Inside Orthopedics: Orthopedics is going bespoke (Podcast 34)

Tiger Buford argues orthopedics is moving toward fully custom, patient-specific implants. Today bespoke devices take weeks and cost a lot, limited to cancer or unusual anatomy. The real opportunity isn't the 3D printing itself but the software platform connecting imaging, manufacturing, and business processes. Tissue printing comes next.
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Brought to you by Tiger Buford. Congratulations, you have found Inside Orthopedics. I am Tiger, your orthopedic industry insider and retained recruiter for early-stage orthopedic companies. This is episode number 34 titled Orthopedics is going bespoke. In this podcast, I'm going to share a trend with you, an inevitable trend that will turn orthopedics upside down. Enjoy Inside Orthopedics, always ad-free. Here we go. Orthopedics is going bespoke. What is bespoke? Bespoke is a funny word that originated actually centuries ago to describe tailored clothing. Today bespoke means custom-made for one customer. I'm declaring today that orthopedics is going bespoke and nobody can stop it. In future procedures, implants will be designed and manufactured to fit the patient for better outcomes. This will be the end of orthopedic implant sizes as we know them. The end of the racks of implants sitting outside the operating room. The end of little-used implants and instruments brought in and out. Orthopedic implants will become bespoke total joints that actually fit, bespoke partial joints that actually fit, bespoke bone plates and nails for complex trauma cases that fix fractures perfectly, bespoke spine fusion devices that fit perfectly for each level, bespoke disc replacements that fit perfectly for each level, bespoke meniscus replacements made from the patient's own cells, bespoke ACL replacements made from patient cells, bespoke tendon replacements made from patient cells, bespoke rotator cuff augments, and so on. Today, bespoke implants are really only used for oncology cases or unusual bone anatomy. The surgeon gets a CT scan, has it sent to the company, an engineer designs an implant solution and sends a plastic model. The surgeon approves the design based on the plastic model. This process all takes weeks. It's expensive. It's slow. It's cumbersome. Tomorrow, bespoke implants will be used in all all orthopedic procedures. Bespoke solutions will be delivered fast, efficiently, and will fit the patient 100% of the time for better outcomes. For a sneak peek at our bespoke future, take a quick look at the disruptive casting startup called Exiom, spelled E-X-I-O-M. .com. Exeom provides the clinic with a little 3D scanner accessory for an iPad. The patient's broken arm or leg is scanned in the clinic, then 48 hours later the bespoke cast is delivered to the clinic. It fits perfect. For more about Exeom, listen to podcast number 20 with the CEO of Axiom. It'll give you a look into the future. So here's, here's my ask: if you have any influence whatsoever inside a device manufacturer, let me share what I see as the big opportunity for you. The big bespoke opportunity for the device companies is in the process not in the technology. Again, the big bespoke opportunity for device companies is in the process, not in the technology. Additive manufacturing technology is the sexy part that everyone likes to talk about, make videos about, uh, demonstrate. However, the big opportunity lies in creating streamlined processes. Let's review the 3 ingredients needed in order for the orthopedic industry to go fully bespoke. Ingredient number 1 is pre-op imaging. Imaging is an easy one. Imaging technology gets better every year. The technology already exists to create sophisticated 3D images of patients' bones, cartilage, tendons, ligaments. Orthopedic healthcare has access to the best CT, MRI, pre-op imaging available. Ingredient number 1 is done. Pre-op imaging. Ingredient number 2: additive manufacturing. Additive manufacturing with proven implant materials is also an easy one. The technology is here to print implantable materials like titanium, stainless steel, PEEK, and even cobalt chrome. More and more new suppliers are jumping into the space as the cost of entry drops each year. I count over 35 or so companies in the printing orthopedic implant space today. And also, you don't need to print. A bespoke startup can outsource the manufacturing piece. This has become the easier piece. So ingredient number 2 is done also. All right, ingredient number 3: business processes. This is the hard one. Streamlined business processes are the opportunity for bespoke startups. Frictionless processes for imaging delivery, communication, scheduling, designing, manufacturing, and delivery of the implant are needed. Device companies are naturally weak in software, communication, and project management with their healthcare customers because they have always defaulted to human reps at the customer level. The new Bespoke processes must be easy for the surgeon, the hospital, the payer, everybody. New processes must be fast, efficient, high quality, and fit the patient 100% of the time. These new processes will disintermediate the normal orthopedics world of selling, marketing, training, and servicing surgeons. Okay, once again, for the orthopedic device manufacturers listening, I want to pause and emphasize the big opportunity here that everyone is missing. The big opportunity is in creating better business processes, creating the backend infrastructure that is agnostic to any imaging format, any surgeon, any manufacturer, any patient. Build the best platform that every surgeon and additive manufacturer must use, and it's game over. So that's the big opportunity in my mind. Now let's take a trip. Let's take a fun trip into the future and see how bespoke will play out as far as I can see. As with all disruptive technologies in orthopedics, our bespoke movement will be driven by the little guys. The first movers will use bespoke as a weapon against the big orthos. They will use bespoke to differentiate and take market share. A small percentage of surgeons will get comfortable with the process and demand of bespoke, and once they do, why would they ever go back to an array of sizes and trials and instruments in the operating room to fit the patient, or try to fit the patient. When will this happen? Well, nobody really knows, but the movement will creep in over the next decade. You will see the bespoke movement gradually, and then one day at Academy, it'll just seem like every device company has a bespoke program overnight. Big ortho certainly cannot drive bespoke. They're blind to the opportunity of bespoke. Big ortho will underestimate the risk of the bespoke startups. They will overestimate the value of their existing business models. Which is millions of implants, instruments, and reps supporting cases. That's, that's the business model. They are burdened with too much implant inventory and too much instrument inventory to disrupt their own business with bespoke. They're also burdened with short-term outlook of delivering quarterly earnings and an endless 90-day Groundhog Day. They have blinders on. In the early days, I expect the big orthos to market against bespoke. They will say that bespoke is expensive, it's time-consuming, creates extra work for the healthcare system, and there are just no outcome data to prove bespoke is better. Once a small percentage of surgeons embrace bespoke for most of their patients, the big orthos will finally capitulate and acquire one of the top bespoke companies. But probably as a defense hedge in order to tell Wall Street that they have definitively invested in bespoke, not because they really want to go that direction. So let's fast forward into the farther future. Sometime in the far, far future, maybe 10 years out, the ultimate killer app for Bespoke will, will be available. Looking beyond titanium and PEEK, Bespoke will provide tissue solutions. Bespoke tissue repair and replacement is the killer app that will revolutionize orthopedic surgery in the future. Tissues in the future will be printed from donor cells. The technology is evolving quickly to print bone, tendon, ligament from a patient's own cells. The technology will also print cells into biomaterial scaffolds. The technology will come first followed by new regulatory pathways, uh, and this will be the killer app. The challenge again will be the business process, but the good news is that once a successful bespoke company has the working streamlined system for delivering titanium, they will be well positioned to deliver things like tendons. Made from the patient's own cells. So this will be a fun one to watch. The bespoke sea change will happen very slowly, then fast. See you at a future AAOS. Take
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