LifeScience Alley, a Minnesota-based medical device industry lobbying group, wants to be more proactive about how it addresses regulatory challenges for its membership.
The ongoing debate over the 510(k) review process at the U.S. Food and Drug Administration and the imposition of the device tax as part of health care reform legislation initially saw the Minnesota trade group defer to national organizations by letting them take the lead in protecting the industry’s interests. Later, it created its own 510(k) task force and ramped up efforts to engage regulators to present its members’ point of views.
Building on that momentum, LifeScience Alley announced that it has created a new position — vice president of government and affiliate affairs to “increase its legislative activity at the federal level and to better coordinate all state and legislative activities under a comprehensive strategy benefiting Minnesota’s life science industry.”
The advocacy group named Shaye Mandle to the newly created position. Mandle has more than 15 years of “policy and coalition-building experience in the public, private and academic sectors,” according to the announcement. Most recently he was executive director of the FedEx Institute of Technology at the University of Memphis and succeeded in attracting a $1 million federal earmark to establish the Center for Entrepreneurship and Innovation and launched the University’s Office of Technology Transfer.
In the private sector, Mandle led federal and state government affairs, university relations, business strategy and M&A for the $150 million R&D operation of Science Applications International Corporation in Arlington, Virginia.
“Due to the variety of challenges facing the medical device and other bioscience sectors right now, it’s more important than ever to have a coordinated and proactive approach to public policy work at the state and federal levels,” said Dale Wahlstrom, CEO of LifeScience Alley, in an email. “Shaye has the breadth and depth of experience to build a comprehensive strategy and to cultivate the relationships necessary to implement it.”
Below is a Q&A with Mandle on what he hopes to achieve in his current role:
MedCity: What will be your first order of business in the next 90 days?
Mandle: Over the course of the next 90 days, what I intend to be doing is putting a more formal structure in place that engages our members to develop ongoing, proactive, state and federal agendas for our various industries — that’s going to include the growth of new industries and supporting regulatory and public policy changes here in Minnesota and in Washington for our members. I want to be identifying issues not as they hit the wire and threaten the industry, but ahead of time. I want to develop three-year cycles of education, legislation drafting and advocacy to improve the health and welfare of the industry.
The next 90 days is going to be messy frankly. I have been in Minnesota less than a year and in this position about a week, so there will be a lot of running around and meeting with people, meeting with legislators and asking for an opportunity to prove my worth.
MedCity: What can you do being in Washington that you cannot do from here?
Mandle: I am not going to have an office in Washington and I think that question is critically important (but I will be traveling there a fair bit). Many of our member companies have memberships with national organizations in Washington and they … certainly get our Washington-based advocacy organizations engaged on a regular basis with members of Congress. Those organizations like AdvaMed, BIO, Medical Device Manufacturers Association, act as strong advocates for issues that are coming up in Congress that can have an adverse effect on the industry.
MedCity: Do you have a position on the repeal of the device tax that Ray Elliott of Boston Scientific recently talked about?
Mandle: LifeScience Alley is partners with large, national groups, MDMA, AdvaMed and BIO. We have been coordinating a lot of activities from the 510(k) review to the issue of tax repeal. So we will be supporting letters going to the leadership in both the House and Senate for the repeal of that. Our position is that that tax is going to inhibit innovation and the growth of our industry.