Responsible innovation in orthopaedics: Addressing new patient needs with tough clinical safeguards

by Laura Piccinini, President, Stryker Europe

The goal posts are always moving. While this is true of medicine in general, it is especially true in orthopaedics. Hip replacements, for example, are one of the most successful medical treatments of all time, and some might ask why innovative new technologies are even necessary in a field that has long boasted a +90% success rate at over 10 years. But much of the legacy of orthopaedics is the treatment of 70-year-olds whose primary goals were to alleviate pain and regain basic motion. Today’s patients — who are just as likely to be 50-year-old yoga teachers who play golf on the side — have higher expectations. And increasingly, they are looking for better performing technologies that support their more active lifestyles, as well as their individual anatomies and pathologies.

To date, our industry has performed admirably in introducing innovations that meet changing patient demands. By capitalizing on everything from advancements in material science to innovation in design, we have been able to improve the wear, longevity and comfort of many of today’s implants — even under greater duress from today’s more active patients. But a passionate dedication to innovation cannot compromise the importance of providing safe and effective solutions for patients.

Global regulatory agencies are thinking along these same lines. In April, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK issued a Device Alert in which they identified that a small number of metal-on-metal hips may develop soft tissue reactions to wear debris and be at risk of early failure and require revision surgery. The subsequent media coverage around metal-on-metal articulations raise some important questions in the industry about how we ensure the long-term safety of the innovations we bring to market as solutions to existing and emerging demands.

In our industry, we need to consider evolving the way we test new technologies. How extensive is the lab testing that new products undergo, and does it reflect a range of factors, including malalignment and anatomic differences? An industry that takes a position of responsibility in driving innovation to meet changing patient and customer demands should focus on building a legacy of confidence through rigorous pre-clinical testing to ensure long-term success and optimal patient outcomes — for which we all strive.