Happy summer, everyone! I hope wherever you’re reading this, the season is treating you well. I’m going to be heading off for some much needed summer vacation - and you know what’s great about vacation? Getting to catch up on all of the reading you’ve been meaning to do!
Well, like every quarterly roundup, you can review all of the headlines you missed over the last three months and see what you need to catch up on.
That is, however, at the bottom of this article after I give you a quick year-end update AND ask YOU to VOTE in the FIRST EVER DEVICE FILES AWARDS!
I cannot believe we’re here. One year ago I hit publish on my first post and hoped someone, anyone, would read it. Today we’re at over 1,400 subscribers and at least an article published a week. Thank you, thank you, thank you for taking the time to read, like, share, follow, and subscribe!!! None of this works without you.
1,400+ subscribers (from zero, in twelve months!)
60+ articles and playbooks across MedTech, wearables, regulatory, reimbursement, and commercialization
Peak 30-day views above 21,000!!!
6 episodes of Commercialization Confidential, plus companion articles
2 annual partners
Turns out, Substack tracks who shares posts. A handful of you have been doing it regularly all year and I want to thank you specifically, because none of this growth really happens without you.
In order of who has shared most this year:
Elizabeth Karow. Yes, my mom is in first place. By a lot. I find this both hilarious and exactly what you would expect from a mom who has been telling everyone she meets about my Substack. Mom, thank you. Also, please stop telling people in check-out lines.
Amanda Penny
Kate Hunter
Ricky (you know who you are, and we have a pretty good guess)
Elena Cavallini
Elisha Palmer
Desaline Joseph
Jacob Gendler
Raphael Vallat
Tom Hale
There are still plenty of people on that list, so again, thank you to all of the leaders and readers across the wearables, tech, and MedTech space who keep showing up on LinkedIn, in my inbox, and at conferences to tell me they enjoy The Device Files. I am still regularly amazed that anyone bothers to read my articles!
Also, I have been hugely delinquent in telling you that Substack has a built-in referral program where you can earn FREE access to premium content for sending people my way. (My bad!) The referral button will now be apart of every post going forward. Use it, get rewarded, take a victory lap.
Seriously though, if The Device Files has been of any use to you in the last year - even if its just been a source of amusement because you think my predictions are ridiculous - I’d truly appreciate you taking a moment to tell five people you know about this Substack. Or, even better, finding one of your favorite articles and sending it their way!
You’re the best.
Vote on The Device Files Awards
So, I had an idea to do some awards. I think it might be fun – but I need you to vote!
I want to make sure we actually use the awards to capture what mattered most to YOU. The categories range from “favorite article” all the way to “what company are you watching closely that nobody else is talking about yet.” Many of them are open-ended on purpose because I want to know what’s on your radar that’s not on mine.
If your company belongs in one of the open-ended categories (Called It, Playing the Long Game, Stealth), nominate it! I won’t see it as bragging - I promise! Some of the best stories I’ve covered this year came from readers telling me to pay attention to something I’d missed about their company, product, or strategic mindset.
So please, please:
Vote on The Device Files Awards
The categories:
Favorite Article of the Year - four nominees from the year’s biggest pieces
Most Surprising Commercialization Lesson - six lessons that came up across the year’s commercialization stories
Biggest HealthTech Trend - eight contenders for what defined the year
The “Called It” Award - which company made the smartest strategic move this year?
The “Playing the Long Game” Award - which company is most likely to win over the next five years?
The “Hype vs Reality” Award - which technology is most likely to disappoint expectations?
The “Stealth” Award - what company or technology are you watching closely?
What Do You Want More of in the Next Year? - six topic areas to choose from
We have the best partners at The Device Files!
Cortex brings human-centered design thinking to medical devices with a focus on wearables. They’ve been a great partner both to this publication but also to clients of The Karow Advisory Group, why? Cuz they’re good guys (and they know their stuff)!
MedTech World continues to grow every year, with a new North America event down in West Palm that was really good (its going to repeat there next year too!). They’re a team that really values putting together a conference that feels intimate yet impactful. Plus, the Malta location is honestly to die for.
If you’re also interested in a partnership with The Device Files, reach out here:
This is the Q2 2026 roundup. If you want to check out prior Quarterly Reviews, you can follow these links:
but without further ado, here is the last quarter’s recap:
“The Company That Cracked Wearable Blood Pressure - And Made It Free” (May 27) - Commercialization Confidential Episode 5 with Gaurav Kohli, founder and CEO of Vital Friend. They built a frictionless, 100% insurance-covered, B2B-into-senior-care commercialization model for BUDDI, their FDA-cleared continuous BP wearable. This company moved at lightning speed to get to market.
“Two “Whoop Killers” in Two Weeks? Don’t Trust the Headlines.” (Jun 3) - Google launched the Fitbit Air and Luna opened its waitlist within two weeks of each other, and the tech press declared the subscription model dead. I read the headlines, called BS on most of them, and laid out what these launches actually mean for the world of wearables.
“The New CMS ACCESS Program is Extending its Application Deadline through May 15. Should You Apply? WHOOP Just Did.” (Apr 16) - CMS extended its ACCESS Program application deadline. WHOOP responded by spinning up a physician-led PC to enroll Medicare beneficiaries. I broke down the strategic question for companies evaluating whether to apply.
“Is CMS Killing Breakthrough MedTech? A View from the Other Side” (May 6) – After the super popular article, How CMS Is Killing Breakthrough Devices, I met some very interesting folks who worked at CMS and could provide insight on the other side of the story. My favorite person? Dr. Lee Fleisher. This article is Part 1 of a three-part series interview with Lee and updates on new programs at CMS and their implication for strategic leaders.
“Whatever Happened to TCET, CMS’s Breakthrough Device Coverage Pathway?” (May 13) - Part 2 of the Lee Fleisher series. TCET was scoped to PMA-class devices by design, which left exactly the devices that needed help (the De Novos and 510(k)s) on the outside. I argue the prioritization decision did not match the stated purpose of the program.
“Has CMS Finally Cracked the Breakthrough Device Coverage Code?” (May 20) - Part 3 of the Lee Fleisher series. CMS killed the NTAP alternative pathway, paused TCET, and announced RAPID. I worked through what all of that actually means for breakthrough device companies, and Lee shared his strategy for pursing market access amongst this chaos.
“How to Lose Your Best Sales Reps Without Even Trying: Lessons from the Boston Scientific Pacemaker Recall” (Apr 22) - BSX’s Accolade pacemaker recall is a case study in what happens when quality, regulatory, and commercial leadership all do their jobs in their own lanes and nobody owns the cross-functional handoff. The cost shows up in the field, where your best reps start updating their LinkedIn profiles.
“Crisis Communication Playbook” (Apr 22) - The operational companion to the Boston Scientific piece (paid subscribers only). Six core principles for running cross-functional crisis communication in a MedTech company, with the field team and the customer at the center of it instead of as an afterthought.
“Jamie Grooms on the Week Axogen Almost Went Under, and the Commercialization Lessons That Came Out of It” (Apr 29) - Commercialization Confidential Episode 4 with Jamie Grooms, co-founder of Axogen and RTI Surgical, and arguably the godfather of Florida MedTech. We talked about the week three things went wrong at Axogen, the $20M they spent digging out of a competitor’s positioning attack, and the marketing-led commercialization playbook he says every founder should be using.
Jessica Richter
“A Proclamation on the Future of Wearables: The Real Reasons Abbott and Mayo Invested in WHOOP” (Apr 8) - WHOOP closed a $575M Series G at a $10.1B valuation with Abbott and Mayo Clinic on the cap table. I broke down what those two strategic investors actually want out of this, and why WHOOP and Oura are positioning themselves as the new health gatekeepers.
“A Comedian, a Cult Movie, and a Question About the Future of Medicine” (Jun 11) - Ronny Chieng’s Harvard Class Day speech, the regulatory architecture that has been resting on the clinician as the smartest party in the room for forty years, and what happens when AI deployment starts to degrade the very expertise the system was built around.
Everyone Thinks They're Doing It Right (or "The Farmer and the Cowman Should Be Friends") (Jun 17) - A year of building The Device Files has me waving the white flag on the MedTech vs TechMed naming debate. I argue the two camps should be on the same team and use real world data to make the case. I also revisited the D.E.V.I.C.E.™ Assessment as a way for any companies to evaluate their readiness and understanding of what it takes to become a medical device. BONUS: We now have a free interactive version of the assessment on the website that gives you a more detailed view. You can take it here too:
Take the D.E.V.I.C.E Assessment
Looking back across the year, the pattern is pretty clear about what landed and what didn’t. Ya’ll love updates on the world of wearables, news on US policy around reimbursement and medical device clearance, translation of experience and case studies in MedTech product commercialization, and you appreciate the strategic insights provided across the articles.
Where I’m going to pivot: The Commercialization Confidential Podcast. First of all, turns out I HATE editing it in Riverside (if you follow me on LinkedIn, you’ve heard)! Secondly, its just too a narrow scope for a podcast (Spencer, if you’re reading this, you were right). I promise the insights have been really interesting, but I think maybe we’ve done enough on that topic.
However, I’m not getting rid of the podcast concept. We’re going to start having a more mixed bag of topics and actually start doing them more often. I don’t have it totally worked out yet, and I’m going to take a break from it over the summer to reimagine everything, but I’m fairly confident we’ll have a rotating cast of both regulatory and market access experts to review anything new that pops up, along with some fun deep conversations on where the world is headed, and who knows what else! AND we will NOT replace all of the articles with podcasts – I promise!
Just do me a favor, please, and let me know what you might be interested in hearing about.
The rest of summer is going to lean a bit philosophical. I have a few pieces in the queue that step back from the news cycle and ask bigger questions about where MedTech is actually headed and a fun series on understanding investor dynamics (because honestly I deserve a vacation from trying to keep up with headlines, plus I’ve been thinking some deep thoughts lately).
Beyond that, year two will continue in basically the same way!
Thank you,
Blythe
Blythe Karow is a strategic management consultant and founder of The Karow Advisory Group. The insights shared here reflect Blythe’s strategic expertise navigating the complex world of MedTech and wearables. Imagine what that same thinking could uncover when applied to your business.
How Blythe can help:
Commercialization & Market Readiness Reviews
Product & Business Strategy
U.S. Market Entry Planning & Education
Strategic Advisory for MedTech, Wearables, and HealthTech
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