『Trying to Keep Up』のカバーアート

Trying to Keep Up

Trying to Keep Up

著者： 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.

2026 TTKU 衛生・健康的な生活 身体的病い・疾患
エピソード
  • The FDA Plot Twist Nobody Asked For – 1/15/26

    The FDA Plot Twist Nobody Asked For – 1/15/26
    2026/03/06

    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
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    58 分
  • De Novos, Drama, and a Very Cool Heart Valve (ft. Alexia Haralambous) – 3/26/26

    De Novos, Drama, and a Very Cool Heart Valve (ft. Alexia Haralambous) – 3/26/26
    2026/03/30

    This week on Trying to Keep Up, Allison and Michael are joined by Alexia Haralambous to break down the latest regulatory activity. They also dive into breakthrough device trends, melanoma device reclassification, and what it all means for innovation, patients, and the future of care at home.

    Key Topics Covered:

    • De Novo clearance: TytoCare Insights for eardrum bulging detection
    • Why broad vs. narrow classifications matter
    • PMAs:
      • aura6000™ system for obstructive sleep apnea
      • Trilogy transcatheter heart valve system
    • Breakthrough devices:
      • MeMed BV Flex™ (bacterial vs. viral test)
      • Noah Labs voice-based heart failure detection
    • Growth of home-based diagnostics and telehealth integration
    • FDA ReDI Conference preview
    • Reclassification of melanoma diagnostic devices (Class III → Class II)
    • Benefit-risk considerations across user populations
    • The evolving regulatory bar for innovation

    Links:

    • NIH – Posting Clinical Trial Informed Consent Forms

    Stay Connected:

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

    Subscribe:

    • Sign up to receive a calendar invite for weekly TTKU sessions
    • YouTube
    • Spotify
    • Apple Podcasts
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    56 分
  • RWE Is Having a Moment + Weirdest Device Reclassifications Yet – 4/2/26

    RWE Is Having a Moment + Weirdest Device Reclassifications Yet – 4/2/26
    2026/04/02

    This week on Trying to Keep Up, Allison and Michael unpack a busy stretch across the FDA and medtech landscape. From new real-world evidence (RWE) examples and patient preference guidance to hiring insights and TAP program expansion, the conversation blends regulatory updates with practical perspective. They also highlight global innovation and share candid takes on FDA culture, communication, and what it really takes to “keep up.”

    Links:

    • OxyCare Uganda (Children’s Prize winner)
    • FDA ReDI Conference (May 19-20, 2026)
    • Real-World Evidence at FDA
    • RWE FDA Voices Blog
    • FDA's TAP Program Details
    • Neurotech Conference 2026
    • FDA's LinkedIn
    • FDA's YouTube
    • Exemptions from Premarket Notification: Class II Medical Devices
    • Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer

    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
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    42 分
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