Originally Published MDDI June 2004

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Close-Up: Regulatory Champions

David W. Feigal Jr.
NDA Partners LLC

What is the driving passion of your work? 

Bringing innovative, safe, and effective medical therapeutics to practice.

What is the greatest regulatory challenge facing the 
industry today? 

Developing compelling scientific paths-to-market at a cost that allows the innovative small companies to flourish. Sound scientific evidence is key for regulatory approval but can be very daunting to collect. 

What is the most common misunderstanding of medical device regulations that you encounter?

That safety is the principal FDA concern, or similarly that an FDA-approved product is safe. The goal is to have a favorable benefit compared to risk. Often it is the lack of clear effectiveness evidence that makes a risk/benefit assessment incomplete.


Bradley Thompson
Baker & Daniels

What is the driving passion of your work?

It is the notion that healthcare is so important and policy issues dictate whether Americans will have access to the care they want and deserve. 

What is the greatest regulatory challenge facing the 
industry today?
Perhaps the greatest challenges are the cost and the uneven access to care. This should be seen as an opportunity to use technology to lower the overall cost of healthcare.

What is the most common misunderstanding of medical device regulations that you encounter?
Understanding the differences and similarities between FDA approval/clearance and the Medicare coverage decision. FDA approval should mean that the technology has met certain important requirements for Medicare coverage, even though there may be additional issues to address.

Jonathan Kahan
Hogan & Hartson

What is the driving passion of your work? 

Intertwining law, science, and medicine. Every new technology raises different issues and often demands new approaches in working with FDA. We see just about every new technology coming down the road. I often feel that I have helped patients get the most advanced care technologically possible.

What is the greatest regulatory challenge facing the 
industry today? 

The advances often outstrip FDA’s technical expertise and outmoded regulations. I was impressed by FDA’s willingness to think a bit out of the box in its workshop on innovations in drug-delivery devices. However, there are significant challenges ahead as industries make advances. 

What is the most common misunderstanding of medical device regulations that you encounter?

Companies think that if they simply explain their new technology to the agency, FDA will recognize the value and clear it to market as quickly as possible. An excellent plan, coupled with open and comprehensive communication with FDA, is the key to expeditious approvals.


Larry Pilot
McKenna, Long & Aldridge

What is the driving passion of your work?

Justice. To assure that laws and regulations are understood and applied by those responsible for compliance, and that those responsible for enforcement use good judgment applying their authority.

What is the greatest regulatory challenge facing the 
industry today?

The greatest challenge for the industry is a need for responsible interpretation and balanced application of law and regulation by FDA. Restoration of the concept of “reasonable assurance of safety and effectiveness” could reduce the harm associated with regulatory challenge and produce public benefit.

What is the most common misunderstanding of medical device regulations that you encounter?

The inability or unwillingness to accept or respect differing points of view between those of the regulator and the regulated. It is time for an independent, objective, and comprehensive review for FDA performance to evaluate the value added to device safety and effectiveness through application of FDA inspection and premarket review resources. 

Copyright ©2004 Medical Device & Diagnostic Industry