Sunday conversation: Stephen Ubl, Advanced Medical Technology Association

WASHINGTON

When Minnesotan Stephen Ubl took charge of the Advanced Medical Technology Association in 2005, he looked first to hire the right people in the right jobs. Then, he turned them loose to lobby for the medical device industry, including companies in his home state. A decade later, Ubl departs from the group known as AdvaMed with a reputation for getting policymakers and politicians to adopt his points of view. Ubl's record was good enough that the pharmaceutical industry's leading lobbying group, Pharma, hired him as chief executive. Before he headed for his new job, Ubl looked back on his time at AdvaMed in a conversation with the Star Tribune.

Q: What did you want to do ­coming in?

A: Washington will always be a relationship-based town. But when I took the job, I said it's not just who you know, but what you know. And more importantly, what you can prove. I set about to create a much stronger internal research capability that spans everything from white papers to peer-reviewed studies.

Q: What were your greatest ­accomplishments?

A: At the core, we're an advocacy organization. Of the successes we've had over the last 10 years, I would say there are three notable accomplishments. Very early in my tenure, CMS [the Centers for Medicare and Medicaid Services] proposed a sweeping reform in how hospital inpatient payments or DRGs [diagnosis-related groups] were calibrated. … In our view, the proposal was significantly flawed. … We embarked on a comprehensive effort to do research to demonstrate our case and educate policymakers. … In the end, the agency completely changed directions, largely tabling them. They have yet to revisit those proposals.

The second thing I would highlight is related to FDA [Food and Drug Administration] reform, which occupied a relatively large chunk of the middle period of my tenure. I think we fundamentally refocused that debate on the role FDA plays in global competitiveness. Again, we had an integrated approach to advocacy where we did research about … approval rates in the U.S. compared to Europe, the safety record in Europe compared to the U.S. We engaged a large, bipartisan group of lawmakers to focus on making ­pragmatic changes at the FDA.

Q: No less a group than the Institute of Medicine (IOM) said FDA should do away with its process of approving devices that are substantially similar to devices already cleared for sale. Did you consider that a real challenge to overcome?

A: I have the utmost respect for the IOM. We believe they could have done a better job of incorporating the views of those involved in developing and manufacturing medical technology. But I do think it speaks to our efforts to educate policymakers. There was a lot of misunderstanding about the effectiveness of the [substantial equivalence approval] process. You had this view permeating at the time that the real issue at FDA was the need for more regulation. Our view was: Let's have smart regulation. Let's make sure we're making the process more timely and predictable so we don't see more high value investments moving offshore. You already have a situation where most first-product introductions are in Europe. I don't think policymakers were aware of that dynamic. … I think we did succeed in shifting the debate away from adding regulation that might not have a commensurate public health benefit toward focusing on making the process more timely and predictable, insuring that American patients have access to medical technology more quickly without sacrificing the gold standard of safety and effectiveness.

Q: That's two things. What's the third?

A: Our work on [repealing] the medical device tax. We don't have a result yet. That's one of the disappointments I have in leaving AdvaMed right now. But it remains the case that we've done a very effective job of educating policymakers on the negative effects the tax has had on the device industry. I am confident that there will be relief on the device tax in the near future.

Q: You worked with some of the most powerful corporate folks in America. How did you juggle those relationships?

A: A key ingredient in our success has been broad board and member engagement. There can be a tendency to assume that because you have a strong association or strong Washington offices, that that's sufficient in terms of engaging with policymakers. I feel strongly that CEOs of the companies, their employees beyond the Beltway, as well as the people they have working for them in Washington, all have to view public policy as part of their day job. And they all have to be very engaged in advocacy. So we made a very concerted effort to bring our CEOs to Washington more frequently and to go outside the Beltway to spend time with employees to educate them on the issues of the day and to encourage them to get involved in the political process.

Jim Spencer • 202-383-6123