Challenges:1. Solving present device problems. With improved device innovation come challenges for developers to keep up with demand and to avoid redundancy. According to Dr. Harwin, the desire to develop a new product or device can lead researchers to reinventing the wheel. Developers should focus on fixing the problems with existing devices rather than creating new products simply for the sake of releasing a new device.
"We want to solve certain problems," he says. "We don't want to create something that is a solution to a non-problem. We can sit back and say, 'I'm going to design a better screw driver because it looks better and turns faster,' but that's not innovative. That's something you can put out there but it won't make a difference in anyone's lives."
Dr. Harwin believes the next problem to be solved in the world of joint replacement is to produce a fully normal joint without any of the drawbacks that even the most advanced implants have today.
2. Creating products with no existing market. The orthopedic device market is more competitive than ever as the demand continues to grow, and companies need to have an edge in order to be successful. They need to find different ways of dealing with the changing marketplace, Dr. Harwin says, including thinking outside of the current demographics.
The next truly innovative product could be for a market which doesn't even exist yet but which anticipates the needs that will eventually come up.
"You have to look at things from a market perspective that the old way of doing things to just make a product cheaper and deliver it faster isn't going to cut it in today's market because every company is doing the same thing," he says.
3. Learning from past industry mistakes. While orthopedic device developers and surgeons are always looking to improve what they do, they have to remember the mistakes from the past and learn from them. "Tinkering with proven technology can be disastrous," Dr. Harwin says. "You have to be very careful about changing things that work. You can make minor changes and the law of unintended consequences kicks in. That's what metal-on-metal was. It sounded like a great idea, and nobody figured there would be allergic reactions or metal ion deposits."
Some new technology sounds promising, he says, but the outcomes must be as good or better without adverse effects. For instance, there is new technology of installing implants that requires special mapping MRIs to give the device a more accurate fit. It does add some extra cost, but it give us better outcomes in the future.
"You have to look at these things 20 years down the line," he says. "I don't want to be the first one jumping on the bandwagon, but I don't want to be the last one either."
Innovations:4. Improved implant materials. As life expectancies climb, people expect to not only live longer, but to also live more active and productive lives. Joint replacement implants will need to meet these expectations by granting patients full mobility and durability.
Older technology, such as those implanted with cement or weaker plastic bearings, presents several challenges. Cement breaks down, crumbles and loosens after repeated impact. Bearing plastic can not only wear out, but also cause joint inflammation and bone problems. These technologies will begin to go by the wayside as more reliable methods take over the market.
"We've made great strides in both hip and knee implants," Dr. Harwin says. "In hip replacements, we have developed technology where cement is not necessary. Implants made out of titanium with a foam metal surface, imitates the properties of bone and is very well tolerated."
Titanium implants, coupled with more advanced and durable plastic, will eliminate the loosening patients used to endure by allowing the bone to grow into the implant, providing biological fixation.
"We can safely say we can eliminate the cemented knee, as well," he says. "We use very strong plastic. It's very hopeful for the baby boomers coming of age. Their knees are wearing out and their hips are wearing out."
5. Knee implants that mimic the body's real motion. Dr. Harwin helped create the Triathlon Total Knee Arthroplasty system, also known as the GetAroundKnee, which more closely mimics the motion of a natural knee than previous devices. According to Dr. Harwin, nearly one million of these knees have already been implanted.
Now he and the design team are about one year away from launching a new knee replacement to build on the success of the Triathlon knee and incorporate even greater medical advancements. However, Dr. Harwin says he and his team always keep future implant costs in mind when developing their products.
"When we started this project, we committed to the principle than when we bring this knee to the market, it will not cost any more than the premium knee we have on the market now," he says.
6. Dual mobility hip implants. Many of the most recent hip implants featured a metal-on-metal design that proved problematic for many patients because of wear and biological reactions. Dr. Harwin, in his consulting role at Stryker Orthpaedics, worked to solve the metal-on-metal problem with the development of the MDM X3, a modular dual mobility hip system that uses a metal or ceramic ball that moves inside a larger, stronger plastic ball. The plastic ball in turn moves within a smooth metal shell.
"It has the properties of the large head without the problems of metal-on-metal," he says. "It's my hip of choice. It's good for active baby boomers."
7. Blood conservation and management. The future of joint replacement is bloodless, Dr. Harwin says, meaning patients will no longer require blood transfusions. As the director of the Total Joint Replacement Bloodless Surgery Program at Beth Israel Medical Center, he's developed a minimally invasive technique to do hip and knee surgeries without the need for blood transfusions.
"A lot of people want this because of problems with blood transfusions," he says. "We are making surgery safer. We can use local epidural or spinal anesthesia instead of a general anesthetic, so patients can breathe on their own with a faster recovery. It's often a game changer and a life changer with less than an hour-long surgery."