Sitemap - 2025 - The Device Files: From Concept to Commercialization
The Wearables Inflection Point
An FDA Development That Might Reshape the World of ML Diagnostics
Six Months After WHOOP: Why the FDA’s Recent Activity Signals a Regulatory Turning Point
How to Build Organizations That Create Breakthrough Products
Diagnosing the Problem: Customer Discovery Lessons in Product Portfolio Strategy
Designing Clinical Trials for Both FDA and Payers
Mapping the Vagus Nerve: Strategic Decisions in Uncharted Medical Territory
The Clinical Wearables Revolution Is Here, and Oura’s $900M Raise Shows Where It’s Heading
The Hidden Costs of ‘Free’ Reimbursement Codes
The Misfit Protocol: Detecting and Deflecting Competitive Intelligence
The Competitive Intelligence Playbook
Strategic Product Announcement Decision Framework
The Product Announcement Dilemma: When to Build Buzz vs. Launch by Surprise
Q3 in Review: Strategic Takeaways for Device Leaders
From Clearance to Cash: How to Cut 18 Months Off Your Reimbursement Timeline
CMS Breakthrough Device Bill Passes House Committee: Time to Get Involved
Apple’s Latest Update Takes Aim at Blood Pressure
New Ways to Support the Device Files
Why Smart MedTech Money Is Looking Down Under
How CMS Is Killing Breakthrough Medical Device Innovation
UPDATE: The More We Learn, the Worse WHOOP's Defense Looks
Will the CMS Health Tech Initiative Usher in a New Era of Wearables Reimbursement?
The Next Episode: Where the Real Opportunities Lie in the Future of Wearables
Mo' Money Mo' Problems: How Investors Are Incentivizing the Wrong Behavior in the Wearables Market
Fight the Power: Is WHOOP Really in the Wrong in This FDA Battle?