How often are good ideas lost due to the complicated regulatory approval process a new medical product must go through?

Memphis Business Journal
February 15, 2008

Joseph Clift

President

Extremity Innovations, Inc.

My experience with the FDA has been a pretty positive one, but I'm not a regulatory expert. Companies like Wright Medical, Medtronic and Smith & Nephew have whole departments that deal with nothing but regulatory issues. Smaller businesses and startups come into contact with the FDA more than some of the larger companies. They have been willing and eager to help us with any problems we've had.

As for the process overall, I'd say it is not too burdensome or cumbersome. I'd rather have the FDA do an extra good job in protecting the public than make things too quick and easy for medical device makers. It's that role as a protector that makes the FDA vital and important.

Buddy Lyons

CFO

arGentis Pharmaceuticals LLC

I've seen lots of ideas that never made it past the FDA, a lot of oncology drugs that never made it. It seems the FDA is retrenching right now with a bunker mentality because of Vioxx and now because of Advantia. The FDA as an entire organization is going seemingly inward and it's getting more difficult to get products through.

For example, there was a company with a drug, a treatment for pancreatic cancer, that didn't make it. They had good data, but not perfect data that showed it extended life in patients with pancreatic cancer. They ended up going bankrupt because the FDA wouldn't approve their drug with the data they had. But that data, from a clinical standpoint, showed efficacy, showed the drug did extend life.

Lisa Lee Michels

Group director of regulatory affairs, orthopedic reconstruction

Smith & Nephew, Inc.

There is a heavy burden on device companies to continually launch innovative products and technologies that are well designed and manufactured in compliance with current good manufacturing practices. It is the ultimate responsibility of device manufacturers to comply with legal and regulatory requirements and to prove their products are safe and effective. Medical device companies must also ensure that a new product does not infringe upon intellectual property rights, is not promoted in an off-label fashion, nor is marketed prior to receiving regulatory approval or clearance. To further exacerbate such challenges, the regulatory approval process for new products can be arduous for device manufacturers. Regulatory bodies throughout the world now exercise greater scrutiny of the product and the manufacturer during the pre- and post-market phases.

Ken Woody

President

Innova, Inc.

One example is the Birmingham Hip Replacement from Smith & Nephew. It's actually an old idea and three companies came out and tried to get it done. Smith & Nephew bought a company that already had it and were able to move it quickly through the FDA. Other companies like Wright Medical and Biomet had similar products, but they had a hard time getting approval. Frankly, it was good for Smith & Nephew to get theirs approved so quickly, but it isn't necessarily the best thing for patients. We had both, at Smith & Nephew and Johnson & Johnson, good ideas that we felt had good market applications and really good opportunities to have patient impact, but were either too costly or were going to take too long to get them through the FDA. So, we had to shelf them. You only have so much money for research and development at the end of the day.

This feature contains responses from industry professionals to questions posed by Memphis Business Journal. To weigh in, contact sections editor Jane Donahoe at jdonahoe @bizjournals.com.