It’s a tradition that goes back years…millennia in fact. It’s believed the ancient Babylonians were the first to make New Year’s resolutions. They would promise to repay debts and return borrowed items. Fast-forward 4,000 years and we’re still doing it today. (I wonder if the Babylonian gyms were as crowded in January as they are after every new year now.)

With this in mind, each year, I identify topics I think members of industry should have on their own, business-centric New Year’s resolution list. At the very least, these items represent my thoughts on where some attention should be paid in the coming year. 

My first item on the list is artificial intelligence (AI). It’s without question that AI stands to make an incredible impact on the world around us—both inside and outside of healthcare. It is going to be leveraged in every area of our lives, from banking to surfing the internet to driving a car. However, for many, it’s still a rather misunderstood technology. 

I’ve attended numerous conferences and industry events where AI was one of the major discussion topics. Even when it wasn’t mentioned in a session summary, it inevitably was brought up by the speaker or through an audience member’s question. And in some areas of medtech, it’s already making a significant impact (e.g., radiology/imaging). 

That said, I’m not sure I can tell you specifically what the difference is between AI, machine learning, and a well-written software program. I know AI relies on data input and can improve as the amount of data grows, enabling it to recognize patterns, determine probable outcomes, and predict likely scenarios. But this brings up one of my concerns—data and the quality of it. 

How can I be sure what I’m feeding an AI-based system is “good” data, free of bias and poor information? How do I best determine the most effective way to capture the important data and leave the rest behind? This uncertainty leads to a feeling of discomfort. Sure, I could work with AI experts who can inform me on any questions I have, but if I don’t feel I have a reasonable understanding of AI, how can I be sure I’m selecting an expert I can trust and not one selling me magic beans?

This is why my first “resolution” for the list is to become comfortable with AI. If you’re like me (and I suspect many in industry are) who feel like your comprehension level with regard to AI is lacking, strive to educate yourself enough to become comfortable with it. I don’t expect a level of expertise, but learn enough to be able to converse about it with those who are experts. Gain a baseline understanding of terms, examples, use cases, challenges, etc. Truly become comfortable speaking about it. 

The next item on my list for 2026 is with regard to the changing regulatory landscape. Here in the U.S., the FDA has had significant transformations take place under the current administration in its first full year. There’s no reason to believe that won’t continue over the course of the next three years. There’s also no guarantee any additional changes will happen. Unfortunately, the most likely scenario is an air of uncertainty will continue, which is never what medical device manufacturers want to hear. 

The “resolution” here is to remain abreast of any changes at FDA, CDRH, or, by extension, within Congress that could significantly impact the medical device industry. Identify reliable sources for regulatory information (such as MPO’s The Source email newsletter and the “Mike on Medtech” podcast; apologies for the shameless plugs). Organizations like RAPS (www.raps.org), AdvaMed (www.advamed.org), and MDMA (www.medicaldevices.org) are all constantly providing updates on the latest happenings. Check social media platforms for others who share regulatory information. 

In addition, while the new regulatory policies in the EU have been put in place, there have been calls for revisions. Are you aware of this? While a U.S.-centric regulatory scope is helpful, it shouldn’t be the only area for which you remain abreast. Find resources for the EU, Asia, U.K., and any other markets in which you wish to sell your products. Discovering vital information late in the process when you’ve got product ready to go is not ideal, will lead to additional costs, and delay your time to market. 

Unfortunately, space only permits me to share these two “resolutions,” but I know there are more others feel are important. What are your medtech/business-centric focus areas for 2026? Are you looking to sell your business and concerned with the recent FTC activity in challenging some deals? Are you a public company and have activist investors making waves? Where’s your line of sight for 2026, and what are you planning to do to address it? Let me know!

Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com