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The Device Files: From Concept to Commercialization

Strategic field notes on commercializing innovation in MedTech, wearables, and digital health.

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Burn the Haystack: Understanding the Investor Mindset, Part Three

The Real Secret to Attracting an Investor

Burn the Haystack: Understanding the Investor Mindset, Part Two

The Ick Factor

Burn the Haystack: Understanding the Investor Mindset

Part 1: Why Investors Think the Way They Do, and Why That’s Rational

Is Remote Monitoring About to Face a Reckoning? Reviewing the New CMS Rule Change Proposal

Last week The Centers for Medicare & Medicaid Services (CMS) published their Calendar Year 2027 Medicare Physician Fee Schedule proposed rule, a 1,592-page document.1 In those proposed new rules were some pretty interesting suggestions around Remote Patient Monitoring (RPM).

The Return of Carnac the Magnificent

It looks like I have to don the turban again.

The Big MedTech Players Are Coming for Wearables

OK, slightly behind on news here with the “year end” wrap-ups, but there was an interesting press release on June 4th.

One Year of The Device Files: WHOOP, Oura, AI, FDA, CMS, and the First Ever Device Files Awards!

Your chance to Vote (and Nominate) for the 2026 Device Files Reader Awards! Plus a year-end wrap up, what the future will bring, and our quarterly overview.

Final Episode of Commercialization Confidential: Best Practices for Hospital Commercialization with Jess Richter

If you’ve been reading The Device Files for a while, you know the usual format.

Everyone Thinks They’re Doing It Right

OR "The Farmer and the Cowman Should be Friends"

A Comedian, a Cult Movie, and a Question About the Future of Medicine

The Doctor Is the Safety Check. About That.

Two "Whoop Killers" in Two Weeks? Don't Trust the Headlines.

The Fitbit Air launched on May 7, 2026.

The Company That Cracked Wearable Blood Pressure - And Made It Free

Commercialization Confidential Episode 5: Gaurave Kohli, CEO of VitalFriend

Has CMS Finally Cracked the Breakthrough Device Coverage Code?

RAPID, TCET, NTAP: CMS’s Latest Coverage Shuffle Explained

Whatever Happened to TCET, CMS’s Breakthrough Device Coverage Pathway?

This is part two of a three-part series on what the breakthrough device coverage problem looks like from inside CMS, in conversation with Dr.

Is CMS Killing Breakthrough MedTech? A View from the Other Side

This article is part one of a three-part interview series with Dr. Lee Fleisher, former Chief Medical Officer of CMS, on what the breakthrough device coverage problem looks like from CMS's point of view.

Jamie Grooms on the Week Axogen Almost Went Under - and the Commercialization Lessons That Came Out of It

A Quick note before we start: I have to say a MAJOR Thank You to Jamie Grooms for this podcast for two reasons:

How to Lose Your Best Sales Reps Without Even Trying: Lessons from the Boston Scientific Pacemaker Recall

Do you ever absentmindedly decide to check on your stock portfolio and then instantly wish you didn’t?

Crisis Communication Playbook

Managing Your Team Through Recalls, Restructuring, and Financial Crises

The New CMS ACCESS Program is Extending its Application Deadline through May 15. Should You Apply? WHOOP Just Did.

Last week I joined the first ever MedTech Innovator Radar Forum in Manhattan Beach, a really great event that showcased approximately 150 MedTech companies through seven rounds of pitch events, plus additional content and networking.

A Proclamation on the Future of Wearables: The Real Reasons Abbott and Mayo Invested in WHOOP

I feel somewhat obliged at this point to cover WHOOP and Oura events – let me know if you, my dear readers, have grown weary of the topic!