Medical device industry veteran Don Urbanowicz, who retired in December after 10 years with Stryker Orthopaedics, sees the shifting relationship of physicians with hospitals as one of the major changes that has taken place in the medical device industry over the past 30 years. “When I got started in the business in 1980 virtually all orthopedic surgeons were independent, either sole practitioners or in group practices. Few were employed by hospitals, ” he remembered. “Over time there has been a shift to hospital employment by physicians and there is an increasing alignment of incentives for efficient health care between physicians and their institutions.”
Urbanowicz see this choice of hospital employment for surgeons as one that could potentially impact their product selection and adoption of new technology. It may also weaken the established bond between sales representatives, surgeons and device companies.
In the past, according to Urbanowicz, the orthopedic business model has been one of regularly introducing new products with incremental improvements and a corresponding price premium. “Device companies are recognizing that incremental product improvements that increase cost but offer no clinical benefits will be less likely to succeed in the marketplace, ” he said. “Today it is about new technologies and products that remove cost from the health care system—doing more with less.”
The most rewarding achievement he has observed during his career in the industry is the high success rate and excellent clinical results surgeons have achieved in the replacement of patients’ hips and knees. “New techniques and instrumentation have resulted in less invasive surgery and patients are leaving the hospital much sooner.” he said.
Looking ahead, Urbanowicz believes reforms in health care will accelerate price pressures on hospitals and medical device companies and that comparative effectiveness research will increase the scrutiny on treatments and products. He believes that much future innovation will come from Israel, China and India.
Urbanowicz predicts that the FDA will continue its enforcement mode and that 510ks will remain under scrutiny forcing device manufacturers to perform more and more clinical trials. “Designing and conducting clinical trials is not a core competency for medical device companies, ” he observed. “Companies will need to accept this new model to remain competitive on the innovation front.”
Urbanowicz began his medical device career with Howmedica and worked for Smith & Nephew, Sofamor Danek and Aircast primarily in senior executive global marketing roles before joining Stryker Orthopaedics in 2001 as Vice-President of Business Development.
Don Urbanowitz may be reached at don.urbanowicz@gmail.com.

