At the end of each year, I like to reach out to the ODT editorial advisory board to get their input on what’s been the top headlines in the orthopedic device space for the year and what they anticipate the new year will bring. It’s a great opportunity to get the thoughts of those throughout the sector who are experiencing many of the ups and downs first hand.
Specifically, I asked the following two questions:
1. What news headline, event, or technology was the most significant in 2022 and why?
2. What’s one expectation you have for 2023 that will make an impact on the medtech industry? (i.e., What will you be keeping an eye on for positive or negative reasons?)
As is often the case, I had several fantastic responses from a number of board members and wanted to take an opportunity to share them with you. You may also like to compare their responses to our own analysis of most significant topics for this past year in Michael Barbella’s Year in Review feature from the November/December issue of ODT.
Dawn A. Lissy, President of Empirical Technologies
2022 Reflections—Additive manufactured devices continue to show incredible advancement in the field of implantable devices and prosthetics. The ability to promote bone in-growth through complex lattice structures and varying porosities means these devices could offer improved patient outcomes. The ability to create custom pieces for individuals at the point of care to improve patient outcomes has revolutionized treatment options. Additive manufacturing has become a staple of the orthopedic and prosthetic world and doesn’t seem to be slowing down.
2023 Expectations—As more companies embrace additive manufacturing, the world of orthopedic implants will become more custom. Manufacturing on-demand, patient-specific, devices will become more common. FDA and regulatory guidance will be better defined as we learn more about powders and the process used for manufacturing. Testing guidelines and protocols will continue to advance to ensure the best patient outcomes.
James B. Schultz, Vice President of Customer Solutions at ECA Medical
2022 Reflections—The movement to the ambulatory surgery center (ASC) for orthopedic and spine surgeries is huge. Orthopedic surgeries have increasingly shifted to the ASC setting in the last 10 years as minimally invasive technology advanced. More recently, CMS, commercial payers, and patients have pushed these procedures to the ambulatory environment, where they can be done safely and at a lower cost than the inpatient setting. Over 68% of all surgeries are moving to the ASC; ortho and spine procedures now make up over 20% of the ASC business and are among the most profitable. Recent discussions with hand/wrist and foot/ankle surgeons indicates they perform between 80% and 90% of their surgeries in the ASC. They prefer sterile-pack implants and surgery-ready instrument sets that are optimized and tailored for the procedure, eliminate instrument cleaning and sterilization, meet or exceed sustainability targets, create force multipliers with current staffing, and take up less inventory space while reducing OR turnover time compared to reusable sets.
2023 Expectations—Robot platforms and single-use, surgery-ready instrumentation adoption in the outpatient market. New rental, lease, or capital purchase options for orthopedic robotic systems are increasing in the ASC segment where they can provide benefit to surgeons and patient outcomes, while also supporting the business model. The advent of minimally invasive surgeries in general and the addition of total knees and spine procedures is driving robot use. Smaller footprint robots and those with lower price points and or creative purchasing and financing options should gain share and use.
Christine Scifert, Partner at MRC Global
The primary thing for regulatory we’ve been focused on this year is the transition in Europe to EU MDR. This continues to be a primary focus for any company currently selling product in Europe. The secondary thing from a regulatory standpoint continues to be the rigorous reviews related to biocompatibility in all markets, even for established materials. I feel like a broken record since this is similar to last year, but these are still key hurdles in 2022 and as we move into 2023.