The Device Files: From Concept to Commercialization

The Device Files: From Concept to Commercialization

Home
Notes
The Device Files Community
Archive

2025Q4 in Review: Strategic Takeaways for Device Leaders

We hit 17,500+ monthly views in December! See what's in store for 2026.
READ THE LATEST
The Wearables Inflection Point
How One Wearable Forced the Industry to Grow Up – and THE Framework for Crossing the MedTech Rubicon
 • Blythe Karow
An FDA Development That Might Reshape the World of ML Diagnostics
Tell Me I’m Wrong
 • Blythe Karow
Six Months After WHOOP: Why the FDA’s Recent Activity Signals a Regulatory Turning Point
It’s been nearly six months since WHOOP received that FDA warning letter in July 2025 about their Blood Pressure Insights feature.1 If you’ve been…
 • Blythe Karow
ONE PRODUCT OR TWO?
A Product Portfolio Decision Playbook
 • Blythe Karow
How to Build Organizations That Create Breakthrough Products
Part 3: Human-Centered Design, Sandbox Environments, and Innovation Culture
 • Blythe Karow
Diagnosing the Problem: Customer Discovery Lessons in Product Portfolio Strategy
This is the second article in a three-part series on human-centered design and how we use it to guide good MedTech product development.
 • Blythe Karow
When Good Design Breaks
Part 1 of 3: Human-Centered Design in Product Development
 • Blythe Karow
The Device Files: From Concept to Commercialization
The Device Files: From Concept to Commercialization
Strategic field notes on commercializing innovation in MedTech, wearables, and digital health.
Recommendations
NEUROTECH FUTURES
NEUROTECH FUTURES
Naveen Rao
Thinking Kat
Thinking Kat
Katrina Rogers
Let's Talk Risk!
Let's Talk Risk!
Naveen Agarwal, Ph.D.
Work with Me
The Karow Advisory Group
If these insights hit home, turn Device Files ideas into outcomes with The Karow Advisory Group
Connect on LinkedIn
Join my growing LinkedIn community and get daily insights.
Book an Intro Call
20 minutes to scope your needs and see if we’re a fit.

The Device Files: From Concept to Commercialization

AboutArchiveRecommendationsSitemap
© 2026 Blythe Karow · Privacy ∙ Terms ∙ Collection notice
Start your SubstackGet the app
Substack is the home for great culture