Trying to Keep Up in June
If May was about AI becoming real, June was about what happens next.
Every week brought another conversation about technologies that are changing how healthcare is delivered—and another reminder that innovation only succeeds when clinical, regulatory, and commercial strategies evolve alongside it.
Across four episodes of TTKU, Allison Komiyama and Michael Nilo explored how emerging technologies—from brain stimulation and digital health to generative AI and large language models—are reshaping the medical device landscape. Along the way, they welcomed experts from neuroscience, clinical research, digital health, and regulatory affairs to discuss what it actually takes to bring these technologies from concept to commercialization.
The conversations covered breakthrough devices, evolving FDA policy, clinical trial strategy, reimbursement planning, and the growing challenge of generating evidence for technologies that seem to evolve faster than regulation itself.
As always, there were terrible dad jokes, regulatory rabbit holes, and enough FDA news to make everyone wonder how anyone manages to keep up.
Watch June Episodes
Episode Highlights
Innovation is moving faster than ever, and FDA is evolving with it.
June’s biggest theme was the rapid pace of innovation.
The team discussed technologies that would have sounded futuristic only a few years ago:
Non-invasive brain stimulation for PTSD and depression
AI-enabled neurological diagnostics
Patient-facing large language models
Sensor-based digital health technologies
Augmented and virtual reality medical devices
Over-the-counter continuous glucose monitors for children
Rather than asking whether these technologies belong in healthcare, the conversations focused on the harder questions:
How should they be evaluated?
How much evidence is enough?
How can FDA encourage innovation without compromising patient safety?
Building evidence has never been more important.
Emerging technologies require emerging evidence strategies.
Throughout June, guests emphasized that companies need to think beyond regulatory submission requirements and build development programs that support long-term success.
Recurring topics included:
Clinical trial design
Site and enrollment challenges
Human factors
Real-world evidence
Breakthrough Devices
Reimbursement planning
Market access
One message came through repeatedly: Evidence generation isn't just about getting to FDA clearance—it's about creating the data needed to support adoption, reimbursement, and better patient outcomes.
Former FDA perspectives continue to shape the conversation.
One of TTKU's greatest strengths is bringing together people who have seen medical device regulation from both sides.
June's guests included former FDA reviewers and leaders who shared practical insights into:
How reviewers approach complex technologies
Why some submissions succeed while others struggle
Where sponsors can reduce unnecessary risk
How policy changes affect day-to-day review
Those conversations helped translate evolving FDA priorities into practical advice companies can actually use.
AI conversations are becoming more nuanced.
Artificial intelligence wasn't a new topic for TTKU, but June showed how quickly the conversation is maturing.
Rather than focusing on AI broadly, the discussions explored:
Generative AI
Large language models (LLMs) in patient care
Predetermined Change Control Plans (PCCPs)
AI lifecycle management
Cybersecurity
Data integrity
Software updates after market authorization
The recurring takeaway was that companies need thoughtful regulatory strategies that evolve alongside increasingly capable technologies.
Healthcare innovation still begins and ends with patients.
Even while discussing complex technologies, every episode returned to the same question: How does this improve patient care?
Whether talking about brain stimulation for PTSD, new approaches to depression treatment, clinical trial execution, pediatric continuous glucose monitors, or home healthcare technologies, the focus remained on improving access, reducing burden, and creating meaningful outcomes for patients.
Technology may drive innovation, but patients remain the reason for it.
Why It Matters
Medical device innovation isn’t slowing down. AI is becoming more capable. Digital health continues expanding. Neuroscience is entering an exciting new era. Regulators, sponsors, clinicians, and patients are all learning alongside one another.
The organizations that succeed won’t simply be the fastest to adopt new technology. They’ll be the ones that:
Build evidence early.
Think beyond regulatory approval.
Integrate regulatory, clinical, and reimbursement strategy.
Stay adaptable as guidance evolves.
Never lose sight of the patient.
That’s exactly what TTKU is designed to help the MedTech community do every week.
June’s Jokes
What do you call a hen staring at a pile of lettuce? → Chicken sees a salad.
Someone built an ATM that only hands out coins. → I can’t believe someone didn’t think of this before. It just makes cents.
What continues to work even after it’s fired? → A neuron.
What do you call a fish with no eyes? → A fsh.
What did the farmer call the cow that had no milk? → An udder failure.
Why do Norwegian boats have barcodes on them? → So they can scan da navy in.
What do you get from a pampered cow? → Spoiled milk.
What kind of hot dogs wear sweaters? → Chili dogs.
Why didn’t the bicycle go to the shop? → It was two tired.
What’s the best present you can give? → A broken drum, because no one can beat that.
Why don’t lobsters ever share? → They’re so shellfish.
Links
If you want to dig deeper, here’s what came up in June episodes:
FDA Updates & Guidance
Final Guidance: Human Factors Information in Medical Device Marketing Submissions
FDA Human Factors Website + FDA Town Hall on July 22
READI-Home Innovation Challenge Webinar
Draft Guidance: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities
EUDAMED implementation and MDR certification considerations
FDA classification orders for newborn screening, SARS-CoV-2 testing, and tinnitus devices
FDA’s updated AI-Enabled Medical Devices database
Medical Devices that Incorporate Sensor-Based Digital Health Technology
Augmented Reality & Virtual Reality in Medical Devices updates
Medical Device Shortages List updates
FDA READI-Home Innovation Challenge updates and FAQs
New FDA-cleared over-the-counter continuous glucose monitor for children
Draft Guidance: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
New Approvals
De Novo: Autonomous Healthcare’s Syncron-E™ for detection of patient-ventilator asynchrony
PMA: AbsorbaSeal™ Vascular Closure Device for sealing femoral artery punctures after catheter-based procedures
PMA: VENTANA PTEN companion diagnostic for prostate cancer treatment selection
PMA: Saypha® ChiQ™ for cheek augmentation
IDE: SpinaFX's Triojection®
510(k): UpDoc’s patient-facing LLM-enabled diabetes management platform
Trying to keep up with regulatory & clinical changes?
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