A former Medtronic executive and founder of MDIC explains how medical device industry and FDA leaders joined forces to create the consortium.
Dale Wahlstrom is vice chair of MDIC’s finance committee and was the consortium’s founding executive director. A longtime Medtronic executive, Dale retired from the company in 2006 and, from 2006 to May 2014, served as President and CEO of LifeScience Alley and The BioBusiness Alliance of Minnesota.
MDIC: As one of MDIC’s founders, what led you to help establish the organization?
Dale: I’m an engineer by training, and I spent most of my working career at Medtronic. The company had about $276 million in revenue when I started in in 1982, and when I left in 2006, it had just tipped $13 billion or $14 billion, I forget which. So I was there for a lot of growth of both the company and the whole industry. And what allowed that growth to happen was collaboration between the doctors, the hospitals, the device companies, and the regulatory bodies. But in the last 15 years or so, as the industry has matured, those relationships have become more complicated and often more difficult. MDIC came about because leaders in the medical device community—including industry, government, and patient advocacy groups—recognized that investing in and redeveloping productive partnerships based on trust is critical for everyone, and for the health of the industry.
MDIC: Why does a productive relationship between the industry and government matter to patients?
Dale: Globally, the U.S. medical device industry is facing much more competition than it used to. Other countries are working hard to attract device companies, and the ones that succeed are often the ones that end up being able to offer patients the earliest access to innovative new treatments. These days, American patients who need improved therapies are often getting them years later than patients in much of the rest of the world. In some cases, they’re not getting them at all. In the past few years, I’ve started to see business plans from companies that have developed advanced technology but do not intend to release it in the United States. A lot of this boils down to money. For example, the cost to do clinical studies is often higher here than in many other countries. But the regulatory climate is crucial to establishment of a productive industry, and many companies perceived the FDA as a less predictable and therefore riskier agency to do business with than the agencies of many other countries.
MDIC: How did MDIC emerge as the means to reinvest in these relationships?
Dale: A few years ago, Art Erdman of the University of Minnesota invited Dr. Jeff Shuren (director of the FDA’s Center for Devices and Radiological Health) to come and speak at the Design of Medical Devices Conference. Then Art called me and said, “Would you be interested in being Dr. Shuren’s chauffeur for the day?” and I said, “Yeah, I’d love it,” because at the time I was the new CEO of the integrated LifeScience Alley and The BioBusiness Alliance of Minnesota. So I picked him up at the airport and drove him around. I found him to be a very open, intelligent and creative person. He gave me a sense of the agencies’ perspective and what he felt the issues were, and I did the same from the perspective of the industry and the communities who depend on medtech for their local economy. We had a sincere and constructive heart-to-heart talk. At the end of the day, we both agreed that we had to do something to reinvest in the relationship between the industry and FDA. So we talked about some concepts, and he asked me if I would put them into a written proposal, which I did. And this is the honest-to-God truth: I hit send on my proposal at about 9 p.m., and I had a response from Jeff by 10:30 p.m., and it was “Let’s do it.” And that’s when we started forming MDIC. The whole concept was re-anchoring the industry on the fact that the people who work in medical devices are all focused on the same thing, which is benefiting the patient. From that point we could begin to rebuild confidence, and ultimately trust.
MDIC: Two years after MDIC’s creation, what changes have you seen as a result of that collaboration?
Dale: There’s an openness and dialogue that, in my thirty-some years in this industry, I’ve never seen. There’s an understanding of issues that the various stakeholders are facing, and a willingness to talk about how to solve them. That does not mean that the issues are solved, but progress is being made.
MDIC: What’s next?
Dale: The next thing that needs to happen is the delivery of results: the redefinition and inclusion of new systems that improve the way we design products and bring them to market. To give just two examples, that could mean new clinical study formats, or mechanisms for people to replace some animal or human studies with computer studies. We need concrete changes that help us bring higher-quality products to patients, more quickly and at lower cost.
MDIC: We’re working on a new strategic plan this fall. What do you hope will come out of that process?
Dale: For me personally, the things that are really critical for MDIC to work on are, number one, very tangible programs and initiatives that companies and reviewers can use to improve their workflow. Number two is to get to the point where the mechanisms for dialogue and engagement between stakeholders in the medical device community become second nature, that they’re not special programs or special efforts. Third, I hope that MDIC will be successful in refining its process for ongoing review and measurement of its work, so that we’re constantly getting feedback on our performance to make sure we’re staying on track.