Trying to Keep Up

Michael Nilo is out this week, but the show must go on. Allison Komiyama welcomes longtime FDA colleague and regulatory strategist Caroline Rhim for a fast-moving conversation on breakthrough devices, FDA review realities, new cancer technologies, and the return of CDRH News.

They unpack two newly authorized devices making headlines: the Amferia Wound Dressing De Novo and the Optune Pax PMA for pancreatic cancer treatment. Caroline explains how tumor treating fields work, why the technology is so compelling, and what these approvals could signal for the future of medical devices.

The conversation then shifts to one of the biggest topics in medtech right now: FDA Breakthrough Device Designation and TAP. Allison and Caroline discuss what the programs actually help with, where companies get tripped up, investor misconceptions, reimbursement expectations, and why “breakthrough” definitely does not mean “easy.”

They also cover:

• The 2025 CDRH Annual Report
• FDA staffing and communication challenges
• Whether CDRH News is finally back from the dead
• Upcoming Real-World Evidence initiatives
• FDA hierarchy, appeals, and how major regulatory decisions can change at the highest levels
• Bald eagles, hummingbirds, ravens, and aggressively competitive birds of prey

Plus: terrible jokes, medtech optimism, and a surprisingly deep conversation about regulatory nuance.

Key Topics Covered

• Amferia Wound Dressing De Novo
• Optune Pax PMA for pancreatic cancer
• Tumor Treating Fields technology
• FDA Breakthrough Device Designation
• TAP (Total Product Life Cycle Advisory Program)
• Reimbursement and investor expectations
• FDA appeals and hierarchy
• 2025 CDRH Annual Report
• CDRH News revival
• Real-World Evidence Town Hall
• General Wellness guidance updates

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by regulatory strategist and former FDA reviewer Allison Kumar to unpack the FDA news dump nobody had time to read.

The trio dives into FDA’s rollout of QMSR, updates to compliance and audit procedures, the launch of the TEMPO Pilot program for digital health technologies, and what recent hiring activity could mean for review timelines and agency capacity. They also unpack the latest MDUFA performance data, PMA publication delays, evolving real-world evidence expectations, and why device-specific guidances may finally be getting more useful.

Along the way, they discuss the new SQUID PMA approval, CDRH Learn updates, eSTAR 6.1 changes, and the growing importance of AI, cybersecurity, and chronic disease technologies at FDA.

Plus: regulatory jokes, dental device trauma, Super Bowl gambling talk, and Allison Komiyama’s accidental lip-filler era.

Key Topics Covered

• FDA QMSR implementation and compliance program updates
• Tempo pilot program for digital health devices
• MDUFA performance metrics and review timelines
• FDA reviewer hiring and return-to-office discussions
• Real-world evidence in De Novos and PMAs
• eSTAR 6.1 updates for De Novo submissions
• Cybersecurity and software guidance updates
• SQUID PMA approval for chronic subdural hematoma treatment
• Device-specific guidance documents and blood pressure device guidance
• CDRH annual report highlights

Links

• Brendan O’Leary MDUFA analysis
• CDRH Learn
• FDA eSTAR Program
• FDA QMSR Resources
• FDA RWE Guidance

This week on Trying to Keep Up, Allison Komiyama and Michael Nilo unpack the latest FDA digital health developments, startup funding realities, and the growing uncertainty around general wellness policy.

The conversation dives into FDA’s upcoming General Wellness Town Hall, newly released draft guidance on cuffless blood pressure devices, and the ripple effects of recent software guidance changes. Allison and Michael also discuss how medtech startups are navigating tighter budgets, where companies are making risky cost-cutting decisions, and why quality systems still matter even when funding gets thin.

They also recap what they’re hearing from JPMorgan Healthcare Week, reflect on the passing of legendary medtech innovator Thomas Fogarty, and debate whether AI-generated 510(k)s are helping—or creating bigger regulatory problems.

Plus: pirate eye patches, ophthalmology jokes, and FDA social media commentary.

Key Topics Covered

• FDA General Wellness Policy Town Hall
• FDA Draft Guidance: Cuffless Blood Pressure Devices
• Digital health and Software as a Medical Device (SaMD) changes
• Medtech fundraising and JPMorgan Healthcare Conference trends
• Startup quality system risks and regulatory shortcuts
• AI-generated regulatory submissions
• Fraudulent test lab concerns
• Remembering Thomas Fogarty and the Stanford Biodesign legacy
• FDA LinkedIn and Instagram strategy

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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The first official episode of Trying to Keep Up (TTKU) is here.

Allison Komiyama and Michael Nilo kick things off by diving into the FDA news, guidance changes, and medtech industry shifts already making waves in 2026. The conversation explores what regulatory and clinical teams should actually pay attention to—without spiraling into doomscroll mode.

As always, the goal is simple: help medtech teams stay informed without losing their minds.

Plus: jokes about aging, running for five straight days, and throwing your back out reaching for toilet paper.

Key Topics Covered

• Infection Control Branch confusion and changes
• CDS Guidance updates
• General Wellness Guidance updates
• Removal of the SaMD guidance
• TEMPO / ACCESS initiatives
• FDA reviewer performance impacts
• Last-minute labeling change requests
• Early 2026 FDA and medtech trends
• Recent approvals since January 1
• Remembering Mike Fogarty

Connect

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

Subscribe

Sign up to receive a calendar invite for weekly TTKU sessions