Bespoke is a funny word that originated centuries ago to describe tailored clothing. Today bespoke means custom made for a one customer.

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 today.

  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 replacement made from the patient’s cells.
  • bespoke ACL replacement made from the patient’s cells.
  • bespoke tendon replacement made from the patient’s cells.
  • bespoke rotator cuff augmentation made from the patient’s cells.
  • and so on…

Today, bespoke implants are 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 all takes weeks. It’s expensive, slow and cumbersome.

Tomorrow, bespoke implants will be used in 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 peak at our bespoke future, take a quick look at the disruptive casting startup – Exiom. Exiom 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 Exiom, listen to my podcast with the CEO here.

The Big Opportunity for you

The big bespoke opportunity for the device companies is in the PROCESS, not in the TECHNOLOGY.  Additive manufacturing technology is the sexy part that everyone likes to talk about about. However, the big opportunity lies in companies creating streamlined processes. 

Let’s review the three ingredients needed in order for our industry to go bespoke.

1) Pre-op Imaging

Imaging is the easy one. Imaging technology gets better every year.  The technology already exists to create a sophisticated 3D image of the patient (bones, cartilage, tendons, ligaments, etc).  Orthopedic healthcare has access to the best CT and MRI pre-op imaging available. Ingredient #1 is done. 

2) Additive Manufacturing

Additive manufacturing with proven implant materials is also easy an easy one. The technology is here to print implantable materials like Ti, SS and PEEK.  More and more new suppliers are jumping into this space as the cost of entry drops each year. I count over 30 companies that are printing orthopedic implant materials today.  A bespoke startup can outsource the manufacturing piece.  Ingredient #2 is done. 

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 healthcare customers, because they default to human reps at the customer level.  The new bespoke processes must be easy for the surgeon, the hospital, and the payor.  New processes must be fast, efficient, high quality and fit the patient 100% of the time. These new processes will dis-intermediate the normal orthopedics world of selling, marketing to, training and servicing surgeons.

Psssss…. Look here

The BIG opportunity is in creating better business processes, creating the infrastructure that is agnostic to any imaging format, any surgeon, any manufacturer, any patient. Build the best platform that everyone must use.

How Bespoke Will Play Out

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 bespoke. Why would they ever go back to an array of sizes, trials and instruments to fit the patient?

When? Well nobody really knows, but the movement will creep in over the next decade. You will see the bespoke movement gradually, then one day at the AAOS, it will seem like every device company has a bespoke program.

Big Ortho cannot and will not drive bespoke. They are blind to opportunity of bespoke.  Big Ortho will underestimate the risk of bespoke startups, and they will overestimate the value of their existing business model – millions of implants, instruments and reps supporting cases. They are burdened with too much implant inventory and too much instrument inventory to disrupt their business with bespoke. They are also burdened with short-term outlook to deliver quarterly earnings in an endless 90-day cycle.  They have blinders on.

So in the early years, I expect the Big Orthos to market against bespoke.  They will say that “bespoke is expensive, time consuming, creates extra work for the healthcare system, and there is no outcomes 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 the top bespoke companies, but probably as a defense hedge in order to tell Wall Street that they have “certainly invested in bespoke”. 

The Ultimate Killer App for Bespoke Businesses

Beyond titanium and PEEK, bespoke will become tissue solutions. Bespoke tissue repair and replacement is the killer app that will revolutionize orthopedic surgery.

Tissues in the future will be printed from donor cells. The technology is evolving quickly to print bone, tendon, ligament etc from the patient’s own cells. The technology will also be able to print cells into printed biomaterial scaffolds. The technology will come first, and followed by the new regulatory pathways.

The challenge again will be the business process. But the good news here is that once a successful bespoke company has a working streamlined system for delivering titanium, they will be well positioned to deliver tendons made from the patient’s cells.

This will be a fun one to watch. The bespoke sea change will happen very slowly… then fast. 

See you at a future AAOS.