Meeting ReportsMedical Device Development

Academic/Industry Challenges for Medical Device Development

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Science Translational Medicine  22 Dec 2010:
Vol. 2, Issue 63, pp. 63mr6
DOI: 10.1126/scitranslmed.3001631

Abstract

A Clinical and Translational Science Awards Industry Forum titled “Promoting Efficient and Effective Collaborations Among Academia, Government, and Industry” was held in February 2010. A workshop at this forum was organized to discuss ways to promote medical device innovation. Specific challenges to the device development process were identified, as well as practical ways to address some of these issues.

Introduction

A breakout session on Medical Device Development was held at a Clinical and Translational Science Awards (CTSA) Industry Forum titled “Promoting Efficient and Effective Collaborations Among Academia, Government, and Industry,” which took place in Bethesda, Maryland, in February 2010. This session brought together university faculty, staff from the National Institutes of Health (NIH) and U.S. Food and Drug Administration (FDA), and leaders from large, small, and early-stage medical device companies. The collective breadth of experience and perspectives of the attendees enabled the group to effectively address the primary objective of the CTSA Industry Forum, which was to reveal the critical issues and barriers threatening collaboration among the academic, government, and industry sectors concerned with translational medical research. The group also identified a number of best practices that member institutions have developed to address these barriers. By understanding the distinct nature of medical device innovation, the impediments and solutions thereto become clearer. Barriers and best practices will be recounted after discussing germane characteristics of medical devices.

The Medical Device Development Process

Before discussing the workshop content, it is important to explicate medical device characteristics. The FDA’s Center for Devices and Radiological Health offers a clear definition of what a medical device is. “A medical device (i) diagnoses, cures, lessens, treats, or prevents disease; (ii) affects the function or structure of the body; and (iii) does not achieve primary intended purposes through chemical action” (1).

Recently, Pietzsch et al. (2) published a comprehensive model of the medical device development process, from concept to post-market surveillance (see Supplementary Material). The emphasis in this workshop was on the beginning of the process: discovery of needs and early-stage concept assessment. These are the precursor hurdles to be understood and overcome before committing to the commercialization of a concept.

Clinical needs provide opportunities for medical device innovation. The needs can be identified in a variety of ways (3): (i) identifying an unmet or under-met clinical need, (ii) new insight into the physiology of a disease, (iii) new insight into a diagnostic or therapeutic approach, (iv) technological innovation that improves an existing diagnostic or therapeutic approach, (v) a change in the health care delivery system that creates pressure to change a diagnostic or therapeutic approach, or (vi) some combination of the above.

Inventing a solution is only a requisite initial step in creating a medical product to address the need of a patient. Intellectual property (IP) analysis, market analysis, identifying and understanding the regulatory pathway that a product will follow, consideration of manufacturability of the product, and understanding how the product will be reimbursed are all important issues to be considered in making the decision to move a concept forward. It can be appreciated that a multidisciplinary team is required to provide the expertise needed to address these issues.

Insights from the Breakout Session

During the breakout session, the following specific challenges to the device development process within the academy were suggested for future stakeholder consideration:

(i) inadequate funding for proof-of-concept (POC) projects;

(ii) incomplete understanding, by faculty, of the medical device commercialization landscape;

(iii) limited understanding of regulatory science—that is, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products (4)—and the process of collaboration with the FDA;

(iv) lack of active project management to speed the development phase;

(v) inconsistent and perceived noncollaborative university IP policies;

(vi) poor communication between stakeholders;

(vii) fragmented medical device companies and markets that are typically smaller than those for drugs, both requiring business development skills and market expertise not readily available in academic settings; and

(viii) disciplinary knowledge silos—virtual nonfenestrated academic environments that act as barriers to intellectual collaboration—and a scarcity of “matchmaking” functions at universities, performed by rare individuals with access to clinical and engineering faculty and the experience and knowledge to create the appropriate connections between engineering and clinical faculty.

A strong consensus expressed during the breakout session is that it is critical to create mechanism(s) to quickly evaluate and approve modest small business innovation research type grants for POC projects with adequate funding. This is underscored by the short medical product life cycle (estimated by some to be ~18 months). Typically, the projects could range from further development of a technology to the production of a prototype medical device. The needed funding might range from $20,000 to $100,000 per project.

As described earlier, medical device innovation is a complex process, which differs substantially from the normative culture in the university of basic research and teaching. Until the recent Stanford University Biodesign book appeared (5), formal teaching materials covering the complete spectrum from the discovery of clinical needs—referred to as “needs finding”—to early-stage assessment of medical device commercialization potential were sparse. An opportunity exists for short courses or webinars to be developed by faculty with deep experience in medical devices to help interested faculty gain an understanding of the process.

The breakout session also identified several areas in which best practices at CTSA-funded institutions should be further described and researched in the medical device space: (i) the development of relevant training materials and courses; (ii) the formation of POC centers (POCCs); (iii) the availability of clinical trial resources for translational project teams; and (iv) the active involvement of industry mentors and advisors in translational research projects. This last point emphasizes a need deriving from the difference in the end points of traditional (basic) research and translational research. For translational research to be productive (brought to the clinic), adherence to relevant timing and budget in meeting defined milestones is critical.

POCCs have developed within the academic setting to facilitate proving the feasibility of the conceptual solution developed by inventors and understanding its commercial potential. POCCs typically accomplish this goal by providing some combination of seed funding, expert assistance, and training. The seed funding would support prototyping and/or further developing the technology. Expert assistance might entail providing project management mentoring, IP support, and analysis of market potential. Different approaches to POCCs exist across the United States. Several examples are listed in (610).

Attendees suggested that an annual national meeting is highly desirable to build a connected community in the device development space by bringing together CTSA grantees and other stakeholders to highlight current and emerging best practices. Topics would include educational curricula (particularly experiential-learning experiences), mentoring programs, IP management practices, faculty training, regulatory and reimbursement issues, and project management. Attendees suggested that the National Center for Research Resources (NCRR; a part of NIH), other NIH Institutes and Centers, and the Foundation of the NIH could be appropriate funding sources and conveners for the meeting.

The session attendees also identified several needs for new resources for the medical device community, including the following:

(i) a Web site similar to InnoCentive [an online bulletin board (11) that connects challenges and problems facing industry with solutions from innovators and problem solvers] that will connect people, ideas, resources, and needs for medical device creation beyond university “borders”;

(ii) a catalog of prototyping capabilities and equipment at CTSA-funded sites;

(iii) educational programs in regulation and business for researchers; and

(iv) a pathway for small businesses and universities to follow for partnering in clinical trials of devices.

CTSA Medical Device Innovation Working Group

The consensus of the breakout session participants was to create a working group named the CTSA Medical Device Innovation Working Group (MDIWG). To this end, a charter was written. The charter opportunity statement is as follows.

Cultural and structural barriers within the academic environment slow medical device innovation. The CTSA consortium has the opportunity to identify critical barriers throughout the translational landscape and, with substantive support by the NIH-NCRR, design and implement effective solutions to increase the pace and impact of medical device innovation. The translational pathways for medical devices are fundamentally different from those for biologics and pharmaceuticals, necessitating the development of specific knowledge, collaborations, and new solutions targeted to the medical device domain.

As envisioned, within the MDIWG, the CTSA consortium will lead a partnership involving all interested stakeholders, including industry, the FDA, and patients.

The goals of the MDIWG are the following:

(i) to support POC research for early-stage evaluation of new medical technologies;

(ii) to ensure the creation of national resources including infrastructure, core resources, and funding that support the unique needs of medical device translation;

(iii) to increase the pace and impact of medical device innovation within the academic environment with a focused, systematic approach to removing structural and cultural barriers within the organization that, in the past, have impeded results;

(iv) to assist in the development of streamlined technology disclosure, evaluation, and commercialization processes; and

(v) to develop mechanisms for sharing best practices in medical device technology transfer, including new approaches to education and mentoring.

Achieving the goals of the MDIWG will require an infusion of added financial resources: funding for POC research, support for an annual national meeting, funding to create the Web site described above, and funding mechanisms for increasing understanding of device development and partnering with industry.

Footnotes

  • Citation: J. H. Linehan, A. Chaney, Academic/Industry Challenges for Medical Device Development. Sci. Transl. Med. 2, 63mr6 (2010).

Supplementary Material

http://stm.sciencemag.org/content/2/63/63mr6/suppl/DC1

Fig. S1. Medical device development: High-level representation of development phases and of functional activities.

References and Notes

  1. Acknowledgments: We would like to express our appreciation to D. J. McCloskey (NCRR) for her excellent service to the workshop as scribe and consultant to this paper. Funding: This project has been funded in whole or in part with Federal funds from NCRR, NIH, through the CTSA Program, part of the Roadmap Initiative, Re-engineering the Clinical Research Enterprise. Relevant grants are to Northwestern University (UL1RR0254741) and Stanford University (5UL1RR025744-03). The manuscript was approved by the CTSA Consortium Publications Committee. Competing interests: J.H.L. is a Consulting Professor of Bioengineering at Stanford University. A.C. is on the Board of Directors of Wellman Inc. and ECI Inc.
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