Everywhere you look in medtech right now, companies are talking about Breakthrough, STeP, or TAP. But are these programs changing outcomes or just becoming the industry’s newest obsession?

In this episode of Trying to Keep Up (TTKU), Allison Komiyama and Michael Nilo unpack the growing industry focus on FDA programs like Breakthrough Devices, STeP, and TAP. They discuss why companies are pursuing these pathways so aggressively, what these programs offer, and how perception, investor pressure, commercialization strategy, and regulatory reality all intersect.

They also cover early-year medtech updates, industry conversations coming out of JPM Week, new approvals making headlines, and the increasing pressure companies feel to stand out in a crowded market.

As always, TTKU blends practical regulatory insight with candid industry commentary, side conversations, jokes, and the kind of anti-doom-scroll discussion that helps medtech teams keep up with what actually matters.

Key Topics Covered

• De Novo clearance for Bridge to Life’s perfusion device
• Sana Health and emerging light-based therapeutics
• Why everyone suddenly wants Breakthrough designation
• The growing interest in STeP and TAP programs
• What the FDA TAP Pilot Assessment report reveals
• FDA resource constraints and impact on program timelines
• Reimbursement challenges post-clearance
• Conference insights: LSI, JPM, CES
• RAC certification announcements and industry milestones
• FDA’s 125th anniversary and agency updates

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group

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