Updating Your Orthopedic Device Priority List for 2024

Call it my 2024 New Year’s Resolutions for the orthopedic industry; call it a “Honey Do” list; call it whatever you like but I’ve identified a number of items orthopedic device manufacturers must keep in mind for next year. Now that COVID-19 has transformed into an endemic disease that will likely cycle much like the flu, it is a more manageable concern compared to its debut in early 2020. As such, it’s time for orthopedic device companies to revisit their priority list and start crossing things off. A number of tasks have likely been on the back burner for several years; it’s time to remember what they are and ensure efforts are moving forward to resolving them. Further, you will gain more insight on some of these from Michael Barbella’s Year in Review (YIR) feature.

Cybersecurity: The digital transformation of healthcare is in full swing. Somewhat surprising, the historically more slow-evolving orthopedic industry is one of the leading sectors in this movement. Digital has morphed the art of orthopedics into a science. With this comes significant challenges, and cybersecurity is at the top of the list for tackling these concerns. My MPO Editor’s Letter centers on this topic, so read that to get more in depth on why this is so important, but suffice to say, it certainly should be on your priority list, whether you’re making digital healthcare or have digital technology running your production floor.

Sterilization: The EPA was looking at EtO concerns prior to the pandemic, but like everything else, its inquiry was put on hold during it. Now, the agency is renewing a push to restrict the use of the carcinogen, even though it is used to sterilize about half of all medical devices. Regardless of the decision determining the chemical’s future, it would be wise to explore alternatives to EtO for any device that might be a candidate for a different method. Fortunately, with the EPA’s attention comes a substantial push to develop new terminal sterilization methods, and a few have already been announced that could represent its future. And of course, there are several proven modalities in place that may work for your next project.

EU’s MDR: Just as the EPA was forced to delay its EtO investigation, the EU had little choice but to reschedule its MDR rollout. While the reasons and insights are spelled out more completely in the YIR feature, the new regulatory protocol provides an opportunity for portfolio evaluation. Given the fact all MDD-certified medical devices require recertification under MDR, companies can take a hard look at the products they currently supply to the EU and see which are truly worth keeping there. Medtech OEMs with products that have significant competition or a very low market share may rethink keeping a device on the market. A cost analysis must be done for every product matching this description. Tighten up the product portfolio—at the same time, perhaps discover clinical areas not covered comprehensively or where innovation is truly needed.

Ambulatory Surgical Centers (ASCs): Another rapidly emerging trend is the increase in ASCs for outpatient procedures. We’ve featured a number of articles throughout the last few years that highlight this trend. With volumes returning to more normal figures, it’s time to ensure this market segment is being properly served through your product portfolio. Do your devices suit the specialized needs of this segment? Could some minor revisions or redesigns make your products attractive to these providers? Along with your portfolio evaluation for the EU and MDR recertification, perhaps reexamine your products to determine if you’re in a position to take advantage of this healthcare growth area.

Reimbursement for Innovation: Another item in the spotlight this year was the reimbursement situation for innovative technologies. While the FDA can designate a device as “breakthrough” if it meets one of several qualifiers, the company may still find it challenging to gain reimbursement. That type of concern won’t make developing innovative medtech much of a priority for an OEM. Fortunately, there have been ongoing discussions and bi-partisan support for a resolution. The “to-do” list item here: Keep an eye on what CMS and/or Congress approves to ensure breakthrough devices have the financial support required to help patients who need them.

Sustainability: Reducing waste, sourcing responsibly, and other environmental factors are important to your customers, which means they must be important to you. Evaluate your products, development projects, and facility to ensure you can positively answer questions regarding sustainability initiatives. If you haven’t already been asked, you can expect those questions soon. v

Sean Fenske, Editor-in-Chief
[email protected]