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.
- Never get involved in a land war in Asia
- 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:
- 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
- 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 🙂
Peter T. Bianco says
I wish I had written this. Truth.
Lisa Suennen says
Peter, thanks for the note! Lisa
Dee Shaw says
I just love how you explain things. Thank you.
Lisa Suennen says
Lisa, another homerun post. My thoughts on why integrated wearables along with bio-sensing phones are the future is that issues such as charging devices et al, while a pain are not unfamiliar to anyone 50 and under.
In other words, I am think this engagement of device integration and medical data as a generational shift and thus not burdensome to boomers under 60, Gen X or Gen Z . The majority of current Medicare beneficiaries will not be the target market for this transitory movement.
Lisa Suennen says
Hi Darryl, thanks for the note. The issue is that the most costly and problematic medical problems are those experienced by those 65 and over. That’s why it’s so important to take account of the issues of recharging, hassle, small buttons, etc. But even the younger crowd forgets to charge things and loses interest in compliance. The data on this are pretty clear. Lisa
I think some medical devices are hesitant to integrate health information because of the risks to protected information. If a device is hacked, is the manufacturer liable? Also, it makes the design, troubleshooting, and customer support more complicated. There is so much more that can benefit patients if this integration occurs and I agree with you that we are getting there.
Thank you for your advocacy!
Lisa Suennen says
Thanks Holly, I agree it’s more complicated. But cars were more complicated than horses so the horse dealers either came around or died out eventually! Lisa
Jim Best says
Loved this, Lisa.
My two cents: Future state of medical device post market surveillance: OR EHRs capture part numbers (this will be augmented by the GUDID database) + Tokenized Patients + Longitudinal, Complete Healthcare Claims Datasets of those patients = Every implanted medical device will be automatically monitored for success or failure. The smart device companies will do this themselves before their competitors or the FDA does it for them. It’s not happening much now, but give it five years. A complete sea change will occur.
Lisa Suennen says
I agree this type of program is the future. Not sure it’s five years, but by 10 for sure. Lisa
Susannah Fox says
Love this post, Lisa!
Remember Hugo Campos and his campaign to get access to his own ICD data? Here’s a KQED story by Eve Harris from 2012 (!!):
And an interview by Ernesto Ramirez on the Quantified Self blog in 2015 provides even more detail about how data access has informed Hugo’s care of his own health, in partnership with his clinician:
Further, look to the #WeAreNotWaiting movement in diabetes, including the work that Tidepool is doing to make it Duh Obvious that medical device data should be accessible:
Is any other medical device sector making progress like what we’re seeing in diabetes?
Lisa Suennen says
Hi Susannah! I think we are starting to see some small movement in cardiology and orthopedics – medical grade wearables are more interesting to some patients/consumers than I would have suspected. But for those with particularly vexing conditions, patients are definitely starting to pay attention to their own data and learn/act accordingly. It’s heartening to watch. L
Matthew Holt says
“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.”
Now, as Ian Morrison would say, you’re a real futurist. Because you didn’t put a date in the sentence with a number in it.
I too am 100% certain this will happen. I’m just not certain it’ll happen before I die, let alone before I get. Medicare card & I’m 60 next year.
Waiting for the rationality of purchasers to change health care seems to happen in geological time…
Lucia Savage says
I think the data integration problems are more in people’s minds than in fact.
But what I loved about this is that it helps me understand why evidence generation lags behind.
Third: yes, to get a piece of the 80% of overall spend that is people over 65, the focus has to be on Medicare payment and coverage rules. But lots of innovators don’t really love going there because it’s complicated and heavily regulated. I know people who can help with both, but one has to want to understand.
Lisa Suennen says
Lucia, people are sometimes afraid to engage with government payers but honestly, once you get those customers, they are enduring! Worth the effort. L
Ben Schwartz says
Yep. Ortho implant device manufacturers are putting sensors in knee replacements now. Next step is to figure out what to do with that data. As you point out, there’s a possibility we won’t like what it’s telling us or that it isn’t as insightful as we thought.
Lisa Suennen says
Yes, Ben, that is definitely possible. Fortunately that’s not what we are seeing at Canary Medical, but we definitely need to deliver more proof to market. We are on it :). Lisa