OrthoTec 2013 Panel Battles Over the Future of Orthopedics (MDDI Online)
It nearly came to blows at Orthotec this week. I’m being bombastic, but we did see some controversy during a panel on tissue engineering and future applications. The panel consisted of some terrifically opinionated experts, including Susan Drapeau, director of biologics R&D at Medtronic, Michael Hiles, VP of research and clinical affairs at Cook BioTech, Arnold Caplan, professor of biology and director of the Skeletal research Center at Case Western Reserve University, Sachin Mamidwar, general manager of OrthoGen, and Kevin Stone, orthopedic surgeon and founder of the Stone Clinic. The panel was led by Scott Bruder, chief medical and science officer at Stryker.
What the Panel Agreed On
The future of orthopedics won’t be in metal and plastic—it will be in tissue engineering.
The Controversy
Susan Drapeau however, was adamant that the changes were a long way off, held back by a challenging regulatory environment, a flux of “biologics” already in the IP market, and a lack of incentive for orthopedics companies to fund or otherwise support development of tissue engineering. She estimated that future of those materials is a long way off, at least 15 years.
Kevin Stone countered, saying companies will have to change their method of product development. They have to encourage small companies by sitting on boards, and providing the expertise that start-ups don’t have, such as regulatory and quality control issues.
Scott Bruder challenged that notion, by presenting the lack of a business case for such altruism. He said Stryker had tried that before and then got burned once the company had regulatory approval. The start-up suddenly forgot all the help they’d been given and then wanted too much for Stryker to buy the company.
Stone, with the help of Arnold Caplan, then said, that is the cost of doing business, and that large firms looking to buy good technology should expect to overpay a bit. After all, by sitting on those boards, large companies are better able to judge the viability of a technology, and they can do so with little monetary risk. “If you don’t think the technology is worthwhile, you can simply get out without having invested,” he said.
Sachin Mamidwar, who is working at a start-up, reminded the delegates that a major difficulty for start-ups is navigating regulatory and quality control—issues that large companies live with everyday.
Michael Hiles said the tissue products on the market now are showing some promise, but they have a long way to go.
Stone reminded the panel and delegates that mentoring would ultimately lead to better technology and a higher level of quality.
The Epilogue
I’m not certain either side was convinced by the other. It was very much a dichotomy of corporate business having immediate pressures and clinical and academia pushing for technology that can take humans to the next level. In truth, it was a hearty and congenial debate. At the end of the day, all sides simply want the best outcomes for patients.
Where do you fall? Are we going to delay (miss the boat entirely) on tissue engineering because large companies can’t see past the business hurdles? Perhaps we should we take the long view and wait for an evolving FDA to say they will work with us? Are there other alternatives that the panel might have overlooked?