Elephants in the Room Indeed—Resolutions for 2025

With another November issue—the final editorial edition of MPO each year—comes another New Year’s resolution list for industry. This year, alongside my own ideas, I’ve borrowed a couple of topics you’ll get much more insight on in Michael Barbella’s annual Year in Review feature (page 48). This year, Mike highlights a number of challenges medtech truly began to work on in 2024 (and all likely to continue throughout 2025 as well). The pandemic caused stakeholders to set several of these issues aside as it was more critical to deal with the impact of COVID-19. Now that we’ve emerged on the other side, it’s time to finally tackle them. 

Artificial intelligence (AI): I’ll ignore the fact AI seems to have become synonymous with any type of software-based product brought to market. They are not the same. That aside, the resolution here concerns the regulatory oversight of AI. The FDA has put forth guidance for a predetermined change control plan as a way to address the oversight of AI. The problem here is detected right in the title—predetermined. If AI is working as it should, it will make changes based on the data it collects as it determines better ways to tackle a problem. That being the case, how would it be possible to predetermine this? Resolution: The FDA needs to go back to the drawing board with regard to its guidance for AI. 

Digital health reimbursement: One of the rare positives that was birthed from the pandemic was the accelerated development, rollout, and implementation of digital health. While this was primarily centered around telehealth, many aspects were thrust into the spotlight and found to be beneficial. The challenge here, however, reaches far beyond telehealth; rather, it’s a concern for many aspects of digital health. That is, whether payers will embrace these technologies and reimburse them adequately to support any increase in cost associated with them. Resolution: Any digital health technology provider better include a market and reimbursement strategy before getting too far along in development or you may end up with a fantastic solution no one will pay for. 

Cybersecurity: This topic has made my New Year’s resolution list for several years already. As such, in 2023, we brought on a columnist to address this topic in every issue. Resolution: If this is still a significant pain point for you in 2025, I’d suggest you go back and read through those columns as well as be sure to check it out in each issue in 2025.  

Sterilization: The EPA’s decision on the use of ethylene oxide (EtO) has caused significant concern from much of industry as to its future. While few think it would be completely done away with, it seems critical to find other methods with which to sterilize the approximately 50% of all devices that rely on the modality. With the development of new products, it is crucial to explore other options. These include the more familiar gamma, e-beam, and steam (each of which present with its own shortcomings and compatibility concerns) or newer innovations, including vaporized hydrogen peroxide, chlorine dioxide, and nitric oxide. Resolution: If you are using EtO, you should be exploring alternatives. Given the newer alternatives that are emerging, any new project should be interested in reviewing all the potential sterilization modalities. 

Nearshoring/Supply Chain: Were your manufacturing capabilities impacted during the pandemic? What about as a result of natural disasters, port strikes, canal blockages, import tariffs, or some other supply chain challenge that was essentially outside of your control? Could a relocation of key suppliers have remedied the situation? What about dual sourcing strategies? The pandemic put a spotlight on the fragility of medtech’s supply chain, but numerous events since have caused it to remain quite bright. Resolution: While nearshoring, dual sourcing, or another supply chain strategy may not be the answer for your specific situation, it would be wise to evaluate where the pain points are (whether potential or actual) and find the best solution to resolve them.

Automation: Labor continues to be a challenge regardless of where your manufacturing is located. With more sophisticated automation systems that provide real-time feedback, medtech is looking more seriously at Industry 4.0 and the vast benefits it can provide. As with the supply chain, automation may not be the right answer for every situation, but if a company is not at least exploring the option of implementing it for their facilities, they could be missing a success strategy. Resolution: Whether labor is a problem for you currently or not, chances are, it will be at some point. As such, see if automation and/or Industry 4.0 offer the tools you need to tackle this issue before it truly emerges. 

What are your industry resolutions that I didn’t cover?
Let me know!

Sean Fenske, Editor-in-Chief

[email protected]