Dr. Makower and Mr. Bright Go to Washington

Have you ever wondered how policy was set in Washington?  Have you ever read an article about some legislation and thought, “what were those policy makers thinking?”  Have you ever thought that you could make a difference?  The Biodesign Alumni received answers to these questions and much more over the course of a dinner on September 4th. 

In a candid and often humorous discussion, Dr. Josh Makower and Eb Bright described their trials and travails working on medtech policy in Washington.  They started the night by explaining how the confluence of negative trends beginning in the early 2000s that affected the medtech industry, particularly small businesses, provoked them to embark on an adventure that would lead them shape policy for the entire medtech industry.

At the time, the USPTO was grinding to a halt with a 3-4 year lag between patent application submission and office actions. Additionally, the introduction of the Quality Review Process (colloquially referred to as the “second set of eyes”) had left examiners second-guessed by their superiors and unmotivated to allow patent applications, bringing uncertainty to the process.  The FDA’s requirements for device clearance/approval (and even IDE study approval) became more unpredictable: there were ever-changing demands from reviewers, a lack of consistency between reviewers, and increasing rounds of questions before coming to a decision.  From Eb’s and Josh’s vantage point, the uniformity of these pessimistic experiences across many different companies in different clinical areas was alarming.

While Josh and Eb were (admittedly) commiserating on the woes of the industry with fellow medtech entrepreneurs at the Phoenix CEO conference in 2008, one person challenged the group to do something about it. This individual argued that the small group of attendees embodied all of the positive aspects of the industry: (1) Their innovation created medical devices to better mankind and provide jobs in our country; and (2) they represented small entrepreneurs trying to make a difference, made all the more powerful by virtue of not having a profit to protect.  After mulling it over, Josh and Eb, among others, realized they truly had a unique opportunity to make an impact.  They decided to tackle it head-on, with Eb focusing his efforts on patent reform legislation and the USPTO and Josh focusing on the regulatory concerns with the FDA.

The initial traction for Eb was difficult; however, the appointment of David Kappos to the position of Director of the USPTO in 2009 was a big break, as he not only listened to the feedback, but welcomed it.  As someone with an industry background, David Kappos understood that it was important for the people at the patent office to understand the difficulties facing industry and organized full-day education sessions for his employees.  It took a bit of luck as well as Eb recounted a last minute coincidental meeting with Congressional staff that led to the insertion of an important phrase crucial for early stage companies, because it required up front disclosure of all arguments during post grant challenge of patents.  In the end, Eb and his team (including Jeff Grainger of The Foundry) became influential with the politicians and staffers who constructed the America Invents Act of 2011.  This act, among other things, develops post-grant opposition, eliminates interference proceedings, and switches the U.S. patent system from a “first to invent” to a “first inventor to file” system.

Josh’s work with the FDA was more difficult, and the team (including Mark Deem of the Foundry) ended up talking directly with high ranking politicians and testifying in front of Congress.  Early on in those discussions, one representative challenged the team about the data supporting their claims that recent changes in the FDA had resulted in a regulatory approvals to grind to a halt.  In a flurry of activity that only a seasoned entrepreneur could lead, Josh et al. conducted a nationwide survey of over 200 medtech companies in two months in order to procure the relevant statistics.  The results were compiled in less than three months in a white paper published in November 2010 titled “FDA impact on U.S. Medical Technology Innovation”.  One of the major findings was that FDA review times drastically underestimate the actual time required to navigate the FDA process to obtain clearance/approval.  In addition, the companies rated European regulatory agencies as more reasonable, transparent and predictable.  The data in this report gave the device industry ammunition during their negotiations with the FDA during reauthorization of the Medical Device User Fee Act (MDUFA) in 2012.

Throughout the evening, Eb and Josh challenged us alumni to get involved as well.  They pointed out that sometimes Washington loses perspective on what is important to industry, and Congress may not have the time or energy to look out for our needs.  The only option is to take our perspective to them and respectfully share our experiences and opinions.

Eb and Josh encouraged us to focus on what we want to accomplish and get good advice from seasoned professionals, especially around anticipating how the politics will play out.  They also taught us that policy is not a zero sum game.  One side does not have to lose for the other to win.  Sometimes, being at the right place at the right time to help shape policy may end up helping everyone involved.  In addition, there is no good or bad side in politics – each position is trying to do their best to serve their constituents. It is up to us, as the constituents, to tell politicians what we want and need to be successful as medtech entrepreneurs.  The closing advice for the night was to maintain our integrity and be prepared to stand up for what we believe in because we will be challenged along the way.

The Biodesign Alumni Association has recently formed a Policy Initiative to focus on impacting policy changes that affect the industry.  This conversation with Eb and Josh helped put forth a vision of what we can accomplish through (1) being proactive to make our voices heard, (2) being persistent and responsive with officials, and (3) developing a plan for effecting change.

This brings us to the following closing questions:

• How do we as an association want to pursue policy initiatives?
• What changes are vital to our industry and worth pursuing?

Please use the blog comments as a way to begin this dialogue.

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Jeremy Koehler is an alumnus of the Stanford Biodesign Fellowship and is a mechanical engineer focusing on design and R&D for innovative medical devices.