Introducing a new medical therapy or technology is a complex, expensive, and time-consuming journey, one that is fraught with significant risk. While innovation often starts with a clear, well-defined unmet clinical need, it must be paired with an equally compelling value proposition. My mentor, Dr. Thomas Fogarty, once said, “An idea, by itself, has no importance whatsoever; it is the implementation of that idea and its acceptance by others that brings benefit to our patients.”
The “others” Tom refers to in this statement comprise the healthcare ecosystem; patients and their families, physicians, providers, payors, regulators, investors and acquirors. The needs of this community are complex, multi-factorial and often competing. To gain acceptance by this community an innovator must find, or make, a path that provides genuine value to each and all parties.
Clearly having a deep understanding of the true needs of all these parties is essential in the early stages of your journey. Through this understanding, the innovator is better able to balance the myriad of clinical, engineering, market, and economic demands of the business they are building.
Operationalizing Innovation: The TCT MedTech Innovation Forum
The complexity of the healthcare innovation landscape and the ecosystem of expertise needed to bring new technologies forward is at the heart of the partnership between the Cardiovascular Research Foundation (CRF), one of the world’s leading nonprofit organizations specializing in clinical innovation, research, and education; and the company I lead, Fogarty Innovation (FI). FI is a nonprofit educational medtech incubator that advances human health by accelerating the invention, development, and deployment of new medical technologies into clinical care.
For the second year, CRF and FI are working together to produce the MedTech Innovation Forum on the first day of the TCT (Transcatheter Cardiovascular Therapeutics) conference, CRF’s annual scientific symposium. Founded by Martin Leon, MD, and now led by Juan Granada, MD, TCT is the world’s foremost educational meeting specializing in cardiovascular medicine. Focused on sharing clinical and scientific information, the program features late-breaking clinical trials and science, live cases demonstrating new techniques and therapies, and case-based presentations with interactive discussions.
The MedTech Innovation Forum expands TCT’s traditional, clinically oriented focus on technological advancement with a deep dive into the entrepreneurial and business constraints of innovation and the opportunity to learn from and interact directly, with leaders from across stakeholder groups. It is a full day of education and discussion that brings together physicians, entrepreneurs, investors, payors, and regulators to identify clinical challenges, uncover opportunities for innovation, and drive a practical understanding of the rewards and complex process required to bring novel medical technologies to market.
With a seasoned leadership team that has a combined 400+ years of startup experience, FI is well-positioned to help CRF provide that perspective – it’s a condensed version of the work we do every day. FI specializes in operationalizing innovation – translating ideas from bench to bedside. We do this by providing intensive hands-on coaching and support to help our companies-in-development navigate the tortuous path to commercialization. We also produce educational programming rooted in practical, real-world experience for entrepreneurs, industry, and government, and use our unique non-profit status to bring disparate groups together and build alliances that increase understanding and cooperation among stakeholders in the innovation ecosystem.
The demand for comprehensive education around health technology innovation is robust. Last year’s inaugural TCT MedTech Innovation Forum attracted over 1,400 physicians, fellows, researchers, innovators, investors, and entrepreneurs, well over our anticipated audience. Afterward, representatives from the FDA reached out to request a larger role in future programs, as the topic and attendees dovetail with the organization’s goal of getting involved with entrepreneurs earlier in the innovation process. As a result, we expanded this year’s Forum to accommodate more participants and an even broader range of stakeholders and interests. The result of this effort is three distinct educational tracks:
Track one, “Global Market Dynamics,” is dedicated to trends shaping the future of medtech innovation. It features in-depth discussions on topics such as global demographics and how they translate to innovation opportunities, the state of the financial ecosystem, the perspectives of senior industry and government leaders, key areas for innovation, and more. The second track, “Hot Topics in MedTech,” explores cutting-edge scientific evidence and insights around current issues such as structural heart disease, digital diagnostics and therapeutics, and mechanical circulatory support.
The third track is “FDA University for Startups.” Conceived and organized by the FDA, this track provides first-time entrepreneurs with valuable insights into regulatory policy and guidance so that they can navigate the US regulatory pathway with confidence. Specific sessions will cover best practices in regulatory affairs, regulatory pain points and relief, and more.
Finally, because digital health cuts across all three tracks, we’ve woven sessions with that focus across the program. Specific sessions include Digitalization of Healthcare and Healthcare Delivery, Digital Diagnostics & Therapeutics, and The Reimbursement Landscape in the Digital Age.
In keeping with the Innovation theme, TCT moved the exciting TCT Shark Tank Innovation Competition into the Forum this year. Celebrating its 10th year, the competition seeks to identify the most innovative device concepts and technological developments with the potential to disrupt the cardiovascular field. Participants will present to a panel of expert judges and compete for an award of $200,000 provided by the Jon DeHaan Foundation.
The TCT Medtech Innovation Forum will give first-time innovators a practical framework for evaluating ideas and a network that can help them advance promising concepts. It will inspire innovation by connecting entrepreneurs to conversations about recent clinical data, discussions of major challenges and disease states, and reflections on device developments that are disrupting the historical standard of care. It is also an opportunity to improve the health and functionality of the ecosystem itself by providing a forum to surface and address stakeholder opportunities, challenges and pain points. By increasing cooperation and collaboration among stakeholders, we can speed the delivery of innovations that improve the quality, access, and affordability of patient care.
Networking, the less-scripted part of the day, is another essential goal. Early-stage investors bet on the team as well as the technology. Ideally, they want teams who will cast a wide net for information, taking into consideration the needs of all stakeholders and the diverse perspectives of different patient populations, then use that input – along with their own experience and insight – to choose a path forward and execute on that plan. Because new information is inevitably acquired along the way, that team also needs the perspective and confidence to monitor the results of those decisions and when warranted, change direction. Building the right team is essential to startup success and convening people with shared passions but disparate experiences, skills, and backgrounds, is a promising place to start.
Addressing Global Challenges and More
All three tracks come together for an opening session, a call to action on the global challenges of health inequity and access to care. While healthcare innovation is complex, the bar is even higher when we talk about inventing affordable, accessible solutions for markets that are less well-developed and funded than the US. Inspiring the healthcare and medtech community to tackle these challenges is one of the larger goals of the Forum. Not only do we need creative solutions designed for lower-resource environments, but the resourcefulness and determination to find or create alternate pathways to fund the development and implementation of these solutions.
Health technology innovation is a worthwhile journey with the potential to solve many of the important problems in care that plague us at a global level – including aging, chronic disease, and unsustainable costs. To realize those benefits, we need partnerships that bring together clinical and research expertise, the perspectives of regulators, payors, and other key stakeholders, and the experience to operationalize those ideas.
My good friend and mentor Allan Will once said, “The most important words of wisdom I’d have for someone who wants to be a medical technology entrepreneur is not to do it because you want to make money or hold a glamorous entrepreneurial role. Do it because you’re passionate about treating patients and helping improve patients’ lives. Do it because you’re passionate about creating a stimulating, rewarding work environment for employees. If that’s what drives you, I think at the end of the day you’ll find you’ve had a very satisfying life.”
The MedTech Innovation Forum will take place on October 23 in San Francisco on the first day of TCT. I hope you will join us to be part of this conversation.
Editor’s Note: Andrew Cleeland is the CEO of Fogarty Innovation. He is a seasoned executive with 30+ years in the medical device industry in both the private and public sectors. He is on the boards of Saluda Medical, Zenflow, Inc. (chairman), MMI S.p.A. (chairman), and NXT Biomedical and holds advisory positions at two top-tier VC’s: Longitude Capital and Arboretum Ventures. Andrew also serves on multiple industry initiatives including the UCSF-Stanford Pediatric Device Consortium; the Medical Device Innovation Consortium; and the Singapore government’s Biomedical Research Council (BMRC).
Andrew is passionate about healthcare and a champion of innovators and innovation in the medtech field. His commitment to mentoring and education is rooted in his passion for helping patients and being a catalyst for positive change. This purpose and drive are captured in one of his favorite quotes, by Mahatma Gandhi: “A small body of determined spirits fired by an unquenchable faith in their mission can alter the course of history.”