Change in our beloved orthopedics industry is both relentless and accelerating.
For an individual working inside the industry to comprehend the magnitude of collective change year over year can be challenging.
Below is my attempt to share the collective changes that have transpired over the last few quarters. I see 18 right now.
1/ Companies Eliminated by Consolidation. Not long ago, Nuvasive and Globus were separate companies and competitors. And Orthofix and SeaSpine were separate companies and competitors. No more. Also, this year a 78 year old global orthopedic company, Lima, was absorbed by Enovis. Lima is no more.
2/ Companies Eliminated by Performance. The list of companies below were recently doing well. Now they are gone or dying. There will be more to come.
- Aesculap – shut down spine business
- Avail MedSystems – asset sale
- Bioventus – in trouble
- Bone Biologics – IPOed too early, market cap is $1M
- Carevature – asset sale
- Conformis – asset sale
- ControlRad – asset sale
- Intellirod Spine (fka OrthoData Inc.) – asset sale
- Lima TechMah Medical – cut US office
- Novum (fka Bio2) – shut down
- Stryker Knee Creations – division shut down
- Surgalign – asset sale
- Trice Medical – desperate for capital
- Titan Medical – asset sale
- TracPatch Health – asset sale
3/ Venture Capital Tight. The venture markets are COMPLETELY CLOSED for any ortho company that is carrying debt and is not able to reach profitability. The good news is that Angel money, seed funding and Series A is still available for special early stage companies.
5/ Public Markets Closed. The IPO door has COMPLETELY CLOSED. Monogram Orthopedic was the last one through the IPO door back in May. MGRM stock is down 80% from it opening day as of this writing. My guess is 4Q 2024 through 2Q2025 will be the IPO sweet spot. There will be IPOs for strong companies that have been waiting to tap into the public markets. Investors in these strong companies have been patiently waiting for access to the IPO market. But perhaps, there will be more IPOs for weak companies that will be forced to go public at low market values, because the venture market has dried up and debt is too expensive. They will be forced to IPO.
6/ Banks in trouble. Silicon Valley Bank, the 16th largest bank in the US, provided venture capital to many orthopedic companies (including strong companies like Treace Medical Concepts and SI-Bone.) In my first startup back in 2008, we got SVB venture money. In 2023, SVB became insolvent and the FDIC had to take it over. Gone.
7/ GLP-1s. This could be biggest disruption in elective surgeries in history. This is real! I am not kidding. Read – The GLP-1 revolution will shrink orthopedic surgeries. This year 12% of all Americans will be taking one of these miracle drugs. Then 18% next year.
8/ Additive Technology. The ubiquity of 3D printing implants and instruments is undeniable, and it is gradually transitioning into a commodity resource. What distinguishes its effectiveness, however, lies not merely in the additive manufacturing process itself but in the finesse of the user interface (UI), surgical planning, adept project management, and seamless communication with the hospital.
9/ VACs. Value Analysis Committees have become the most challenging selling hurdle. Hospitals have increasingly relied on VACs to scrutinize and approve new medical devices. These committees evaluate the cost-effectiveness and clinical benefits of products, adding a significant hurdle to the sales process. Fewer and fewer surgeons have influence over these bureaucratic committees. Great advice discussed on BoneChat is here.
10/ Artificial Intelligence. AI technology has been used as “hype” to raise money, but now AI has become a “joke”. Very few ortho companies are actually using real Machine Learning (ML) algorithms. Also, very few ortho companies have large enough data sets with proper labeling to effective use AI for effective pattern matching. Read “Don’t believe everything you see at AAOS.”
11/ The FDA. The Regulatory hurdle in the US has gotten higher and higher with the FDA. In particular, the IDE/PMA pathway has become extremely risky financially and in risky in duration. We may only see one IDE/PMA clearance each year.
12/ ASCs. The migration of procedures moving from hospitals to ASCs is relentless.
13/ Disposable single-use kits. There seems to be endless demand for procedure specific disposable surgery kits, driven by the ASC customer.
14/ Virtual Reality. VR, once seen as the future in orthopedics, has become a baseline surgical training tool.
15/ FIM geography. Startups have flipped from doing their early surgeries in the EU to doing them in the US because of the burdensome regulatory pathway in EU. The CE used to be a breeze.
16/ Goodbye EU. Many US device companies will not be able to meet the EuMDR regs in time and will have to stop selling products in the EU.
17/ The Big 5. The big public ortho companies are growing revenue at record levels, while laying off staff in record numbers. They have learned how to grow sales with less people, post Covid.
18/ Let’s work in person. Remote work opportunities for job hunters are slowly melting away.