Classic Blunders in the Digitization of Medical Devices

About 4 ½ years ago I wrote a piece called “Medical Devices: Pigs Have Flown, Hell Hast Frozen Over – and It’s a Good Thing.”  The focus was how I was at a medical device conference, and, for the first time, there was an actual, legit conversation being had about the integration of digital technologies into traditional medical devices.  This followed an article I wrote in 2014 (2014!) when I started talking about the concept of digital/device convergence.  It was pretty quiet between 2014 and 2018 when it came to this topic.    Most people told me it would never happen.

In the 2014 article, I quoted a conversation I had with some JP Morgan medical device bankers; to wit: “I asked my JP Morgan colleagues whether they thought we would soon see the traditional medical device players embark on significant digital health initiatives, but they were more reticent, saying that the traditional players were still pretty leery of this new set of medtech aspirants. Taking on that level of information technology product risk is still somewhat anathema to the traditional medical device culture and, equally importantly, the hacker tech culture of IT-style engineers is vastly different than the meticulous scientific method engineer culture of traditional medtech teams, according to my JP Morgan friends.   And yet I have to believe that we will get there pretty soon. Digital health, in the form of real medical devices, not fitness products, could be a real savior for the medtech firms that have seen major adoption headwinds and slow growth in their traditional markets.

So here we are in 2023 (2023!  How did that happen?!) and I think “pretty soon” may have begun to arrive.  It’s been more of a marathon than a sprint, as they say, but exhibit A is that I now work actually work at a company that marries sensors with implantable medical devices to enable what is, essentially, a check engine light for humans.

But even with the progress being made to create a medical device-digital mind meld, I find that most of the large medical device companies (and even some of the small ones) are making two classic blunders.

1. Never get involved in a land war in Asia
2. Never go in against a Sicilian when death is on the line)

Oh, wait, those are the classic blunders from The Princess Bride.

The pertinent new ones are:

3. Building the digital program to support the sale of the product for the benefit of the company rather than to support the practice for the benefit of the physician and patient
4. Thinking that digitization is a valuable thing in and of itself, when the real value is in proving that having data makes a difference in cost and outcome

As to blunder number one (list 2), having spoken to at least seven zillion physicians, chief technology officers and health systems, it is 100% clear and true that no such person or entity wants to look at multiple, unintegrated software platforms to review data for any purpose, whether it’s for surgical planning, remote patient monitoring, whatever.  They want one source of dataflow in their workflow and they want to see all of the products they use in that software source.  Extra bonus points if that source is the pre-existing electronic medical record (EMR).  While an individual product with an individual software portal for looking only at that product is fine for a short while when the device is new, it is not a long-term solution.  Rather, purveyors of digitally-enabled medical devices must fit into the platform ecosystem out there in the world, alongside their competitors’ products.    And can you blame them?  I would not want to walk into my kitchen and have each appliance running on a different electrical system.  It’s bad enough trying to figure out my damn TV remotes – universal remote -HA!.  Good thing they bounce when hurled across the room.

I have seen many companies describe how adding a data stream to their devices makes them more valuable. I agree, but the value isn’t in expanding the price of a product because it CAN collect data.  The value is in using the collected data to prove that the device itself IS better.  In other words, the way to make real money from integrated digital/device products is by using data to create evidence that having the data makes a meaningful positive difference in clinical and/or financial outcome.

This means that companies must make a serious commitment to the resources to make that happen (data science, analytics, competitive analysis, outcome studies) AND, and here’s where the anxiety starts to build, be honest with themselves about whether the data demonstrates that their product is, in fact, more valuable than their own not-digitally-enabled product as well as others’ similar products.  That last requirement is a real buzzkill for many companies, and they aren’t willing to take a chance on finding out.  Cannibalize my own revenue stream? Prove that my product isn’t quite as good as the other guys?  Are you nuts?  Comparative effectiveness is a four-letter word when spoken by product development teams; it’s like a prayer for payers and provider organizations.    I am 100% confident that, in the end, if companies don’t do this work themselves, researchers will do it for them, and purchasers will read those studies and act accordingly.

The wearables world has begun to figure this out and are more actively investing in studies and evidence creation, but most of the wearables did not evolve out of medical device companies.  Rather, they started and continue to operate as digital companies that happen to have some wrist-worn or similar hardware (and their investors think that hardware part is a damn nuisance because only SaaS can be the once and future king.  Here’s the issue though:  the best check engine lights cannot be wrist-worn.  They must be inherent to the devices and impossible to remove.  They must be charged at all important times and not subject to a patient’s bad memory, laziness or loss of charging cord.  Wearables rapidly become drawer-ables.  Implanted medical devices, properly designed, are the ultimate future.

A good way to think about this is in the context of your car.  If you had to remember to bring a laptop into your car every time your drove it in order to be informed about problems with the tires, gas tank, brake system, etc, that would be just fine until you didn’t bring the laptop, forgetting it on the counter while you were looking for your cell phone.  At first you would be fine – hey, no problems today, so do I really need to drag this thing around?  And when you forget to charge it, it’s pretty useless anyway; on a long drive, the charge would fizzle out just when your check engine light would be telling you that your tire pressure has dropped precipitously.  A check engine light needs to be fully integrated into the car, not an appendage.  That is the future of digitally-enabled medical devices.

We are not entirely there yet, but it’s happening.  And just in a nick of time since my friends and I are getting to that age that they make funny groaning sounds every time they get out of bed or off the couch.  Those sounds are some version of “ouch” which will also likely be heard by voice analyzers someday, letting you know if you are just a wuss, or if you actually have to remember where you put the cell phone so you can call your doctor.  Let’s hope that phone is charged!

 

PS–This is the real classic blunder scene 🙂