BIOMEDevice is the Boston area premier med-tech conference and this year we caught up with keynote speaker Scott Huennekens the former CEO of Verb Surgical, Volcano Corporation.

Interview With Scott Huennekens

Accumold: What is the future in medicine you clearly see that most do not? People like yourself, who are experts in their field typically see things that are very, very clear to them but no matter what they do, no matter how they preach that message, it just doesn’t seem to resonate. What would those things be, if any?

Scott Huennekens: I think the main one is, it’s starting to resonate, but having spent the last almost five years working up on the Google campus, the ability to leverage technology and connectivity of data into what I call Medtech 3.0, it’s not moving as fast, and it’s not being adopted as quickly in the medical device industry or healthcare period, as it in other sectors of the economy. So, what I mean by that is that when I started my career you made a catheter or device, a pretty simple device, that was Medtech 1.0.  Medtech 2.0, that started having some microelectronics or advanced technology like defibrillators and implantable devices that had capabilities, etc. With Medtech 3.0, it’s the medical device, plus the connectivity, plus the data.

And that, those three elements, start to be the product, and so where we can learn things by integrating multiple medical devices together in their information, that’s not taking place.  A lot of these devices are closed platforms; their companies have closed platforms; they don’t want to have open platforms where other elements can interface with their data to get to a better solution. So, I think the lack of connectivity, the lack of use of data, the lack of open platforms, are inhibiting our ability to get to solutions and improve care for patients, which is very frustrating for me.

Accumold:  Is it a matter of everyone kind of ‘throwing rocks’ at the other technologies and saying, ‘Our technology records the right kind of data, but their technology, we can’t validate that or verify their data, so we don’t want to be associated with it?’

Scott Huennekens: No, it’s multi-factorial; it’s everything from HIPAA restrictions on patient data, it’s regulatory restrictions on two or three devices interfacing with each other to make a care decision. And how do you get that approved? If you look at Continuous Glucose Monitors, you have a transmitter, a pump and a sensor that can be made by three different companies. Now the FDA allows interoperability between those, but it’s just been in the last two years, you know, if you had a piece of software that you added on to your device, then you have to get it approved even if it had a common interface like an API. 

So, it would be like saying every app on an iPhone had to go through a different approval process.  That’s changing per our regulatory laws, and then it is individual devices, so if IFS Webster puts a market meter, well they don’t want to give someone else access to have their catheter run on their system; or their software operates on their system.  They would rather control that so that you may have to use their catheter, which might not be as good — they want that to be a total solution. And then there are reimbursement considerations as well.

For example, in a lot of cases, the therapy gets reimbursed. Well, what if it would be better for there to be a therapy guidance or diagnostic that was used with the therapy? Well, the therapy company says, ‘I don’t want to give up part of my reimbursement to have that.‘ So, if it’s multi-factorial, you just have to knock each of these down, but you’re going to be limited on what you can achieve having these in place. And it goes to position as well.  We have more reimbursement-based medicine than evidence-based medicine, where the physician also would like to use some other tool or diagnostic, but he can’t get paid for it, so his hospital says, ‘he can’t use it.’

Accumold:  As technology becomes smaller, more sophisticated and stable and more precise, what opportunities in medicine will present themselves that were previously not foreseeable or thinkable?

Scott Huennekens: Well, I think that you see that everything from the simplicity of an Apple watch as a medical device where its sensors are very small, it’s the connectivity that is the backbone. We, as a medical device industry, ride on these other industrial complexes that have larger markets.  We benefit from computing power, connectivity, nanotechnology, 3-D printing, sensors; all of those are going through 10x improvements. So, there will be a lot more, kind of, onboard sensors on a person in many different forms. For example: our ability to have diagnoses that are more real-time to actually understand information to guide the therapy, whether the therapy is wearable itself, like the Continuous Glucose Monitor, or an implantable defibrillator, or whatever it might be.

I’m 25+ years into my medical device career and I’m a bit envious of all of these other, younger, people who are going to get to take advantage of this. Google X had a great slide when I was there, which explained there are at least ten to twelve different technologies that are all going through 10x effects here in the next ten years, and it may even be greater.

It could be algorithmic versus linear, and be 100x improvements; Connectivity with 5G, opens up all kinds of possibilities; the Cloud and the ability to sort data very cheaply and access that data relative to solutions, AI and G-learning, data storage computing power, robotics, it’s just, you go on, and all the sensors, so you just go on and on, Genomic, you’ll have online Genomic data coupled with your personal, kind of almost environmental data.

Because a person has adapted his or her Genomics to what they have done; smoked, drank, worked, didn’t work out; whatever it is, that will have a higher sensitivity and specificity, and it can be longitudinal over time, as well.  So it’s a very interesting, compelling time to develop new solutions.

We need to get rid of some of those barriers, however — the friction that exists, because the rules relative to data, the rules relative to regulatory approvals, the rules relative to what gets reimbursed, are built around a paradigm that’s outdated, and it has to evolve. That’s where I draw this curve in presentations where technology, i.e.., ‘XY Technology,’ has been going along and increasing at a moderate slope. Now over the last ten years and in the next ten-plus years, it’s exponentially growing at a much steeper rate.

Humans and governments and physician societies’ ability to adapt is more along the lines of the old technology curve, so the difference between humans’ ability to adapt, regulations and the government’s ability to adapt and the technology curve creates the gap of efficiency that exists.  It is our job, in the industry, and as patients and consumers, to try to push governments’ positions and abilities; medical device companies, etc., to bend that curve up. 

You see in other industries, where an Uber, a Lyft, or an Air B&B face these regulations, and they can’t grow as fast as they’d like. The same goes for medical devices.  The technology is there to enable it, but the other things are not; and/or people have their vested interests where they fight against it to protect their economic interests or power positions in a particular area.

 

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