From The Editor | March 22, 2016

New AdvaMed CEO Scott Whitaker Discusses His Vision For Medtech

By Doug Roe, Chief Editor

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In part one of our interview with incoming AdvaMed CEO Scott Whitaker, we took a look back at his start in advocacy, as well as his career path to this point. He shared how he believes his experiences with the U.S. Department of Health and Human Services (HHS) and the Biotechnology Innovation Organization (BIO, the largest trade and advocacy association in biotech) have prepared him for this new opportunity.

Part two of our conversation is a look forward to Whitaker’s plans — both for himself and for the organization — during his first year with the global medtech trade association, and beyond.

Med Device Online: What thoughts do you have on the growing convergence of the drug and device industries?

Scott Whitaker: The healthcare system has changed so much. It is no longer structured in independent vertical columns. Just a few years ago you were either in the pharma space or the device space, the provider or the payer space. Those lines have blurred. As innovation and new technology continue to expand what is possible, everything has become interconnected.

An example of that interconnection is drug delivery devices. We still have not figured out how to get most biologics into an oral-dose form, so you need a way to deliver it, and that makes drug and device dependent upon one another. My daughter is Type I diabetic, so I have seen firsthand how a traditional biotech product like insulin — fantastic medicine, though it is — cannot effectively treat patients without a delivery device. But together, drug and device can help a patient to survive and live a normal life.

MDO: What are your plans for your first year at AdvaMed?

Whitaker: I am inheriting a great senior leadership team, which makes the transition process much easier for me. I think my role will be to help focus on specific areas where I can have the biggest impact. At this point, those areas are still being defined.

However, we do have some key legislative and regulatory issues to deal with, such as the device tax. The tax’s two-year suspension was a great first step, but that conversation needs to continue on Capitol Hill (with the ultimate goal being complete repeal). It will be one of our top priorities.

Another focus for us will be working with FDA on the latest reauthorization of MDUFMA — dubbed MDUFA IV. We need to get that system right, making sure that there is a clear, transparent, and informative process in place, one that is also predictable. It is an issue that I have worked on in pharma with the Prescription Drug User Fee Act (PDUFA). I am very familiar with how you can effect change. Of course, PDUFA is different from MDUFA IV, but they are very similar from the standpoint of importance to the industry and change management processes.

We also have the 21st Century Cures Act to address; we will need to evaluate where we stand, and then determine our priorities moving forward.

MDO: In your previous positions, you have had more emphasis on operations and inward-facing responsibilities. As AdvaMed CEO, do you see yourself being more of a public focal point?

Whitaker: I think my position will be a combination of inward- and outward-facing roles. I think balance is important, and I want to put myself in front of those challenges where I can have the most positive impact.

I will be out in a public way, telling our story, when I am the appropriate person to tell the story to a particular audience. We are going to use our full leadership team, and we are going to engage with our CEOs and industry leaders to collectively tell the medtech community’s story. We are going to engage more aggressively with the patient community, as well. We all are interdependent, and we need to share that complete picture.

That said, there certainly is a role for the CEO to play in being the industry leader, talking about the incredible nature of what we do. I have done that, to some degree, at BIO — though Jim has been the primary leader — and I am eager to do it on a larger scale on behalf of AdvaMed.

Internally, I want to make sure that this organization is well-run for our members, that we are providing them great value, and that we are serving all segments of this industry.

MDO: Do you have a long-term vision for your role at AdvaMed? How you would like to see the organization evolve?

Whitaker: It is too soon to define those goals. I would like to work with AdvaMed’s senior teams and  board of directors to develop that strategy together.

If we properly tell the story of what we are doing and why it is so important, I think policy makers will understand that we need to get this right. It is not just about economic activity and job creation. It is about something that we can all agree on: the patients we serve. They need access to new medical technology to improve their lives.