Everyone Thinks They’re Doing It Right
OR "The Farmer and the Cowman Should be Friends"
Before we jump into this article, I have a quick question for you:
Thank you for humoring my curiosity on this one! If you didn’t get it, don’t worry - there’s a video at the end. Now for the article:
Most of you know that The Device Files gained popularity last year when WHOOP got a warning letter from the FDA and, unlike basically every other company in history, decided to push back on the FDA instead of doing as they were told. (and I was covering it)
For many, this was big drama – especially for those of us from the MedTech world. We were shocked that anyone would think to stand up to the FDA and honestly did NOT think things would play out the way it did. Historically you just did not stand up to the FDA once a warning letter was received. You worked with them, gave them what they ask for (more or less), and you certainly did not pick a public fight.
On the flip side, there was a huge contingent of non-MedTech folks that thought this was great. WHOOP was fighting the good fight; the FDA guidance wasn’t clear and things needed to change to not throttle innovation.
You could pretty much tell which industry someone was from by how they reacted to the news.
It was almost like watching politics in the sense that people just came from completely different viewpoints with differing ideas and worries about the “other side”. I certainly have expressed some of my own worries. The main one being that the “Silicon Valley mindset” of moving fast and breaking things, along with monetizing data, is a horrible way to approach anything around health and patient safety and data. Another one is that we didn’t think the wellness devices had enough accuracy for the medical world – bad data in, poor insights out.
Since then, however, I’ve made a lot of new friends through The Device Files - I’ve even been crowned the Queen of Wearables (Thank you, thank you… genteel arm wave) - and I’ve met a lot of these tech founders.
Over the last year I’ve learned a few lessons and developed some new world views, including:
The MedTech world could learn a lot from the Tech world on the value of time in business. MedTech moves too slowly and we could use a kick in the seat when it comes to the speed in which we GSD (that’s Get Shit Done for anyone who doesn’t know the acronym 😊).
Most of the folks in the Tech world do want to go about things the “right way” and often think they ARE doing all of the things - like protecting user data and providing really good accuracy in their devices.
I’m not here to say they’re wrong
I’m here to finally wave the white flag and say that if you want to call yourselves “TechMed” – fine. I’m not going to fight you on it. But I am still going to tell you that if you are in the TechMed space you need to honor the fact that you are playing either IN medical device (Software as a Medical Device, wearables looking to add interpretive features, AI communicating with patients, etc.) or close enough to it that you need someone in the room with that MedTech experience.
Why? Well two reasons:
How can you ensure you are doing it the “right way” and/or not crossing lines? Trust me. Just like how you wouldn’t expect me to make a good ML algorithm vibe coding on Claude – I don’t think ChatGPT is going to help you make sure you’ll get all of the nuances of what it takes to be a medical device or avoid crossing the line.
The data say you’re less likely to succeed if you try to recreate the wheel yourselves. SignalFire, an early-stage venture firm, looked at more than 300 founders behind billion-dollar HealthTech companies. 45.5% came in from outside healthcare entirely; from software, fintech, and enterprise tech.¹ Nearly half of the people building the most valuable companies in this space have no background in it. SignalFire’s own conclusion from the data was that teams that win pair tech-native talent with medical insiders who know how to navigate the slow, messy complexity of the system, and first-time founders especially win by surrounding themselves with people who fill the gaps.¹
You don’t know what you don’t know
That report tracks with what I see at a lot of conferences. I meet a lot of companies that fit this exactly. People with great products aimed in wellness, medical device, or healthcare who have the instincts to move quickly and make great products, but who have no one on the team who has taken a medical device to market. Not because they cut corners, but because they don’t know people in the space – it’s just not their network. And by extension, they also don’t have a network of people who understand MedTech quality control systems, cybersecurity testing, market access experts, marketing groups that stay within the bounds of appropriate medical lines.
So you end up with smart, well-funded, well-intentioned companies that are confident they are doing it right but often have real gaps they cannot see - precisely because no one on the team has even been witness to the thing they are missing before.
Most people reading this fall into one of three buckets
You are a medical device. Nothing to debate. The work is making sure you have actually covered everything being a medical device requires, which is harder than it sounds.
You are not a medical device today, but you know some version or feature of your product is aiming there eventually. Will you build toward that standard now, because the rework later costs far more than doing it right from the start?
Or do you fully believe you are not a medical device and never will be. This is an interesting bucket because oftentimes companies believe they are not a medical device and therefor think they don’t need anyone in the room with that experience – which can often cause serious problems down the road.
This article is for all of you, but I want to add a particular callout for group three.
To Group Three: Even if you are right, even if you never file a thing with the FDA - do you actually know the gap between how you operate today and at what point you might wander into regulated territory? Can you evaluate the strategic implication of attempting to cross that chasm and whether it might be worth the investment? Do you ever wonder if might be in your best interest to meet some medical device standards just to ensure you’re treating user data properly or even just as a great competitive positioning to the market?
If your reaction is “why on earth would anyone do that?” I can give you two reasons (and yes, I AM using a LOT of numbered lists today):
You might be getting deeply integrated into the healthcare system. If you are handling real user data that connects to their health, sitting inside clinical workflows, or selling into hospitals that take this seriously, then holding yourself to a device-grade standard for data and security could protect your users and your company. It can also be a real differentiator when a health system’s procurement team starts asking hard questions or for users when you start to seem commoditized compared to all the other wristbands (or whatever form factor or offering you have).
You never know when the FDA might come knocking. It has happened to companies that were confident they were fine, right up until they weren’t. Either they never really “got” the rules or the rules changed – and given our current political system, the rules seem to be changing a lot more frequently with more impact.
If the line shifts and you all of a sudden can’t sell your product because it hasn’t received FDA authorization, your company is going to take a hit. How prepared you are makes the difference between quarters and years of operating without that product income. I could point you to examples right now of companies that spent years getting back to market while, by their own account, nothing about the actual product changed. The product was fine, but what it took to turn around and get authorized as a device was a major gap. So, is it maybe worth it to your company or investors to at least explore what the gap is and whether its worth closing the gap a bit?
Find out where you stand
About six months ago I introduced the D.E.V.I.C.E.™ Assessment. Its a framework I created that any company can use regardless of which of those buckets you fall into and can help you see the different areas involved in MedTech so you can evaluate whether you need to address some or all of them.
I’ll give you the quick overview here to check out, but I also have a new widget on my website where you can TAKE the assessment and get a score – you can even get a more detailed report that helps you understand your risk. And (here comes the shameless plug), if after taking the assessment you think chatting with me about incorporating some MedTech strategic advisory might be a smart move for your company, I’m happy to jump on a call to discuss.
The D.E.V.I.C.E.™ Assessment
D, Development Discipline. Product Development Discipline and Design History. Whether you have to file with the FDA or not, are you building with real design controls, a documented design history, and risk management woven through it?
E, Engagement and Economics. FDA Engagement & Reimbursement Strategy. You know your product. Do you know your potential regulatory path, who pays for this, what the clinical workflow looks like, and the health economics behind it?
V, Verification and Validation. Can you prove the thing does what you say it does, in the real world, with edge cases and clear pass/fail criteria? “It worked when we tested it” is not the same answer.
I, Intelligence and Information governance. In medical devices, everything comes back to one question: is this safe for the patient? Data is part of that. You should know what you collect, where it lives, who can touch it, and whether your security would hold up to the scrutiny a device gets.
C, Claims and Category boundaries. Everything starts with your claims, the plain statement of who you help and how. Do you have a real claims library that marketing, sales, and product actually follow, with evidence behind each one? Or is everyone freelancing what they say about the product? This part is actually crucial for ALL companies because you also need to know what you can’t say if you’re hoping to avoid being a medical device!
E, Evidence. Does your proof actually match your claims, at the level the FDA, payers, and clinicians each expect? If you don’t have the proof yet, do you have a strategy to get it?
Click here to take the D.E.V.I.C.E.™ Assessment (in case you were worried - its FREE):
https//www.thekarowgroup.com/#assessment
The full version on the website turns each of these into specific questions, scores you, and shows you where you might need some extra attention. You get a readiness percentage output right away, and if you want the detailed version, a per-section report with guidance on each dimension can be emailed to you.
To wrap: I opened this article by talking about people picking sides. MedTech in one camp, TechMed in the other, each a little wary of the other’s instincts. In case you missed where I was heading here, the point of this article (beyond my shameless self-promotion) is that there shouldn’t BE sides. Getting the right products to market that help patients and improve the healthcare system, means working together. The tech world has speed and instincts and MedTech knows how to operate in the system. We are supposed to be on the same team here!
Or, if you’re like I am and love a good musical, “The farmer and the cowman should be friends. Territory Folks should stick together!”
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.
Footnotes
¹ SignalFire, "SignalFire Report: Who's Really Building Health & PharmaTech Unicorns," published May 14, 2025. https://www.signalfire.com/blog/health-and-pharma-tech-unicorn-founders