Orthopaedic implant development has been a career-long passion of mine. Many years ago, I had a vision for implants that were specific for the distal extremities—wrist/hand and foot/ankle. Every implant company I asked took a pass. We know how that worked out, with companies continuing to enter the market and distal extremities growth outpacing more mature segments. So the question is, where are we going? As a foot/ankle surgeon, I’ll share what I see in my crystal ball on plates, biologics and total ankle replacement. We have a lot of unfinished work.
The best way to describe the current state of product development would be through experiences with different companies as they “sell” their products. Please accept my humor in the passages below (yes, these vignettes actually happened).
“Hey doc, how are you? I’m new to OrthoA and I have something that will change your practice.”
“I’m in the middle of a busy clinic; don’t come back.”
A week later my secretary asks me if I’ll meet with the regional manager from OrthoA who is flying up from Texas just to meet with me.
My secretary asks if I’ll meet with the regional manager from OrthoB.
“No, please have my PA meet her. If it’s interesting, then I’ll take a look.”
I didn’t take a look.
I’m greeted/ambushed in the O.R. lounge between cases by two reps from OrthoC. “We have something that will change your practice!”
“I can’t talk; seriously, my next case is in 15 minutes.”
“Okay, here is a white paper on this new additively-manufactured implant that has never had a single failure. The implant, screws and instruments are all individually packaged, so you only use what you need. We’d like you to be part of our team, and we’ll fly you to California for training.”
“Doctor, your case was delayed; Joey hurt his shoulder lifting that new tray that has 101 plates and 400 screws. They went all over the floor, so we have a mess to clean up.”
And the rep goes on, “The material that’s used in the implant has special bone healing properties and the coating promotes bone ingrowth.”
“So, how do I get out the implant if I get the first failure?”
“That will never happen. So, will you be our champion for the New Technology Committee?”
Here’s what surgeons really need and want to hear: a cost-effective method to consistently and reliably solve problems. Do we care if the implant is additively manufactured?
I’ve seen plates that are coated or textured in locations that do not enhance healing. The complex geometries that are possible with additive manufacturing are amazing only if they lead to improved outcomes.
Do we want individual packaging for the implants?
Let’s use ankle fracture plating as an example. I need one plate, nine screws, one drill bit, drill guides, bone clamps and a depth gauge. The typical time from when I ask for an implant until I start insertion from a peel pack/box is 3 to 4 minutes. Multiply 3 to 4 minutes by 10 and you get 30 to 40 minutes. Multiply 30 to 40 minutes by $60/minute of O.R. time and you get $1,800 to $2,400 of waiting time. The average profit for an orthopaedic case in an ambulatory surgery center is $3,800. I’m unsure of where the cost savings is coming from with this approach.
New materials are also a problem. I’ve been in practice long enough to have seen disasters from new materials that had been tested on a small scale by design surgeons. The metal-on-metal hips development should give everyone pause on the topic of new materials. Surgeons have to tell patients about the failures and hope that the patient will then trust us to clean up the mess. This is an experience that no one on the industry side has to manage, and it’s not pleasant.
The material advances need to solve real problems. For example, my fusion rate for the great toe is 95%. While 100% is the goal, getting the last 5% may be cost prohibitive, and proving the increase in healing will take a study that is highly powered. The other problem is that when the implant needs to be removed, will the ingrowth complicate the explantation?
Cost remains an issue. The days of implant costs being a blank check are gone. I practice in a physician-owned hospital. We set capitation rates for our implants, regardless of the company. We also have a monthly updated list of “implant waste.” If I have to swap out a screw, it’s posted for everyone to see what I wasted. If someone drops a graft or implant, we all know.
This is a significant peer-pressure tactic. Employed physicians, a growing number, are under greater scrutiny. The doom and gloom of today’s market is centered on “creating” another plate, screw or staple that’s like every other on the market. Also, a new color, logo or package doesn’t have the sizzle to sell.
Opportunities in Foot and Ankle
The world of foot and ankle, though, is vibrant and full of opportunity to solve real problems. Honesty in implant “improvement” must take place at the design stage. Foot and ankle has the trifecta of implants. Depending on the case, I need hardware, soft tissue reconstruction and a biologic enhancer. This is unique in orthopaedics, and the company that wins recognizes the problem to be solved in its totality and not just a piecemeal approach.
Surgical solutions need to be comprehensive and techniques well-designed to give improved outcomes even for the average surgeon. Suppliers need to be geared to help device companies reduce costs and improve quality. Everyone in the chain needs to be focused on improved outcomes, not just a nice intra-operative radiograph.
Looking deeper into my crystal ball, I see new biologic solutions. Metal is nice and it works, but nothing beats biology. An example would be woven ligament replacements that are seeded with fibroblasts to become true ligament replacements. These would have the correct anatomic dimensions. Two specific examples would be repair of the spring ligament and the plantar plate. Using an inelastic, non-anatomic suture just seems like a poor effort. The results received from repairing degenerative and avascular ligaments with current techniques need attention. These are common problems that don’t have the “social media” impact of the rare total talus replacement radiograph.
Total ankle replacement is actually very complex. For a proper ankle replacement to perform short- and long-term, the foot must be balanced and function. All ankle replacements I perform have at least one other problem. The ankle doesn’t function in isolation, and it’s best to consider the ankle/hindfoot complex. There may be ligament/tendon contractures/instabilities that need to be addressed.
Knee replacement surgeons spend significant time addressing the collateral ligament balancing of the knee. We have to balance the entire foot as well as the ankle; a complex task that is more art than science. The goal is to maintain a balanced foot that will be flexible and stable. The ankle is small and unforgiving. Failures are difficult to salvage. How can total ankle replacement be improved? Instrumentation for implantation, bearing surfaces that have greater durability, lessened inflammation from the wear particles and better techniques to balance soft tissues. The practical problem is that we are only performing 10,000 replacements annually, so costs matter, again.
My final suggestion is that all of the players, contract manufacturers, raw material suppliers, regulatory and logistics people leave their silos and visit the O.R.
Observe and listen to surgeons, sterile processing, material handlers and supervisors.
Suspend your view of the world to see the possibilities. You are part of a large interdependent team that needs to work together to create the best possible outcomes.
David Kay, M.D., is a foot and ankle surgeon, Partner at Crystal Clinic and Managing Partner at Extremity Development Company, an incubator focused on next-generation extremity products. Dr. Kay founded OrthoHelix in 1995 to develop innovative implants and instruments for small bone reconstructive foot and ankle surgery. OrthoHelix was acquired by Tornier in 2012 for $140 million.