Trying to Keep Up in April
A lot happened. We’re still trying to keep up.
April felt like one long “wait, what just happened?” moment. Between shifting priorities at the FDA, new programs, and ongoing resource constraints, there was a lot to unpack. On Trying to Keep Up, we did what we always do. We talked through it in real time. Some of it made sense, some of it didn’t, and some of it is still very much a “we’ll see.” But at least there were jokes.
Episode Highlights
The FDA is changing. Everyone is adjusting.
If April had a headline, this would be it.
Across episodes, we kept coming back to the same reality: things are moving, but not always in a straight line. New initiatives show up. Old ones pause, then come back in a different form. Guidance evolves. Expectations shift.
And at the same time, there’s a very real capacity issue.
“I’m one of four lead reviewers right now… down from 15.”
That’s not a theoretical problem. That’s something teams need to plan around.
So the conversation shifted from “what is happening?” to “how do we actually work within this?”
Clinical strategy needs to stay focused and efficient.
We talked a lot about clinical strategy this month—not in a “cut corners” way, in a “be intentional” way.
The focus:
Design studies that answer the right questions
Align early with regulatory expectations
Avoid overbuilding just for the sake of it
There’s a balance here. You don’t need the biggest trial. You do need the right one.
New programs sound great. Execution is the question.
Several FDA initiatives came up throughout the month:
Faster pathways tied to reimbursement
Real-time clinical trial pilots
More coordination between FDA and CMS
On paper, all of this sounds great—faster access, better alignment, more efficiency. But the question we kept asking was: how does this actually work?
Because:
More programs = more complexity
More submissions = more review burden
More coordination = more moving parts
There’s optimism, but it’s cautious. Teams need to evaluate not just eligibility, but whether participation improves their overall strategy.
Data visibility continues to lag behind activity.
Another recurring theme was limited transparency. Public information doesn’t always align with the pace of approvals and regulatory decisions.
We’re still seeing:
Delays in De Novo decision summaries
Gaps in public data
Gaps in timing of breakthrough designations
Limited visibility into decision-making timelines
That matters because companies build strategy around what they can see. When that visibility isn’t there, it slows everything down.
The human side of MedTech still drives the work.
Even with technical depth, the conversations stayed grounded in real-world experience.
April episodes touched on:
How teams manage workload and uncertainty
How roles evolve across regulatory and clinical functions
The importance of communication across disciplines
Execution depends on people. Strategy only works when teams can carry it forward.
Jokes Are Part of the Show
April delivered some of the podcast’s best (and worst) jokes:
Regulatory humor that hits a little too close to home
510K: Boldly claim innovation while aggressively proving you changed almost nothing.
Verification vs. Validation: Did you build it right vs. did you build the right thing…and did you document it 12 ways?
Design Controls: If it’s not documented, it didn’t happen. If it is, it’ll be reviewed forever.
What do you call a small, scruffy dog that can’t breathe? → a Malt-wheeze
What do you call a T-Rex that sells guns? → a small arms dealer
What do you call two identical octopuses? → i-tentacle
Why don’t sand dollars take a bath? → They wash up on shore.
Why did the chef serve dinner late? → He used a slow cooker.
Does anyone know any jokes about sodium? → Na
What did one toilet say to the other? → You look flushed.
What do you call a cow with a crown? → Dairy Queen
What do you call a knighted steak? → Sir Loin
If you notice a bunch of cows sleeping in a field, does that mean it’s pasture bedtime?
Did you hear that scientists have grown human vocal cords in a petri dish? → The results speak for themselves.
Links
If you want to dig deeper, here’s what came up in April episodes:
Children’s Prize winner: OxyCare Uganda
NIH HEAL Initiative: optimization of therapeutic medical devices through team science mechanistic research
CMS and FDA announce RAPID coverage pathway to accelerate patient access to life-changing medical devices
MITRE cybersecurity papers: Cybersecurity Risk Analysis for Medical Devices in the Era of Evolving Technologies + Considerations for Managing Challenges in Software Bill of Materials (SBOM) Data Normalization
FDA
Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices
READI Home Innovation Challenge: advancing home-based care technologies
MDR coding resources: How to code an MDR adverse event report + MDR Data Files
Tips to Help Charge Medical Devices Safely and Avoid Overheating
New De Novos / PMAs / HDEs
De Novo Database (DEN250033)
De Novo: neuropacs™ AI-powered, imaging-enabled software for neurodegenerative diseases
De Novo: XplantR Explant Tool for open aortic endograft explant
Federal Register Notice: PMA Data Collection
HDE: River™ Stent for severe, refractory idiopathic intracranial hypertension
Reclassifications
Why It Matters
April reinforced something we’ve been saying for a while. You can’t wait for things to settle down. Regulatory expectations will keep shifting. Clinical strategies will keep evolving. Timelines will keep moving.
The teams that do well are the ones that:
Plan early
Stay flexible
Make decisions with imperfect information
That’s where NMCG comes in. We help teams build practical strategies that hold up in real conditions, not just ideal ones.
RAPID pathways, real-time trials, and a major Class I recall—what it all means for MedTech right now.
In this episode of Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by Véronique Li (Exponent) to unpack a fast-moving week across the FDA and CMS.
The discussion starts with the newly announced RAPID pathway, which aims to accelerate Medicare coverage for eligible breakthrough devices. The team explores what this could mean for reimbursement timelines, review burden, and overall regulatory strategy—especially in the context of ongoing staffing constraints.
They also break down the FDA’s proposed real-time clinical trial (RTCT) pilot, which leverages AI and continuous data monitoring to improve efficiency and safety. While the concept shows promise, the group highlights key questions around implementation, protocol design, and statistical impact.
Additional topics include:
A near-even split between U.S. and OUS 510(k) submissions—and what’s driving it
Ongoing gaps in FDA transparency, including delays in De Novo summaries
The progression of an early alert into a Class I recall for a blood glucose monitoring device, with potential global impact
Increasing cybersecurity expectations and the challenges of SBOM standardization
New FDA communications, safety updates, and reclassification activity
As always, the episode blends practical regulatory insight with candid discussion on what’s working, what’s unclear, and what to watch next.
Tune in to stay current on the policies, trends, and real-world implications shaping MedTech today.
Links
CMS and FDA announce RAPID coverage pathway to accelerate patient access to life-changing medical devices
Real-time clinical trials (RTCT)
MDR coding resources
How to code an MDR adverse event report
MDR Data Files
Tips to Help Charge Medical Devices Safely and Avoid Overheating
MITRE cybersecurity papers
Cybersecurity Risk Analysis for Medical Devices in the Era of Evolving Technologies
Considerations for Managing Challenges in SBOM Data Normalization
FDA Reclassification database
FDA Takes Step Forward on Testosterone Therapy for Men