This week on Trying to Keep Up, Michael Nilo is flying solo while Allison Komiyama is off galivanting across the pond. Joining him is clinical research and medical device leader Caroline Rhim for a discussion on the current state of clinical trials, emerging technologies, and the evolving regulatory landscape.

Michael and Caroline dive into what sponsors are experiencing in today's clinical research environment, from enrollment and site challenges to shifting evidence expectations and the increasing need to align regulatory, clinical, and reimbursement strategies early in development. Drawing on Caroline's experience across MedTech and clinical operations, the discussion focuses on practical lessons for companies trying to move innovative technologies from concept to commercialization.

The episode also covers:

• The current clinical trial landscape and sponsor challenges

• FDA approval of the AbsorbaSeal™ Vascular Closure Device

• SpinaFX's Triojection® IDE approval and breakthrough technologies

• Myopia treatment innovation and emerging clinical evidence

• New FDA draft guidance on communications with payors

• Reimbursement planning and market access strategy

• Human factors guidance updates and the upcoming FDA town hall

• FDA classification orders for newborn screening, SARS-CoV-2 testing, and tinnitus devices

• EUDAMED implementation and MDR certification considerations

• Trends in breakthrough device designations and what they mean for innovators

Plus: cow jokes, clinical trial war stories, regulatory detours, and Michael doing his best to keep the show on the rails while Allison is away.