On the heels of our continued partnership with the FDA, we had the privilege to catch up with Murray Sheldon, MD, Associate Director of Technology and Innovation at the FDA, Center for Devices and Radiological Health. Dr. Sheldon shares his views on the organization’s role in advancing medical technology, recent successes, as well as future challenges and opportunities.
Dr. Sheldon is uniquely positioned to help bring medical technology safely and quickly to patients. Prior to joining the FDA in late 2012, Dr. Sheldon served for 10 yeas as medical director of several cardiovascular medical device companies, including BioVentrix, Solinas Medical and Arbor Surgical Technologies, which was sold to Medtronic. Before working in the medtech industry, he was in private practice for 20 years, serving as a staff surgeon in several medical centers in Northern California, performing cardiac, thoracic and vascular surgery.
Q. How do you view the FDA’s role in advancing new medical technology, and how has it evolved over the years?
A. Since joining the FDA three-and-a-half years ago, I have been looking forward to helping improve the landscape of medtech development. Although we at the FDA are a regulatory entity, we believe that we can play a supporting role in significantly advancing medical technology.
In the past, we had been viewed, to a certain extent, as an obstacle for the industry, driving products to be developed outside of the U.S., which is not good for those who need the life-saving devices that could be optimized in our country.
As part of my role at the FDA, we have identified protecting and promoting health, and ensuring that innovative technology gets to patients, as a priority. We are achieving this by playing a more active role: by improving our regulatory pathways, customizing decisions based on individuals’ needs and by working more closely with developers to craft high-quality approaches to developing and regulating products that have a significant likelihood of getting to market and patients quickly.
Q. What has been the feedback of the steps you have taken to streamline the approval process?
A. When you are going to develop a new medical device, where you conduct the earliest feasibility studies is also where you usually market those devices first. In 2013, we set a priority to increase the number of early feasibility and first-in-human-trials here in the U.S. We created a new guidance document, outlining how we would encourage early feasibility trials in all of our pre-market divisions. The result: we doubled the number of studies submitted to be conducted in our country.
As an example, prior to my joining the FDA, a lot of early clinical studies were done in Europe. Today, we are seeing more European companies come to the U.S. for their development. We are successfully stemming the tide of development leaving the U.S., positioning us as the country of choice to conduct trials – a strong indicator that we are heading in the right direction.
Q. What initially attracted you to partner with the Fogarty Institute and what led you to continue the partnership?
A. I cut my teeth with medical device development with Dr. Fogarty, someone I have known and respected for a long time. After six months of my tenure at the FDA, we brought in a group of outside expert stakeholders, including Dr. Fogarty, to help us understand the barriers to device development, real and perceived, and to suggest ways to improve our processes.
What we realized is that although highly skilled in medicine and biomedical engineering, many of the FDA staff had not worked in the medtech development community, and because of that, there was a limited understanding of the challenges startup companies are facing when bringing their products to market.
Dr. Fogarty reached out to us, offering the Fogarty Institute as a test bed to link FDA staff and startups. We conducted a pilot program at the Institute last year, which was so successful, that in 2016 we are continuing and expanding the partnership with eight staff who will attend four different sessions.
Q. How did choose the staff going to the Institute?
A. We wanted to make sure that whomever we chose, would not be someone who would interact with the startup for a regulatory submission in the future. But we also wanted to choose staff whose decision-making would be impactful and who could implement and share the gained knowledge. The first year, we chose two representatives from our early feasibility representatives in our Office of Device Evaluation. This year, we have representatives from four different Offices participating. In the end, it would be ideal if all our staff was exposed to this type of experience.
Q. What are some of the key lessons learned from the partnership with the Institute and how will it help the FDA with its approval process moving forward?
A. Our staff was really impressed by the skills and quality of the development community. They were impressed that medtech entrepreneurs are not “fly by night cowboys,” but truly hold patient care as their primary motivation.
They were also surprised by how little they actually understood about the many of the challenges faced by startups, including raising capital, establishing a supply chain of materials they need, setting up animal labs, conducting clinical trials and putting all the pieces together.
Our staff went in with their eyes wide open and came out as a different kind of reviewer. For the companies that FDA staff interacted with, breaking the barriers of being viewed solely as a regulator, and learning that the FDA shares in common the same motivations for device development, (improved patient care), was a critical step forward. We entered as potential “opponents” and came out as colleagues.
Q. What are your top tips for medtech startups that are in their inception phases?
A. Our recommendations include:
- Have a good sense of what it is you are developing.
- Determine who needs your product, what is the landscape and what are the improvements needed over potential existing products.
- Develop a value proposition for the patients and products you are targeting.
- Confirm that what you are developing is feasible.
- Determine if your business development plan will be sustainable.
- Research existing patents to determine if your product is likely to win one.
- Assess if you can identify the right people and team members to get your product to market.
- Learn about the regulatory hurdles you are going to face, and the insurance coverage and reimbursement landscape.
Q. When is the most beneficial time for a startup to engage with the FDA?
A. We highly recommend early and often. When you develop a prototype, you should have an initial discussion with the FDA to benefit from early feedback on regulatory requirements to get the product to market and the likely best regulatory pathway to pursue. Without knowing, you may risk going down the wrong path and/or developing the wrong kind of evidence.
Q. What are the challenges and the opportunities you see for the FDA moving forward, within the medtech industry?
A. The challenge is the rapid pace of device development in the U.S. and around the world, especially with IT and software. Innovation is exploding around us, the pace of development is quicker than ever, and it is a challenge to keep up and guide companies in the right direction so they can create usable medtech devices.
The opportunity is for the FDA to learn and grow with the development ecosystem and to be part of this rapidly changing world we are living in together.
Innovation will continue and the only guarantee is that everything will always change. The best course of action is to embrace both the challenges and the opportunities, as a team.