Trying to Keep Up

TTKU
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The FDA moves fast. Guidance changes. Policies evolve. Submissions get weird. Former-FDA reviewers Michael Nilo and Allison Komiyama started Trying To Keep Up for a simple reason: they were already spending time each week to jump on a call and ask, “Wait…what just happened at CDRH?” So they turned that call into a live conversation. Each week they (try to) unpack what’s actually happening at CDRH...from policy changes and regulatory curveballs to the ripple effects hitting real companies, real submissions, and real timelines. Expect: • Hot takes on FDA updates • Deep regulatory dives (and occasionally shallow ones) • Guests, Q&A, and off-script conversations • A healthy dose of jokes and regulatory nerd humor This isn’t a polished podcast and there’s no rigid agenda...just two former FDAers (and sometimes guests) talking through a regulatory landscape that seems to change by the week. If you work in MedTech and sometimes feel like the rules changed overnight…you’re not alone. We’re all just trying to keep up.

  1. EPISODE 1

    The FDA Plot Twist Nobody Asked For – 1/15/26

    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 changesCDS Guidance updatesGeneral Wellness Guidance updatesRemoval of the SaMD guidanceTEMPO / ACCESS initiativesFDA reviewer performance impactsLast-minute labeling change requestsEarly 2026 FDA and medtech trendsRecent approvals since January 1Remembering Mike Fogarty  Connect Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting Group  Subscribe Sign up to receive a calendar invite for weekly TTKU sessions

    58 min

  2. EPISODE 2

    The MedTech Rush Toward Breakthrough, STeP, and TAP - 1/22/26

    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 deviceSana Health and emerging light-based therapeuticsWhy everyone suddenly wants Breakthrough designationThe growing interest in STeP and TAP programsWhat the FDA TAP Pilot Assessment report revealsFDA resource constraints and impact on program timelinesReimbursement challenges post-clearanceConference insights: LSI, JPM, CESRAC certification announcements and industry milestonesFDA’s 125th anniversary and agency updates  Connect Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting Group  Subscribe Sign up to receive a calendar invite for weekly TTKU sessions

    32 min

  3. EPISODE 3

    General Wellness Chaos, AI 510(k)s, and MedTech Money Returns – 1/29/26

    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 HallFDA Draft Guidance: Cuffless Blood Pressure DevicesDigital health and Software as a Medical Device (SaMD) changesMedtech fundraising and JPMorgan Healthcare Conference trendsStartup quality system risks and regulatory shortcutsAI-generated regulatory submissionsFraudulent test lab concernsRemembering Thomas Fogarty and the Stanford Biodesign legacyFDA LinkedIn and Instagram strategy

    31 min

  4. EPISODE 4

    FDA’s Busy Week: QMSR, TEMPO, SQUID, and RWE (ft. Allison Kumar) – 2/5/26

    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 updatesTempo pilot program for digital health devicesMDUFA performance metrics and review timelinesFDA reviewer hiring and return-to-office discussionsReal-world evidence in De Novos and PMAseSTAR 6.1 updates for De Novo submissionsCybersecurity and software guidance updatesSQUID PMA approval for chronic subdural hematoma treatmentDevice-specific guidance documents and blood pressure device guidanceCDRH annual report highlights  Links Brendan O’Leary MDUFA analysisCDRH LearnFDA eSTAR ProgramFDA QMSR ResourcesFDA RWE Guidance

    41 min

  5. EPISODE 5

    Breakthrough Devices, FDA Shakeups, and Fish on Seaweed (ft. Caroline Rhim) - 2/12/26

    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 ReportFDA staffing and communication challengesWhether CDRH News is finally back from the deadUpcoming Real-World Evidence initiativesFDA hierarchy, appeals, and how major regulatory decisions can change at the highest levelsBald 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 NovoOptune Pax PMA for pancreatic cancerTumor Treating Fields technologyFDA Breakthrough Device DesignationTAP (Total Product Life Cycle Advisory Program)Reimbursement and investor expectationsFDA appeals and hierarchy2025 CDRH Annual ReportCDRH News revivalReal-World Evidence Town HallGeneral Wellness guidance updates

    43 min

  6. EPISODE 6

    MDR Mayhem, RWE Reality, and Robot Surgery (ft. Nicholas Werner) – 2/19/26

    This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by regulatory affairs leader Nicholas Werner for a wide-ranging conversation on FDA updates, global regulatory uncertainty, robotic surgery controversy, and why nobody seems to know what’s happening with harmonization anymore.   The episode starts exactly where you’d expect: terrible jokes, awkward livestream energy, and an unforgettable discussion about the now-infamous RFK Jr./Kid Rock HHS video. From there, the team dives into several notable FDA approvals and clearances, including Optune Pax for pancreatic cancer treatment, the LimiFlex Dynamic Sagittal Tether as a spinal fusion alternative, and newly approved orthokeratology lenses designed to reshape the eye overnight.   Nick also shares insights from the ophthalmic device world, including the growing conversation around myopia control and how FDA’s approach differs globally.   The conversation then shifts into some of the biggest regulatory debates happening right now: Intuitive Surgical’s controversial new 510(k)Real-world evidence guidance becoming officially activeQuestions around QMSR expectations for IDE studiesFDA down-classification discussionsMHRA’s decision to indefinitely recognize CE-marked devicesProposed MDR amendments in EuropeThe potential impact of Melissa Torres leaving FDA on global harmonization efforts  As always, the team balances serious regulatory discussion with plenty of chaos, sarcasm, and stories about daycare illnesses, pirates wearing eye patches, and whether hamster balls could solve pediatric infection control. Key Topics Covered FDA PMA approvals: Optune Pax and LimiFlexOrthokeratology lenses and myopia controlAntimicrobial wound dressing De Novo classificationIntuitive Surgical’s new robotic surgery 510(k)FDA real-world evidence guidance rolloutQMSR expectations for IDE clinical trialsFDA device down-classification discussionsMHRA recognition of CE-marked devicesMDR amendment proposals in EuropeMelissa Torres leaving FDA and harmonization concernsModerna vaccine review reversalWhy CDRH Learn returning matters to industry

    46 min

  7. EPISODE 7

    AI Pregnancy Devices, GLP-1 Competition, and FDA Chaos (ft. Jemin Dedania) – 2/26/26

    This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA reviewer and current MDIC NEST leader Jemin Dedania for a fast-moving conversation on FDA reclassification proposals, new AI-enabled devices, real-world evidence, and the latest regulatory headlines.   The group breaks down a newly cleared AI pregnancy timing tool, a PMA approval for the Allurion Gastric Balloon System, and what FDA’s proposed down-classification list could mean for orthopedic, spinal, dental, and surgical device manufacturers. They also discuss emergency use authorizations, rare disease initiatives, digital health leadership changes, and why regulatory precedent matters more than most startups realize.   Plus: bad doctor jokes, cow jokes, and a surprising amount of discussion about medical lube classifications.   Key Topics Covered Delivery Date AI De Novo clearanceAllurion Gastric Balloon System PMA approvalGLP-1 drugs vs. medical device weight-loss technologiesFDA proposed down-classification and exemption updatesOrthopedic and spinal instrument regulatory strategyReal-world evidence and MDIC NEST initiativesDigital health leadership changes at FDAEmergency use authorizations and respiratory testingFDA framework for ultra-rare disease therapiesWhy regulatory intelligence matters for startups  Links & Resources Mentioned FDA Reclassification DatabaseFederal Register Notice: Medical Device ExemptionsFDA Framework for Ultra-Rare Diseases  Connect Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupJemin Dedania | MDIC NEST  Subscribe Sign up to receive a calendar invite for weekly TTKU sessions

    32 min

  8. EPISODE 8

    FDA “Valentine’s Day Massacre” & What’s Next (ft. Monica Fahrenholtz) – 3/5/26

    This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by regulatory consultant Monica Fahrenholtz, who shares a firsthand account of the unprecedented disruption inside FDA during the past year—from mass layoffs to return-to-office chaos and the ripple effects still being felt across the MedTech ecosystem.   Monica walks through what it was actually like inside FDA during the “Valentine’s Day massacre,” including abrupt terminations, communication breakdowns, and how review teams continued hitting regulatory deadlines despite extreme instability. The conversation highlights the resilience of FDA reviewers and the operational risks companies should still be planning for today.   The team also breaks down key regulatory updates: A new De Novo clearance for LifeVac, an anti-choking device now formally entering the regulated spaceA PMA approval for the Synergy Disc®, an expanding cervical disc replacement systemUpdates from MDUFA VI negotiations, including potential improvements to the De Novo processOngoing questions around FDA’s use of AI tools following security concerns and policy shiftsNew and updated FDA guidance and safety communications, including choking response protocols Links AI-Enabled Medical DevicesMedical Devices that Incorporate Sensor-Based Digital Health TechnologyAugmented Reality and Virtual Reality in Medical DevicesFDA Update: Choking Rescue Protocols Connect  Allison Komiyama, PhD, RAC, FRAPS | Bluestocking HealthMichael Nilo, MS | Nilo Medical Consulting GroupMonica Fahrenholtz, PhD | Fahrenholtz Consulting Group Subscribe Sign up to receive a calendar invite for weekly TTKU sessions

    1h 51m
See All Season 1 (18)

About

The FDA moves fast. Guidance changes. Policies evolve. Submissions get weird. Former-FDA reviewers Michael Nilo and Allison Komiyama started Trying To Keep Up for a simple reason: they were already spending time each week to jump on a call and ask, “Wait…what just happened at CDRH?” So they turned that call into a live conversation. Each week they (try to) unpack what’s actually happening at CDRH...from policy changes and regulatory curveballs to the ripple effects hitting real companies, real submissions, and real timelines. Expect: • Hot takes on FDA updates • Deep regulatory dives (and occasionally shallow ones) • Guests, Q&A, and off-script conversations • A healthy dose of jokes and regulatory nerd humor This isn’t a polished podcast and there’s no rigid agenda...just two former FDAers (and sometimes guests) talking through a regulatory landscape that seems to change by the week. If you work in MedTech and sometimes feel like the rules changed overnight…you’re not alone. We’re all just trying to keep up.

Information

  • Creator
    TTKU
  • Episodes
    18
  • Seasons
    1
  • Rating
    Clean
  • Copyright
    © 2026 TTKU
  • Show Website
    Trying to Keep Up

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