My Digitally Focused New Year’s Resolutions

Last issue, I brought up some of the challenges involved with the digital evolution that’s taking place within the sector (in orthopedics, it seems like old news to say “digital revolution”; the industry is evolving). While I pointed out a number of bumps in the road being experienced, from reimbursement to cybersecurity, I wanted to continue that “conversation” and really highlight several areas orthopedic device makers should be considering for their own professional New Year’s resolution lists for 2025.

Some of these were also mentioned in my November MPO Editor’s Letter, which focused on the New Year’s resolution list for the medical device industry at large. Surprisingly, in many respects, the orthopedic industry is one of the leaders in the “digital” aspect (as Michael Barbella so eloquently highlighted in this issue’s Year in Review feature, starting on page 28). I say “surprising” because while orthopedic implants have seen few significant changes in the last decade (with a couple of interesting exceptions), the technology around the implant has experienced a dramatic transformation. 

Cybersecurity—I will continue to beat this dead horse until I can’t do it any longer. I can’t help but express just how important this is. Then again, now that the FDA has required cybersecurity protocols as part of a digitally enabled product submission, it seems they’ll take over for me. And the message coming from them can be much more convincing. 

Hackers aren’t going away. Ransomware isn’t going away. Most importantly, lawsuits resulting from data breaches or injury due to a system malfunction aren’t going away. The costs are real, but the expense of not adequately addressing this issue in your smart products is worse. So, I implore you to find the right partner to help ensure your digital products are as secure as they can be and your plan for security updates is realistic and manageable. 

Reimbursement—As I mentioned in the aforementioned last issue Letter, reimbursement for digital and smart solutions is challenging when the results being produced by these technologies are not proving to be substantially better than their established counterparts. Recent studies are calling into question the value of robotic surgical systems and whether they are truly superior solutions for surgeons. Of course, many of these studies are looking at revision and infection rates. They are not always examining time spent on a procedure, the fatigue of the doctor, etc. However, which do you think a payor is looking at? 

With this in mind, if you are proposing or developing a new smart technology for the orthopedic industry (really, this is true of any market sector for healthcare), be sure you have a reimbursement argument that makes sense. Unfortunately, you could have the best smart device in the world but if you can’t make the case for it to payors, it’s not going to get adopted because no one will pay for it. Early in your product development, the reimbursement strategy must be determined. 

Regulatory—Another challenge with digital to focus on is regulatory concerns. FDA has become well-informed on the ins and outs of digital healthcare. As such, they are asking hard questions and device developers need to have adequate answers. Again, if you have the best new tool for orthopedic surgery but can’t respond to the agency’s inquiries, you’re device is as good as dead. Along with your design, be sure to work on your regulatory strategy. 

Supplier support—The first three items are all for the orthopedic OEMs to consider when making their New Year’s resolutions lists. However, what about the supply chain and service providers? What’s happening with them? Are they evolving along with the industry to ensure they can meet the needs of both today and tomorrow? 

If you’re a company that supports the development and manufacture of orthopedic devices, are you able to address a customer’s needs when they bring you a design for a smart technology? If not, you need to begin to review your procedures and capabilities to determine where additional training may be needed. Do you know where value-add capabilities could be introduced without a steep learning curve for your employees? Is there a way you can differentiate yourself from other, more traditional suppliers serving the ortho industry such that you stand out as a supplier that can provide solutions for both analog and smart projects?

The industry is changing and you need to ensure you have your eye on possible avenues through which you can evolve with it. Don’t be left behind; start thinking about possible adjustments you can make to remain relevant. Look how fast the industry has changed in the last decade—how will it evolve in the next 10 years?

Sean Fenske, Editor-in-Chief

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