Hardware Podcasts

#448: MedTech Investment: Outcomes, Regulations, and the Shift to At-Home Care

Global Medical Device Podcast · 23 Feb 2026 · 1h 00m · Episode 448

What this episode covers

Ivanny Franklin, Managing Partner at MedSight Capital, discusses her investment thesis for revenue-generating medical device companies, emphasizing the necessity of clear regulatory pathways (510(k) vs. PMA) and clinical evidence. She highlights the shift toward at-home monitoring and OTC diagnostics, noting the tension between patient empowerment and physician adoption, while explaining how Special Purpose Vehicles (SPVs) allow family offices to invest nimbly in specific deals. Franklin also addresses the high failure rates in AI-integrated devices due to evolving regulations, advising founders to prioritize safety, efficacy, and honest communication regarding reimbursement codes to avoid immediate disqualification from funding.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
MedSight Capital, NAMSA
Also
NMPA, FDA, CFDA, MDR, IVDR, PMA, 510(k), CMS, LSI

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