An MD&DI August 1998 Column
Steve Kahn doesn't object to the constant changes he faces as group manager of regulatory compliance. In fact, he thrives on them. "I try to be involved at the forefront of new developments," he says. So far, his attempts have been successful.
Kahn began working exclusively in the medical device area seven years ago when he became manager of sterilization microbiology at DePuy Orthopaedics' joint replacement implant facility (Warsaw, IN). Prior to joining DePuy, Kahn worked for Bayer Corp. (Elkhart, IN), a pharmaceutical and medical device manufacturer, where he spent 10 years involved in microbiology and regulatory compliance. During his time at Bayer (formerly Miles), Kahn began the transition from the pharmaceutical to the medical device industry.
Steve Kahn responds to the changing needs of the orthopedic industry.
The greatest challenge for Kahn in the past few years has been the implementation of ISO and CE requirements according to the European medical device directives. As an advisor and member of the project team, Kahn was responsible for jump-starting the process by explaining the rules and regulations and training team members. The implementation affected every aspect of the business. "We had to get everybody to buy into the program and understand that it wasn't just a regulatory task," he explains. As Kahn learned, the key to the success of this operation was working together as a team. "Everyone was involved. It took a lot of coordination and cooperation," he relates.
The most difficult task, according to Kahn, was implementing the different documentation requirements, which involved revising current procedures and writing a lot of new ones. DePuy had to change each and every label and product insert for its 20,000-plus product line. In many cases, the company also had to change the engineering drawings and prints to add the etchings of the CE marks on the instruments.
Recognizing the need for change and responding to it accordingly has led to some of Kahn's personal accomplishments, one of those being his involvement in obtaining FDA approval of gas plasma
sterilization as an industrial application. DePuy was the first company to achieve this. Traditionally, there have been three industrial sterilization techniques available: ethylene oxide, gamma radiation, and steam. The orthopedic industry had been using gamma radiation, but research recently determined that it could cause oxidation of the joint replacement implants' polyethylene components, leading to a potential for increased wear and tear. "There was definitely a market need for a better sterilization technique," says Kahn, "and I needed to figure out a way through this." The industry began moving away from gamma radiation and using ethylene oxide instead, but when management approached Kahn to find an alternative sterilization method, he started examining new technologies. Instead of switching from gamma radiation to ethylene oxide, DePuy switched to gas plasma sterilization, which was fairly new. In simulator tests, gas plasmasterilized polyethylene showed improved wear performance over the same material sterilized by other methods.
As gas plasma sterilization is a new technique, part of Kahn's challenge has been convincing other countries that it is legitimate. He explains that some of the European countries only have one or two standards that can be used as a basis of comparison with the United States. "There are a lot of regulatory hurdles when you're dealing with a new technology, and the country has nothing to compare it to," he explains. "Some countries say, 'If it's good enough for FDA, it's good enough for us.'" But with other countries, like Japan, the struggle for acceptance of the sterilization process continues. Kahn stresses the importance of finding a balance between control and flexibility when dealing with the government. "There's always going to be some give and take."
No doubt Kahn will continue to face regulatory hurdles at home and abroad as the orthopedic industry prepares for the future. He believes that joint replacement implants will start using gene therapy and tissue engineering to replace metal and ceramic parts. This new technology, referred to as orthobiologics, is already under way at DePuy with the development of a new product for soft tissue repair made from a biologic material called small intestine submucosa (SIS). "Science is moving at a very rapid pace," says Kahn. "In terms of the orthopedic industry, the way we do business will probably be completely different in the next 20 to 30 years." Whatever those changes may be, Kahn is ready to embrace them.
Kassandra Kania is assistant editor of MD&DI.