Trends and Challenges in Research Innovation

The first part of the session titled “Innovation in Transition: Models, Global Trends, Regulatory Challenges, and Funding Opportunities” started with a presentation from John B. Simpson, MD, PhD, chief executive officer at Avinger, Inc, called “Individual-Based Innovation.” Dr Simpson briefly described the lumivascular approach to treatment of cardiovascular disease, which is image-guided atherectomy. This technology combines imaging and therapy in a single device without radiation exposure to the patient.

Next, “University-Based Technology Transfer” was presented by Karin Immergluck, PhD, associate director and acting director of technology management at the University of California San Francisco Office of Innovation. Because it is becoming more difficult for researchers to get funding, especially for translational type projects, UCSF has created an office that promotes development alliances between the university and industry for joint drug discovery and clinical development.

Hanson S. Gifford, BSME, of The Foundry, LLC, presented “Incubators and Accelerators.” Although the term “incubator” can mean many things, in this talk it represented a serial entrepreneurial approach to device development. According to the presentation, the Foundry team, which has dozens of ongoing studies and over 300 patents pending, has become successful due to alignment of interests and sustained funding, in addition to efficiency, persistence, and creativity.

In “Corporate Partnerships or Development,” Mike Buck, vice president of global market development at Abbott Vascular, indicated that his company is embracing a more open innovation model focused on increased partnership. Companies are no longer solely relying on internal R&D but are developing external, corporate partnership considerations. This approach was successful for Abbott in its pursuit of bioabsorbable vascular solutions.

The keynote lecture, “Emerging Regulatory and Financial Changes: Impact on Global Medical Device Innovation,” was given by Jack L. Lewin, MD, president and CEO of Cardiovascular Research Foundation in Washington, DC. Dr Lewin described barriers to cardiovascular device innovation, including growing regulatory burdens, limitations of small businesses as device start-ups, the proposed ACA device tax, and new payment reform models, which may disincentivize innovation. According to Dr Lewin, device innovation depends on the dynamics of the following: acceleration of scientific discovery, advancement of engineering, rapid progress in information exchange and analytics, and payment and delivery system reforms. He also discussed rethinking the global regulatory enterprise. Overall, he remains optimistic about device innovation, saying, “It’s a fantastic time to be in healthcare, and in particular, cardiovascular medicine.”

The next presentation was “The Compelling Case for Innovation in Emerging Markets and Reverse Innovation,” by Peter J. Fitzgerald, MD, PhD, professor of medicine & engineering at Stanford University Medical Center. After discussing factors that currently impede innovation—regulation, legislation, and litigation—Dr Fitzgerald reviewed ongoing innovations in Israel, Taiwan, and

China. He believes that the United States will again lead the way in healthcare advancements in the future, and efforts will focus on prevention and improving healthcare delivery.

In “Emerging Funding Models and Partnerships: Fueling the Innovation Engine,” Casey McGlynn, JD, with Wilson Sonsini Goodrich & Rosati, discussed a new model of funding for innovative processes. Because there is a lack of venture capital available to medical technology today, this new model is necessary. The “early exit” model involves selling prior to commercialization and partnering with existing organizations (often large universities or incubators) to eliminate or reduce dependence on venture capital. According to Mr McGlynn, this is a very viable model today and it allows for more control by the entrepreneur.

The final portion of this session, “New FDA Innovation Pathways: Returning Early Stage Device Development to the United States,” was presented by Andrew Farb, MD, medical officer at the US Food and Drug Administration (FDA). According to Dr Farb, the FDA’s goals are to provide early patient access to devices and regain US leadership in innovation. This involves a culture change to focus on “promoting public health, not only protecting it.” Changes include a focus on risk:benefit principle application throughout the regulatory decision, early feasibility studies, and “just-in-time” testing.