technology
Hosted by TTKU · technology · EN
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.
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Contact path
Verified email
Booking probability
32%
Guest openness
Selective
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Signup to Generate a PitchThe 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.
Trying to Keep Up is hosted by TTKU. The show has published 41 episodes to date.
Recent episodes include "FDA's Next Moves: PCCPs, De Novo, and AI (ft. Michael Owens), 10/22/26" (22 October 2026, 62 minutes), "From FDA Reviewer to MedTech CEO: The 12-Year Overnight Success (ft. Shreya Mehta) - 10/15/26" (15 October 2026, 57 minutes), and "FDA’s 2027 Priorities, Human Factors, and Breakthroughs (ft. Tim Marjenin), 10/1/26" (1 October 2026, 60 minutes).
Trying to Keep Up publishes roughly weekly, with episodes averaging 52 minutes across 41 episodes.
Booking probability for Trying to Keep Up is 32%, and the host is rated Selective on guests. Trying to Keep Up requires a Pod Score of 80 or higher. Trying to Keep Up's contact route on record: verified email.
The strongest fits for Trying to Keep Up are Health & Wellness Services. Trying to Keep Up has a technology audience.
TTKU hosts Trying to Keep Up, a technology podcast with 41 episodes published.
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Episode #41
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo welcome Michael Owens, MS BME, RAC , a former FDA orthopedic device reviewer and assistant director with nearly 15 years of agency experience. Fresh...
Episode #40
What does it take to go from reviewing medical devices at the FDA to leading a company through PMA approval, fundraising, and commercialization? This week on Trying to Keep Up , Allison Komiyama and Michael Nilo welcome...
Episode #38
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by Tim Marjenin, VP of Neurology Regulatory Affairs at MCRA. Tim spent 16 years at the FDA as a lead reviewer and manager in the neuro group...
Episode #37
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by Laura Gilmour, MS, former FDA biomedical engineer and reviewer and Founder & Principal Consultant of LG Strategies, for a packed...
Episode #36
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by Rob Allen, PhD, former FDA biomedical engineer and current Senior Director of Regulatory Affairs – Biocompatibility at MCRA, an IQVIA...
Episode #35
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by former FDA branch chief and regulatory expert David Pudwill, aka Mr. Regulatory, for a packed conversation covering AI-enabled...
Episode #10
When does an AI chatbot become a medical device, and how do you regulate technology that can change the way it responds to patients? This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Aubrey...
Episode #34
How do you balance protecting patients from risk with getting potentially life-changing medical technology to the people who need it? This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by...
Episode #33
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by Keith Christopher , former FDA reviewer and current Director of U.S. Regulatory Affairs at JNPMEDI , for an appropriately global episode...
Episode #32
In a world where medical technology is evolving at breakneck speed, the latest innovation could change the way we experience blood draws forever. This week on Trying to Keep Up , Allison Komiyama and Michael Nilo dive...
Episode #31
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo tackle another busy week in MedTech, exploring how FDA policy is increasingly supporting a future where more medical devices move from hospitals into...
Episode #30
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by Daysi Diaz-Diesta , PhD, DABT, Senior Toxicologist at Gradient and ISO Working Group 17 Convener, for a conversation spanning AI-enabled...
Episode #29
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by Matt Trachtenberg , former FDA reviewer and Senior Director of Regulatory Affairs at Tempus AI , to discuss another eventful week in...
Episode #28
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo welcome Mike Ryan , former FDA Deputy Office Director for the Office of Regulatory Programs (ORP) and current consultant at ELIQUENT Life Sciences , for...
Episode #27
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo are joined by former FDA colleague and regulatory expert Dulciana Chan to unpack another busy week across medical devices, diagnostics, and FDA policy...
Episode #26
<p>This week on Trying to Keep Up, Allison Komiyama and Michael Nilo dive into another busy week in medical device regulation, highlighting new FDA activity affecting sponsors, startups, and regulatory...
Episode #26
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo dive into another busy week in medical device regulation, highlighting new FDA activity affecting sponsors, startups, and regulatory professionals. The...
Episode #25
<p>This week on Trying to Keep Up, Allison Komiyama and Michael Nilo celebrate a holiday-week edition of the podcast while unpacking several important developments affecting medical device and biotechnology...
Episode #25
This week on Trying to Keep Up , Allison Komiyama and Michael Nilo celebrate a holiday-week edition of the podcast while unpacking several important developments affecting medical device and biotechnology companies...
Episode #24
<p>This week on Trying to Keep Up, Allison Komiyama and Michael Nilo welcome Alex Cadotte, former FDA reviewer and current Vice President of Digital Health, AI, and Radiology Regulatory Affairs at MCRA, an IQVIA...
Recent guests on Trying to Keep Up. Study who booked and why before you pitch.
MS BME, RAC, Mableton, Georgia
Senior Director of Regulatory Affairs – Biocompatibility, Intermountain Healthcare
Head of People Deployment & Recruitment, Freeman's Event Partners
Hall of Fame NFL athletic trainer and sports medicine expert, The Dan Le Batard Show with Stugotz
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