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Biotechnology/Medical Devices: Research

Biotechnology Research | Medical Device Research | Desired Skills

Many non-academic (“industry”) research career options exist within the fields of drug development and medical-device development. Careers within the biotechnology and medical device fields are expected to grow faster than average. The challenge to these industries lies in strict regulatory requirements and the funding to bring new products to market.

Biotechnology Research

Discovery research, perhaps the most direct route from academic training into industrial research/biotechnology, offers career tracks throughout research and management. Unlike government research, which serves to drive policy, industry research is motivated by enterprise to develop useful products for the marketplace or to create entirely new markets based on an innovative technology.

Building on basic science, biotechnology companies use applied research to develop and commercialize cutting-edge products and technologies. Within therapeutic biotechnology, product development moves from discovery research to preclinical studies, into clinical development and regulatory affairs, and finally on to commercial operations (marketing, sales, and technical support). The process from conception to production can be a lengthy one, and legal and regulatory pressures, along with the public’s perception of emerging technologies, can influence the development and marketability of products and services.

Product development of instruments, reagents, diagnostics and platform technologies in nontherapeutic biotechnology is often a faster and less expensive process, as clinical trials are not required. The motivation behind product innovation is driven by market research, the expansion of an existing product line, or extant technical gaps. Components of the nontherapeutic development process include research/product development; manufacturing; and marketing, sales, and technical support. Industry research is largely collaborative, and project leaders often manage the process to completion.

Medical Device Research

The closely related and broad field of medical devices includes the development of healthcare products and procedures that diagnose, treat, cure, or prevent disease by means other than or in addition to pharmaceuticals or biologics. This field is an exciting place for researchers and biomedical engineers interested in bridging knowledge from many technical sources, as they conduct research or develop new medical products and procedures.

Product development within the medical device field begins with engineering and product design, undergoes clinical development/trials and regulatory affairs, and moves to sales and marketing.

In addition to scientific skills and training, it may be helpful to have an understanding of regulatory issues, safety standards, and project management. Medical device researchers may work in a single setting or in multiple diverse settings, including hospitals, laboratories, manufacturing, and business.

Desired Skills for Biotechnology and Medical Device Research

• Content:  Familiarity with the diseases targeted and techniques used within the biotech/medical device organization. While general scientific skill sets are important, you may need to “market” these toward each organization’s needs.
• Analytical:  The ability to analyze the needs of patients and customers, and to design appropriate experiments and solutions.
• Communication:  Listening to and seeking out others’ ideas, and incorporating them into the problem-solving process. Expressing oneself clearly.
• Team Player:  Contributing individual skill sets to come up with a proposed solution or plan of action.

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Alumni in Biotechnology/ Medical Devices: Research

Suraj pradhan, neuroscience phd, mace cheng, genetics phd, julie granka, biology phd.

SYSTEMATIC REVIEW article

Medical device development process, and associated risks and legislative aspects-systematic review.

• 1 Faculty of Informatics and Management, University of Hradec Kralove, Hradec Kralove, Czechia
• 2 Biomedical Research Centrum, University Hospital Hradec Kralove, Hradec Kralove, Czechia
• 3 Faculty of Computing, Universiti Teknologi Malaysia & Media and Game Innovation Centre of Excellence (MaGICX), Universiti Teknologi Malaysia, Kuala Lumpur, Malaysia

Objective: Medical device development, from the product's conception to release to market, is very complex and relies significantly on the application of exact processes. This paper aims to provide an analysis and summary of current research in the field of medical device development methodologies, discuss its phases, and evaluate the associated legislative and risk aspects.

Methods: The literature search was conducted to detect peer-reviewed studies in Scopus, Web of Science, and Science Direct, on content published between 2007 and November 2019. Based on exclusion and inclusion criteria, 13 papers were included in the first session and 11 were included in the second session. Thus, a total of 24 papers were analyzed. Most of the publications originated in the United States (7 out of 24).

Results: The medical device development process comprises one to seven stages. Six studies also contain a model of the medical device development process for all stages or for just some of the stages. These studies specifically describe the concept stage during which all uncertainties, such as the clinical need definition, customer requirements/needs, finances, reimbursement strategy, team selection, and legal aspects, must be considered.

Conclusion: The crucial factor in healthcare safety is the stability of factors over a long production time. Good manufacturing practices cannot be tested on individual batches of products; they must be inherently built into the manufacturing process. The key issues that must be addressed in the future are the consistency in the classification of devices throughout the EU and globally, and the transparency of approval processes.

Introduction

Each year, a considerable amount of medical technologies are developed ( 1 ), and billions of crowns are invested in their development to meet the increasing demand for medical technology innovation (MDI). Research shows that extensive implementation of healthcare services worldwide is heavily dependent on medical technologies. According to the healthcare use statistics provided by Organization for Economic Co-operation and Development (OECD) ( 2 ), numbers of medical technologies are constantly rising. As a result, more healthcare technology needs to be developed ( 3 ). Innovative processes in the pharmaceutical industry appear every 10–20 years, while medical technology becomes outdated within months. Thus, new medical device development processes, which meet the needs of contemporary drug treatments, are currently being investigated and developed.

Nevertheless, there are only a few technologies and resources that penetrate the market. Medical device development (MDD) is expensive and risky. High risk of technology failure in the market leads to the question: Would it be appropriate to create a process or guide to assess healthcare technology at the beginning of the development process so that the development process and future impacts can be addressed on time? ( 4 ).

Currently, around 88% of corporations that develop medical device technologies are not able to provide considerable returns for their investors ( 5 ). Companies mainly concentrate on regulatory approval targets, without careful scheduling that considers establishing a less costly and more sustainable process ( 6 ). Therefore, well-prepared and well-thought launch strategies that capture inefficiencies in a timely manner and lower total costs are crucial in ensuring a successful product development process and satisfying stakeholder requirements.

Product development, from conception to release to market, is a very complex process ( 7 , 8 ). It significantly relies on the application of exact processes that enable developers to optimally stage development, testing, validation, verification, and market release ( 9 ).

Current MDD processes have to respond to several process challenges ( 10 , 11 ); projects seldom advance as scheduled, and often modifications are introduced during the course of project development and implementation ( 12 ). These processes do not respect the current legislative changes that are taking place at the European Union (EU) level. Risk analysis is mostly separately addressed, with respect to specific phases of MDD.

The MDD process has been satisfactorily described in literature; however, there is a lack of comprehensive models that would support design teams with different experiences and backgrounds. In general, published studies in this area either address the MDD with a specific focus on regulations ( 9 , 13 , 14 ) or provide proposals for various approaches to MDD ( 9 , 15 , 16 ).

This paper provides an analysis and summary of current research in the field of MDD methodologies, discusses the phases of MDD, and evaluates associated legislative and risk aspects.

Research Strategy

The systematic review is based on PRISMA guidelines ( 17 , 18 ). The databases searched (by authors P.M. and W.N.) included Scopus (2007–2019) and Web of Science (2007–2019). In addition, legislative documents on the Research Topic, as well as the websites of medical companies dealing with the phases of MDD were explored. Keywords included the following collocations: “ medical device AND process AND development ” in Web of Knowledge and Scopus. Few more studies were found searching with the more specific keyword groups “ medical device AND process AND development AND investment evaluation ” and “ medical device AND stage development .” A Boolean operator procedure was used in the search. The database was searched from 1 October 2019 until 20 November 2019.

Research Questions

To achieve the objective of this review, the main research questions (RQ) were derived as follows:

RQ1 What are the phases of the MDD process?

RQ2 What are the regulation needs related to MDD?

RQ3 What are the risk factors in MDD?

RQ4 With which phases of the MDD process are regulation needs and risk factors associated?

Article Selection and Data Collection

The article selection process was divided into two sessions, and combined with an analysis, as shown in Figure 1 . In the first session, we searched for publications between 2007 and 2017, and in the second session, we searched for articles published between 2017 and 2019.

Figure 1 . Illustration of search strategy.

The First Session

From the database/journal searches, 1,112 titles/abstracts were retrieved. The titles and abstracts of identified studies were checked by the lead author (J.K.) for relevance. Subsequently, the search was performed again, and it focused on the occurrence of at least one keyword in the title or abstract to significantly narrow down the selection. It provided the authors with a relevant entry-level file base. A total of 82 studies were found. The search procedure is illustrated below. As the search findings in:

Table 1 shows, most of the studies ( 19 ) were generated by the keyword string “medical device AND process AND development” in Web of Knowledge and Scopus. A few more studies were found by searching for a more specific keyword group: “medical device AND process AND development AND investment evaluation,” as well as by the search string “medical device AND stage development.”

Table 1 . An overview of distribution of publications found in the first session.

In cases of uncertainty, the full text of studies were checked for relevance. After removing duplicates and the titles/abstracts that were unrelated to the stages of the development process, we detected 38 peer-reviewed studies written in English. We included original articles and reviews. Of these, only 31 articles were relevant to the MDD process. These studies were investigated in full by BK and PM, with guidance from PM. Four more studies were detected from the references of the retrieved studies; thus, 35 articles were considered against our study's inclusion and exclusion criteria. On the basis of the criteria, 13 studies were included in the final analysis.

The Second Session

For articles published between 2017 and 2019, the search started with potential keywords based on the trends of the publication ( Table 2 ). Two keywords were used as the main keywords that best corresponded to the objective of this research. Then, the details and abstract of the publication were extracted, and we agreed to narrow down the selection to articles from the database. Only articles that had the string “medical device development” in their title or abstracts were selected. A total of 28 papers were detected to fulfill the criteria. Thereafter, we performed manual full-text analyses, leaving 12 papers after the inclusion and exclusion criteria check. These 12 papers were combined with the 13 papers that we extracted from the first session. The whole process for the first and second sessions is illustrated in Figure 1 .

Table 2 . An overview of publication distributions for the second session.

A combination of reviews and original studies were analyzed. Studies were selected on the basis of the following inclusion criteria:

I1 The publication date of the article is between 2007 and 2017.

I2 Reviewed full-text studies in scientific journals in English.

I3 The aim of the research is to suggest MDD processes.

I4 The study results proposed MDD processes or specifications associated with existing referenced phases of MDD.

I5 The study aimed to provide an overview of existing approaches in relation to risks and valid legislation.

The studies with the following attributes were gradually excluded from the analysis:

E1 The article was not written in English.

E2 The article did not mention the main string (“medical device development”) in its title or abstract.

E3 The article did not concern the research topic. For example,

• Cosgrove et al. ( 20 ) focused on a framework of key performance indicators to identify reductions in energy consumption in a medical device production facility;

• Songkajorn and Thawesaengskulthai ( 3 ) concentrated on one specific country and the development of medical devices according to the country's legislation;

• Cho and Kim ( 21 ) and Shaw ( 22 ) aimed at risk analysis;

• Songkajorn and Thawesaengskulthai ( 3 ) included incomplete data about the stages of MDD;

• Vaezi et al. ( 23 ) focused on the exploration of medical manufacturers' beliefs

• attitudes toward user involvement in the medical device design and development ( 24 );

• Bruse et al. ( 25 ) focused on data analysis of image processing that will assist clinicians in decision making during MDD;

• Ciubuc et al. ( 26 ) focused on theoretical and experimental approaches to the detection of dopamine.

• The article described the development of healthcare software [e.g., ( 27 , 28 )].

E4 The distribution of publications based on their origin is shown in Table 3 .

Table 3 . The distribution of the publication based on origin.

Text Analysis

During the review process, text analyses were performed to assist the reviewer's decision. We used VOSviewer software to extract the relation between the co-occurrence of keywords before we decided on the keywords to be used in our search. Figures 2 , 3 show the mapping of keyword co-occurrence for keywords A and B for the analysis of the second session (publications, 2017–2019).

Figure 2 . Keyword cluster for the second session; keyword A.

Figure 3 . Keyword cluster for the second session; keyword B.

Keyword Clusters

Figure 4 shows the mapping of terms that co-occurred in the title and abstract during Step 5 of both sessions. A total of 61 non-duplicate publications were retrieved (35 from the first session and 28 from the second).

Figure 4 . Title/abstract text-mapping in Step 5 (search strategy procedure).

In the abovementioned figures, one can observe the areas that are solved in the publications. After excluding the topics and areas that are directly related to the technical solutions of MDD (e.g., represented by biomaterial, diagnosis, therapy, computational fluid dynamics), two main areas of study remained: regulatory/legislative aspects and risk/risk management. These two areas are further specified as they are related to the stages of MDD.

We detected a total of 13 research studies on the topic. Five of them originated in the United States, four in the United Kingdom, one in Canada, one in Thailand, and one in Portugal. One study was of multiple origin, i.e., USA, Canada, and Denmark. According to these studies, the MDD process comprises one to seven stages. Six studies ( 3 , 9 , 29 – 32 ) also contained a model of the MDD process for all stages or just some of the stages. The findings of the selected studies, especially the stages of the development of new medical devices, and presence or absence of relevant legislative aspects and risks, are summarized in Table 4 below. The columns are ordered according to the alphabetical name of the first author of the selected study. To minimize bias or systematic error, every time we combined the published paper, the duplication check is performed automatically using JaBref's software and manually based on author, title, and DOI. Other than that, each author also plays a role in checking either the classification of term or the content of each table, interpreting the real content published. Other than that, we are analyzing all the published articles and explain the process step-by-step in this article.

Table 4 . Stages of MDD, an overview of the findings from the selected research studies.

The findings in Table 4 show that there is no agreement on the number of stages required for the development of medical devices. The number of product life cycle stages usually ranges from four to six. The study by Ocampo and Kaminski ( 42 ) suggests three stages—pre-development, development, and post-development (the PDP model). The specific medical device development is written in Table 4 . Some studies, such as that of Girling et al. ( 30 ), Hede et al. ( 34 ), and Johnson and Moultrie ( 35 ), focus only on one stage of the MDD process, especially the concept stage during which all uncertainties such as the clinical need definition, customer requirements and needs, finances, reimbursement strategy, team selection, or legal aspects must be considered. The most representative studies are that of Medina et al. ( 31 ) and Pietzsch et al. ( 9 ), which include all key phases of the MDD life cycle, as well as legal aspects and risk factors; other studies are less detailed, and their model often lacks case studies [e.g., ( 32 )]. Although Privitera et al. ( 38 ) reviews 18 medical devices as case studies and the reviews include legislative and risk analysis aspects, the research focuses only on the design stage of the MDD process. This is also true for the study by Panescu ( 37 ), whose descriptions of individual stages are very generic. He does not formulate a way to implement individual activities but only lists the activities and the order in which they should be performed. Moreover, the stages are not connected to specific legislative conditions or the type of medical device according to its level of risk.

According to Pietzsch et al. ( 9 ), the comprehensive MDD life cycle comprises five phases. Before the commencement of Phase 1, a clinical needs analysis must be conducted. Sometimes, this phase is referred to as Phase 0. Furthermore, preliminary market analysis must be conducted to check whether there is a satisfactory market opportunity for this clinical need and whether the new product is compatible with the company's strategy and ability to successfully commercialize this product. This phase is followed by Phase 1, with several important steps. These include a financial review and market analysis or competitive assessment that focuses on needs assessment and validation, demographics analysis, and SWOT analysis. These are followed by the legal intellectual property (IP) analysis and the regulatory review. The final step is to develop a business plan. In Phase 2, a cross-functional team is formed to formulate the concept, evaluate feasibility, and develop a design plan. Models and prototypes are made, and an initial design for manufacturing is developed. In addition, regulatory and reimbursement strategies from Phase 1 are further specified in this phase to comply with new requirements. In Phase 3, verification and validation tests are conducted to ensure that the quality of the device meets set standards and customer needs. In addition, regulatory and reimbursement activities continue in this phase. In Phase 4, formal design prints are made, and preparations are commenced for a medical device launch. The key step in this phase in the United States is the receipt of regulatory approval/clearance from the FDA. Phase 5 includes the product launch and post-market monitoring. If the device appears to succeed, it is distributed for widespread clinical use. Post-market activities involve post-market monitoring, quality audits, clinical validation, and the constant improvement of products and processes. Medina et al.'s ( 31 ) MDD stages resemble those of Pietzsch et al. ( 9 ). However, in comparison with Pietzsch et al.'s, they form the cross-functional team earlier on in Phase 1, while product launch preparation is a part of Phase 5.

Generally, the abovementioned linear stage-gate processes of the chosen authors have been used for almost three decades and been pivotal contributions for the medical device industry ( 49 ), because they are both conceptual and functional. Furthermore, they acknowledge that MDI is a manageable process ( 49 ).

Nevertheless, for the general model to be at least partially usable as a best practice, it must be updated to link to valid legislation, related risks, and valid changes in the management system of individual activities related to the audit trends and development of modern technologies, which affect most business activities.

The findings of the selected studies on the Research Topic show that the comprehensive MDD life cycle comprises five phases: opportunity and risk analysis phase, concept and feasibility phase, verification and validation phase, product launch preparation phase, and product launch and post-launch assessment phase. These individual MDD phases are linear and separated by gates that are characterized by certain set criteria that must be met before MDD can proceed further. That is why the whole MDD process is also called a linear stage-gate process, which is the most commonly used process in the development and innovation of medical devices.

However, Goldenberg and Gravagna ( 6 ) identified several gaps in the traditional stage-gate product development process. They point out that the stage-gate approach is linear, without a full life cycle plan and that companies, especially smaller ones, mainly focus on regulatory approval milestones than on providing significant returns to potential stakeholders. They suggest implementing an integrated customer engagement roadmap approach that identifies all stakeholder requirements/needs and device-specific marketing messages for product differentiation. Furthermore, detailed information on budget, timeline for data studies, and communications and marketing is included. Overall, a global launch strategy is implemented.

In addition, Cooper and Sommer ( 33 ) proposed the hybrid “agile-stage-gate” approach, which can be integrated into the traditional stage-gate model for the following benefits:

• It is built on customer needs in a cost-effective way.

• It reacts quickly to needs.

• It copes with uncertainty and ambiguity that are typical of innovative developments.

• It deals with resourcing issues more directly.

Furthermore, the sources of risks that can threaten the whole MDD process, in terms of price, timing, and quality, should be carefully considered to avoid failure. The key issue is meeting user needs. As far as the legislation aspects are concerned, the key issues are consistency in the classification of devices in the EU countries, as well as the transparency of the approval process worldwide.

Risk Aspects

Individual MDD phases are closely connected with risks ( 50 – 54 ) that the individual steps bring about. For example, developing a new medical device is quite costly and risky ( 36 ); its success significantly relies on the application of accurate processes ( 9 ). Product designers and developers attempt to reduce these risks; however, tough competition encourages them to investigate the sources of risks during the MDD process, which can threaten the MDD process in terms of price, timing, and quality ( 38 , 41 ). Aguwa et al. ( 55 ) reported that medical technology is quite unsuccessful (90%) during the first prototype test, which should be carefully considered by any MDD company. Some researchers have evaluated risks in medical device design. Privitera et al. ( 38 ) indicated the integration of human factors as one of the methods to reduce risks during the design stage of the MDD process; however, challenges exist because of the implementation of standards. These challenges can be solved if both parties, medical device developers and users, cooperate. Schmuland et al. ( 56 ) provided practical ideas to allow medical device manufacturers to evaluate residual risk of their devices. Risk analysis (ISO 14971) and failure analysis (FMEA) were combined by Chan et al. ( 57 ) to ensure device quality in the design phase of the MDD process, with a case study of a ventilation breathing circuit. Rane and Kirkire ( 41 ) summarized the key risks into three main groups: user-related sources of risks, internal sources of risks, and third party-related sources of risks. User-related risks include poor translation of user requirements or unmet user needs/requirements. Internal risks are due to the lack of application of adequate standards to check device performance; poor consideration of the effect of labeling and packaging; or poor communication among device developers, end users, and marketing. Third party-related sources of risks may include lack of training for end users; improper or poor assessment of progress by reviewers; and poor planning for regulatory and clinical approvals and tests. Their findings indicate that the most important source of risks is unmet user needs, which means that user needs should be met to successfully market any device.

The detection of risks and their sources in the MDD process plays a significant role, because it can prevent a lot of adverse effects of the use of medical devices by end users, save a lot of time on design and development of the medical device, and reduce costs during the MDD process. Therefore, the MDD process should be critically planned and modeled to decrease the number of risks and their severity.

Legislative Aspects

Global harmonization in the field of medical device regulation is following the pathway set by the pharmaceutical industry at the turn of the 1980s ( 58 ). In 1989, regulatory bodies of the United States, EU, and Japan came to the conclusion that it would be more effective for the industry to develop universal standards for all aspects of drug development, manufacturing, and pharmacovigilance, with the aim to bring more safety to the process of drug manufacturing ( Table 5 ).

Table 5 . The regulation in the European Union and in the United States of America.

Therefore, the International Council 1 for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was founded. Since then, almost all important pharmaceutical markets have closely similar legislation that stems from ICH guidelines. ICH plays a crucial role in adopting novel policies for the safety of pharmaceuticals.

The Global Harmonization Task Force (GHTF), founded in 1992, was replaced in 2011 by the International Medical Device Regulators Forum (IMDRF). In an ever-changing global market, focus on harmonization is needed to achieve the desired level of safety of medical devices. During the 1980s, almost no regulation of medical devices existed. Since the 1990s, some regulations have emerged mainly in the United States and the EU, as well as in the East Asia region, mainly in Japan and Taiwan. Since the beginning of the new millennium, one can observe convergence in the regulation of the medical devices industry owing to the work of the GHTF. However, a global world needs global approaches. That is why the IMDRF came to life. The two largest markets for medical devices are Europe and North America. Regulatory requirements converge on both sides of the Atlantic; yet, American rules had been stricter compared to European rules—until the recent approval of the new medical devices regulation (MDR) by the European Parliament. The rules concerning medical devices had been much more relaxed in the EU; however, after the large-scale scandal involving Poly Implant Prothèse (PIP)-manufactured breast implants, the European Union embarked on the path leading to the approval of the MDR. As thorough as it is, it is still inferior to Title 21, Part 812 and 820 of the Code of Federal Regulations set by the United States, also referred to as current good manufacturing practices (cGMP).

In the EU, the key role is versed on the so-called “accredited notified bodies” that are privately held for-profit companies. Their nature poses a great risk for the whole system. Since there is only a limited number of such bodies (gradually decreasing), and because of the mandatory re-evaluation of all medical devices approved in the EU common market, there will be shortages of available capacity for re-evaluation. Simultaneously, notified bodies would probably be less willing to inspect small companies, which make only a few types of medical devices and tend to be generally less prepared for the transition to novel regulations, because it will be much profitable to inspect large companies with diverse portfolios and better prepared paperwork.

Another limiting factor is the relatively large number of such bodies compared to the situation in the United States where all inspectors are employees of the Food and Drug Administration (FDA), and partially the Center for Devices and Radiological Health (CDRH). It seems plausible that there could be significant differences between the level of scrutiny among bodies based in distant parts of the EU. As such, the key factor of proposed regulation could be endangered by this flaw. Another issue that is addressed by the MDR is post-marketing vigilance of medical devices. The novel regulations impose the duty of post-marketing follow-up for all devices marketed in the EU.

Since the beginning of the PIP breast implant scandals, there has been a steady shift in the perception of how to achieve this goal within the industry. Before the MDR came into effect, the focus had been more on the safety of individual products. Thus, almost all effort was put to releasing the product by obtaining the CE mark. However, as a lesson learned from the pharmaceutical industry, safety should be achieved primarily by setting up a rigorous framework of rules for the whole product life cycle. A quick overview of the regulations in the EU and the United States could be seen in Table 5 . The EU and the United States were chosen because other states are modeling regulations after theirs. For further information on the topic, readers are kindly referred to the reviews by Gupta and Thomke ( 10 ) and Ocampo and Kaminski ( 42 ), which discuss the global regulation aspects of medical devices.

In Japan, as stated in Niimi ( 40 ), the risks are divided into four classes: Class I, Class II, Class III, and Class IV, where the highest risk is in Class III and Class IV, which are for highly controlled medical devices and need the approval from the minister and a review by the Pharmaceutical and Medical Devices Agency (PMDA).

Regarding the phases involved in MDD, and the related regulations and risk factors, the results indicate that the general model applied in the MDD process should follow the well-established linear stage-gate process, which is conceptual and manageable from the perspective of innovation. Nevertheless, the model should include recently suggested approaches such as implementing an integrated customer engagement roadmap. In addition, the model must respond to current valid legislation processes, their changes, and related risks, as well as to the valid changes in the management system of individual activities related to the audit trends and development of modern technologies, which affect most business activities. The crucial factor in healthcare safety ( 59 , 60 ) is the stability of factors over a long production time. Good manufacturing practices cannot be tested on individual batches of products; they must be inherently built into the manufacturing process. This is the goal that medical device regulations and cGMP are trying to achieve. The key issues that must be addressed in the future are consistency in the classification of devices throughout the EU and globally, and the transparency of the approval processes.

Strengths and Limitations of this Study

• This review presents in-depth specifications of the stages of the medical device development process and the associated risks, which are not described in organizational or managerial research. It provides a general point of view as opposed to large numbers of case studies.

• Research findings are strategically important for healthcare development, because they clearly state the requirements for medical device development and offer a way for researchers to apply this specific process in general managerial research.

• This study is limited in the sense that it cannot cover all consequences of changes in legislative aspects.

Author Contributions

PM and KK suggested the design of the study. WI wrote the methodology. WI and PM searched the databases. PM, AS, BK, JH, and KK prepared the tables, wrote the manuscript, and reviewed the paper. All authors approved this version of the paper.

This study was supported by the research project The Czech Science Foundation (GACR) 2017 No. 17-03037S Investment evaluation of medical device development run at the Faculty of Informatics and Management, University of Hradec Kralove, Czech Republic.

Conflict of Interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

The handling editor declared a past co-authorship with the author KK.

Abbreviations

MD, Medical device; MDD, Medical device development; FDA, Food and Drug Administration; CDRH, Center for Devices and Radiological Health; GHTF, The Global Harmonization Task Force; MDR, International Medical Device Regulators Forum; MDR, Medical Devices Regulation; cGMP, Current Good Manufacturing Practices; FMEA, Failure analysis; TOPSIS, Technique for Order Performance by Similarity to Ideal Solution; SEM, Structural Equation Modeling.

1. ^ Between 1990 and 2015, it was known as the International Conference on Harmonization.

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Keywords: medical devices, development, stages, risks, legislations

Citation: Marešová P, Klímová B, Honegr J, Kuča K, Ibrahim WNH and Selamat A (2020) Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review. Front. Public Health 8:308. doi: 10.3389/fpubh.2020.00308

Received: 08 January 2020; Accepted: 05 June 2020; Published: 30 July 2020.

Reviewed by:

Copyright © 2020 Marešová, Klímová, Honegr, Kuča, Ibrahim and Selamat. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Kamil Kuča, kamil.kuca@uhk.cz

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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Health technology assessment of medical devices: current landscape, challenges, and a way forward

1 Real World Solutions, IQVIA, Shanghai, 200124 China

2 National Health Commission Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai, 200032 China

Xinran Zhao

Yingyao chen, associated data.

The data used and/or analyzed during the study are available from the corresponding author on reasonable request.

Health Technology Assessment (HTA) has been widely recognized as informing healthcare decision-making, and interest in HTA of medical devices has been steadily increasing. How does the assessment of medical devices differ from that of drug therapies, and what innovations can be adopted to overcome the inherent challenges in medical device HTA?

HTA Accelerator Database was used to describe the landscape of HTA reports for medical devices from HTA bodies, and a literature search was conducted to understand the growth trend of relevant HTA publications in four case studies. Another literature review was conducted for a narrative synthesis of the characteristic differences and challenges of HTA in medical devices. We further conducted a focused Internet search of guidelines and a narrative review of methodologies specific to the HTA of medical devices.

The evidence of HTA reports and journal publications on medical devices around the world has been growing. The challenges in assessing medical devices include scarcity of well-designed randomized controlled trials, inconsistent real-world evidence data sources and methods, device-user interaction, short product lifecycles, inexplicit target population, and a lack of direct medical outcomes. Practical solutions in terms of methodological advancement of HTA for medical devices were also discussed in some HTA guidelines and literature.

To better conduct HTA on medical devices, we recommend considering multi-source evidence such as real-world evidence; standardizing HTA processes, methodologies, and criteria; and integrating HTA into decision-making.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12962-022-00389-6.

Introduction

Health Technology Assessment (HTA) is a multidisciplinary process that uses a number of methods to determine the value of health technologies at different stages of their life cycle. HTA aims to provide evidence for health policy decision-making and for establishing an equitable, efficient, and high-quality health system [ 1 ]. Since its first application in the United States in the 1970s, HTA has developed rapidly and has been applied globally, becoming the basis for health decisions such as pricing and reimbursement in many different countries and regions. However, more of the existing HTA research concerns medicines rather than medical devices. Medical devices differ considerably from drug therapies in terms of their product lifecycle, regulatory environment, diversity, user–device interaction, and so on [ 2 ]. Even within medical devices, there are significant differences between therapeutic, instrumental, and diagnostic products. Moreover, various studies have investigated how these differences have posed great challenges to the HTA of medical devices and have thus called for applying a more innovative approach to medical devices compared to drugs. However, few studies have offered practical or actionable solutions. There is still a lack of consensus on the HTA of medical devices with regard to dimensions, process, criteria, and methods.

This study aimed to (1) describe the current landscape of HTA activities specific to medical devices; (2) analyze the characteristics of medical devices and the resulting challenges in the HTA of medical devices compared to pharmaceuticals; (3) perform a focused search of websites of official HTA agencies to identify international HTA guidelines specific to medical devices, intending to summarize implementable solutions to the HTA of medical devices. In addition, we supplemented the analysis of HTA guidelines with a narrative review of existing studies discussing the challenges of, and potential suggestions for, the HTA of medical devices.

To understand the landscape for HTA conducted on medical devices, we performed a retrospective analysis using IQVIA’s HTA Accelerator Database ( www.iqvia.com/landing/hta-accelerator ). It contains over 33,000 HTA publications that cover 100 HTA bodies in 40 countries. The primary data source came from the HTA submissions that could be tracked by local language. Market access experts from IQVIA were responsible for regularly tracking and translating all newly published HTA reports. The database captured over 250 available data elements such as the general information in the HTA report, including publication country, agency, publication date, disease area, product types, comparators, recommendations, etc. In this study, we focused only on HTA reports specific to medical devices in the HTA Accelerator Database by selecting the product type as “medical device.” We limited the assessment type of HTA submissions to health technology assessment or rapid review (including the assessment of safety, efficacy, cost-effectiveness, etc.), while other submissions such as clinical guidelines and public health reviews were excluded. As the earliest reports dated back to the year 2000, we extracted HTA reports published from 2000 onwards.

To better demonstrate the current research progress on the HTA status of medical devices, we examined four case studies on medical devices, including (1) stents (2) hip and knee arthroplasty, (3) the da Vinci Surgical System, and (4) transcatheter aortic valve implantation (TAVI) and mitral valve repair (TMVR). We did not intend for the case studies to be representative of all medical devices as there is a great deal of diversity in medical devices beyond those four cases, such as diagnostic or instrumental devices. Instead, through our choice of target devices, we aimed to cover a range of heterogeneous cases in terms of disease epidemiology, procedure characteristics, technology maturity, and demographics. We used the number of HTA-related publications to measure the activity level of the current HTA research. We conducted a literature search and tracked the growth trend of relevant HTA publications on PubMed, Embase, and Web of Science. We included HTA studies and economic evaluations and excluded relevant systematic reviews or meta-analyses. The detailed search strategy in each database is listed in Additional file 1 : Table S1.

In addition, a narrative literature review was conducted for a synthesis of the characteristic differences and challenges of HTA in Medical Devices. The literature search was performed using PubMed, Embase, and Web of Science. We included relevant empirical studies or reviews discussing the use of HTA for medical devices. The detailed search strategy in each database is listed in Additional file 1 : Table S2.

Two reviewers (J.M. and Y.H.) independently assessed the titles and abstracts of all identified study and then reviewed full text to determine the potential eligibility for the above narrative literature review. Disagreements on whether a specific study should be considered were resolved by a third investigator (X.Z.).

To guide the efficient application of HTAs, we performed a gray literature search of official websites of major HTA agencies to identify HTA guidelines with respect to medical devices. As guidelines represent a consensus in the academic community, we believed that international HTA guidelines have reflected, to some extent, the current best possible practice. We complemented the search by reviewing the bibliographies of relevant literature identified through a target literature review of methodological publications on the HTA of medical devices. Only those (either guidelines or articles) that were specific to medical devices and elaborate economic evaluation, decision-analytic modeling, and/or HTA were included.

Current status of the HTA of medical devices

Published reports from hta bodies.

In total, around 2300 HTA reports from agencies across 30 countries or regions were identified. We presents the overall trend of HTA report submissions in Fig.  1 . Overall, the body of HTA reports for medical devices increased across the world. Before 2010, the number of HTA reports published for medical devices was limited, ranging from three in 2000 to 20 in 2009. Since 2011, the number of published HTA reports has increased rapidly to reach 340 reports in 2019. Within the last 20 years, there has been a 100-fold increase in the number of HTA reports for medical devices.

Number of Health Technology Assessment (HTA) reports for medical devices by country-year: 2000–2020

Journal publications on HTA of medical devices

Figure  2 shows the growth trend of HTA-related publications on the four selected devices, respectively. Overall, we observed a general upward trend in the four products, despite annual fluctuations, indicating that the HTA of medical devices has been growing rapidly. In addition, the level of development of HTA was also related to the characteristics of the medical device, such as technology maturity and disease epidemiology. We observed from Fig.  2 a that there was a larger body of publications on stents compared to other devices since the stent was a mature device with broader applicable patient populations, indications, and long years of availability. In a comparison, TAVI and TMVR, as a relatively new product, had fewer relevant HTA publications. Additionally, there was significant growth in HTA publications for all four devices since their first market launch. The overall trend in relevant publications suggested a progressive increase in the HTA publications and academic interest in medical devices.

Summary of HTA-related literature. a Annual number of HTA-related publications on stents; b annual number of HTA-related publications on hip and knee arthroplasty; c annual number of HTA-related publications on Da Vinci; d annual number of HTA-related publications on TAVI and TMVR

Narrative synthesis of characteristic differences and challenges of HTA of medical devices

After a literature search on journal publications discussing HTA of medical devices, a total of 1646 records were identified, and 26 publications were included in our review after title and abstract screening or full text review. The PRISMA flowchart of literature review is provided in Additional file 1 : Fig. S1.

The characteristic differences and challenges of HTA in medical devices are summarized in Table ​ Table1. 1 . Overall, there were several key characteristic differences between drugs and medical devices, including the availability of treatment outcomes and other factors that may impact efficacy. First, the treatment outcome for medical devices was not as clear and straightforward as it would be with drugs, because an intervention with device involves the medical devices themselves as well as other subsequent treatments. Furthermore, devices usually had multiple applications, making it hard to assess each application in the same way that traditional drugs were assessed for an individual indication. Second, Randomized Controlled Trials (RCTs) for medical devices are rare compared to drugs, resulting in a lack of sufficient efficacy/effectiveness data and making it difficult for economic evaluation. Third, the product life cycle of medical devices was generally much shorter than that of drugs, which may result in multiple specifications within a single product class and unclear definition of standard of care. Additionally, the efficacy of medical device treatments depends on the medical devices themselves and their use.

Summary of characteristic differences and challenges of HTA of medical devices

Discussions on practical solutions for the challenges of HTA of medical devices

We obtained a total of eight HTA guidelines specific to medical devices issued by HTA agencies or research initiatives across six regions. The National Institute for Health and Care Excellence (NICE) in the United Kingdom issued an HTA methods guide for their Medical Technologies Evaluation Programme in 2011 [ 29 ]. Following the methods guide, NICE also issued the Diagnostics Assessment Programme manual specifically for diagnostic technologies demonstrating higher test accuracy, but at a greater cost compared to those in current use [ 30 ]. In Canada, Health Quality Ontario (HQO) released a method and process guide for HTA in 2018, with a scope spanning from medical devices, diagnostics, and surgical procedures to complex health system interventions [ 31 ]. In Australia, two HTA guidelines have been developed separately for therapeutic and diagnostic devices by the Medical Services Advisory Committee (MSAC) [ 32 , 33 ]. In the Asia–Pacific region, the Singapore Agency for Care Effectiveness (ACE) was the only national HTA organization that has released HTA guidelines on medical devices [ 34 ]. Apart from these official HTA agencies, an international collaborative network also contributed to the methodological advancement of HTA for medical devices. For example, the European Network for Health Technology Assessment (EUnetHTA), has launched a series of research initiatives to develop a methodological framework for HTA of therapeutic medical devices [ 35 ].

Available clinical evidence

Given that RCT evidence for medical devices was generally limited, an open-minded and flexible attitude to other forms of evidence e.g., case reports (series), cohort studies, case control studies, and real-world studies was highly recommended [ 29 , 34 , 35 ]. Both the UK and EUnetHTA guidelines have pointed out the high risk of bias in non-randomized controlled trials [ 30 , 35 ]. At the same time, several tools have been developed, although they may not be specific for medical devices. The Cochrane Risk of Bias Assessment Tool for Non-Randomized Studies of Interventions (ACROBAT-NRSI) could be used to assess the risk of bias in non-randomized controlled studies [ 36 ]. In addition, the quality assessment for case reports (series) could refer to the checklist developed by the Canadian Institute of Health Economics [ 37 ].

The draft guidance released by the United States Food and Drug Administration (FDA) in 2016 has spurred a surge in the literature describing how real-world evidence (RWE) can be used to support regulatory approval for medical devices [ 38 ]. RWE refers to any evidence on healthcare generated from multiple sources outside clinical trial settings, which is usually in the form of electronic medical records (EMR), electronic health records (EHR), hospital databases, patient registries, claims data, etc. [ 39 ]. In addition to market authorization, RWE was also relevant in post-marketing surveillance, coverage decisions, outcome-based contracting, resource use, and treatment compliance [ 40 , 41 ]. Especially for medical device products for which the regulatory environment does not require RCTs, or in situations where RCTs traditionally have been lacking such as measuring disease burden and detecting new safety signals, RWE could offer unique perspectives.

Unlike randomized clinical trials, most RWE comes from observational studies and might have many drawbacks. While current medical device-specific HTA guidelines have underscored the potential bias associated with RWE and several tools may be available for assessment of bias for non-randomized studies, few guidelines have addressed other common issues including data quality, availability, standards, and privacy [ 29 , 30 , 32 , 33 , 35 , 42 ]. For example, a European study that mapped RWE studies of three medical device products has revealed that the accessibility of data sources for RWE varied greatly across European countries. The study also suggested the types and definitions of variables included in each data source were not consistent, making a comparison across databases impossible [ 43 ]. Therefore, there is a need for RWE guidance on medical devices which would not only provide overarching frameworks but also standardize methods and processes ranging from data storage, collection, and sharing to analytic approaches.

Device–user interaction

International medical device-specific HTA guidelines have emphasized the need to account for the learning curve effect in HTA. The EUnetHTA has suggested that it is necessary to establish a break-in period before the formal evaluation to ensure that users have sufficient time to adapt to the new technology. Also, various degrees of operator proficiency across different types of medical research centers (e.g., teaching hospitals and non-teaching hospitals) would lead to heterogeneity in HTA. Therefore, the EUnetHTA proposed a three-tiered approach to accounting for the learning curve in its HTA guidelines for therapeutic devices. Firstly, assessors should screen for studies that estimate an association between user proficiency or healthcare settings (e.g., teaching or non-teaching hospitals) and clinical outcomes. Secondly, if the effect of the learning curve was not reported in the RCT and relevant information could not be obtained by contacting the investigators, then other types of evidence such as non-randomized controlled and non-comparative effectiveness studies could also be considered in order to explore the association between operator proficiency, types of study centers, and clinical outcomes. Lastly, subgroup analyses could be applied where existing studies were divided into different subgroups based on the level of operator proficiency. Statistical methods such as meta-analysis could be used to estimate the difference in medical outcomes between these subgroups and hence quantify the effect of the learning curve [ 35 ]. The radiofrequency ablation (RFA) for liver tumors treatment serves as an example. In a systematic review, researchers divided 100 case reports into four subgroups according to the surgeons’ previous RFA experience (i.e., having done < 20, 21–50, 51–99, > 100 cases respectively). The results of the meta-analysis showed the tumor recurrence rate decreased (18%, 16%, 14%, and 10% respectively in the four subgroups) as surgeons accumulated experience [ 44 ].

Short product life cycle and quick upgrade

In practice, a Bayesian approach was recommended to account for the iterative nature of medical devices in HTA [ 35 ]. The Bayesian approach is a statistical method that infers the posterior distribution of unknown parameters according to Bayes’ theorem based on prior knowledge and sample data. Considering that medical devices are incrementally upgraded with minor modifications, clinical trials and/or early research data of the former version of the medical device product, sometimes even data of comparator products could be a source for prior information used in the Bayesian approach.

Inexplicit target population and lack of direct clinical outcomes

Given the lack of direct clinical outcomes for screening and diagnostic devices, the HQO allows the use of established surrogate endpoints or intermediate clinical indicators to predict patients’ final medical outcomes. For instance, the association between intermediate indicators (e.g., blood pressure) and cardiovascular-related deaths has already been established through statistical models [ 31 ]. In terms of evaluating screening or diagnostic technologies, NICE, MSAC, and EUnetHTA stress that product performance should be reflected in the entire care pathway. In this way, the HTA should not only evaluate the test accuracy, but also consider the impact of the diagnostic results (no matter how accurate they were) on subsequent treatment pathways and the final medical outcomes [ 30 , 32 , 35 ]. One particular technique described by international HTA guidelines is the linked analysis [ 30 , 32 ]. In its first step, a linked analysis collects comprehensive data on the test accuracy of diagnostic technologies and the effectiveness of subsequent clinical interventions following the diagnostic results. Then, these data are modeled to simulate the whole care pathway and to estimate the impact of the diagnostic device on the final medical outcome [ 30 ]. However, it is worth mentioning that there were two premises for conducting linked analysis: (1) the effectiveness of clinical interventions subsequent to the diagnostic results must be established by confirmatory trials and should be available; (2) Patients’ baseline characteristics in these confirmatory trials of the subsequent clinical interventions should resemble the population to which the diagnostic devices were applied.

Considering multi-source evidence such as real-world evidence

Most HTAs of pharmaceuticals have been performed using economic evaluations with parameters derived from RCTs. However, the market authorization for most medical devices does not require rigorous RCTs, leading to limited clinical evidence. The scarcity of clinical research has made RWE particularly important in generating clinical effectiveness and safety data for the HTA of medical devices. Unlike the ideal experimental environment of RCTs, the “real world” refers to actual clinical settings where patients have not been selected based on pre-specified criteria. Patients enrolled in RWE studies tend to cover different subgroups so that they are representative of the whole population. For this reason, RWE reflects the true effects of clinical interventions. Correspondingly, HTA based on RWE could provide healthcare decision-makers with insights that came from real-world settings. As the uptake of newly introduced medical devices often requires a break-in period, this creates the perfect timing to collect real-world data on products’ safety and effectiveness. In addition to RWE, HTA could also collect public opinions from multiple third parties (patients, manufacturers, health care providers) regarding current evidence, treatment pattern, and patient categories.

Standardization of tools and evaluation criteria for HTA of medical devices

Existing HTA guidelines mainly focus on drugs and cannot be applied directly to the HTA of medical devices even with adaptation. Therefore, we suggest that separate HTA guidelines for medical devices are needed to standardize the topic identification, selection of comparator, evaluation methods, cost measurement, effect/utility measurement, evidence synthesis, systemic review, and ethnic requirements. Moreover, the HTA report should follow a consistent reporting paradigm. We also recommend that decision-makers follow the same HTA guidelines to conduct HTA appraisals. The formulation of HTA guidelines should be transparent and publicly available. At the same time, regular updates are necessary to reflect the evolution of HTA methods, and international collaboration is needed in overcoming the inherent challenges in medical device HTA.

Intergration of HTA of medical devices into decision-making

As a bridge connecting scientific research and health decision-making, the development of HTA is closely interwoven with established mechanisms such that the results of HTA could be translated into real practice. HTA as well as value assessment methods have been adopted around the world in national coverage decisions for pharmaceuticals. Nevertheless, the application of HTA in medical devices decision-making is in an earlier stage with higher uncertainty. Therefore, it is essential to explore an effective mechanism that would enable the translation of the results of HTA of medical devices into decision-making. Specifically, the decision translation mechanism could take the form of regulatory authorization, market access and reimbursement, and price negotiations where HTA could be introduced. We believe that better integration of HTA into decision-making would further encourage evidence generation and the adoption of HTA standards and ultimately promote an evidence-based, decision-making culture.

The body of HTA reports and journal publications on medical devices around the world has been growing. Our analysis revealed that medical devices differ considerably from pharmaceuticals in many respects, which has made the HTA of medical devices quite challenging. These challenges include scarcity of well-designed RCTs, inconsistent RWE data sources and methods, device-user interaction, short product lifecycle, inexplicit target population, and lack of direct medical outcomes.

Practical solutions found in the HTA guidelines to account for these challenges include (1) adopting an open mind toward evidence other than that generated through an RCT, such as RWE, especially as newly introduced medical devices often require a break-in period; (2) accounting for the learning curve that impacts the device-user interaction through several means including subgroup analyses; (3) applying a Bayesian approach to account for the iterative nature of medical devices; and (4) ensuring that product performance is measured across the entire care pathway through techniques such as linked analyses.

Based on the results of the above analysis, we call on both academic communities and relevant agencies to standardize the process, methodologies, and criteria of HTAs on medical devices, particularly when an HTA has involved RWE studies. We also recommend that national authorities better integrate the HTA of medical devices into decision-making and promote a more evidence-based culture.

Acknowledgements

The authors would like to thank the following persons, who graciously contributed their valuable time, knowledge, and input over the course of this research: Yanfeng Ren (Fudan University), Xinyu Liang (University of Michigan), Guanqi Hong (employee of IQVIA), Xinyi Wang (employee of IQVIA), Yaping Ai (employee of IQVIA), Min Jin (employee of IQVIA).

Institutional review board statement

Not applicable.

Author contributions

Conceptualization, JM, YH, YW, YC and MH; methodology, JM, JL and YX; investigation, YH and YY; formal analysis, YH and JM; data curation, JM, YH, XZ and YY; writing—original draft preparation, YH and JM; writing—review and editing, YY, MH, XZ, YW and YC; supervision, JL, YX, MH and YC. All authors read and approved the final manuscript.

This work was supported by the National Key Research and Development Program of China (No. 2018YFC1312900).

Availability of data and materials

Declarations.

The authors declare that they have no competing interests.

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Jian Ming and Yunzhen He contributed equally to this work

Contributor Information

Yan Wei, Email: nc.ude.naduf@iewnay .

Yingyao Chen, Email: nc.ude.umhs@nehcyy .

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We have been supporting medical device development for many years! In fact, we helped author industry standards that are the basis for FDA human factors guidance. We help our clients to incorporate user feedback early and often in the development process as well as:

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A healthcare company sought to compare their injection device with comparable ones on the market in order to determine if it is considered “state-of-the-art.”

A Fortune 50 healthcare organization was developing an AI-enabled electronic medical record designed to improve providers’ situational awareness, communication, collaboration, and response.

A healthcare company sought HFE support in the development of an HF plan for a drug/device combination product and its accompanying IFU.​

A medical device manufacturer sought HF engineering support to develop HFE deliverables and conduct a validation study for an aesthetics device. ​

A pharmaceutical company needed to test usability of an app for patients facing a serious medical condition.

A global healthcare company sought to improve speech detection algorithms used by health care professionals (HCPs) to access patient information.

A developer of digital health self-assessment tools sought usability testing for an innovative smartphone app designed to help healthcare professionals and patients better understand MS.

A manufacturer of personal care products sought to assess the ability of users to follow cleaning and disinfection protocols in a clinical setting.

A pharmaceutical company planned to make an existing infusion pump available to a new patient population.

A pharmaceutical company wanted to understand if potential functionalities of a digital therapy met user needs.

A pharmaceutical company sought to understand how people with diabetes use technology to manage their disease.

A pharmaceutical manufacturer sought to improve the design and usability of a currently available pump carrying accessory.

Medical device research

Affiliation.

• 1 E-Health Research Centre, Commonwealth Scientific and Industrial Research Organisation (CSIRO), Queensland, Australia. [email protected]
• PMID: 16293027
• DOI: 10.1586/17434440.2.1.41

This perspective provides a commentary on the quality of life improvements made available from advances in medical device technology. An opinion of the elements necessary to bring innovation into medical device research is offered. In order to enhance the output of medical device research, strong interactive links are needed between clinicians and researchers to ensure research activities are focused on the needs of patients. Alliances with industry umbrella groups can support these links and facilitate the commercialization of new ideas generated from the research. Several forecasts for the medical device market obtained from other sources are also presented.

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Biomedical Research

Research with device products.

Research involving the use of devices is complex and varied. Some protocols use marketed devices that are not generally considered to be medical devices, such as a Fitbit or virtual reality. Some devices are simply used to collect research data. On the other end of the spectrum, a device may be implanted into a participant. Some device use involves the return of results to participants (e.g., lab tests, MRIs, ECGs, etc.) while other device uses do not. Additionally, an algorithm, software or even artificial intelligence may be considered a device on a protocol, contingent upon its impact on prospective participants.

What is a Device?

A device might be an instrument, apparatus, implement, machine, contrivance, implant, in-vitro diagnostic, lab developed test, in vitro reagent, assay, software application, algorithm, or other similar or related article or component, part, or accessory.

Considerations for Research with Devices

Research with devices.

When evaluating a protocol, the IRB considers the following seven questions. Click here for a visual representation .

• What type of device is being used? (i.e., assay, MRI, software, etc.)
• How is the device used on the submitted protocol?
• Is it being used according to the definition of a medical device?
• If used as a medical device, is it the subject of the investigation?
• Is the device marketed? If yes, is it being used on label or being used in an investigational manner?
• Is the protocol subject to IDE regulations (requires an IDE) or is it exempt from IDE regulations (does not require an IDE)?
• If the protocol is subject to IDE regulations, what is the risk of the device, as used on the protocol? Device risk determinations are made on a protocol basis, not a device basis.

FDA Definition of a Medical Device

A medical device is:

• Recognized in the official National Formulary of the United States Pharmacopoeia ; OR
• Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or other conditions; OR
• Intended to affect the structure or function of the body AND
• Does not achieve its primary intended purposes through chemical action within or on the body AND is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Exemption from IDE Regulations Guidance

An application to use a device in a study in order to collect safety or effectiveness data is called an investigational device exemption (IDE). The FDA regulations detailing these requirements also detail certain categories of research that do not require an IDE (i.e., exempt from IDE regulations). Click below for detailed guidance on the applicability of IDE regulations entitled, Exemption from IDE Regulations Guidance.

Requesting an Exemption from IDE Regulations Determination

Penn medicine office of clinical research regulatory services.

Penn Medicine Principal Investigators are recommended to request an exemption determination from the Office of Clinical Research Regulatory Services. OCR Regulatory will conduct exemption determinations for any product type.

Non-Penn Medicine Principal Investigators may request an exemption determination from the IRB. In order to request an exemption determination, submit the Research with Devices Form with your initial application.

Any Principal Investigators may seek an exemption determination directly from the FDA. See Additional Information section below.

Protocols that Require an IDE

If the protocol is not exempt from the IDE regulations, the IRB must determine the risk of the device as used on the protocol. NOTE: Risk determinations are not definitive and may change, should unanticipated adverse device effects occur, or evidence suggests that the risk of the device is greater or lower than originally anticipated.

Non-Significant Risk Protocol: Use of the device on the protocol does not meet the definition of significant risk.

Significant Risk Protocol: Use of an investigational device that presents a potential for serious risk* to the health, safety or welfare of a subject due to its intended use AND is used:

• As an implant OR
• For supporting or sustaining human life OR
• Of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health OR
• Presents some other serious risk to patient’s health, safety, or welfare

Serious Risk

“Serious risk” is considered to be any risk that would be considered a serious adverse event.

• Is life-threatening, or cause death, or
• Causes hospitalization, disability or permanent damage, congenital anomaly/birth defect, or
• Requires a medical / surgical intervention to prevent permanent impairment or damage, or
• Is any other serious medical event that may adversely affect the safety or welfare of subjects.
• The device is a novel device with no predicate (a predicate is a medical device that may be legally marketed in the U.S. and is used as a point of comparison for new medical devices)
• A device used for an indication not previously evaluated by the research team, the FDA, or peer review, without medical and or scientific rational justifying the safety of the device(s)

Additional Information

Submitting a request for an exemption or risk determination to fda.

Unsure about risk of the device? Sponsors or sponsor-investigators can submit a Study Risk Determination Q Submission to the FDA. The only required documents consist of: Cover letter, device description, and protocol. A full IDE application is NOT required. FDA will determine whether the protocol qualifies for exemption and issue a determination letter. If the protocol is not exempt, FDA will provide a risk determination. Please review the FDA Guidance linked below.

Investigational Plans

IDE protocols require an investigational plan. See below for guidance on investigational plans. For guidance on submitting an IDE to the FDA, please contact the PSOM Office of Clinical Research, Regulatory Support Team. Regulatory Support

Treatment of a Patient with an Unapproved Device Product

An unapproved product can be administered for treatment purposes under the FDA’s expanded access program, if certain criteria are met. For more information, please click below.

Requirements for Conducting Clinical Investigations

Requirements for abbreviated ide holders.

For guidance on the Requirements for Abbreviated IDE Holders please contact the PSOM Office of Clinical Research, Regulatory Support Team.

PSOM Policies and Procedures

Perelman School of Medicine policies and procedures apply to device research when research involves Penn Medicine patients and / or PSOM faculty. This includes research that is led by Faculty from non-Penn Medicine schools such as School of Nursing, Engineering, or SAS. Questions about these policies and procedures can be directed to the Office of Clinical Research.

PI Acknowledgement of Responsibilities in Biomedical Research

The Principal Investigator is responsible for:

• Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations;
• Protecting the rights, safety, and welfare of subjects under the investigator’s care; and
• The control of drug(s) or device(s) used in the investigation.

The Principal Investigator’s Acknowledgement of Responsibilities document has been developed as a reminder of the responsibilities of the principal investigator in a clinical investigation.

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Medical Device Market Research in Seconds with AlphaSense

Whether you are conducting research to better understand the market, track your competitors, or spot your next big investment in the medical device space, AlphaSense can help you make the right business decisions with confidence and speed.

AlphaSense is a leading provider of market intelligence, including 10,000+ high-quality business sources such as news and trade journals, global and SEC filings, and industry research from over 1,500 leading research providers—all in a single platform.

Competitive intelligence teams, researchers, and strategists in the medical device sector have access to private company documents, regulatory documents, expert calls, and industry research through our platform—all of which are necessary for comprehensive market research and confident decision-making. 

AlphaSense also saves you hours per project by centralizing the insights you need and delivering them to you with intelligent, AI-based smart search technology. Features like Smart Synonyms ™ and Smart Summaries recognize the intent behind your search and zero in on the most important insights contained within each source, while Trending Topics and customized dashboards enable you to monitor the precise themes and companies that are of most interest and value to your strategic goals.

Advanced filtering features help you easily get to the types of content needed for your specific research. And automated real-time alerts ensure you never miss an update from the companies, treatment areas, and industries you most care about.

These features and more are why G2 has consistently rated AlphaSense a leader in market intelligence for corporations and financial institutions alike.

• Frequently Asked Questions

How Top Medical Device Companies Use AlphaSense

The medical device industry is the booming fast-growing sub-sector of the medical technology (medtech) industry . While this industry has been around for decades, the 2020 global pandemic proved to be a catalyst for accelerated growth in this space—a trend that is only expected to continue into the foreseeable future.

The medical device industry has proven to be one of the most opportunistic—capable of improving patient outcomes worldwide and transforming the healthcare system as we know it—with increased demand from investors. It’s also constantly expanding, as new entrants and innovations are entering the space at a rapid clip. 

That’s why it’s never been more important for medical device companies to have an airtight market research process and a proactive strategy. Without the right tool, the task of parsing through vast quantities of data, locating the right insights, and then analyzing and implementing those insights becomes herculean. Moreover, manual market research dramatically slows you down and leaves you vulnerable to human error and missed insights. 

AlphaSense not only helps you stay informed on the critical insights that matter most, but empowers you to apply those insights towards specific strategic goals, go-to-market motions and commercialization tactics. Our platform speeds up your time to insight so you can increase research confidence and be more proactive in strategy-building. 

Here’s how our medtech and medical device clients use AlphaSense to succeed: 

Competitive Intelligence

AlphaSense surfaces all the competitive insights you need so that you can benchmark against peers, find out about any emerging competitors or technologies, generate ideas for new product development, and identify competitive risks—all in one place.

You can receive real-time alerts for 510(k) filings, competitors’ earnings reports, topical broker research, and expert call transcripts. And with our company recognition and Search Summaries features, you will always be first to know about any competitor updates, such as launches and recalls of new devices, technologies, or treatment methods.

Corporate Development and M&A

AlphaSense allows you to get smart on an investment target, emerging technology, intellectual property, or competitive landscape by using AI to find insights faster. Our natural language processing (NLP) feature, theme extraction , enables you to spot interesting assets within the noise by uncovering financial metrics beyond those found in standard 10-Ks or 10-Qs. 

Theme extraction allows you to see how incumbent companies are conducting their M&A strategy, including what types of companies are getting acquired or who they are funded by, as well as how large healthcare firms are approaching their investments in smaller medtech companies. 

This feature is critical in this space because new companies, technologies, and devices are constantly emerging, and having access to a tool like AlphaSense keeps you in-the-know— without the information overload.

You can also use AlphaSense to gain intel on private companies . Instantly access funding round information, acquisition history, public comps, and peer comparison charts—without digging through multiple, potentially fruitless, sources.

Market Landscaping

AlphaSense ensures you never miss a critical industry update with customizable watchlists and real-time alerts for any companies or treatment areas you are interested in. 

AlphaSense also makes it simple to monitor specific subsectors of the medtech industry by searching those topics on the platform and seeing how the keywords have trended over time. 

For instance, if you are interested in the TAM and growth outlooks for cardiovascular devices, you can uncover key insights such as: the U.S. forecast for adults with heart disease, current existing treatments and new diagnostic technologies for cardiovascular health, the main players in the cardiovascular medtech space, how much healthcare systems have invested already in cardiovascular medical equipment, and so on, by simply searching “cardiovascular” AND “medical devices” and filtering for each content set in our platform. 

Commercialization

If you are interested in commercializing a product, device, or technology, AlphaSense can help you extract market data from qualitative sources to develop TAM analyses, evaluate market opportunities to forecast sales, and develop go-to market strategies. 

AlphaSense also allows you to find answers to key questions during commercialization:

• Is the concept novel and validated? To answer this, you need to evaluate the market landscape—what kinds of companies are in this space, what technologies are being used, what are the health systems using this tech, what other companies have tried bringing a similar product to market in the past, and what do experts and doctors say about similar devices or technologies?
• Has the concept cleared the regulatory and FDA requirements? For this, you can consult regulatory documents such as 510(k) filings, FDA statements, and European Medicines Agency documents, all housed on the AlphaSense platform.
• Is your product faster, better, or more cost-effective than competitors’? For this, you can rely on competitive signals and M&A tracking , so you can always be aware of key factors such as a huge incumbent adding a similar company to its portfolio, health system/consumer spending in a potential target market, and what pricing and profitability look like for similar technology. 

One important consideration in commercialization is the possibility of partnering with a biopharma company or health system in order to lower cost or expand reach. For this, you must have a tool that enables you to conduct in-depth research on public and private companies.

Finally, successful commercialization involves finding reliable manufacturing and distribution partners. AlphaSense can help uncover who is currently making similar devices, how they are shipped, and what geographic regions are best to target with the supply chain.

Accelerate Your Medical Device Research Process With AlphaSense

AlphaSense aggregates all the essential market research perspectives you need in one place, so you can have a complete picture of the company profiles, markets, or trends you are researching. 

Combined with proprietary AI and automation functionality not found on other platforms, AlphaSense helps you dramatically increase the breadth, depth, and accuracy of your research. 

Here’s what you get when you use the AlphaSense platform for your market intelligence:

Aggregated Market Research

AlphaSense houses a vast universe of over 10,000 trusted content sources, including but not limited to:

• Company documents such as event transcripts, global filings, press releases, company presentations, product brochures, and ESG reports, in addition to private company documents
• Industry research from the world’s top financial research firms, including Cowen, Morgan Stanley, Bank of America, Jefferies, and JP Morgan, as well as our proprietary equity research content set Wall Street Insights that is specifically tailored for corporate clients
• Unique industry expert perspectives from customers, competitors, medical experts, doctors, and partners
• Thousands of curated news sources, trade publications, and regulatory information such as 510(k)s 

Our platform not only houses all of the content you need to make rapid data-driven decisions, it also helps you cut through the noise with advanced search functionality.

Semantic Search

Instead of digging through fragmented reports and alerts, you can rely on our semantic search to ensure you never miss out on critical insights. Our AI search technology automatically recognizes what you are looking for and delivers the results that match the intent behind your query. This means you don’t have to do multiple searches to get the results you need, and you can be more confident in the comprehensiveness and accuracy of your research. 

Sentiment Analysis 

With AlphaSense , you can use AI-based sentiment analysis to identify, quantify, and analyze levels of emotion within text, particularly earnings calls and expert transcripts. Understanding sentiment can help you catch the subtle inflection points in language that move markets and provide early indicators of shifting corporate performance. This feature works in seconds, saving hours previously spent combing through company documents and expert transcripts for the best insights.

Generative AI

Unlike other generative AI (genAI) tools that are focused on consumer users and trained on publicly available content across the web, AlphaSense takes an entirely different approach. As a platform purpose-built to drive the world’s biggest business and financial decisions, our Smart Summaries feature leverages our 10+ years of AI tech development and draws from a curated collection of high-quality business content.

With Smart Summaries, you can glean instant earnings insights—reducing time spent on research during earnings season, quickly capture company outlook, and generate an expert-approved SWOT analysis straight from former competitors, partners, and employees. Additionally, all sources are cited, so you can verify any information by simply consulting the source documents.

Medical Device Insights From the AlphaSense Platform

Analyzing expert transcripts: 4 trending conversations in medtech.

We pull from our database of expert call transcripts to uncover the top trending medtech topics, as discussed by medical professionals and industry leaders.

Tracking the Next M&A Deal: 16 Medtech Companies to Watch

We use our platform to identify the most lucrative M&A opportunities in the medtech space, based on products, growths, and margins.

Medtech Trends Leading the Post-Pandemic Healthcare Conversation

We use our platform’s vast content database—including equity research, earnings transcripts, news, and expert calls—to identify the top themes and topics in the medtech space that are trending quarter over quarter. 

Case Study: Fortune 500 Medical Device Leader Produces Higher Quality Analysis

Read about how a Fortune 500 medical device leader uses AlphaSense to increase efficiency in their market research and analysis process.

The overall forecast for the global medical device market is overwhelmingly positive, with an expected revenue of $595 billion in 2024 and a CAGR of 6.1% from 2022 to 2030 . The healthcare sectors expected to be most affected by growth in the medical device space in the near future include:

• Cardiovascular
• Neurovascular

Some of the top trends in the medical device industry today are:

• Continued growth of in-vitro diagnostics and digital therapeutics
• High growth rate in wearable and biometric monitoring devices
• Challenges with entering the European marketplace
• Increased speed to market
• Greater focus on sustainability and ESG

For more information on these trends, as well as additional trends driving the medical device industry, check out our post Medical Device Trends and Outlook for 2024 .

Effective market research for all medtech companies involves analyzing market size, identifying target audiences, assessing competition, and understanding the regulatory landscape. For medical device companies in particular, market research also involves evaluating emerging technologies and tracking medical device manufacturers, suppliers and distributors. 

In the AlphaSense platform, our content database contains all the key information on your competitors and the market landscape, and our advanced AI search technology makes it easy to track specific topics, themes, and companies over time and ensure you never miss a critical update.

Because of the fast pace and constant innovation characterizing this sector, market research is imperative for developing a more proactive strategic approach and staying competitive and aware of any pertinent developments in the field. 

Market research in the medical device space helps companies and investors identify emerging trends and competitors, find new opportunities, assess potential risks, prioritize R&D efforts, and make informed strategic decisions. 

Also, it’s imperative for companies and investors in this space to be well aware of any M&A deals or device approvals that might make it more difficult to sell a device or enter a space, or that could create a gap that needs to be filled.

Common challenges could include data accuracy, regulatory complexities, and the need for specialized expertise. 

Additionally, the medical device space is rife with smaller market players and startups who do not yet have public data on their earnings or revenue. It’s important that you are able to track these new entrants before they become too large to compete with, partner, or acquire. 

A market research platform that aggregates accurate, reliable data and provides access to public and private company documents, regulatory information, and expert perspectives can help overcome all these challenges.

There are several ways for medical device companies to access reliable market data and analysis. They can rely on their own surveys and studies, which provides greater control but could introduce limitations or bias and also requires more resources. 

Alternatively, medical device companies can rely on a market research platform like AlphaSense that aggregates premium, public, private, and proprietary sources including regulatory documents, industry reports, company documents, equity research, and expert calls (medical doctors make up a high percentage of the experts in our transcript library).

Regulatory compliance is crucial in the medical device space. Understanding and staying compliant with FDA and international regulations is vital to ensure product viability and successful market entry. One of the most important sources of truth for regulatory compliance are 510(k) filings (which can be found in real time on our platform), which show product approvals and recalls and can inform R&D, partnership, and commercialization strategies.

Market research helps in identifying gaps and unmet medical needs by analyzing patient demographics, healthcare provider feedback, and emerging healthcare trends, disease landscapes and projected market need for certain treatments.

Market research provides valuable data on consumer preferences, pain points, and unmet needs of healthcare providers. This information helps companies tailor their products to meet specific demands and stay competitive. Additionally, market research is crucial for keeping tabs on competitors’ product development and upcoming launches, so that you can be more proactive with your strategy.

In 2023, the key players in the medical device space are: Medtronic, Abbott Laboratories, Johnson & Johnson, Siemens Healthineers, Fresenius, Roche, Becton Dickinson, GE Healthcare, Stryker, Danaher.

To read about how AlphaSense helped Fresenius create a more efficient workflow and enhance their research process, check out this case study .

Try AlphaSense for Free

With AlphaSense, you can conduct comprehensive qualitative research that gives you the competitive edge and empowers your ability to make smarter, more confident decisions. Stay ahead of the rapidly evolving medical device landscape and level up your strategy today.

Medtech Market Research

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Publications

Analysis of devices authorized by the FDA for clinical decision support in critical care

JAMA Internal Medicine October 9, 2023

Read the full article

Research Areas

• Communication & Decision Making
• Care Delivery & Outcomes

PAIR Center Research Team

Alexander T. Moffett

Gary Weissman

• Acute Care Health Services Research
• Health Informatics

The use of predictive clinical decision support (CDS) devices (ie, those that use machine learning [ML] or artificial intelligence [AI]) has the potential to improve outcomes in critical care, but a clear regulatory framework is lacking. Recent guidance from the US Food and Drug Administration (FDA) suggests most CDS tools for critical illness will be regulated because of the time-sensitive nature of the decisions informed by these devices. However, growing concerns about the clinical impact of predictive CDS systems raise questions about whether current device regulatory frameworks, developed before advanced statistical learning methods were widely available, are sufficient to ensure effectiveness and safety.

Jessica T Lee, Alexander T Moffett, George Maliha, Zahra Faraji, Genevieve P Kanter, Gary E Weissman

iData Research

Biotech market research.

Accurate, reliable medical device research is key to thriving in an ever-changing market. Biotech market research from iData is designed to give companies a true picture of the size of the market , growth potential and more so that they have the best possible information to help them achieve their strategic objectives.

Every medical device industry report we produce is compiled using time-tested, unassailable methodology so that recipients can be certain they are getting the strong intelligence they need in order to make the best decisions.

Biotech Medical Device Industry Overview

The biotechnology market encompasses a wide range of industries, including the life sciences and many others. These are just a few of the areas of the U.S. medical device market that we analyze as it pertains to biotech:

• Cell cultures and engineering
• DNA mapping
• DNA sequencing
• Protein engineering
• Protein sequencing
• Protein synthesis

While there are myriad areas where biotech market research is applicable, the largest is the medicinal field. Biotech plays an undeniably large role in the research and development of pharmaceuticals, involving the formation of new drugs, genetic analysis and much more. As this industry continues to flourish, established players in the field are increasingly looking toward possible mergers and/or acquisitions.

As companies look to expand their product portfolios, they need reliable, accurate medical device industry analysis in order to have the clearest picture possible of the industry landscape. For more than a decade, iData has delivered the solid information needed to help companies determine their medical device marketing strategy.

Industry-Leading Medical Device Industry Reports

iData has a deep understanding of the many different biotech medical device market segments, and uses several different perspectives when evaluating each one. We can customize a medical device industry report to fit your exact needs, whether you want a global perspective or you’re looking for research into a specific geography, application area or anything else.

Our sophisticated, advanced research contains exhaustive medical device industry statistics and analysis to give our clients invaluable insights into the market.

Our medical device market forecast research can help your company stay ahead of any potential volatility in the industry. It can take years for companies to start seeing returns on their investments in developing products, and the biotech industry can sometimes show vulnerability to declines in government funding and/or venture capital. Reports from iData can alert you to both positive and negative trends in the industry so you can stay ahead of developments and position your company for sustained growth.

At iData Research, we offer a variety of services that are all aimed at helping healthcare organizations succeed. Several Fortune 500 companies have turned to us for market intelligence, including Johnson & Johnson, 3M, Medtronic and many others. Whether you are an investor, run a biotech company or have any other interests in the industry, iData can provide the research you need to make the most well-informed choices possible.

Learn why we have become the industry standard for research in the U.S. medical market by calling 1 (866) 964-3282 or by getting in touch with us online .

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Carl Zeiss Meditec AG Completes Acquisition of Dutch Ophthalmic Research Center (D.O.R.C.); Companies Unite to Shape Ophthalmology Market

Zeiss secures regulatory approvals to acquire d.o.r.c.; companies now shift focus to integration implementation, fueling world-class innovation, and driving market expansion strategy for ophthalmic medical devices and surgery..

Jena, Germany | April 4, 2024 | Carl Zeiss Meditec AG

Carl Zeiss Meditec AG announced today that, after securing all required regulatory approvals, it has completed the acquisition of 100% of D.O.R.C. (Dutch Ophthalmic Research Center) from the investment firm Eurazeo SE, Paris, France. The acquisition enhances and complements ZEISS Medical Technology’s broad ophthalmic portfolio and range of digitally connected workflow solutions for addressing a wide variety of eye conditions, spanning retina and cornea disorders, cataract, glaucoma, and refractive errors.

“Together we are better. Today holds significant importance for us as we bring our teams together and turn our collective attention toward delivering breakthrough innovations and solutions for our customers. We are very excited to welcome D.O.R.C.’s team members to our ZEISS family and to begin integrating our products and practices as we work toward a brighter future together,” says Dr. Markus Weber, President and CEO of Carl Zeiss Meditec AG.

“Together we can offer an unmatched portfolio of advanced technologies and digital workflows. With D.O.R.C., we have an incredible opportunity to serve ophthalmologists around the world with more complete workflows and solutions than ever before,” says Euan S. Thomson, Ph.D., President of Ophthalmology and Head of the Digital Business Unit for ZEISS Medical Technology. “We’ve set our sights high to become the top player in the world for ophthalmology by leveraging our workflow solutions, enhancing our portfolio offerings and market position in the anterior surgery segment, and by significantly expanding our presence in the posterior surgery segment.”

“Together we are stronger. With four decades behind our amazing business and surgeon-inspired innovation, we look forward to writing the next chapter of our success story together with ZEISS Medical Technology,” says Pierre Billardon, CEO of D.O.R.C. “By joining forces, we can extend our reach, scale our efforts, and accelerate ophthalmic surgery advancements for more surgeons faster than before. I am filled with a great sense of pride and gratitude for every D.O.R.C. team member. Together, we have achieved so much to arrive at this pivotal moment in our journey. And together with ZEISS, we have so much more to accomplish in our bright future ahead to help patients see again.”

Combination of portfolios will create unmatched end-to-end solution within the digitally-connected ZEISS Retina Surgery Workflow

As a leading player in the retina surgical devices and consumables market, D.O.R.C.’s contributions will be critical to ZEISS Medical Technology’s long-term strategy and success going forward. With D.O.R.C., ZEISS is in a unique position to offer an unmatched portfolio of market-leading technologies to ophthalmologists, including an expanded, digitally-connected Retina Surgery Workflow from ZEISS. The companies’ portfolios are highly complementary and the powerful combination of the EVA NEXUS® platform from D.O.R.C. with ZEISS’s extensive range of visualization, diagnostic and therapeutic devices, and surgical instruments and consumables, all connected to a digital ecosystem, will enable the creation of efficient clinical workflows that will reshape the ophthalmology market for the benefit of surgeons and their patients alike.

D.O.R.C. brings to the acquisition one of the market’s most advanced dual-function systems - the EVA NEXUS platform. EVA NEXUS is the core of a strong portfolio, comprising a full range of accessories, instruments and liquids, offering one of the best-in-class solutions across vitreo-retinal (VR) and combined cataract procedures. The expansion that D.O.R.C.’s overall portfolio brings to ZEISS ensures that surgeons will have more options to choose the solutions that best meet their specific surgical requirements and preferences.

With the completion of this acquisition, health care professionals can expect to benefit from an extensive and unique combination of digitally connected devices and workflow solutions, from clinical pre-operative needs to the surgical operating room. This supports efficient clinical workflows and helps surgeons to improve outcomes for their patients. The two companies’ immediate priorities span maintaining business continuity and customer satisfaction, cultivating areas of deep expertise, and enhancing the value of their solutions and services for current and future customers.

Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another. For country-specific product information, see the appropriate country website. Product specifications are subject to change in design and scope of delivery as a result of ongoing technical development.

Head of Group Finance and Investor Relations Carl Zeiss Meditec AG

• +49 3641 220-116
• Download vCard

Head of Global Communications Ophthalmology Carl Zeiss Meditec AG

• +1 925 487 3036

About Carl Zeiss Meditec AG

Carl Zeiss Meditec AG (ISIN: DE0005313704), which is listed on the MDAX and TecDAX of the German stock exchange, is one of the world's leading medical technology companies. The Company supplies innovative technologies and application-oriented solutions designed to help doctors improve the quality of life of their patients. The Company offers complete solutions, including implants and consumables, to diagnose and treat eye diseases. The Company creates innovative visualization solutions in the field of microsurgery. With approximately 4,823 employees worldwide, the Group generated revenue of €2,089.3m in fiscal year 2022/23 (to 30 September).

The Group’s head office is located in Jena, Germany, and it has subsidiaries in Germany and abroad; more than 50 percent of its employees are based in the USA, Japan, Spain and France. The Center for Application and Research (CARIn) in Bangalore, India and the Carl Zeiss Innovations Center for Research and Development in Shanghai, China, strengthen the Company's presence in these rapidly developing economies. Around 41 percent of Carl Zeiss Meditec AG’s shares are in free float. The remaining approx. 59 percent are held by Carl Zeiss AG, one of the world’s leading groups in the optical and optoelectronic industries.

For more information visit our website at www.zeiss.com/med

About D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

D.O.R.C. is one of the world’s leading suppliers of equipment, instruments, and liquids for ophthalmic surgery. For 40 years, D.O.R.C. has grown into a successful international business, shaping its product portfolio through close collaboration with leading top surgeons. The company improves eye surgery globally and maximizes surgeon control by providing innovative quality approaches for eye disorders. Its products are exported to more than 80 countries worldwide. The company is headquartered in Zuidland, the Netherlands, and has more than 800 employees.

Further articles

Publication of a Related Party Transaction pursuant to Article 111c of the AktG with the aim of European distribution

ZEISS Sets Stage for Future of Ophthalmic Surgery and 3D Visualization at ASCRS 2024

Press portal.

Get all press releases of the Carl Zeiss Meditec AG here:

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A new way to detect radiation involving cheap ceramics

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The radiation detectors used today for applications like inspecting cargo ships for smuggled nuclear materials are expensive and cannot operate in harsh environments, among other disadvantages. Now, in work funded largely by the U.S. Department of Homeland Security with early support from the U.S. Department of Energy, MIT engineers have demonstrated a fundamentally new way to detect radiation that could allow much cheaper detectors and a plethora of new applications.

They are working with Radiation Monitoring Devices , a company in Watertown, Massachusetts, to transfer the research as quickly as possible into detector products.

In a 2022 paper in Nature Materials , many of the same engineers reported for the first time how ultraviolet light can significantly improve the performance of fuel cells and other devices based on the movement of charged atoms, rather than those atoms’ constituent electrons.

In the current work, published recently in Advanced Materials , the team shows that the same concept can be extended to a new application: the detection of gamma rays emitted by the radioactive decay of nuclear materials.

“Our approach involves materials and mechanisms very different than those in presently used detectors, with potentially enormous benefits in terms of reduced cost, ability to operate under harsh conditions, and simplified processing,” says Harry L. Tuller, the R.P. Simmons Professor of Ceramics and Electronic Materials in MIT’s Department of Materials Science and Engineering (DMSE).

Tuller leads the work with key collaborators Jennifer L. M. Rupp, a former associate professor of materials science and engineering at MIT who is now a professor of electrochemical materials at Technical University Munich in Germany, and Ju Li, the Battelle Energy Alliance Professor in Nuclear Engineering and a professor of materials science and engineering. All are also affiliated with MIT’s Materials Research Laboratory

“After learning the Nature Materials work, I realized the same underlying principle should work for gamma-ray detection — in fact, may work even better than [UV] light because gamma rays are more penetrating — and proposed some experiments to Harry and Jennifer,” says Li.

Says Rupp, “Employing shorter-range gamma rays enable [us] to extend the opto-ionic to a radio-ionic effect by modulating ionic carriers and defects at material interfaces by photogenerated electronic ones.”

Other authors of the Advanced Materials paper are first author Thomas Defferriere, a DMSE postdoc, and Ahmed Sami Helal, a postdoc in MIT’s Department of Nuclear Science and Engineering.

Modifying barriers

Charge can be carried through a material in different ways. We are most familiar with the charge that is carried by the electrons that help make up an atom. Common applications include solar cells. But there are many devices — like fuel cells and lithium batteries — that depend on the motion of the charged atoms, or ions, themselves rather than just their electrons.

The materials behind applications based on the movement of ions, known as solid electrolytes, are ceramics. Ceramics, in turn, are composed of tiny crystallite grains that are compacted and fired at high temperatures to form a dense structure. The problem is that ions traveling through the material are often stymied at the boundaries between the grains.

In their 2022 paper, the MIT team showed that ultraviolet (UV) light shone on a solid electrolyte essentially causes electronic perturbations at the grain boundaries that ultimately lower the barrier that ions encounter at those boundaries. The result: “We were able to enhance the flow of the ions by a factor of three,” says Tuller, making for a much more efficient system.

Vast potential

At the time, the team was excited about the potential of applying what they’d found to different systems. In the 2022 work, the team used UV light, which is quickly absorbed very near the surface of a material. As a result, that specific technique is only effective in thin films of materials. (Fortunately, many applications of solid electrolytes involve thin films.)

Light can be thought of as particles — photons — with different wavelengths and energies. These range from very low-energy radio waves to the very high-energy gamma rays emitted by the radioactive decay of nuclear materials. Visible light — and UV light — are of intermediate energies, and fit between the two extremes.

The MIT technique reported in 2022 worked with UV light. Would it work with other wavelengths of light, potentially opening up new applications? Yes, the team found. In the current paper they show that gamma rays also modify the grain boundaries resulting in a faster flow of ions that, in turn, can be easily detected. And because the high-energy gamma rays penetrate much more deeply than UV light, “this extends the work to inexpensive bulk ceramics in addition to thin films,” says Tuller. It also allows a new application: an alternative approach to detecting nuclear materials.

Today’s state-of-the-art radiation detectors depend on a completely different mechanism than the one identified in the MIT work. They rely on signals derived from electrons and their counterparts, holes, rather than ions. But these electronic charge carriers must move comparatively great distances to the electrodes that “capture” them to create a signal. And along the way, they can be easily lost as they, for example, hit imperfections in a material. That’s why today’s detectors are made with extremely pure single crystals of material that allow an unimpeded path. They can be made with only certain materials and are difficult to process, making them expensive and hard to scale into large devices.

Using imperfections

In contrast, the new technique works because of the imperfections — grains — in the material. “The difference is that we rely on ionic currents being modulated at grain boundaries versus the state-of-the-art that relies on collecting electronic carriers from long distances,” Defferriere says.

Says Rupp, “It is remarkable that the bulk ‘grains’ of the ceramic materials tested revealed high stabilities of the chemistry and structure towards gamma rays, and solely the grain boundary regions reacted in charge redistribution of majority and minority carriers and defects.”

Comments Li, “This radiation-ionic effect is distinct from the conventional mechanisms for radiation detection where electrons or photons are collected. Here, the ionic current is being collected.”

Igor Lubomirsky, a professor in the Department of Materials and Interfaces at the Weizmann Institute of Science, Israel, who was not involved in the current work, says, “I found the approach followed by the MIT group in utilizing polycrystalline oxygen ion conductors very fruitful given the [materials’] promise for providing reliable operation under irradiation under the harsh conditions expected in nuclear reactors where such detectors often suffer from fatigue and aging. [They also] benefit from much-reduced fabrication costs.”

As a result, the MIT engineers are hopeful that their work could result in new, less expensive detectors. For example, they envision trucks loaded with cargo from container ships driving through a structure that has detectors on both sides as they leave a port. “Ideally, you’d have either an array of detectors or a very large detector, and that’s where [today’s detectors] really don’t scale very well,” Tuller says.

Another potential application involves accessing geothermal energy, or the extreme heat below our feet that is being explored as a carbon-free alternative to fossil fuels. Ceramic sensors at the ends of drill bits could detect pockets of heat — radiation — to drill toward. Ceramics can easily withstand extreme temperatures of more than 800 degrees Fahrenheit and the extreme pressures found deep below the Earth’s surface.

The team is excited about additional applications for their work. “This was a demonstration of principle with just one material,” says Tuller, “but there are thousands of other materials good at conducting ions.”

Concludes Defferriere: “It’s the start of a journey on the development of the technology, so there’s a lot to do and a lot to discover.”

This work is currently supported by the U.S. Department of Homeland Security, Countering Weapons of Mass Destruction Office. This support does not constitute an express or implied endorsement on the part of the government. It was also funded by the U.S. Defense Threat Reduction Agency.

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