Hips and knees: Consumers Union calls for no-cost revision warranties | MassDevice

Adding patient warranties to hip and knee implants would be a disruptive move if it’s ever offered…or mandated.

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Implants are Big Business. The article states that there were 1.2 million hip and knee surgeries in the U.S. in 2011. That number is expected to increase to 4 million by 2030 as the last of the Baby Boomers ages into their golden years. Half of those surgeries, however, will be in patients under 65.

Of course, a major challenge in orthopedic implants is making them and implanting them so they last the life of the patient. With many people living well into their 80s and 90s today, an implant may be expected to last 25-30 years.  Revision surgery is messy and expensive. Patients are not happy about having to undergo implant surgery for a second time just because they outlived the first implant. And the risks of implant surgery increase as patients age.

Since implants are a fraction of the cost of joint surgery (a substantial fraction, but a fraction nonetheless), offering a warranty on the entire revision surgery would be a huge financial liability for the medical device manufacturers and unlikely to happen unless compelled by law. Of course, there are other big players involved, namely Medicare. Since most of the implant failures occur in older patients, Medicare foots almost all of the bill.

As we get deeper into healthcare reform and start to have fact-based discussions about costs vs.outcomes (one can hope, right?), issues like this should surface for policymakers to address. Why should a medical device company benefit from an inferior design by being paid for a second implant? What about surgeons and hospitals – if the implant is installed incorrectly, shouldn’t the surgeon and hospital bear some of the cost of fixing it, even if it’s ten or fifteen years later?

In my opinion, perfecting the design of hip and knee implants is a high stakes strategy. The first company to succeed in deploying a “lifetime” implant will start to gain market share at the expense of its competitors. Perhaps it will evolve a business case that enables it to offer the revision warranty. In that event, the market share gains will accelerate and weaker companies will disappear or be absorbed by the stronger.

I would bet that there are many biomedical engineers and researchers feverishly working on this challenge right now.

Takeaways: While in many ways we are in the golden age of medical devices, major changes are on the horizon. Things like lifetime costs and outcomes-based decision making are getting more attention every day. Advocacy groups like AARP and Consumers Union are becoming more vocal and more active. Government agencies are more involved than ever and there’s no end in sight. You should be prepared as the old ways are ending. Not for much longer can you count on selling a device by persuading a physician to demand it and then being able to bank on that revenue stream for years. Data – lots of it, and exhaustively analyzed – will be the most persuasive way to sell and to affect policy.

Read more: Hips and knees: Consumers Union calls for no-cost revision warranties | MassDevice.