Regulatory as a strategy for healthtech
MDisrupt is proud to present a multi-part webinar series that explores the major steps to building digital health solutions from inception to adoption featuring some of the industry’s leading experts.
In episode two, we’ll cover:
- Regulatory terms 101 (LDT, 510K, analytical validation, clinical validation SAMD, intended use).
- When is it wellness versus enforcement discretion versus medical device?
- What is the process for getting a regulatory clearance? How long does it take? How much does it cost?
- What studies do I need to do and how should I start them?
Meet the Panelists
Cara Tenenbaum, JD, MBA (Moderator)
Principal, Strathmore Health Strategy
Cara is a seasoned health policy expert, advocate, and writer with almost two decades of health policy experience. That includes experience in the patient advocacy field, having been the head of policy for a small non-profit focusing on women’s health. There, she handled all advocacy, including appropriations, authorizing legislation, drafting testimony, presenting testimony, preparing regulatory comment letters and working with all operating divisions of HHS, as needed. Additionally, she functioned as spokesperson for the organization, appearing on national and international TV as well as in print.
Cara was at the FDA for six years, working in both the Office of External Affairs in the Commissioner’s Office and the Office of the Center Director in the Center for Devices and Radiological Health. There, Cara worked on issues at the intersection of policy, legislation and advocacy, helping further the Agency’s agenda with patient and provider groups. One of her key responsibilities was in digital health.
Cara has numerous legal publications, including an article on user-centered digital health regulation that summarized a study with the Solomon Center at Yale Law School on digital health.
She holds a JD and MBA from Case Western Reserve University and a BA in Economics from the University of Maryland, College Park.
Kwame Ulmer, MBA
Managing Partner, MedTech Impact Partners
Kwame Ulmer is the Managing Partner at MedTech Impact Partners – A Regulatory Strategy Consulting Firm. Kwame brings over two decades of experience evaluating medical technologies in the government and private sector, and serving in senior operating roles at medical device companies to help companies successfully engage the FDA. He has personally evaluated more than 1,000 medical technologies in his career. Kwame spent 12 years at the FDA in progressive leadership roles. He also served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation operating company.
He is also a venture partner at Wavemaker Three-Sixty Health – the leading Southern-California based, early stage venture capital firm (Seed and Series A) focused on the healthcare industry. He leads the medtech practice and participates in all aspects of fund management (e.g. deal sourcing, diligence, negotiation and advising portfolio company management teams). Kwame sits on the board and advises several privately held medtech companies.
Kwame serves on the boards of Essenvia Inc and Strados Labs. Kwame is a board member of the Lincoln University Foundation, University of Virginia Licensing and Ventures Group and California Life Sciences. He is also a lecturer and researcher in medtech innovation at the University of California, Los Angeles. Kwame founded MedTech Color, a nonprofit with a mission to advance the representation of persons of color in the medical device industry. He earned his B.S. in Physics from Lincoln University, and has two Masters degrees from the University of Virginia, in Materials Engineering and Business Administration.
Lucia Savage, JD
Chief Privacy and Regulatory Officer, Omada Health
Lucia Savage is a nationally-recognized expert on health care regulation, digital health and health information privacy. Using strategic advice to advance digital technology to deliver health care, she drives the Omada Health’s privacy, regulatory and public policy strategies. Founded in 2011, Omada Health is one of the oldest virtual-first digital healthcare providers in the U.S. and has provided well-established cardio-metabolic and physical therapy protocols via a virtual-first approach to almost 1 million individuals.
Ms. Savage also is:
- An Advisor to Evidation Health, a digital health research platform that measures health in everyday life and enables anyone to participate in ground-breaking research and health programs,
- A member of the Board of Directors of Tidepool, a 501(c)(3) that is developing an open-source, fully interoperable closed-loop insulin pump (clearance pending at FDA) that allows people with diabetes to see and understand their own data; and
- A member of the Board of Directors of Academy Health, where she is chair of its Committee on Advocacy and Public Policy.
Lucia is Rock Health’s 2021 “Top 50 in Digital Health” for her policy acumen and digital health advocacy, is a contributing author to Amazon bestsellers “Mobile Medicine: Overcoming People, Culture and Governance,” and “Advanced Health Technology: Managing Risk While Tackling Barriers to Rapid Acceleration and has testified before the Senate Committee on Health, Education, Labor and Pensions on health information interoperability and digital health.
Prior to joining Omada, she served the Obama Administration as Chief Privacy Officer at the U. S. Department of Health and Human Services Office of the National Coordinator for Health IT. Lucia has a B.A. with Honor from Mills College and received her Juris Doctor summa cum laude from New York University School of Law.
Raji Pillai, PhD
Founder and President, Medical Affairs Consulting
Raji is a clinical and scientific affairs leader, experienced in strategic alliances, collaborations, KOL cultivation and conducting post market studies and clinical trials under GCP guidelines. Raji is a seasoned expert in developing innovative medical devices and molecular diagnostics under FDA and CLIA regulations and has a long track record of building high-performing, cross-disciplinary teams.
She has a degree in Biochemistry from Smith College, a Ph.D. in Biological Chemistry from UCLA and completed postdoctoral research in Biochemistry at the Stanford University School of Medicine.