Yared: Let me give you one secret. I started my career as an information technology engineer, doing image processing, 3D image reconstruction for MRIs and CT scanners for General Electric, almost more than two decades ago. I've been very close to the space, observing it, and over the past five years within AdvaMed we started looking at where do we draw the boundary on the reach of our medical device trade association.

You can argue both ways, but with time it became obvious that our boundary has to include all of the efforts using information technology, whether you talk about wireless technologies, mobile technologies, big data, artificial intelligence and so forth, as part of the AdvaMed umbrella. If you look today, we're seeing more and more development in this space, from mobile devices that provide individualized, personalized health care information directly to the patient to [IBM's] Watson and harnessing big data to finding global solutions here for entire patient populations. We're seeing the entire gamut, and the space is vibrant. It's good for our medtech industry because it's also getting access to capital from other places as well; the places that are usually flagged for information technology.

It's moving very fast, and our existing processes are not well adapted to it. In a town hall meeting a couple of years ago, Jeff Shuren gave an example, whereby if a company develops an accessory to go on an iPhone, by the time this accessory goes through the traditional regulatory processes, the iPhone has gone through two or three generations and it's not anymore compatible with the device that patients will be using.

So, we have to rethink this and have an open mind about it. Inside the FDA, they've been referring to this project of simplified regulatory pathways specifically for digital health tools as the "FDA Precheck," so similar to the TSA Precheck. It's a streamlined, faster process. (Also see "Software Fast Track? US FDA Asks Developers To Envision 'Precheck' Program" - Medtech Insight, 9 March, 2017.)

We at AdvaMed are very excited to be part of this conversation. We will most likely publish a white paper in this regard in the next couple of months. The idea here is that some of our processes that have been built around traditional technologies have to be adapted because either we have very novel ways of looking at things, but also the existing technologies. If you look today at a pacemaker, it has the computational power of a computer on your desk. And yet, by the time we get through the regulatory process—it takes five to seven years—some of the components in it are reaching the edge of obsolescence in time.

So, you get all of that thinking that's going on right now, and this is why within AdvaMed we have created AdvaMed Digital. (Also see "IBM Digs Deeper Roots In Medtech, As AdvaMed Builds Digital Footprint" - Medtech Insight, 13 January, 2017.) I told you initially at the beginning of this discussion about the AdvaMed Accel, which is a special specific effort to support smaller companies we created five years ago. Last year, we created AdvaMed Digital, and the idea here is to leverage the association's broad experience in medical technologies and the policies regarding medical technologies, from ethics to regulatory to reimbursement and so forth, but also add to it, the specialized expertise needed to understand and support the digital health care sector.

Podcast: Nadim Yared Hits The Ground Running As AdvaMed Chair

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