Build Smart, Not Fast: What the FDA Really Cares About in Digital Therapeutics
A practitioner perspective by Justin Kozak, Executive VP, Founder Shield.
The argument
DTx startups fail regulatory review by chasing flashy features instead of foundations. A regulatory-first mindset centered on clinical validity, safety, and data protection, with risk planning embedded early, gets products to market faster than feature-heavy builds that need rework.
Why we picked it
The HTC editorial desk curates practitioner perspectives that pass a simple test: would a health system executive, product leader, or investor act differently after reading it? This piece by Justin Kozak earns its place - it comes from the operating trenches of digital therapeutics, not the conference stage, and it takes a position specific enough to disagree with.
The bigger picture
The AI adoption question runs through every executive conversation in 2026. The evidence base is finally arriving: the largest controlled study of ambient documentation, published in JAMA, found clinicians saved 16 minutes of documentation time per day - but only a third of users hit the usage threshold for maximum benefit (our coverage). Meanwhile Rock Health has stopped labeling AI as a differentiator at all, because every company claims it - which is exactly why operating discipline of the kind described here separates winners from demo-ware.
Read it alongside our own reporting in Digital Therapeutics, where the data behind this debate is covered daily on the HTC Wire.