An MD&DI June 1997 Column
SNAPSHOTGünter Frey sees a change in the role of regulatory affairs.
As a young nurse orderly in the German military, Günter Frey saw firsthand that patients and clinicians need access to the latest technology. The experience of relying on equipment when he needed it inspired a personal dedication to producing quality medical devices. As director of regulatory affairs for Pryon Corp. (Menomo-nee Falls, WI), he has had an opportunity to put that dedication into practice by guiding the company through the ISO 9001 and EN 46001 certification process in just eight months.
After immigrating to the United States in 1988, Frey used his degree in biomedical engineering to land a position with a manufacturer of electrocardiographic products. After a short period as a software test engineer, he was promoted to manager of quality assurance and regulatory affairs, a career that he has found interesting and challenging. Soon after his move to Pryon in April 1994, he was asked to research getting ISO 9000 certification for the firm.
"Patients are entitled to access the latest technology available. Although harmonization is making it easier to get products approved worldwide, it continues to remain a challenge and time to market is critical," Frey says. He believes assisting OEM partners to incorporate the most recent technological advances into their devices is essential, especially in an environment where reducing health-care costs while improving patient care puts even more pressure on manufacturers.
This environment is a driving force behind Pryon's business strategy, and Frey takes these issues seriously in his role at the company. Just six months after Pryon's ISO certification, Frey orchestrated the company's self-certification status under Annex II of the European Medical Devices Directive. These certifications are crucial to Pryon and its ability to provide a competitive advantage to its customers. According to Frey, because manufacturers must respond to the evolving health-care environments, more and more are pursuing OEM/supplier agreements to gain access to new or additional technologies more quickly. "As a medical device manufacturer and an OEM supplier itself, Pryon's end-use devices will have already undergone the regulatory review process, allowing our partners to reference or utilize Pryon's data in their own regulatory submissions," says Frey.
Holding a quality certification not only gives Pryon a competitive advantage in a worldwide market, but also enables it to share this advantage with its OEM customers. Self-certification, which enables Pryon to market a product as much as six months sooner, is a key marketing advantage the company anticipates it can pass on to other manufacturers that incorporate its technologies into their products.
In July 1996, Protocol Systems (Beaverton, OR) acquired Pryon. The strategy behind the purchase was to gain direct access to Pryon's current and developing vital signsmonitoring technologies, according to Frey. "Successful long-term strategic alliances play an important role in a company's ability to remain competitive. Pryon continues to identify OEM partners around the world with which to form such alliances."
Navigating through the worldwide regulatory environment presents a number of challenges that successful partnerships can help overcome. Frey says Pryon's ability to provide its OEM partners with certain products that have already received a CE mark or 510(k) notification addresses many international and domestic marketing issues for its partners. "A company's core competency no longer lies strictly with the technology it has developed, but also in the correct application of the regulatory requirements surrounding the technology," he says. Integration of proprietary technologies enables partners to reduce time to market and development costs.
Significant issues concerning global harmonization still remain, Frey says, such as differing incident reporting requirements among European Union member states, and the unresolved potential for labeling devices in 11 languages within Europe alone. "These are not necessarily small issues for manufacturers to deal with." Having grown up and worked in Europe helps Frey understand the culture and regulatory environment; however, he says he doesn't take being in the United States for granted. "I feel fortunate to be in a place where I can make a contribution to putting higher-quality products on the market."