13 of the 15 patients successfully healing their fusion/osteotomy site [ 13 ]. Nearly all of the patients in this cohort had a history of previous failed arthrodesis or significant bone loss/deformity from trauma. Reconstructive options for these patients without the assistance of 3D printed technology would be extremely complex and would likely involve large structural allografts and multiple surgeries. Hlad et al. reported on the use of custom 3D titanium implants in the management of bone loss in the setting of failed foot and ankle surgery. They used a titanium cage in cases of a failed total ankle arthroplasty and nonunions of a calcaneal osteotomy and a first tarsometatarsal (TMT) joint arthrodesis. They demonstrated successful healing at 1 year post-op with no complications [ 14 ]. 3D printing has revolutionized the treatment of challenging foot and ankle pathology. It allows for better preoperative planning, improved accuracy with bone cuts and osteotomies, and also allows for customized implants in cases of complex deformity and bone loss. The following cases are examples of complex foot and ankle cases in which 3D printing technology was used in surgical management at the author’s institution. The custom metal implants in these cases were designed use the Materialise 3D printing software (Materialise, Plymouth, MI). The implants were printed using the DMP Flex 350 metal 3D printer (3D systems corporation, Rock Hill, SC).

Clinical applications of 3D printing in complex foot and ankle reconstruction: case series

Case 1: tibiotalocalcaneal (ttc) arthrodesis in setting of failed total ankle arthroplasty.

Failed ankle arthroplasty can be challenging to manage. As talar components collapse, the native talus is eroded away and a large bone defect is often present. These cases can be managed with TTC arthrodesis and bulk structural allograft – most commonly a femoral head. Unfortunately, these complex reconstructions are prone to nonunion (when the bones do not heal together) and the graft can collapse over time. 3D printed cages can serve as augments in these cases to provide structural support and conform to the anatomy of the patient. These cages can be designed to have space for bone grafting and have surfaces designed to improve bony incorporation. Figure  1 is the case of a 65 year old gentleman who presented with a failed total ankle arthroplasty. His talar component had collapsed and eroded through most of the remaining talar bone and into the subtalar joint. He also presented with a medial malleolus fracture. The patient underwent a TTC arthrodesis augmented with a 3D printed titanium cage.

figure 1

Tibiotalocalcaneal (TTC) arthrodesis for case of failed total ankle arthroplasty. a AP and lateral radiographs demonstrate STAR ankle prosthesis with evidence of talar component collapse with erosion into subtalar joint. Medial malleolus fracture present as well. b Patient underwent TTC arthrodesis with 3D titanium cage. The cage is packed with allograft/autograft to enhance healing

Case 2: Total talus arthroplasty in the setting of talar avascular necrosis

Avascular necrosis of the talus (AVN) is a challenging clinical entity to treat. This disease process occurs when the blood supply to the talus is damaged either by a systemic process or trauma. Nonoperative treatment frequently requires prolonged periods of immobilization which can be detrimental to a patient’s functioning. While early stages of disease can be managed with joint preserving procedures such as core decompression and vascularized bone grafting, advanced disease commonly presents with talar bone collapse. For these advanced cases, prior to 3D printing technology, arthrodesis was routinely the only surgical option, especially with arthritic changes in the ankle or subtalar joint. Like in the previous case, arthrodesis involves removing all avascular bone which leaves a large bone defect. In some instances, talar AVN can present without significant arthritic changes in the surrounding joints. These cases are amenable to total talus arthroplasty with custom 3D printed implants. This implant is designed based on CT images of the talus from the contralateral limb. The implant is made from cobalt chrome and is smooth to allow for gliding at adjacent articulations. Figure  2 represents a case of a 45 year old female who developed talar avascular necrosis in the setting of a previous subchondroplasty. She underwent total talus arthroplasty with a custom 3D printed implant.

figure 2

Total talus arthroplasty for talar avascular necrosis. a AP and lateral radiographs demonstrate significant sclerosis of the talar body with some central collapse b Sagittal T2 and T1 cuts demonstrating diffuse talar avascular necrosis. c Total talus arthroplasty with custom 3D printed cobalt chrome prosthesis. Implant is designed based on imaging from the contralateral normal talus

Case 3: Navicular titanium cage in setting of navicular bone loss from ballistic fracture

Ballistic trauma to the foot can be difficult to manage. There injuries typically result in severe comminution making anatomic reconstruction difficult. Ballistic fractures of the navicular can result in shortening of the medial column and this deformity can alter gait biomechanics. Figure  3 is the case of a 23 year old male who sustained a ballistic navicular fracture resulting in severe comminution not amenable to surgical fixation. The patient had a three printed navicular cage designed for a medial column arthrodesis. The implant was designed based on the normal contralateral navicular from a CT scan and built to have struts that would extend out of the navicular cage into the talus and cuneiform to help increase stability. These struts also had bony ingrowth surfaces to promote incorporation. Furthermore, the implant was designed to have multiple possible screws to further enhance stability. In order to ensure the appropriate cuts were made for the struts and the implant, custom cutting guides were also designed to help ensure appropriate fit of the implant.

figure 3

Navicular 3D cage for ballistic navicular fracture. a AP and lateral XRs of the foot demonstrating a ballistic comminuted navicular fracture. b Sterile operative tray with the 3D printed objects. The plastic objects in the left of the tray are the sizers that are used to determine the implant size that will be used. The bottom of the image shows the custom 3D printed cutting guides. The top contains the 3D printed implants. Multiple sizes are printed and the sizers are used to determine which implant will be used. c Immediate postoperative images with the cage construct in place

Case 4: custom 3D printed cutting guide for a tibial osteotomy

Angular deformity can be challenging to correct especially when deformity is present in multiple planes. Preoperative planning for these cases is crucial and all planes of deformity must be considered when templating osteotomies and hardware placement. 3D printing technology can be helpful in these cases by providing precise cutting guides to assist with the osteotomies. Figure  4 demonstrates a case that used 3D printed custom cutting guides and implants. This is a 50 year old female who has a history of previous supramalleolar tibial osteotomy (SMO) for a varus deformity that ultimately failed and required a revision surgery. Unfortunately, her revision procedure also went on to a nonunion and she continues to have residual coronal and sagittal plane deformity. She underwent a nonunion takedown and revision distal tibial osteotomy with the assistance of 3D printed custom guides and implants. The implant was designed to fit the patient’s anatomy and correct the deformity. The implant also was printed with a plate attached to it so that fixation could be added directly to the construct.

figure 4

Custom cutting guide for revision tibial osteotomy. a AP and lateral views of the ankle demonstrating previous SMO with nonunion. b Custom 3D printed sizers, corresponding implants, and custom cutting guides. Cutting guide pinned in place to make appropriate bone cut. c Immediate postoperative images with implant in place, bone graft, and additional medial plate added for stability

Limitations to 3D printing technology

While these cases highlight the versatility of 3D printing within foot and ankle surgery, it is important to understand the limitations that come with this new technology. One of the main drawbacks of using custom 3D printed implants is the cost associated with making the implant. Healthcare costs are a tremendous burden on hospitals and patients – thus use of expensive implants may be denied in favor of more traditional and cheaper implants. However, as the technology continues to improve, costs of production will decrease and make these implants more affordable. The time it takes to design and manufacture the implant is also a limitation and it can take at a minimum four to 6 weeks for an implant to be made. This time delay has functional and economic consequences to the patient who continues to have pain and may be unable to work. It is important to note that this four to 6 week time frame is from experience at our institution and may vary between locations and practices. Finally, the technology is new thus there is a learning curve associated with its use. Each case is unique and presents its own challenges which adds complexity to using a custom implant and instrumentation. Surgeons must take extra time to prepare for each case and inspect the instruments and hardware before the case begins to better anticipate any intraoperative difficulties that may arise with its use.

3D printing technology has revolutionized the manufacturing industry. As the technology has advanced over the past several years, its clinical utility and applications have also increased. 3D printing in orthopaedic surgery can be used to improve preoperative planning, customize implants and instruments, and improve surgeon education and training. Within foot and ankle surgery, orthopaedic surgeons can use 3D printing technology in the surgical management of complex deformity and cases of significant bone loss.

Availability of data and materials

Not applicable.

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Rishin J. Kadakia, Colleen M. Wixted, Nicholas B. Allen, Andrew E. Hanselman & Samuel B. Adams

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Kadakia, R.J., Wixted, C.M., Allen, N.B. et al. Clinical applications of custom 3D printed implants in complex lower extremity reconstruction. 3D Print Med 6 , 29 (2020). https://doi.org/10.1186/s41205-020-00083-4

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  • Laura E Diment ,
  • Mark S Thompson ,
  • Jeroen H M Bergmann
  • Department of Engineering Science , University of Oxford , Oxford , UK
  • Correspondence to Dr Jeroen H M Bergmann; jeroen.bergmann{at}eng.ox.ac.uk

Objective To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields.

Design Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

Data sources PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar.

Methods A double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study.

Results Of the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy.

Conclusions All medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are clinically relevant before they become part of standard clinical practice.

  • printing, three-dimensional
  • health care evaluation mechanisms
  • medical devices
  • personalised healthcare
  • fabrication
  • additive manufacturing

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-016891

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Strengths and limitations of this study

This is the first rigorous systematic literature review of three-dimensional printing for clinical uses.

Validated quality assessment and clinical level of evidence tools are used to assess the progress made in different medical fields.

The study is limited to a critical appraisal of individual studies, rather than a meta-analysis, because of the breadth of uses (from anatomical models and surgical guides to therapeutic devices) and the lack of comparable hypotheses.

Due to the speed of innovation in the field, the review will need to be updated frequently.

Introduction 

Three-dimensional (3D) printing is likely to play a pivotal role in transforming healthcare and clinical practice because it provides the opportunity to create customised devices designed for the complexity and individual variances of the patient populations. 1

Additive manufacturing, more commonly referred to as 3D printing, is an industrial production technique that enables a 3D digital model to be converted into a physical model by printing it layer by layer. For decades, 3D printing has been used for rapid prototyping, but the recent advances in the available materials, speed, resolution, accuracy, reliability, cost and repeatability of 3D printing technologies have broadened the possibilities for clinical uses. 2 3 Many medical fields are already using 3D printing to manufacture custom surgical tools, guides, dose delivery devices, implants, external prosthetics or orthotics and devices for preoperative planning or education. 2 4 5 Tailoring devices and procedures to the patient are expected to reduce the time required for surgery, treatment or recovery, while increasing the accuracy and success of the outcome. 1 The worldwide 3D printing industry’s revenue from products and services is over US$4 billion and fast growing, with 13.1% of the industry attributed to the medical sector. 6

In most medical fields, 3D printing applications are still in the research and development stage or have only just entered clinical practice within the last decade, and hence, there has been a lack of research into the clinical efficacy, effectiveness and long-term follow-up in comparison to traditional technologies. 7 Efficacy refers to the performance of the device under ideal and controlled conditions, and effectiveness refers to its performance under typical clinical conditions. 8 The Food and Drug Administration states that 3D-printed medical devices are required to meet the same regulations as their non–3D-printed counterparts. Because 3D-printed devices can have different safety and efficacy issues than the equivalent devices, additional testing may be required to demonstrate safety, efficacy and effectiveness. 9 Hospitals and clinics will need to adopt new medical product procedures when they want to introduce 3D printing for healthcare, and more evidence of device efficacy and effectiveness will help make an informed discussion before prescribing 3D-printed devices for patients. Providing a critical appraisal of the efficacy and effectiveness of 3D-printed medical devices gives healthcare professionals a resource to assess the validity of the devices and provides researchers with an overview of areas that require further research and validation.

Previous systematic reviews summarise 3D-printed medical devices being used in specific medical fields, such as plastic and reconstructive surgery 10 and preoperative planning for liver resections, 11 and increasingly available 3D printing processes used in dentistry and mandibular reconstructions. 12–14 Systematic reviews on the advantages of 3D-printed devices over conventional methods in surgery have found improved clinical outcomes and reductions in operating times and manufacturing costs. 5 15 However, the reviews do not critically appraise the studies and are therefore subject to bias. The only systematic review that did assess bias for a very specific field found no difference in patient outcomes when 3D-printed instrumentation for total knee replacements was compared with conventional instrumentation. 16 This highlights the need for a systematic review that incorporates a critical appraisal of the studies that are included.

This review aims to assess the clinical efficacy and effectiveness of 3D-printed devices through performing a systematic literature search, categorising reports of 3D-printed device usage by medical field and purpose and assessing the reports’ scientific quality. The key findings of studies that compare 3D-printed medical devices with their non–3D-printed counterparts are presented, and the gaps in research were highlighted.

Search strategy

The applied protocol (not previously registered) used systematic methods to search for relevant studies, screen them for eligibility and assess their quality. The review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. 17 A literature search was performed using PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar. A combination of 45 relevant keywords were used to collect all studies that included a 3D-printed device and a clinical trial. Due to the word and character limit search restrictions in IEEE Xplore and Google Scholar, a narrower search of 15 terms was performed for these databases. The search includes all publications up to January 2017. The complete search strategy is provided in the online supplementary material . Mendeley was used as a reference manager.

Study selection

After removing all duplicates from the databases, the title and abstract of each publication was reviewed using a double-blinded method (undertaken by LED and JHMB) to determine eligibility for inclusion.

The inclusion criteria were:

Relevance: papers were required to report first-hand on the results of a clinical study that assessed the efficacy and effectiveness of a 3D-printed device.

Language: only papers written or translated into English were included in the review.

Peer review: records that had no peer review or where the level of peer review could not be traced were excluded from the review.

Where the results of the reviewers (LED and JHMB) conflicted, the reviewers discussed their reasoning for inclusion/exclusion, and where required for clarification of the paper’s relevance, the paper’s introduction and methods were assessed. Consensus on eligibility was achieved for all papers. Included articles underwent a full-text review, and references cited in these studies were also examined for relevance using the same inclusion criteria.

Quality assessment

The studies were then rated according to their level of evidence, based on the Oxford Centre for Evidence-based Medicine Levels of Evidence, 18 as summarised in table 1 . Systematic reviews and opinion papers were excluded because they cannot provide the original data in a suitable format to be assessed using the quality assessment method used in this review. Where studies used 3D-printed devices but the hypothesis, aim or objective was focused on an outcome other than the effect of the 3D-printed device, the paper has been graded as the level of evidence shown for the device. All levels of evidence were included in the review, but only those that used a control group (levels 1–3) were critically analysed.

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Centre for Evidence-based Medicine Levels of Evidence

Studies were then placed in medical fields based on the International Classification of Diseases chapter divisions 19 and categorised by the purpose of the device. The three categories were devices used for preoperative planning, devices to aid surgery and therapeutic devices.

To analyse the quality of the studies under review, critical appraisal tools were assessed to find one that met the following criteria:

Suitable for assessing the quality of both randomised and non-randomised studies,

Well regarded and commonly used for quality assessments in systematic reviews.

Demonstrates internal consistency, test–retest reliability and criterion validity.

Assesses the risk of bias, the participant selection methods, the study protocol and the validity, reliability and responsiveness of the study’s results.

Simple and intuitive to interpret.

Does not assign weights to the items in the scale where there is a lack of empirical evidence to support the assignment. 20

The Downs and Black Quality Index 21 meets all but the final criterion on this list. To overcome this limitation, responses have been left in their raw form (yes/no/unable to determine/not applicable, in accordance with the definitions provided by Downs and Black 21 ) and presented in a table to enable the reader to visualise the category trends, as recommended by the Cochrane Handbook for Systematic Reviews of Interventions. 20

The study details and data relating to the quality of study design and reporting were manually extracted from each paper by one reviewer (LED). The study details included medical field, study design, device category, device purpose, number of participants, age and gender of participants and aims and outcomes of the study. The data relating to study design and reporting were extracted according to the criteria used by the Downs and Black Quality Index, divided into reporting, external validity, bias, confounding and power. Where there were uncertainties as to how the study fitted with the Downs and Black Quality Index criteria, the other two authors were consulted, and in all cases, an agreement was reached.

The search yielded 4505 records, and after removing duplicates, 3084 abstracts were screened. A total of 350 studies met the inclusion criteria and were included in the review ( figure 1 ).

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Flow chart of the selection and sorting method.

Due to the large number of included studies, this paper gives an overview of the level of evidence found for 3D-printed medical devices in each medical field and then focuses on the outcomes of the level 1 studies. Information for all studies included in the review and a critical appraisal of all comparative studies is provided in online supplementary material .

A wide range of 3D-printed devices have been developed and clinically trialled. The most common device types were anatomical models for preplanning surgeries (40.9%), followed by guides to aid in surgery (37.1%). The studies covered nine medical fields, with the majority (58.3%) of studies falling into the oral and maxillofacial surgery field, which included dentistry and orthopaedic surgery of the jaw, face and skull, and those covering the musculoskeletal system (23.7%) making up the second group. Some studies spanned multiple medical fields, such as neoplasms that occur in the circulatory system. In these cases, the authors selected the most prominent field of the paper. Only 14.0% of included studies used a control group (levels 1–3 in figure 2 ), whereas 41.4% were level 5 studies. The average number of participants per controlled trial was 41 (36 for randomised controlled trials (RCTs)), compared with 17 for all studies.

Number of studies per level of evidence given by medical field. Levels of evidence are colour coded and fields are visually separated by alternating between white and grey columns.

All 21 level 1 studies fell within the oral and maxillofacial surgery or musculoskeletal system categories, with one cross-field study fitting in both oral and maxillofacial surgery and neoplasms ( table 2 summarises all RCTs). All level 1 studies, with the exception of Stephens et al , 22 used objective measures as their indicators of device efficacy and effectiveness. Of these, the seven models used for preoperative planning were all modelling bone or fracture fixation plates, though the locations spanned skull, face, mandible, arm, spine, hip and ankle. All aimed to assess the effectiveness of using the models for surgical planning in treating specific conditions. Six out of seven studies used operating time, four used accuracy of the surgery and three used blood loss as key indicators of device effectiveness. Aesthetics, recovery time and postsurgery function were also used as indicators of device effectiveness. All level 1 studies of 3D-printed models for preoperative planning that used time, accuracy or blood loss as indicators of device effectiveness reported that the test group had better outcomes than the control group, with statistical significance at P<0.05 found for four studies that assessed operating time, three studies that assessed accuracy and two studies that assessed blood loss. The two studies that assessed recovery time found no difference between groups, one of the two studies that assessed user function found statistically significant differences in the test group and the other found no difference between groups.

Summary of randomised controlled trials (type: p=preoperative planning, S=surgical tool or guide, T=therapeutic device)

Of the 11 RCTs that assessed 3D-printed guides or templates that supported navigation and surgery (of the mandible, teeth, shoulder, spine, hip or knee), 9 studies used accuracy of positioning as an indicator of device effectiveness, all of which found an improvement when using the guide or template and 8 of which showed statistically significant results at P<0.05. All four studies that used time as an indicator of device effectiveness showed decreased operating times when using the guide or template (all with P<0.05), and five of the six studies that used changes at the operation site (blood loss, inflammatory response, tactile sensation or aesthetics) found statistically significant improvements at P<0.05.

Only three therapeutic devices were tested using RCTs. These were zirconia crowns, which were found to have a better marginal gap and internal fit than the conventional crowns tested (P<0.05); cranial implants, which showed less vertical ridge resorption over time (P<0.05); and osteosynthesis plates for intercondylar humeral fractures, which showed a reduction in operating time (P<0.05) but no difference in elbow function during recovery.

While most level 1 studies found statistically significant improvements at P<0.05 when using the 3D-printed device, none performed an analysis on the clinical relevance of these improvements.

Critical appraisal of the RCTs from each medical field is shown in table 3 . The table includes the abridged quality index questions. Studies with higher levels of evidence typically rated better across all areas assessed using the quality index. However, many of the RCTs did not demonstrate external validity and did not blind participants or those measuring the outcomes or assess confounding factors between groups. Only 57% of the RCTs included follow-up.

Critical appraisal of studies with the highest level of evidence from each medical field

The results show that a wide range of 3D-printed devices have been clinically trialled, but few papers have rigorously assessed the efficacy or effectiveness of clinical 3D-printed devices. The 3D-printed devices tested were mainly designed for planning surgeries, particularly using anatomical models or surgical guides to aid cutting or navigating, with little attention dedicated to 3D-printed interventions. This is likely due to the lower complexity of the anatomical models and surgical guides and the smaller risk to the patient than therapeutic devices, resulting in less rigorous regulation and safety testing requirements. Approximately twice as many studies were in oral and maxillofacial surgery than in the musculoskeletal system, the two largest fields, but the musculoskeletal system, despite its more recent uptake of 3D printing, had almost double the number of level 1 studies. This is perhaps because clinical trials in musculoskeletal surgery typically aim to demonstrate quantitative clinical outcomes, driving more rapid growth in the level of evidence of studies than oral and maxillofacial surgery where aesthetics is a priority and individual outcomes are harder to quantify.

The RCT listed under neoplasms was an anatomical model used for planning mandibular surgery, but with a focus on tumour removal, fitting into both categories. Therefore, no RCTs were found outside the oral and maxillofacial surgery or musculoskeletal system fields. The primary indicators of success used to determine the efficacy and effectiveness of 3D-printed devices across all medical fields were operating time, accuracy of surgery or positioning, fit, changes at the operation site (particularly blood loss, inflammation and aesthetics), recovery time and functional outcomes. From the studies that compared against a control, the 3D-printed devices used for preoperative planning and aiding surgery consistently found decreases in operating time and increases in surgical accuracy, the two most commonly reported indicators of effectiveness. Operating time is an obvious choice as an indicator for device success because it is easy to measure and quantify and corresponds to decreased blood loss and faster recovery. The main aims of anatomical models and surgical guides are to provide better information to the surgeon on the surgical site and to guide the surgeon’s hand. Therefore, measuring the accuracy of the surgeries indicates whether these aims have been met. To make more decisive conclusions regarding the performance of 3D-printed medical devices in oral and maxillofacial surgery and musculoskeletal surgery, it is important to assess the long-term effects. Few papers assessed the long-term differences of using the 3D-printed devices and those that did had mixed results as to whether there were any differences in recovery times and outcomes. The other aspect that should be addressed in future studies is the appropriate choice of outcome measures. In the studies analysed in this review, there appears to be no evaluation of how the selected outcome measures match the purpose of the device.

Therapeutic devices such as implants, prosthetic limbs and orthotics offer the promise of revolutionising the medical industry because of their ability to be custom made for the patient, but most therapeutic devices are still early stage, with little research into their efficacy and effectiveness in a clinical setting. There were not enough therapeutic devices tested against a control group to find and evaluate repeated measures of success.

Most studies reviewed were poor quality, meaning that their study designs demonstrated levels of evidence for the 3D-printed device of 4 or 5, with no use of a control group. The 41.4% of papers that reported on individual case studies or provided only qualitative results did not clinically validate the devices that they reported on and therefore add little value to their fields. Few included follow-up or addressed the external validity, bias or confounding factors (see online supplementary material for full comparison of studies). The vast majority of papers reported positive outcomes for the patients, but few studies demonstrated clinically significant findings. Even the level 1 studies demonstrated limited external validity and rarely blinded participants or those measuring the outcomes to the intervention.

The RCTs all demonstrated statistically significant results in favour of using the 3D-printed device over the current clinical practice to which it was compared. However, one RCT 23 concluded that the improvement with 3D printing was too small to provide a clinical advantage, and none performed an analysis on the clinical relevance of these differences. The studies consistently used p values of <0.05 as their measure of device success, but taking into consideration the false discovery rate, it is likely that this will only show a real effect about 70% of the time under ideal testing conditions. 24 While the critical analysis in table 3 shows all level 1 studies as adequately powered, this is because the Quality Index bases its definition of ‘adequately powered’ on whether a difference due to chance is less than 5%. Therefore, given that all level 1 studies had 40 or fewer participants in each group, many of these studies are likely to be underpowered. 24 Considering the possibility of underpowered studies, the publication bias towards positive trials and the fact that all RCTs in this review were single-site trials, the likelihood that the results shown in these papers reflect a real effect is lower than suggested by the reviewed studies. 25 Until independent groups start validating 3D-printed devices, it is also difficult to avoid researcher bias.

Most 3D-printed device studies that were excluded from this review had uses in medical training or as moulds for manufacturing and therefore did not meet the inclusion requirements. A few other studies were excluded because they had not been translated into English.

Previous reviews have documented the uses of 3D printing for developing patient-specific medical devices. However, there has been limited research into assessing the efficacy and effectiveness of these devices. This rigorous systematic review design is the first to compare 3D-printed devices across all medical fields and assess their efficacy and effectiveness, describing key benefits that have been found from using 3D-printed devices clinically. The progress made in different medical fields is compared using validated quality assessment and clinical level of evidence tools. It demonstrates that the fields of oral and maxillofacial surgery and the musculoskeletal system are leading the way in validating 3D-printed devices for clinical use. Multiple high-quality studies have been performed on surgical guides for maxillofacial, hip and knee surgeries. This growing body of comparable high-quality research sets an example for other fields to emulate in order to demonstrate the efficacy and effectiveness required to integrate these 3D-printed devices into clinical practice.

A critical appraisal of the efficacy and effectiveness of 3D-printed devices across medical fields provides clinicians with an evidence-based approach to determine the applicability of 3D printing within their field. It also gives researchers an overview of areas that require further research and validation. It encourages investigators to discover what methods have been successfully validated in other medical fields and promotes potential collaborations between fields.

Three-dimensional printing provides a way of customising devices to improve patient outcomes. Available techniques and materials will increase, as 3D printing technology continues to be developed. There is therefore a growing need for validation of new devices, materials and techniques to ensure best patient outcomes. Much research has already gone into developing 3D-printed devices for medical purposes. However, this drive for new technology development has not yet been matched with a drive for critical appraisal of the devices to demonstrate their efficacy and effectiveness. Even the fields that are leading the way in critically evaluating new 3D-printed devices will be required to increase their output as 3D printing continues to grow in popularity and functionality.

The early research covered by this review shows that 3D printing can be valuable for use in medicine. The next important step to take is growing the body of research that focuses on validating 3D-printed devices. All fields require more rigorous and long-term assessments into the efficacy, effectiveness and safety of 3D-printed devices before they are introduced into standard clinical practice. The study is limited to a critical appraisal of individual studies, rather than a meta-analysis, because of the breadth of uses for anatomical models, surgical guides and therapeutic devices and the lack of comparable hypotheses. Funders can take an active role in promoting not only early technological development but also the subsequent clinical trials. Demonstration of clinical efficacy, effectiveness and device safety will become increasingly important as higher risk 3D-printed devices are developed and unconventional manufacturers, such as hospitals and clinics, incorporate 3D printing of patient-specific medical devices into standard clinical practice.

Fields such as oral and maxillofacial surgery, who were early in the uptake of 3D printing, are beginning to stabilise, with a steady number of studies being published each year, but other fields, such as musculoskeletal and circulatory systems, are more recently gaining traction, with increasing numbers of studies performed each year. 3D-printed drug delivery devices and biological 3D printing technologies for printing tissue show huge promise but have not been clinically trialled and so are not included here. 26 This is likely to change within the near future. It is therefore recommended that, in this fast-growing and dynamic environment, this review is updated every few years.

This review demonstrates that 3D printing is already being used to develop a broad range of medical devices with clinically effective results. The medical fields of oral and maxillofacial surgery and the musculoskeletal system are leading the way in validating the efficacy and effectiveness of 3D-printed devices and have found that 3D-printed anatomical models and surgical guides are reducing operating times and increasing surgical accuracy. However, the efficacy and effectiveness of 3D-printed devices remains undetermined for the majority of medical fields. 3D-printed devices can have an important role to play in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are clinically relevant before these devices can become part of standard clinical practice.

Supplementary material 1

Supplementary material 2.

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Contributors LED, JHMB and MST designed the review. LED and JHMB collected and analysed the data with input from MST. LED drafted the manuscript. All authors contributed to subsequent drafts and approved the final version of the manuscript.

Funding The researchers are financially supported by the General Sir John Monash Foundation and the Wellcome Trust (103383/B/13/Z).

Competing interests None declared.

Provenance and peer review Not commissioned; externally peer reviewed.

Data sharing statement All additional data are available in the supplementary material.

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case study 3d printing medical

  • Feb 14, 2022

7 Stunning Use Cases For 3D Printing In Medical Field

3D printing, or additive manufacturing, is revolutionizing the medical industry over the past decade. Medical professionals are utilizing 3D printing technology to develop new medical tools, orthopedic implants, and prosthetics as well as the customized replicas of tissues, bones and organs.

3D printed hip implant with novel biomaterial that has excellent biocompatibility and promotes bone healing

3D printed hip implant with new generation of biomaterial that has excellent biocompatibility and promotes bone healing.

Table of Contents

Rising of 3D printing in medical field

Benefits of 3D printing for patient and doctors

Real-life applications of 3D printing in medical field

Let's get started with medical 3D printing

Rising of 3D Printing in Medical Field

According to the Global Market Insights, healthcare 3D printing market size was valued at over USD 1.7 billion in 2020 and is estimated to expand with a CAGR of more than 22.3% between 2021 and 2027.

case study 3d printing medical

North America dominates the market for healthcare 3D printing possessing 40% of the market’s shares, valued for over USD 701.4 million. Credit: Global Market Insights

The increasing support for quality control and safety measures from FDA is largely driving the industry development in North America. Additionally, a higher intensity of research and development activities is noted in North America by academic institutions as well as manufacturers.

Benefits of 3D Printing for Patients and Doctors

Personalized healthcare.

case study 3d printing medical

Shapeshift production process for customized wearables. Credit: 3D Natives

With recent technology and material advance, additive manufacturing allows for the design and print of more complex designs and material options than conventional manufacturing method. Healthcare professionals can now easily create customized medical tools and implants that are perfectly adapted to a patient’s anatomy, or a specific surgery.

The better fit of prosthetics and implants can drastically reduce the chance of infection, provide pain-free functions and speed up the recovery process.

Fast Design and Production

Traditional prosthetics and implants can take weeks to design and manufacture, especially if they are custom made for a patient.

With 3D printing techniques, healthcare professionals can design and print the object in-house on a professional 3D printer within a few days (and sometimes even less), which is much faster than molded or machine parts.

This could significantly reduce patients’ waiting time and lower the chances of complications that may occur as a result of delayed or unavailable medical devices.

Increase Cost Efficient

3D printing provides patients with affordable tailor-made prostheses and implants that are so expensive in traditional manufacturing processes. There is also no need to make any specialized tooling, jigs or fixtures, and there are no minimum volume requirements.

The entire process – from scanning, to 3D modeling and printing – can be performed simply by a single person and an inexpensive desktop 3D printer, saving time, labor, and money.

Real-life Applications of 3D printing in medical field

1. 3d anatomical models for surgical planning.

Surgeons performed a tumor removal surgery with great success after planning and rehearsing with a 3D printed organ replica

Tumor removal surgery performed with 3D planning at SJD Barcelona Children's Hospital. Credit: SJD Barcelona Children's Hospital

In 2013, SJD Barcelona Children's Hospital used 3D printing to plan the first-ever complex cancer surgery in a 5-year-old boy with great success. The boy was diagnosed with neuroblastoma, a rare childhood cancer develops in nerve tissues. To remove the tumor without endangering the patient’s life, surgeons had to skillfully avoid cutting the blood vessels and surrounding organs.

After two unsuccessful attempts, the team created a life-sized, 3D printed replica of the boy's tumor using materials with texture similar to the organs. Using the 3D model, surgeons carefully analyzed the anatomical relationships of tumor, vessels and organs and simulated the highly complex tumor excision. After rehearsing for more than a week, the surgeons successfully removed the tumor from the boy’s body. And the boy was expected to fully recover without additional surgeries.

Since then, 3D technology has been implemented by the hospital professionals in around 100 surgeries since 2017 to plan complex surgical procedures, create cutting guides and surgical tools, design patient specific prostheses and implants. Currently, 3D printing has been rolled out to other specialists in the Hospital including traumatology, maxillofacial surgery, cancer surgery, neurosurgery, cardiology, plastic surgery and dental surgery.

2. Prosthetic limb

scientists introduced an affordable way to create custom fit leg socket for patient using 3d printing

Prosthetic socket is tailored to fit the leg of each patient using 3D technology. Credit: University of Toronto Scientific Instruments Collection

There are more than 57.7 million people living with limb loss worldwide. While prosthetic devices can help patients getting around more easily, they remain too expensive and uncomfortable. The problem has become even more obvious in children with limb loss – they outgrow prosthetics quickly and require frequent replacement. It costs an average of USD 80,000 per limb to keep a child outfitted with an appropriate prosthetic.

Using 3D printing technology, the University of Toronto introduced a low-cost, time-saving way to produce custom fit leg socket for children . The process is simple: a technician scan the residual limb, model a socket based on the 3D scanned data, and press "print". After 6 to 9 hours, a socket that is designed specifically for the patient will be ready.

3. Mass Production of Emergency Medical Supplies

A high school student developed a 3D print design for mass production of finger splint in a minute.

3D printed finger splint designed by Ian McHale for temporary stabilization of a finger or joint after an injury. Credit: Thingiverse

Ian McHale, a senior at Steinert High School in United States, developed a design for producing finger splint on a low-end 3D printer in about 10 minutes for less than USD 2 cents of recycled plastic .

McHale understood the difficulties for developing countries in ordering large supplies from overseas, let alone custom splints. That’s why McHale decided to design 3D printed finger splints that were more affordable and readily available. Depending on the platform size, 30 – 40 splints could be printed in a single run. This splint design is also beneficial to clinics, remote hospitals and first-aid posts when supplies run low or special medical tools are required.

McHale’s design won the first prize in his division at the Mercer Science and Engineering Fair and was awarded by the United States Army and Air Force. He believed with a 3D printer, splints can be created on an individual basis and modified to fit various finger sizes. Currently, his design of the 3D printed finger splints is available for free downloading at Thingiverse and he invites people to design their personalized finger splints.

4. Bone Replacement

A China hospital 3D printed an artificial bone with PEEK instead of titanium alloy in a bone replacement surgery

The KMU Hospital 3D printed an artificial collarbone (clavicle) using PEEK instead of traditional titanium alloy for bone replacement. Source: 3Dnatives

In 2018, the medical team at Kunming Medical University Hospital (KMU Hospital) in China, in collaboration with the 3D printer company IEMAI 3D, successfully transplanted the world's first 3D printed PEEK collarbone . This was performed on a 57-year-old man with advance cancer whose collarbone had to be cut off to remove cancer cells from affected tissues and organs.

To fix the collarbone after resection, doctors at KMU Hospital decided to use a PEEK prosthesis instead of using the traditional titanium mesh – as it won’t affect the patient's later treatment with chemotherapy. PEEK also guarantees faster recovery and demonstrates no side effects to patients.

The introduction of PEEK, ULTEM, PMMA and other thermoplastics to the medical field is opening the way for more patients to undergo implant surgery, as it would not affect their possible future treatments.

5. Skull Reconstruction

A girl with brain tumor had her skull reconstructed with a 3d printed cranial implant.

Tiffany Cullern underwent surgery to remove a brain tumor and had her skull constructed with a 3D printed skull implant after complications. Source: All3DP

Tiffany Cullern, a 20-year-old girl in Britain, had her skull reconstructed with a 3D printed skull plate .

The young girl suffered from a extremely rare brain tumor. The tumor was a size of a golf ball and kept growing. While surgeons were able to removed the tumor, Cullern was unresponsive with her brain swelled after the surgery. Surgeons could only undergo another operation to remove her skull in order to relive pressure. Since doctors were unsure whether Cullern’s brain would swell again, they leave her skull out until the condition was stable.

Leaving the head with a hand-sized hole for 3 months, Cullern was finally implanted with a 3D printed skull piece made of titanium, plastic, and calcium. She recently got engaged to her boyfriend and is thankful to have her head back to normal and is happy to move on in her life.

6. Human Corneas

Dr Steve Swioklo and Prof Che Connon successfully 3D printed the world’s first human cornea. Credit: Newcastle University

In 2018, the first human corneas was 3D printed by scientists at Newcastle University in United Kingdom.

The researchers worked by mixing healthy corneal stems cells with alginate and collagen to create a printable solution – “bio-ink”. Using a simple 3D bio-printer, the bio-ink was successfully extruded to form the shape of a human cornea in less than 10 minutes.

3D printed corneas were designed according to patient’s unique specifications. By scanning a patient’s eye, researchers could use the data to rapidly print a cornea which matched the size and shape.

Although the 3D printed corneas still require further testing before they are usable for transplant, the scientists at Newcastle University believed 3D printed corneas could relieve the global shortage of donor corneas in near future.

7. Heart Valves

scientists 3D printed a living heart valve that possess the same anatomical structure as native valve

A 3D printed artificial heart valve. Source: 3D Printing Indutry

Jonathan Butcher and his team at Cornell University pioneered 3D tissue printing technology to create living heart valves that possess the same anatomical structure as native valve.

To precisely produce an artificial valve, Butcher’s team had developed algorithms that process 3D image datasets of a native valve and automatically form the full 3D model of the heart valve. Bio-printing is then conducted in a dual syringe system with a mixture of alginate/gelatin hydrogel, smooth muscle cells and valve interstitial cells to mimic the structure of the valve root and leaflets.

Butcher believed bioprinting would gain much more traction in the tissue engineering and biomedical community over the coming years. The patient-specific tissue models would help healthcare professionals in learning disease pathogenesis and screening drug efficacy, or making living tissue replacements tailored directly to patient geometry.

Time to Get Started with Medical 3D Printing!

It is obvious that the trend of using 3D printing in medical field will keep growing, and it is time for us to utilize it to improve patient care.

If you find too complicated to start everything on your own, you can consider consulting with experienced companies. Novus provides medical grade 3D printing filament and 3D printing services for hospitals, researchers and vets.

Contact our expert advisors today at [email protected] for a free consultation.

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International Conference on Design, Simulation, Manufacturing: The Innovation Exchange

ADM 2021: Design Tools and Methods in Industrial Engineering II pp 535–545 Cite as

3D Printing of Prototypes Starting from Medical Imaging: A Liver Case Study

  • Robinson Guachi   ORCID: orcid.org/0000-0002-0476-6973 15 , 16 ,
  • Michele Bici   ORCID: orcid.org/0000-0002-7744-2152 15 ,
  • Fabiano Bini   ORCID: orcid.org/0000-0002-5641-1189 15 ,
  • Marcelo Esteban Calispa   ORCID: orcid.org/0000-0002-4085-8488 17 ,
  • Cristina Oscullo   ORCID: orcid.org/0000-0001-7622-4922 16 ,
  • Lorena Guachi   ORCID: orcid.org/0000-0002-8951-8150 16 , 18 ,
  • Francesca Campana   ORCID: orcid.org/0000-0002-6833-8505 15 &
  • Franco Marinozzi   ORCID: orcid.org/0000-0002-4872-2980 15  
  • Conference paper
  • First Online: 01 December 2021

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Part of the Lecture Notes in Mechanical Engineering book series (LNME)

Hepatic diseases are serious condition worldwide, and several times doctors analyse the situation and elaborates a preoperative planning based exclusively on the medical images, which are a drawback since they only provide a 2D vision and the location of the damaged tissues in the three-dimensional space cannot be easily determined by surgeons. Nowadays, with the advancement of Computer Aided Design (CAD) technologies and image segmentation, a digital liver model can be obtained to help understand the particular medical case; even with the geometric model, a virtual simulation can be elaborated. This work is divided into two phases; the first phase involves a workflow to create a liver geometrical model from medical images. Whereas the second phase provides a methodology to achieve liver prototype, using the technique of fused deposition modelling (FDM). The two stages determine and evaluate the most influencing parameters to make this design repeatable in different hepatic diseases. The reported case study provides a valuable method for optimizing preoperative plans for liver disease. In addition, the prototype built with additive manufacturing will allow the new doctors to speed up their learning curve, since they can manipulate the real geometry of the patient's liver with their hands.

  • Image segmentation
  • Convolutional neural network
  • 3D printing
  • Liver disease

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Robinson Guachi, Michele Bici, Fabiano Bini, Francesca Campana & Franco Marinozzi

Department of Mechatronics, Universidad Internacional del Ecuador - UIDE, 170411, Av. Simón Bolívar, Quito, Ecuador

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Guachi, R. et al. (2022). 3D Printing of Prototypes Starting from Medical Imaging: A Liver Case Study. In: Rizzi, C., Campana, F., Bici, M., Gherardini, F., Ingrassia, T., Cicconi, P. (eds) Design Tools and Methods in Industrial Engineering II. ADM 2021. Lecture Notes in Mechanical Engineering. Springer, Cham. https://doi.org/10.1007/978-3-030-91234-5_54

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Challenges of 3D printing technology for manufacturing biomedical products: A case study of Malaysian manufacturing firms

N. shahrubudin.

a Department of Production and Operation Management, Faculty of Technology Management and Business, Universiti Tun Hussein Onn Malaysia (UTHM), Parit Raja, 86400, Batu Pahat, Johor, Malaysia

b School of Materials Science and Engineering, UNSW, Sydney, NSW 2052, Australia

c Faculty of Engineering Technology, Universiti Tun Hussein Onn Malaysia (UTHM), Educational Hub Malaysia Pagoh, 84600 Panchor, Johor, Malaysia

M.H.A. Kadir

Additive manufacturing has attracted increasing attention worldwide, especially in the healthcare, biomedical, aerospace, and construction industries. In Malaysia, insufficient acceptance of this technology by local industries has resulted in a call for government and local practitioners to promulgate the development of this technology for various industries, particularly for biomedical products. The current study intends to frame the challenges endured by biomedical industries who use 3D printing technology for their manufacturing processes. Qualitative methods, particularly in-depth interviews, were used to identify the challenges faced by manufacturing firms when producing 3D printed biomedical products. This work was able to identify twelve key challenges when deploying additive manufacturing in biomedical products and these include issues related to binder selection, poor mechanical properties, low-dimensional accuracy, high levels of powder agglomeration, nozzle size, distribution size, limited choice of materials, texture and colour, lifespan of materials, customization of fit and design, layer height, and, lastly, build-failure. Furthermore, there also are six challenges in the management of manufacturing biomedical products using 3D printing technology, and these include staff re-education, product pricing, limited guidelines, cyber-security issues, marketing, and patents and copyright. This study discusses the reality faced by 3D printing players when producing biomedical products in Malaysia, and presents a primary reference for practitioners in other developing countries.

Business; Biomedical products; Additive manufacturing; 3D printing technology

1. Introduction

Additive manufacturing (AM), also known as 3D printing involves use of digital CAD modelling to build 3D objects by joining materials layer-by-layer [ 1 ]. The future demand for this technology lies in its capability to perform different print functions and "print-it-all" structures. These functions are progressively perceived as the driving force for researchers and practitioners even though 3D printing technology has seen significant developments in the last three decades [ 2 ]. Moreover, this technology has widely been applied towards the agricultural, biomedical, automotive, and aerospace industries [ 3 ]. 3D printing technology has emerged in recent years as a flexible and powerful technique in advanced manufacturing. According to Garcia et al. [ 4 ], this technology is used widely in the manufacturing industry and medical education field. The different methodologies used for additive manufacturing in the industry include fused deposition modelling (FDM), stereolithography (SLA), selective laser sintering (SLS), and bioprinting [ 5 ].

Although the 3D printing technology in Malaysia is clearly in the early developmental stage, this technology is expected to expand and become one of the country's major innovation, particularly in engineering, manufacturing, arts, education, and medicine. The vast majority of researchers have focused exclusively on engineering applications with focus on materials [ 6 ], processes [ 7 ], techniques [ 8 ], and machinery [ 9 ] used in optimization. To date, only limited studies have focused on the management aspects of technology, with discussions on the challenges [ 10 ] and supply chain management [ 11 ]. The existing studies on 3D printing technology have centred on developments in Europe and the USA, with limited focus on biomedical product fabrication, especially in developing countries like Malaysia [ 12 ].

Sandstrom [ 13 ] was concerned about the adaptation of 3D printing technology in the hearing aid manufacturing industry but the operational and technological challenges faced by producers were neglected. According to Shirazi et al. [ 14 ], 3D printed biomedical products differ from other printed products because they involve biocompatible materials and clinical testing ( in vitro and in vivo ) resulting in operational and technological challenges that are specific to the materials used. Thus, this study discusses the practices involved in manufacturing printed 3D biomaterial products, and, subsequently, fills the gap in the existing research from a management perspective. This study indicates a framework specific to the development of biomedical products. An in-depth interview with three local companies was carried out as the proposed framework to derive real perspectives from real players involved in 3D printing technology for producing biomedical products in Malaysia.

2. Literature review

2.1. 3d printing technology.

3D printing can create physical objects from a geometric representation by successive additions of materials [ 15 ]. The 3D printing technology has experienced phenomenal development in recent years ever since it was first commercialized in 1980 [ 16 ]. Since then, this technology has been principally used to create complex walls [ 17 ], endodontic guides [ 18 ], sport shoes [ 19 ], engine parts for the aviation industry [ 20 ], and tumour reconstruction [ 21 ]. Commonly, the 3D printing manufacturing process begins with a CAD drawing, followed by objects being sliced into layers, and, lastly, a layer-by-layer 3D build is printed. The 3D printing technology is equipped to fabricate functional parts with a wide range and combination of materials, including aluminium alloy [ 22 ], thermoplastic filaments [ 23 ], zirconia [ 24 ], carbon fibre-reinforced polymer composites [ 25 ], hydrogels [ 26 ], nanogels [ 26 ], and others. An ideal 3D printed biomaterial should morphologically mimic living tissue, be biocompatible, and be easily printable with tuneable degradation rates [ 27 ].

There are several types of 3D printing technologies with different functionalities. According to ASTM Standard F2792 [ 1 ], this technology can be classified into seven groups: binder jetting, directed energy deposition, material extrusion, material jetting, powder bed fusion, sheet lamination, and vat photo-polymerisation. More than 350 types of industrial 3D printing machines and 450 materials have been identified in the marketplace [ 28 ]. These machinery have their own specific applications, and pros and cons. According to Jammalamadaka and Tappa [ 29 ], well-known printers for biomedical products are those that are inkjet-based and extrusion-based.

There have been various types of 3D printers used dating back to 1984 with Charles Hull's ideas about a computer system based on stereolithography that uses the STL file format to interpret data in a CAD file [ 30 ]. The instructions in the STL file are encapsulated with information, such as the colour, texture, and thickness of the object to be printed [ 31 ]. Moreover, different types of printer are designed to print different products, of various scales in various industries, such as healthcare [ 32 ], food [ 33 ], automotive [ 34 ], and architecture [ 35 ]. In the 21 st century, 3D printing technology began expanding into aircraft manufacturing (producing robotic components), and, subsequently, established the Industry 4.0 paradigm in institutions of higher learning and manufacturing sectors [ 36 ]. The following are several advantages derived from using 3D printing technology [ 37 ]:

  • • Customise desired products in a short time;
  • • Create complex objects and shapes that otherwise might be impossible to create through any conventional method;
  • • Produce biocompatible products, such as organs or replacement tissues, in a short time compared to conventional methods;
  • • Cost-effective; and
  • • Non-requirement of storage of goods or materials.

To sum up, there are several characteristic features for each 3D printing technology application and this could the larger-scale implementation of this technology.

2.2. Application of 3D printing for producing biomedical products

Recently, 3D printing technology has rapidly flourished in the industry for the purpose of designing, developing, and manufacturing new products. There are numerous applications of 3D printing technology for producing biomedical products such as drugs, artificial skin, bone cartilage, tissue, and organs, and in cancer research and education.

2.2.1. Drug delivery

In August 2015, the FDA endorsed the use of 3D printing technology for pharmaceutical research and manufacturing [ 38 ]. A higher production volume of medicines is achievable through 3D printing technology due to the printer's ability to control the exact drop size and shape. This process allows for higher reproducibility of medicine and formulates a ready dose-shape based on a complex medication discharge profile. An example in drug delivery is the oral tablet produced by 3D printing technology. Oral tablets are the most difficult to manufacture and its successful production by using 3D printing technology is open to further scrutiny [ 39 ]. The previous process produces an oral tablet via a complex layer of mixing, milling and dry and wet granulation of powdered ingredients formed through moulds or the compression. Each of these traditional steps involve difficulties, such as drug degradation, form change, and potential problems with formulation or batch failures [ 34 ]. Some of the examples of oral tablets are flat-faced [ 40 ], spritam (levetiracetam) [ 41 ], and paracetamol [ 42 ]. Presently, analysts use vapour-stream as a 3D printing method to keep drug measurements on an assortment of surfaces that incorporate dissolvable Listerine tabs [ 43 ]. In the meantime, 3D printing technology can also produce antibiotic and chemotherapeutic drugs that are customized according to patient anatomy and clinical presentation [ 44 ].

2.2.2. Skin

A process to create a generic 3D-skin structure with minimal costs using 3D printing technology has been successfully achieved. This 3D printed skin is useful as a medium to test pharmaceutical products, beautifying agents, and synthetic items. New 3D human skin models could replace animal trials to assess dermal sensitivity to a medical design. Subsequently, it will enable specialists to achieve precise results after repetitive printing trials [ 45 ]. So far, in vitro and in situ are two existing approaches in skin bioprinting. Both approaches have a similar process except for tissue maturation and the site of printing. The in vitro bio-printed skin maturation begins in a bioreactor before it is grafted on the skin. Meanwhile, the in situ bioprinting constitutes the direct printing of pre-cultured cells over an injured site. This process supports a recovering wound upon local maturation [ 46 ]. Several types of bioprinting technology have been used to prepare 3D-skin, such as laser-assisted [ 47 ], micro-extrusion [ 48 ], and inkjet bioprinting [ 49 ]. To facilitate the 3D printed skin process, a range of natural biomaterials like cellulose [ 47 ], alginate [ 50 ], GelMA-collagen [ 51 ], hydrogels [ 52 ], keratinocytes (KCs) [ 48 ], fibroblasts (FBs) [ 48 ], carbon nanotubes [ 53 ], and others have been employed. The availability of suitable biomaterials and technology advancement has resulted in bioprinting being used successfully to fabricate 3D-skin [ 47 ].

2.2.3. Bone cartilage

Bone cartilage is a a highly diverse and dynamic tissue, both in function and structure. These properties are due to its ability to perform a wide array of functions, including response to a variety of physical, metabolic, and endocrine stimuli. For mutual injuries, bone has a self-healing capability to form scar-free tissue. However, there are injuries that might emerge in non-union or union delays that require bone regeneration [ 54 ]. In this case, 3D printing technology can print tissues to fill out voids in bone defects that are caused by tumour resection, trauma, injury, or infection [ 55 ]. This treatment is distinct and provides an alternative to auto-unions and allografts to maintain health or enhance the in vivo capacity. Examples of products manufactured by 3D printing technology include cranial portions, bone frameworks, embedding bearings in skull, and bio-fired inserts [ 56 ]. Recently, Liu et al. [ 57 ], suggested that these 3D printing technologies have a higher possibility of repairing fractured bone structure. Meanwhile, Du et al. [ 58 ], constructed a bioinspired multilayer osteochondral scaffold consisting of hydroxyapatite (HA)/polycaprolactone (PCL) and PCL microspheres using the SLS process. The derived scaffolds present excellent biocompatibility and can induce articulate cartilage formation in cases of osteochondral defects in a rabbit.

2.2.4. Tissues

In a similar manner, 3D printing technology can be utilized to supplant, re-establish, maintain, or enhance the capacity of tissues. The substitute tissues created by 3D printing technology have organized interconnected pores, are biocompatible, and possess excellent mechanical properties. The organized interconnected pores are crucial for wastes removal and improving oxygen and nutrient supply, while the mechanical properties help to match the tissue at the site of the implantation [ 59 ]. For example, tissue processes that utilize 3D printing technology have printed some delicate tissue structures such as tooth-supporting tissues and jawbones [ 60 ].

2.2.5. Organs

By using 3D printing technology, autologous organs can be printed without any need for immunosuppressive medication or waiting for a donor. This can potentially put an end to the illegal trade in human organs [ 61 ]. With the help of 3D printing technology, it is possible to directly print human organs for replacing damaged organs caused by infections, mishaps, or congenital defects [ 62 ]. The most commonly printed organs with this technology are the liver, heart valve, ear, and spinal columns [ 63 ]. There are currently new ventures to deliver bio-printed organs that are made with the vascular design of a natural organ produced through bio-printing design. The uniform cells can be isolated, cultured in vitro and differentiated into specific cell types, which then regenerate specific tissues [ 64 ]. According to Jang et al. [ 65 ], the organ transplantation process is preceded by hydrogel composite systems, and this can be carried out via use of repaired and bio-printed organs in a bioreactor [ 39 ].

2.2.6. Cancer research

3D printing technology can revolutionize cancer treatment by printing personalized hydrogels, prostheses, and therapeutic implants [ 66 ]. Early diagnosis is essential for reducing cancer mortality and effectively treating the disease. Therefore, the development of accurate and sensitive methods to detect cancer at its early stages has been intensively studied [ 67 ]. Thus, utilizing 3D printing technology allows patients to obtain more dependable and accurate information. Presently, 3D demonstration of in vitro diseases allows more noteworthy cell feasibility, higher expansion rate, and higher chemo-resistance to anti-cancer medications and helps in providing data related to the qualities of a genuine tumour [ 68 , 69 ]. For example, 3D printing technology can produce the mandible template using PLA polymer filament or titanium. The template is sterilized according to the Sterrad (low-temperature hydrogen peroxide gas plasma technology) process, which uses H 2 O 2 plasma and UV irradiation before it is available for treating cancer patients [ 69 ].

2.2.7. Educational

3D printout models can be used in the learning process to help neurosurgeons hone surgical skills. By implementing 3D printing technology, neurosurgeons can enhance their precision and provide short opportunities to mentor the process throughout the clinical system. As the 3D display provides a re-enactment of a genuine patient's condition, the printer helps the neurosurgeon by providing hands-on experience. Additionally, 3D printing provides visual instrumentation that allows the specialist to share data with patients. Neurosurgeons can share their expertise in pathology and its related concerns to provide long-term care-overview for the immediate prescription of medication to patients [ 70 ]. At the same time, 3D printed models can also be used to educate patients and help them to better understand their conditions [ 71 ]. Figure 1 shows the present application of 3D printing technology in biomedical products.

Figure 1

The applications of 3D printing technology for biomedical products.

3. Research framework

This study has developed a conceptual framework related to the challenges faced by 3D printing technology based on previous studies. These challenges are laid out in the following sections.

3.1. Processing

3.1.1. materials.

One of the challenges when making bone tissue using 3D printing technology is binder fitting [ 56 ]. Not all binders are suitable for use in the sintering process. For example, when producing bone tissue using stereolithography (SLA), only photopolymers are suitable. Among the different binders, organic ones are considered to be the best in producing high quality 3D printed parts or products. However, during the long operational process, this organic binder affects the plastic parts of 3D printing machines [ 56 ]. Conversely, Bogue [ 59 ] claimed that the selection of a suitable binder is the main challenge when fabricating 3D scaffolds.

Bose et al. [ 56 ], mentioned that the focus in fabricating bone tissue lies in optimising the mechanical properties of the porous scaffold. This scaffold is generally a ceramic material which is known to have high porosity and low mechanical properties. This challenge was also supported by Egan et al. [ 72 ], who claimed that engineered scaffold tissue is difficult to optimize due to the complexity involved in interfacing mechanical properties and biological systems. The design requires consideration on mechanical properties, biological performances, and fabrication constraints. The mechanical integrity of the scaffold structure is essential for the promotion of cellular growth. Vasireddi & Basu [ 73 ] stated that achieving sufficient mechanical strength and manufacturing feasibility are among the salient challenges. The well-perceived requirement of materials used for fabrication is still inadequate to print varying structures owing to the fact that these aspects include consideration of geometric selection criteria, thickness of the layer, and the minimum ratio between distribution ratios of pore sizes.

Furthermore, the particle size of the powder influences the thickness of the printed layer [ 73 ]. Distribution of sizes and shapes of the powder also affect the quality of scaffolds [ 73 ]. Lack of pore interconnectivity affects the mechanical properties of 3D scaffolds. The powder must be biocompatible and biodegradable as scaffolds need to promote tissue regeneration after implantation [ 74 ]. Hydrogel materials can further aid cell migration and growth to improve the speed of tissue regeneration and repair by replacing a functional material with bionic characteristics resembling extracellular matrix with highly networked 3D structures.

According to Boetker et al. [ 75 ], the challenge of adopting 3D printing technology is to determine suitable materials that can match the flow properties and requirements for adjusting the nozzle temperature and speed of 3D printing. The flow properties are sensitive to the number of undissolved particles used in the printing process. To date, materials used for 3D printing have been limited by the particle properties. Lee et al. [ 76 ], mentioned that the challenge for 3D printing technology when producing membranes and membrane module components is the selection of materials for printing [ 76 ]. The limited choice of materials suitable for designing membrane modules is the main challenge when producing 3D printed objects. Yap et al. [ 77 ], suggested that the challenge in printing 3D objects is the limited choice of materials, such as biocompatible or bioresorbable materials. The materials used to print 3D objects are selected based on the printing resolution, 3D printing process, and the material requirements based on similarity and suitability for organs and tissues. The materials must be selected and refined according to the purpose or application in the model [ 77 ].

Yap et al. [ 77 ], found that the challenge in fabricating ophthalmic models includes the texture and colour of products that need to be similar to the printed organ. Meanwhile, according to Chang [ 78 ], a challenge faced when producing 3D printed biomedical products is the similarity in colour to the printed product. Multi-extruder 3D printers are available but provide unrealistic results because the melted plastic cools down as soon as it touches the supporting bed and becomes solidified. These multi-extruder 3D printers cannot mix solidified droplets to obtain a continuous full-colour object as the droplets are too large. Some colour 3D printers also try to mix coloured materials before extruding them, but it is difficult to mix melted thermoplastic since it melts >200 °C and cools rapidly if not insulated.

3.1.2. Printers

Pires et al. [ 79 ], reported that the challenge of 3D printing technology in tissue engineering is with maintaining the accurate dimensions, particularly with the thickness. The accuracy of 3D prints depends on the design of the products as 3D printing technology is not suitable for unsupported long-thin features or flat surfaces. Accuracy will also reduce the size of the part. Scott [ 80 ] also mentioned that dimensional accuracy is an issue with fused deposition modelling (FDM)-based printing. However, by using inkjet or poly-jet models, it is possible to obtain very high levels of accuracy and resolution. The dimensional accuracy of a part is determined by several factors, such as the software, XY resolution, screw movements of the machines on the platform and the firmware controls on the projector.

Powder agglomeration is a challenge faced by most manufacturers when producing samples [ 79 ]. Larger pore agglomeration results in a non-homogeneous microstructure that eventually eliminates the binder, specifically during sintering which leads to poor densification. Powder morphology and sintering temperature also affects the HA densification, behaviour, microstructure, porosity, and stability. According to Shirazi et al. [ 14 ], the increasing speed of the laser scanner causes parts of the sample to be solidified. This effect is due to the expanding interactions between the powder and the laser beam over time, which reduces the delivery rate of energy onto the powder bed. However, a laser scanner with a lower speed results in high amounts of energy being transferred to the material, leading to high levels of sintering and in turn, less porosity.

According to Husain et al. [ 81 ], one of the challenges of current 3D printing technology for producing biomedical products is the difficulty in achieving a nanoscale resolution for clinically relevant biomedical products. Advanced 3D bioprinting techniques were developed to fabricate the next generation of complex biocompatible and biomimetic tissue constructs, such as vascular grafts, dermal dressing, osteochondral tissues, and neural tissues. This statement was also supported by Vasireddi & Basu [ 73 ], who said that the challenge of producing 3D scaffolds is the limited resolution of a 3D printer caused by the size of the nozzle [ 73 ]. This statement was supported by Yan et al. [ 74 ], who claimed that problems, such as limited printing resolution during the process, need to be resolved.

3.2. Management

From the management's perspective, several challenges were identified. Firstly, according to Sandstrom [ 13 ], the challenge related to the adaptation of 3D printed hearing aids in the industry is the re-education of staff to adopt the new technology. The use of software and printers requires the acquisition of new skills by all technicians. Highly skilled technicians are needed in the manual stages involved in producing a 3D hearing aid which include the sculpting, moulding, and curing stages. The technician requires manual and visual skills. Meanwhile, Lind et al. [ 82 ], claimed that current workers require specific skills in organizing 3D printing technology, especially for biomedical products. The company requires highly skilled workers when implementing 3D printing technology for biomedical products.

The next challenge in adopting 3D printing technology is the cost [ 13 ]. The application of 3D printing technology for biomedical products is affected by several cost factors, such as cost of materials, utility, and technological maintenance. In addition, the implementation of 3D printing is associated with various forms of related investment, including hardware, software, and system integration [ 83 ].

According to Mellor et al. [ 12 ], the challenge to develop new businesses in the 3D printing manufacturing industry is related to the size of the company. Proven theories in large enterprises might not be suitable for small businesses. The structure of the organization is a key factor in implementing a 3D printing business. Companies that adopt the technology without redesigning their organizational structure and processes will be the first to encounter difficulties. On the other hand, there are challenges when using 3D printing technology in a different manufacturing industry. It is more feasible to use 3D printing technology in small scale production, especially when there is uncertainty with regard to the demand [ 84 ].

Meanwhile, Gao et al. [ 85 ], found that the challenge of producing a 3D product is the lack of guidelines for a fundamental design. The materials and machines used vary according to the type of biomedical products that need to be produced. Therefore, a designer is required to carry out a trial and error process to obtain the desired products. This claim was also supported by Pavlovich et al. [ 86 ], who stated that the coordinated standards and regulatory pathways for biomedical products are still lacking. The quality control system should be integrated into the manufacturing process to ensure that the 3D printed biomedical products are well defined, characterized, and meet the regulatory standards.

Lastly, according to Sturm et al. [ 87 ], using 3D printing technology presents opportunities for cyber-attacks to impact the physical world. This is because 3D printing technology needs internet connectivity to function and is often connected to internal networks. This allows for useful features, such as remote diagnosis troubleshooting, which also opens up the potential for a cyber-attack that compromises the systems remotely [ 87 ]. Hoffman and Volpe [ 88 ] mentioned that 3D printing technology offers numerous attack surfaces for cyber operations, including the CAD model, the STL file, the tool-path file, and the physical machine itself. As a result, the confidentiality, integrity, availability of data and even fabricated physical components in these systems are at risk. A hacker might target the confidentiality of the digital build files to steal intellectual property and production information or compromise the integrity of the critical data and software to disrupt or sabotage the 3D printing process [ 88 ].

There are various examples of challenges that occur before, during, or after utilizing 3D printing technology for manufacturing biomedical products. Figure 2 shows a summary of the challenges faced when utilizing 3D printing technology to manufacture biomedical products based on the literature.

Figure 2

Summary of the challenges of 3D printing technology for biomedical products.

4. Research methodology

This study used a descriptive method to investigate the challenges of utilizing 3D printing on biomedical products in Malaysia, which involved interviews at Company X, Y, and Z. Three persons representing the top management of Companies X, Y, and Z were interviewed. They included an application engineer, a mechanical engineer, and a technical development manager. The qualitative case study method was chosen in this study, as it enables a strong description to address the research questions [ 89 ].

4.1. Company background

Company X (Respondent 1) was founded in 1990. The company's objective was to develop new uses of 3D printing that have excellent potential. Since its founding, it has gained much experience in solving problems related to software, engineering, and 3D printing services that, together form the backbone of the industry. Furthermore, its open and flexible platforms enable various industries, such as healthcare, automotive, aerospace, art and design, and consumer goods to build innovative applications of 3D printing. This company has become the largest group of software developers in the industry and is one of the largest facilities involved in 3D printing technology in the world. Ultimately, this company is giving its customers a choice of transforming and adopting new digital manufacturing processes and to launch innovations. By utilizing 3D printing, the relevant stakeholders have the potential to change the culture of their industry in the future.

Company Y (Respondent 2) was established in the 2000s with the aim of delivering solutions using the latest high-end technologies. Since then, this company has gained much experience in all aspects of 3D printing technology, especially in 3D bioprinters and has developed customised scientific setups and fabrication machines with programmed system controls. Company Y is also proficient in the field of customized machinery, design museum gallery, rapid prototyping, and professional laser cutting, and highly proficient in 3D living tissue printing.

Since 1980, Company Z (Respondent 3) is the leading and most established CAD, CAM, and CAE solutions provider in Malaysia. This company has grown into a leading product design and manufacturing solutions provider in Malaysia. With numerous clients from corporations, government sectors, and educational partners, this company has established a strong presence locally and expanded its business coverage nationwide. With innovation as its core, this organization effortlessly pursues the best-in-class design solutions and new technologies. In Malaysia, this organization works with Stratasys and is responsible for distributing, selling, and supporting their products in this country. Company Z has branches throughout the country in Penang, Johor, Selangor, and Sarawak. All the branches of the company are capable of distributing CAD/CAM/CAE software solutions using rapid prototyping 3D printers or 3D scanners, and provide consultancy and engineering services, technical support or training, and certification courses to their customers.

5. Results and discussion

5.1. challenges faced during processing, 5.1.1. materials.

Several challenges were identified after the interview sessions, with a primary focus on the selection of suitable binders, which vary according to the types of products.

Respondent R1 stated that:

“One of the most challenging tasks faced by engineers and designers is to select a suitable binder for the 3D printing process because each product or design has its own unique binder .” –R1

Meanwhile, Respondent R2 stated:

“So, (like for) anything, to produce biomedical products, we have to select suitable binders because not all types of binders are biocompatible.” – R2

Overall, based on the data collected, Respondents R1 and R2 noted that the selection of suitable binders varied according to the type of product that they wanted to produce. Different binders can have different effects on the biocompatibility of 3D printed biomedical products.

Binder selection is based on the targeted application and capabilities of the printer and printer head. For biodegradable parts, the binder must also be biodegradable, non-toxic, easy to handle, and readily available. In the context of renewable materials, the binder should also be based on natural or renewable resources. Hence, due to these requirements, common binders for 3D-printing are not acceptable [ 90 ]. The 3D printing technology might use metal, polymer, hydrogels, resin, glass, ceramic, or polymer as materials to build 3D printed products. The binder is placed layer-by-layer onto a powder by the 3D printing machine's head. Therefore, the selection of suitable binders can be considered a challenge in the utilization of 3D printing technology for biomedical products.

The mechanical strength of products is another challenge in 3D printing technology. In terms of mechanical strength, the challenge of producing 3D printed biomedical products is to determine the suitable strength of 3D printed products. Most engineers worry if the biomedical product is not strong enough and has low mechanical strength. The engineer needs to check the 3D printed biomedical product to determine whether it has adequate tensile strength and stiffness to avoid end products that are of low quality and have low mechanical strength.

According to Respondent R1,

“You need to check the implant, either if it is suitable or appropriate with the tensile stress strength, Young's modulus or not. All these must (be) measure(d). This is because, the products sometime do not achieve or meet the required mechanical properties. For example, 3D printed biomedical products become brittle and/or have low Young's modulus. So, we can see that the mechanical strength of a product is considered as one of the challenges to produce 3D printed biomedical products.” –R1

In addition, Respondent R3 stated:

“For specific 3D printed materials, the mechanical performance of the final print is very important. There are challenges to produce 3D printed biomedical products with good mechanical strength and suitable to the human body. The final printed part mainly depends on the inter-diffusion and re-entanglement between the deposition rasters of the fused polymer.” – R3

Hence, the development of prostheses is something that is external to the body and often requires the use of materials that not only look like human skin but also matches the strength of the human body part. The well-perceived requirement for material fabrication is still inadequate for various structures because these aspects include criteria, such as geometric selection, layer thickness, and the minimum ratio between pore sizes [ 73 ]. Zhang et al. [ 91 ], found that mechanical properties are sensitive to printing parameters, such as laser scanning speed, powder layer thickness and laser power. Mechanical properties are very important for load-bearing bone tissue reconstruction. Implants with too much stiffness would bear the most stress under pressure, but bone tissue cannot be stimulated by stress. The ideal bone tissue engineering scaffold has macro-pores of ~300–900 μm and a porosity of 60–95%. 3D printing technology, such as SLM, can produce precise porous titanium implants with a pore size of 400–1000 μm, which exhibit excellent osteointegration performance in vivo [ 91 ]. Furthermore, according to Ji et al. , (2018), a scaffold pore diameter ranging between 200 and 400 μm is considered adequate [ 92 ]. Meanwhile, Qing et al. [ 93 ], pointed out that emphasis should be on capsule and tendon reconstruction. The joint capsule and load points of muscle and tendons are unstable and break down due to massive bone defects. Therefore, before processing the implants, the prosthesis is wrapped in polypropylene monofilament knitted mesh (PMKM) [ 93 ]. Therefore, the mechanical strength of products is another challenge affecting the utilisation of 3D printing technology.

The size distribution and shape of the powder are challenges in the production of 3D printed biomedical products. Good powder density, including flowability, directly affects the potential to produce good layers during the printing process. Respondent R1 stated that the physical and chemical properties of the powder not only impact the 3D printing process but also affect the properties and quality of 3D printed biomedical products. For example, to produce the trachea, the particle size of the powder must exhibit good biocompatibility and biodegradability, and the trachea must integrate with human tissue to promote tissue regeneration after implantation. Respondent R3 also supported this statement.

Respondent R3 stated that:

“The size distribution and shape of the powder can affect the optical and thermal properties of particles. The layer properties of the powder largely depend on the powder flowability and density. Lack of pore interconnectivity network caused by the lower bounds of porosity affects the mechanical properties of 3D printed biomedical products” –R3

From the transcribed data, Respondents R1 and R3 stated that the size distribution and shape of the powder is the main challenge when utilizing 3D printing technology for biomedical products. This is because the size distribution and shape of the powder can directly affect the production of good 3D printed products.

According to Mostafaie et al. [ 94 ], small powder particles produce a large quantity of small pores distributed throughout the entire part, while large powder particles produce a small number of large pores heterogeneously distributed in the product [ 94 ]. Generally, spherical particles within a narrow size range are preferred as they flow more easily and can be deposited more homogeneously. On the other hand, if the size range is too narrow, the powder packing density decreases, which then generates voids and inhomogeneities in the final component. Oversized particles might cause defects in the powder's thin layer and in as the structure of the finished component [ 95 ]. Therefore, the selection of the type of powder of an appropriate size and shape is very important for all the companies.

Hence, the limited choice of materials that possess excellent properties for the human body or organ is a challenge faced when producing 3D printed biomedical products. The materials used to produce 3D printed biomedical products must be similar and suitable to human organs and tissues. Respondent R1 stated that materials must be selected properly and scrutinised according to the purpose and application. This is because, sometimes, the customer would request a flexible material that is difficult to break, so the respondent must make it clear how to produce a flexible product that is difficult to fracture. Respondent R2 also supported a similar statement by Respondent R1.

Respondent R1 mentioned that:

“ So, actually we have to examine numerous properties about the material. First, it must be biocompatible to make sure this material can be used in the patient's body .”

Respondent R1 also stated that:

“Sometimes the challenge is to choose (the) right material properties. Because sometimes the customer says he wants (a) flexible material (that) does not break. However, this is difficult for us to (achieve). We have to make it clear, how to make it flexible, but not broken or torn. So, (to obtain the) ideal material properties according to customer requirements in materials selection is the challenge for us.”

Based on the transcribed data, all the respondents stated that the limited choice of materials is the main challenge when utilizing 3D printing technology for biomedical products. This is because the materials must be biocompatible, of good quality, and safe for use in the patient's body.

Therefore, each material has its own properties, which may have varying suitabilities for producing biomedical products using 3D printing technology. There are certain materials that have good printing properties but weak cell-culture properties. It is very challenging to ensure that the material can dissolve in the patient's body and allow it to function naturally. According to Jammalamadaka & Tappa [ 29 ], biomaterials are classified based on numerous criteria, such as chemical and physical composition, biodegradability, type of origin, and generation of modifications. The choice of biomaterial is determined depending on the target tissue. Furthermore, Gopinathan & Noh [ 96 ] pointed out that the biomaterial properties include the printability, biocompatibility, cytocompatibility, and bioactivity of the cells after printing. Therefore, the selection of appropriate materials is very important for all companies. According to the requirements of the desired tissue and organ, the biomaterials should be selected and can be modified to regenerate the appropriate tissue structure or organ.

Furthermore, in 3D printing, products, texture, and colour play a huge role in making the products stand out. According to Respondent R3, customers request products that are identical to the true organ so that they want to feel like they are really doing an emergency surgery. The old machines allow printing with different materials but with limited colour choice. Therefore, they invented new 3D printing machines so that coloured products can be printed.

Respondent R3 stated:

“When the customers perform the operation or surgical training, (the) colour of the 3D organs is white. (However), (a) 3D organ or 3D part must have colour. So, they request (that we) make (the) products similar to a true organ.” – R3

Hence, Respondent R3 stated that the texture and colour are some of the challenges when producing 3D printed biomedical products.

A newly discovered challenge when utilizing 3D printing technology in this study was the lifespan of materials. Respondent R3 mentioned that each material used has a limited life span and that this is an important factor to be considered. Theoretically, if a material is used after the specified expiry date, its properties might be affected, and this could lead to products that are harmful to the patient. From a clinical point of view, this could lead to failures such as excessive wear, fracture, or discoloration.

“All the material(s) have (expiry) date(s). The lifetime for the resin is very short. Therefore, the expired material is very (challenging) for us. When we purchase a syringe of composite, three important aspects are the storage condition, batch number and the expiration date. Most of the direct materials have a limited shelf life.” – Respondent 3

According to Respondent R3, all the materials have an expiry date; for example, the resin's lifetime is very short. Therefore, the selection of appropriate materials with a long-life span is important. Expired materials cannot enter the human body as it would then adversely affect the patient. This is due to the reduction in the product quality, which makes the product become brittle and causing cracking and discolouration. Hence, the research and development of novel resins with a longer lifespan must be intensively conducted to overcome this problem.

5.1.2. Printers

Low dimensional accuracy is a challenge in the utilization of 3D printing technology to produce 3D printed biomedical products. The design plays an important role in producing highly accurate 3D printed products. Respondent R1 said that the accuracy of 3D printed biomedical products depends on the design. For example, variations in curing and cooling can lead to shrinkage or warping. Respondent R2 also supported the statement of Respondent R1 and mentioned that:

“Long (and) thin unsupported features or a flat surface will cause low dimensional accuracy of a 3D printed product.” –R2

Respondent R2 added that:

“Accuracy also depends on materials. For instance, standard SLA resin will produce more dimensionally accurate parts than flexible resin. Standard materials are recommended for parts where high accuracy is critical” – R2

From the transcribed data, R1 and R2 informed that the design and materials play important roles to produce biomedical products. According to R1 and R2, the design and materials play important roles in producing highly accurate 3D printed biomedical products.

Therefore, it can be concluded that developing the exact shape, size, and minute geometrical textures on artificial biomedical implants are essentially important for its proper functionality [ 97 ]. However, it is difficult to produce 3D printed biomedical products with the exact size and structure when using randomly selected machines and materials. Thus, if the dimensional accuracy is low, then the product will not fit in the body, and, at the same time will affect the clinical success rate of the product. Machines and materials should be carefully chosen to achieve the appropriate level of accuracy. According to Bertol et al. [ 98 ], the dimensional accuracy of the printed implants measured by 3D laser scanning showed an average of 200 μm, which allows its application in craniofacial structures [ 98 ]. Meanwhile, according to Osman et al. [ 99 ], digital light processing (DLP) has proved to be efficient for printing customized zirconia dental implants with sufficient dimensional accuracy. Hence, to produce 3D printed biomedical products, low dimensional accuracy is the main challenge. Therefore, the engineer and doctor should prudently choose the right machines and materials to produce 3D printed biomedical products.

In 3D printing technology, powder agglomeration is another challenge when producing 3D printed biomedical products. The binders are difficult to eliminate during sintering and this leads to poor densification when non-homogeneous microstructures result from agglomeration with larger pores.

According to Respondent R2:

“It is difficult to produce (a) printed product (without) relating to the agglomeration of powder. Compared to other 3D printed products, 3D printed biomedical products have more problems related to the agglomeration of powder. The large pores caused by agglomeration can affect the 3D printed biomedical product and sintering temperature can affect the densification, behaviour, microstructure, and porosity of 3D printed biomedical products.” –R2

In a nutshell, the limitation of powder agglomeration is one of the challenges in the utilization of 3D printing technology to produce biomedical products. Agglomeration can affect the process of producing 3D printed parts, such as causing low densification, which is very difficult to eliminate during sintering.

Therefore, the powder for 3D printing needs to fulfil certain requirements for the successful printing of 3D printed products. The required accuracy, such as in the layer thickness for z direction as well as print resolution for x and y directions defines the upper boundary for the particle sizes. Handling and processing properties, such as a tendency to agglomerate, electrostatic charging, and flowability that diminishes below a certain particle size should also be considered. Thus, if powder agglomeration occurs, the product will crack and produce large pores. Hence, the particle distribution needs to be carefully set to avoid powder agglomeration [ 90 ].

The printer nozzle size is another challenge in the utilization of 3D printing technology for biomedical products. The diameter of the nozzle directly affects the 3D printer extrusion width of each line in the product.

According to Respondent R1:

“Now, in theory, smaller sizes of the nozzle(s) do allow (us) to achieve successful precision.” –R1
“If you use (a) 3D printer for doing large quantities of 3D printed biomedical products, you will want to make sure your extruder is laying down the right amount. Depending on the 3D printer, several nozzles can be interchanged reasonably easy.” – R3

From the interviews, Respondent R3 supported the answers of R1 whereby the size of the nozzle can be considered a challenge in the utilization of 3D printing technology for biomedical products. The size of the nozzle is very important to ensure that the production of 3D printed biomedical products occurs smoothly. Smaller nozzle sizes can allow for the construction of biocompatible and biomimetic complex tissues.

According to Do et al. [ 100 ], the shear stress from the multi-sized nozzles could negatively impact cell viability during the printing process. Meanwhile, Patra et al. [ 101 ], stated that nozzle size will affect the viability of the materials printed. The nozzle size also affects the stacking of different printing paths. For example, the round nozzle could produce a product with a cross-section of an elliptical shape, and, hence result in high void density in the printed part. The nozzle size also affects the surface finish of the part because of the staircase effect, especially in large-scale 3D printing [ 102 ]. Conversely, Blaeser et al. [ 103 ], pointed out that the level of shear stress is directly influenced by different printing parameters, such as nozzle diameter. These phenomena are even more crucial in bioprinting, where hydrogels of high viscosity and small nozzles are applied to improve the final printing resolution. In conclusion, when selecting the 3D printing nozzle size, the major factor is all about balancing how much filament is extruded and the speed of the process. A smaller nozzle size allows the manufacturer to achieve better precision in printing.

A new challenge has been identified, which is to customize the fit and design of a 3D vascularized organ. For example, skulls have irregular shapes, and so it is difficult to make cranial implants. Implants and prostheses can be made in any imaginable geometry through the translation of X-ray, MRI, or CT scans into digital STL files. According to Respondent 1, the engineer must ensure that the fit and design of the object is customized to a desired shape, size and fit. A design is provided according to the size and specifications of a certain patient and it cannot be used for other patients because each human has unique body parts.

“Because this is a patient's specific implant that I designed for you, so I cannot use this product for your friends. This is because the design just (fits) your body. So, if I design one for you, I cannot use that design for your friends.” – R1

In order to bio-print thick tissues, highly repeatable and straightforward technologies and protocols should be developed in a logical manner, beginning from simple to difficult steps. For example, the eardrum is a very small part. Hence, it is very challenging for engineers to produce an eardrum of a certain size or specification according to a patient. Respondent R2 said:

“Okay, I give the example, eardrum. So, get the test, limitation printed. This printer can go up to 5 microns.” – R2

Respondents R1 and R2 stated that a product is designed according to the size and specification of certain patients and cannot be used for other patients. Therefore, customizing the fit and design is one of the challenges in producing 3D printed products. In conclusion, multi-physics, as well as analytical and computational modelling techniques should be used to determine the best microarchitecture for specific applications. All the relevant mechanical, biological, and physical properties of the biomaterial should be considered when producing a 3D printed object.

Furthermore, a new challenge in 3D printing technology in this study is the layer height. All 3D printing methods are based on a layer-by-layer building of a part. Printing is fast and produces the best prints with the right layer height. Choosing the appropriate layer height with the most accurate material setting is another challenge in utilizing 3D printing technology for biomedical products.

A high layer height usually results in a printed part with hard surfaces. The downside to this is an increase in the time to complete a print. Examples of processes, such as that used by FDM and SLA machines, prove that layer height is an important design parameter that impacts the printing time, cost, visual appearance and physical properties of a printed part. Respondent R2 mentioned that:

“Printing parameters like layer height play a crucial role in fabricating biocompatible scaffolds with required mechanical strength and pore size. Layer height is ordinary. The faster it prints, the less the quality of the product. If we want to produce a delicate model and want to be 30 millimetres (mm), then we have to set it up for slow production. Because, a higher layer means lower quality.” – R2

Respondent R2 believes that another challenge of utilizing 3D printing technology for biomedical products is the need to choose the right layer height with accurate material settings. This is because the faster the printer prints, the lower the quality of the biomedical product. To produce a delicate model, the set up must be for a slow production. A higher number of layers means that a lower quality product is produced.

In order to cope with this challenge, the engineer must optimise the best layer height by conducting numerous experiments to check and seek a solution. 3D printing builds a printed part by printing one layer at a time. Each subsequent layer is printed on the previous layer, and, finally, builds the desired 3D shape. Then, in order to make a solid and reliable final print, the engineer ensures that each layer is fully bonded to the layer below it. Furthermore, the engineer needs to make sure that the layer height matches the nozzle diameter.

Lastly, “build failure” is another new emerging challenge in 3D printing technology. The common cause of this is due to 3D materials that are not lying horizontal on the build plate when preparing the software, including rafts that cause the print to separate from the base, not adding supports when a model has any part overhanging in empty space, and creating models that are too thin. The “build failure” can also occur when the filament is jammed, or when there is loss of power or from extrusion errors.

“To produce 3D printed biomedical products using the printer, the first step is to export the file from the computer to the printer. Next, the printer will process the information contained in the file and then will print the . This situation is called “build failed”. –R1

Respondent R3 also said:

“Sometimes, we do the production of (a) 3D printed biomedical products. The challenge we face is (when) the build failed. This happens when the machine (loses) power suddenly. So, it will look like “spaghetti”. –R3

Based on the interview sessions, Respondent R3 supported the answer of R1, who said that “build failed” can be considered a challenge in the utilization of 3D printing technology for biomedical products. When this happens, the printing process should be restarted beginning with the first step. The best way to prevent over extrusion is to ensure that the layer height is less than the nozzle diameter and the speed of the cooling fan is increased. Additionally, to avoid this issue, the engineers should check the nozzle for clogs and increase the hot-end temperature [ 104 ].

5.2. Challenges in management

Possessing a high level of knowledge and skill in using software is very important for producing 3D printed objects. Company X provides training programmes for new employees in order to produce high quality products with high dimensional accuracy and features. Various programmes are conducted, such as mentor-mentee, employee exchange programmes to Belgium, and others to obtain new experience. As for the business or sales sector, employees will have access to taks or training for their workers.

“ We have training in Belgium for new workers, so new employees can get the new information about 3D printing technology. Even here, we have dedicated trainers. The trainers are (workers) who (have) been working a long time. So, those trainers will be mentors for (newbies). Therefore, usually we will set the programme or training for them and do it internally. If it is about business or sales, we will have access to another company to come here to do some training or talk. Usually because of many years of experiences (in) 3D printing, we have internal trainers that can give training or (talks). ”

Respondent R3 also supported Respondent R1, by stating that the re-education of staff can be considered as a challenge in the utilization of 3D printing technology. According to Respondent R3, their company is not just making normal 3D printers that are commonly available. It aims to make 3D printers to produce biomedical products with high precision. Therefore, employees working in this company must possess the expertise. The company provides training to its employees because it has several working procedures that need to be followed and it requires employees with expertise for these roles. All employees need to gain expertise in diverse physicochemical and biopharmaceutical characteristics of active pharmaceutical ingredients (APIs) through each stage of product development. Respondent R3 mentioned that:

“ We are not just making a normal 3D printer that is available on the Internet. We are aiming to make 3D printers that can print with high precision. The (workers) required to work in the company (have) to be (experts). So, the company (provides) some extra training for the (workers) so that they become (experts). ”

Respondents R1 and R3 implied that the re-education of staff can be considered a challenge when utilizing 3D printing technology. The employers of Respondents R1 and R3 are serious about upgrading their employee education and skill levels. In order to produce biomedical products, employees need special skills, like additional information pertaining to the biocompatibility of materials, the process of producing 3D printed biomedical products and how to design these biomedical products. This is because these companies must closely follow certain product or industry specifications.

The demands and expectations of 3D printing technology are high. Therefore, engineering and technical skills are required for the successful deployment of a wide range of 3D printing technology, from product design, material, technology, and, lastly, data management. At the same time, successful engineers must be creative, resourceful, and ready to “figure things out” in an industry that continues to develop and evolve. Therefore, the re-education of staff can be considered a challenge in the utilization of 3D printing technology for biomedical products.

Apart from that, the materials for 3D printing are very costly. The cost of buying a 3D printing machine is one of the most significant cost elements involved in utilizing 3D printing technology in the manufacturing industry. The price of a 3D printer is very expensive, ranging from 116,000 USD to 232,000 USD. The price of the machine depends on the ability of the machine to produce a product with certain specifications. A lower price means lower print quality, materials, build size, and functionality.

“ Second, the price of this machine is very expensive. To start the project, (USD)116 thousand to 1 million is required. But now, the bio-printer that we bring is affordable, below (USD)232 thousand. So, we have a goal (that) in Malaysia all universities (should) have a bio-printer.” – R2

In conclusion, Respondents R2 and R3 agreed that the cost of machines is a challenge when utilizing 3D printing technology for biomedical products. The best 3D machines for the manufacturing industry are those that are reliable, easy to use and maintain, and that are capable of producing accurate and detailed prints. In addition, the 3D printing machine needs to be large enough for complex items and versatile enough to handle different materials. Conversely, the price of materials needed for producing 3D printed biomedical products is expensive because each biomaterial has specificic requirements in terms of material, mechanical and chemical properties, as well as cell-material interactions, processing methods, and the need for FDA approval [ 5 ]. Therefore, the cost of machines and materials used is a challenge when utilizing 3D printing technology for biomedical products.

Besides that, the size of the company does not affect the adoption of 3D printing technology for biomedical products. The assumption is that an increase in productivity is not due to the size of the organisation. According to Respondent 2:

“(The) size of (the) company (does) not affect the (utilization) of 3D printing technology. This is because the company only needs some experts to produce biomedical products.” –R2

In conclusion, the size of the company does not affect the adoption of 3D printing technology for biomedical products.

Next, the procedures and standards required for using 3D printing technology is also a challenge for the management of 3D printing technology companies. The procedures and standards required for using 3D printing technology is currently complicated. Each company also has its own standards when supplying medical products. For example, the medical products supplied to customers must be safe for human consumption. For industrial products, companies need to ensure that their product functions as per the requirements. Different products have different standards and uses different materials and processing methods. According to Respondent R2, the company also needs to apply for permission from the International Organization for Standardization (ISO) to invent and use 3D printing technology for producing biomedical products. According to Respondent R1:

“When providing services to customers, certain standards must be followed. We have standards when supplying medical products to customers. For example, the medical product supplied to customers must be safe for the patient. For industrial products, we need to ensure (that the) product functions well. Different products have different standards as well as the material and processing method used (employed).” – R1

Respondent R2 mentioned that:

“Many procedures need to (be undertaken) such as (the) need to apply (for) permission from ISO. After (obtaining) the permission from the ISO, we (will then) continue to produce the products.” –R2

Based on the collected data, two out of three respondents agreed that the procedures and standards are among the challenges in the utilization of 3D printing technology for manufacturing biomedical products.

Furthermore, cybersecurity is also a challenge in the management of 3D printing technology for biomedical products. According to Respondent R1, malicious cyber-attacks can affect the physical performance of 3D printing machines, the equipment, STL file and the component in the manufacturing system, which can cause a change in the shape, structural stiffness, natural frequency, and weight of the biomedical products. Respondent 3 also supported this statement when they said:

“When we run the production using 3D printing technology, a malicious input could come from an integrated connection layer in the form of a malicious real-time controlling command that can change the production design.” – R3

Hence, cybersecurity issue is another challenge to 3D printing technology used for manufacturing biomedical products. The sabotage can be executed remotely via internet access, which is ubiquitous in the 3D printing technology environment. The entire 3D printing technology data chain from design to manufacturing needs to be secured to maintain the integrity of both the digital data and the physical printed product when using 3D printing technology.

Marketing is also a new emerging challenge in the production of 3D printing technology. Data analysis shows that only two respondents implied that marketing is considered a challenge when utilizing 3D printing technology for producing biomedical products. They believe that, in Malaysia, the marketing of 3D printing technology for biomedical products is still in the infancy stage compared to Europe, the USA, or Singapore. In Europe and the USA, 3D printing is really in the mainstream and most of the medical divisions know about 3D printing. However, in Malaysia, there are not more than ten companies that apply 3D printing technology in their manufacturing businesses. Not surprisingly, not many Malaysians know of the existence of 3D printing technology in the production of biomedical products. This can be seen in the following statements:

“Marketing is also another challenge, especially in the Asian market. This is because in Europe and the USA, 3D printing is really in mainstream use and most of the medical divisions know about 3D printing. " – R1

Respondent R2 said that:

“When we joined some events and conferences, some people were clueless about 3D printing because they (have) never heard of the technology. And it is possible that most people still (do) not know about the existence of 3D printing technology for manufacturing biomedical products in Malaysia.” –R2

Simply put, Respondents R1 and R2 believed that the marketing of 3D printing technology for manufacturing biomedical products in Malaysia is still at the infancy stage compared to Europe, the USA, or even Singapore. This is because people in Malaysia are unfamiliar with the use of 3D printing technology for manufacturing biomedical products. Thus, marketing is one of the challenges when producing 3D printed biomedical products and selling them. Therefore, every company needs to draw up effective marketing strategies (promotions and advertisements), so that netizens are aware of the existence of 3D printing technology in Malaysia. There are no shortcuts in achieving the goal of the 3D printing industry through a proper marketing strategy. The management needs to be ready to invest a lot of time, patience, effort and finances towards this goal. When they pay attention to key elements of a good marketing strategy, it will be easier to develop an effective and logical plan that will lead to the successful adoption of 3D printing technology in the manufacturing industry.

Lastly, based on the transcribed data, another new challenge in utilizing 3D printing technology for manufacturing biomedical products is the patent and copyright issues. Patents protect 3D printed biomedical inventions such as new designs, processes, machines, or chemicals [ 105 ]. The central idea is that patents protect ideas, not just expressions of them. The main effect of patents is to give their holders the right to challenge any use of the invention by a third party. Meanwhile, a copyright is to protect the expression of ideas. Artistic works are generally considered as expressions of ideas; for example, books, songs, and computer programs [ 105 ]. The patent and copyright issue is one of the challenges that exists in all companies. Thus, if people were aware of the process to make the software or invention and copied it, it would be difficult to prove the original owner of the software or invention and that other people had copied it. A 3D printed biomedical product is designed using computer-aided drafting (CAD) software, which produces files that contain proprietary information. The theft or loss of these files could be disastrous to companies, potentially leading to digital sabotage or design theft.

“Yes! We faced (it). But, it (is) (mostly) (due) to the software when to make 3D printed biomedical products likes a leg. For example, a skilled hacker penetrated one of the remote sites' firewall and stole the technical design files. “Look-alike” products were then released to the market at a cheaper price. When this situation occurs, first, you need (to) make a report to (the) IPA (Intellectual Property Academy) and (say), “Ok, this is my invention. This is my product and I should have ownership, all right?” So, (it is the same) for software. Usually, if I make (a) software and then you also see the process that I used to make (the) software and you copy it, it is really hard to prove that (it) is my creation and (another person copied) my invention. (It is so), especially for software, because in (the) whole process of 3D printing, the software is very important for us. This is because we will start using CT or MRI, then convert the data into a 3D model and use the software for creating new things. So, software is our focus for IPA. So, your question on how important the software is, well the answer is Yes. It is very important to us.” –R1

Meanwhile, Respondent R2 mentioned that Malaysia is approximately three to five years behind in utilizing 3D printing technology, with many inventions having been already patented abroad. However, there are still innumerable opportunities for the company to patent its biomaterial products. For example in the case of a common biopolymer such as alginate, they cannot register any patents because other companies are very advanced and have already patented numerous products in this field.

Respondent R2 mentioned:

“ In terms of (patents), there are many (patents). Indeed, we (looked) at 2016–2017 abroad, many (inventions) (had) been (patented). In Malaysia, we are late, three years to five years only in 3D printing technology. There are still many more opportunities for us to patent our own biomaterials products. Like (these) (bio-cells) (while showing in glass bottles), they are proprietary or self-brewing, the alginate. We cannot make the patents because we are late. ”

Respondent R3 agreed with Respondents R1 and R2. In his company, the formulation of materials or the invention of new products is very important. Therefore, all formulations or inventions are protected by copyrights and patents. Conclusively, based on the collected data, all respondents alleged that patents and copyright issues are among the challenges of utilizing 3D printing technology for biomedical products. It is suggested that the government provide incentives or establish a subsidiary to reduce the burden of companies having to deal with patents and copyright issues.

This study found several new elements in the challenge of utilizing 3D printing technology for manufacturing biomedical products. Figure 3 provides an overview of the challenges faced when utilizing 3D printing technology for biomedical products.

Figure 3

Overview of the challenges of 3D printing technology for biomedical products in Malaysia.

6. Conclusions

In summary, the results show that in respect of processing and materials, there are eight challenges when utilizing 3D printing technology for manufacturing biomedical products, which are as follows:

  • - selection of a suitable binder : various binders have varying effects on the product's biocompatibility, where the compatible one are the organic-based.
  • - poor mechanical properties : the product should have adequate tensile and compress strength also flexible rigidity after printing process.
  • - low dimensional accuracy : product fitting requires a precise design, the challenge is to overcome the shrinkage of the product during the curing and cooling process.
  • - powder agglomeration limitations : the particulate powder must be distributed evenly before sintering to prevent agglomeration and low densification product.
  • - nozzle size : appropriate nozzle size will determine the printed structure and design accuracy.
  • - distribution of size : over or under-fit particles may cause defects on the finished products.
  • - limited choice of materials : sources of raw materials for the construction of a similar and suitable product to human organs and tissues are still limited; and,
  • - texture and colour similarity/dissimilarity with organs : customer demands are always beyond current capabilities, so they need to be aware of limitations.

These challenges were faced by the core players of the existing industry in 3D printing technology for biomedical products in Malaysia, which then arises another four significant processing and materials challenges as follows;

  • - low lifespan of the materials : Inventory such as tracking records and storage of materials and product is crucial because most biomaterials have low lifespan, and expired compound reduces the quality of the product which makes the product brittle and causes cracking and discoloration.
  • - customization of fit and design : the concept of a product's recyclable design is difficult as the product is designed to the size and function of certain patients and can not be used in other patients.
  • - layer height: optimizing the best layer height is still dependent on multiple trials to check and find a solution that has been found as time consuming and costly.
  • - build failed : loss of connectivity or buggy control performance on software-hardware to perform tasks, resulting in failure of network and access to the set framework.

Apart from this, in the management aspect, there are four challenges when utilizing 3D printing technology for manufacturing biomedical products, which are re-education of staff, high-priced products, and lack of guidelines, and cyber-security issues. The size of the business is removed from the list of challenges because it was discovered that the size of a company or organization does not affect printing productivity. Nonetheless, marketing, patents, and copyright were found to be new challenges.

Overall, this study is important for the biomedical manufacturing sector as it offers information about the use of 3D printing technology for manufacturing biomedical products in developing countries such as Malaysia. This study could be a guideline for new manufacturers, human resources and the management sector. For new companies intending to adopt this technology, the qualitative sharing experience from this study will provide an early insight into what the company will encounter. It is anticipated that the findings of this study will assist Malaysians to obtain concise information about the utilization of 3D printing technology in the manufacturing industry.

Tackling the newbie's readiness to develop and implement this technology is critical, as is the confidence of the customers to purchase the products. This paper highlighted the fact that, to manufacture medical product, 3D printing technology is safe and effective. Hence, this paper hopes that the challenges discussed will encourage and empower newbies, policy makers, and government sectors to carefully adopt this technology and respond to consumer trust and demand appropriately.

Declarations

Author contribution statement.

N. Shahrubudin: Conceived and designed the experiments; Performed the experiments; Analyzed and interpreted the data; Wrote the paper.

P. Koshy, J. Alipal, M. H. A Kadir: Analyzed and interpreted the data; Wrote the paper T. C. Lee: Conceived and designed the experiments; Analyzed and interpreted the data; Contributed reagents, materials, analysis tools or data; Wrote the paper.

Funding statement

This work was supported by the Ministry of Higher Education and Universiti Tun Hussein Onn Malaysia for the financial support provided for this research through Research Grant Scheme, FRGS Vot K097 and Research Fund E15501, RMC UTHM.

Competing interest statement

The authors declare no conflict of interest.

Additional information

No additional information is available for this paper.

IMAGES

  1. Guide to 3D Printing Medical Devices

    case study 3d printing medical

  2. Bioprinting: A Guide to 3D Printed Body Parts

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  3. 3D Printing of Medical Devices at the Point of Care

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  4. The 'tremendous potential' held by 3D printing in personalised surgery

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  5. 3D Printing in medical field

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  6. Growth of 3D Printing in the Medical Field Projected to Improve Patient

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