The Impact of Business Strategy and the FDA on the Future of Spine Surgery

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At the 11th Annual Spine, Orthopedic & Pain-Management Driven ASC Conference on June 14, Frank Phillips, MD, of Rush University Medical Center and Northwest Orthopedics, both in Chicago, and Nameer R. Haider, MD, of Spinal & Skeletal Pain Medicine in Utica, N.Y., discussed the impact of business strategy and the Food and Drug Administration on the future of spine surgery.

 

Both physicians identified trends that have emerged recently that show where the future of orthopedic surgery is headed. “The tide is really turning towards minimally invasive surgery,” said Dr. Phillips. He said that many physicians are coming out of their residency trained in MSI, a trend that will make the technique increasingly common in both hospitals and ASCs. “It will definitely become the standard if it hasn’t already,” he said.

 

Dr. Haider cited neuromodulation as a technique that is and will continue to be used to treat a variety of conditions, from obesity to sleep apena. “This technology will definitely be utilized more in the coming years,” he said.

 

However, Dr. Haider remarked that neuromodulation is being used more extensively in Europe than it is in America, mostly because regulatory approval processes in the U.S. delay the introduction of some of the most cutting-edge innovations into the market. He gave the example of a company he has worked with that makes innovative cervical replacement discs that look and function like natural discs. The company has quickly become the top device manufacturer in Germany, but the company has yet to start the lengthy FDA approval process and therefore will not be in this market for years, he said.

 

“Most of funding for these startups has come from European investors,” said Dr. Haider. “Things are becoming so difficult for innovative products in the U.S. that if you have the idea it’s not until seven years later that it comes to fruition and you see it on the market,” he said.

 

Both panelists agreed that the lengthy and costly regulatory process in the U.S. means that while innovation still comes from mostly smaller companies, it is the larger companies who have the resources to see a product through to approval. Dr. Phillips said this leads to smaller companies who have an innovative device being bought up by the larger companies.

 

Investing in innovative technology, whether a company’s own research and development or the purchase of a smaller company, has really become a business decision, said Dr. Phillips. “They’re looking to see what the profi­t margin will be,” because it now takes about five to seven years for investors to get their money back, he said. But this does not mean that there will not be investors: “They will invest if there’s real innovation, and a real opportunity” for success, he said.

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