How to Move Forward After a Thumbs Down from FDA

Brian Fahey, CEO of Adona Medical, is leading the development of the Adona Interatrial Shunt, a smart implant designed to manage heart failure. This adjustable shunt, integrated with bi-atrial pressure monitoring, helps regulate blood flow between the heart's upper chambers and enables remote monitoring of patients. In this interview, Brian talks about the importance of identifying and mitigating medtech’s three major risk factors, how to assess ideas strategically, and how to approach investors and potential M&A transactions.

Konrad Morzkowski is the co-founder and CEO of WearLinq and a member of Forbes’ 30 under 30 list. His company developed an FDA-cleared EKG monitor, eWave, which provides continuous cardiac monitoring for weeks at a time. WearLinq also connects patients to virtual cardiologists offering diagnoses and referrals, making it particularly valuable for patients in rural or underserved areas. In this interview, Konrad shares how he optimizes fundraising efforts by aligning them with important milestones, his unconventional methods to gather voice of customer research, and how his startup moved rapidly through product design iterations.

Under Bryan Lord’s leadership, Pristine Surgical has developed Summit, a fully integrated single-use, digital arthroscope with 4K resolution. In this interview, Bryan shares the story of how he evolved his career to become a medtech entrepreneur and the lessons he learned along the way—about how to protect your competitive advantage, how to achieve market pull vs. market push, and the importance of collaborating with experienced mentors.