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Sounding Board: 2024 Noteworthy Events and 2025 Predictions

Several members of the MPO editorial advisory board offer comments on newsworth events in 2024 and offer their thoughts on 2025.

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By: Sean Fenske

Editor-in-Chief

Each year, MPO reaches out to its editorial advisory board members to gain access to their thoughts of the previous year and see what they are anticipating for the coming year. This is done alongside Michael Barbella’s Year in Review feature.

For the most recent version of this Q&A, a number of board members shared their thoughts on the following questions specifically:

1. What news headline, event, or technology was the most significant in 2024 and why?

2. What’s one expectation you have for 2025 that will make an impact on the medtech industry? (i.e., What will you be keeping an eye on for positive or negative reasons?)

Kate Benedict, President, Health Solutions, Flex

2024: In 2023, the U.S. Food and Drug Administration approved more novel medical technologies than ever before, creating a highly competitive landscape that requires healthcare and pharmaceutical companies to deliver differentiated products with increased productivity and speed. This trend is driving more companies to rethink their existing manufacturing models and outsource to trusted partners, enabling them to optimize their product lifecycles while redirecting in-house resources into innovation.

2025: Looking ahead to 2025, one significant expectation I have is the increased adoption of strategic outsourcing models, or “network optimization,” within the healthcare industry. As companies face mounting pressures to enhance efficiency, reduce supply chain risks, and concentrate their in-house teams on core competencies, outsourcing will continue to grow as a strategic imperative.

By leveraging specialized external partners, healthcare and pharmaceutical companies can streamline operations and access expertise that may not be available internally. This approach not only allows for greater flexibility in scaling production but also helps them manage complex supply chains, reducing overall risk.

Randy Clark, President, Vicarious Surgical Inc.

2024: The progress of soft tissue robotics companies such as CMR, Virtual Incision, Ascensus, Vicarious Surgical, and Intuitive have all made great headlines in 2024. These companies achieved significant milestones in surgical robotics because they furthered the development of their platform and expanded the applications; some even incorporated AI and machine learning for enhanced performance. As these technologies become available for a broader range of procedures, it will potentially lead to greater adoption and ultimately benefit more patients.

2025: In 2025, I anticipate a surge in global development and, for those with approval, the adoption of single-port robotic surgery platforms. This approach, where all instruments are inserted through a single small incision, has the potential to revolutionize minimally invasive surgery. By further minimizing invasiveness, single-port robotics can lead to reduced pain, faster recovery times, and improved cosmetic outcomes for patients. This trend will drive innovation in areas like soft tissue robotics, flexible robotics, miniaturized instruments, and advanced imaging, pushing the boundaries of what’s possible in minimally invasive procedures. However, it’s essential to ensure these advancements are accessible to a wide range of patients and healthcare providers.

Kevin Hess, President, Surface Solutions Group LLC

2024: In 2024, the most significant development in the medtech industry, particularly for the functional coatings market, involved the escalating concerns and regulatory actions surrounding per- and polyfluoroalkyl substances (PFAS). These chemicals—known for their resistance to heat, biocompatibility, and inertness—have been integral in various medical technologies due to their durability and performance. However, the year saw a pivotal shift with increasing regulatory scrutiny. The focus on PFAS in 2024 was about the industry’s response to new regulations, supply chain disruptions, and the quest for PFAS-free alternatives, marking a transformative moment for how medical technologies are approached regarding material use and sustainability.

2025: Looking forward to 2025, everything will depend on how the medtech industry navigates the regulatory landscape concerning PFAS. Given the discussions and regulatory proposals, especially from the EU’s REACH restriction proposals, the industry is expected to face increased pressure to transition away from PFAS where alternatives are viable. I would expect this shift to lead to accelerated research into PFAS alternatives that meet the stringent performance requirements of medical devices. The balance between adhering to new PFAS restrictions and ensuring patient care and device efficacy will be crucial. This might require regulatory bodies to allow for longer timelines for transition in medical applications where PFAS alternatives are not immediately available or suitable. I also expect chemical and coating manufacturers to begin to phase out PFAS, some of which has been seen already. This will cause supply chain disruptions for medtech companies.

At Surface Solutions Group, our focus will be on continuing to pioneer materials that offer the benefits of PFAS without the drawbacks, ensure our compliance with emerging regulations, and maintain leadership in providing solutions for medical functional coatings. The approach will be multi-faceted, involving R&D for new materials, close collaboration with regulatory bodies for realistic transition timelines, and a robust strategy for managing supply chain dependencies. This proactive stance not only aligns with potential future regulations but also positions our company as a leader in sustainable and safe medical coating solutions.

Steve Maylish, Industry Consultant

2024: I think the news headline, event, or technology that was the most significant in 2024 for our industry was the election in November.

2025: The reason for this is the implications it meant for 2025. In one direction, you could have seen the Affordable Care Act (ACA) being expanded, drug prices being further negotiated, continued protection from pre-existing condition exemptions with healthcare coverage, continued protection from insurance coverage maximums, and additional investments in vaccines, diagnostics and medical innovation. With the other direction, we may see a repeal of the ACA, drug price negotiation off the table, exemptions back into insurance policies, a decrease in vaccine development, diagnostic tests, pandemic preparedness, and innovation.

John Nino, CEO, Life Science Outsourcing

2024: The continued integration of artificial intelligence (AI) in medical device manufacturing has been one of the most significant developments in 2024. AI’s role in streamlining processes, enhancing product quality, and reducing time-to-market has reshaped how companies like ours approach product development and compliance. This has allowed us to optimize our operations, delivering faster and more precise solutions to our customers.

2025: One thing I’ll be keeping an eye on is how the COVID-19 pandemic continues to evolve. Variant outbreaks will likely still impact the life sciences industry, particularly in areas such as global supply chains, regulatory requirements, and workforce dynamics. Adaptability will be crucial as the industry navigates this ongoing challenge, ensuring that medical device manufacturing remains resilient and responsive to changing health landscapes.

Bryce Rutter, Ph.D., Head of Consulting Services, Noble, an AptarPharma company

2024: AI has been the most significant technology discussion in 2024. While its origins are decades-old, today’s computational horsepower allows us to rapidly expand the application of AI into a wide variety of industries and product categories like never before. First, let’s dispel the myth that AI will replace everyone who is currently designing medtech devices. The discussion in 2024 over AI and occupational relevancy as a medtech designer is reminiscent of the same discussions with the introduction of AutoCAD, followed by Photoshop and Illustrator, and many other disruptive software technologies to follow up. All proved to be powerful tools, but like all tools, it is up to the craftsman to apply them in the most effective ways. And remember that AI provides users a distillation based on a summary of best guesses and patterns in what it scrubbed, and sometimes it will connect the wrong dots and, not unlike humans, have “hallucinations.”

2025: I’m interested in how the industry responds to the geometric increase in data that is being generated by new medtech devices. There seems to be a lot of confusion about the difference between data and information and, as a result, users are inundated with useless and confusing data that increases use errors and valuable and limited cognitive processing bandwidth. Information is a synthesis of raw data that provides relevant time-sensitive guidance and/or status reporting. The crux of the situation is to figure out what data is relevant and then how to best represent this data in the most informative format—metaphorically, as a schematic or literal representation, or in a mixed reality environment. The solution to these data riddles will be solved at the intersection of cognitive human factors, computer science, and user experience design. The overriding design principle is to keep it simple and not let technology for technology’s sake get in the way of the clear and concise user interface and user experience design.

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