Sounding Board: Significant Events of 2023 & Perspectives on 2024

As I do every year to accompany Michael Barbella’s annual Year in Review feature, I reached out to MPO’s editorial advisory board members to solicit for their thoughts on the past year and what they expect or will be looking at in 2024. Specifically, I asked for responses to the following two questions.
 

1. What news headline, event, or technology was the most significant in 2023 and why?
2. What’s one expectation you have for 2024 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 always, we received great feedback from several board members who shared their thoughts on the questions.
 
Note: These responses were provided during the first week of October 2023. This should be taken into account given any events that take place during the remainder of the year.
 

Randy Clark, President of Health Solutions for Flex

2023 Significant Event: “Myth Busters: What Might Be Next for Virtual Health?” by Deloitte is one of my favorite headlines because it reminds us that virtual health is here to stay—with far-reaching benefits for both patients and providers. Today’s patients want greater visibility and control of their own health instead of having information and decisions siloed with healthcare providers. Combined with an aging population and the rise of chronic diseases, this shift is driving explosive demand for remote patient monitoring and wearable medical devices to provide more access to healthcare and enhance patient outcomes globally. According to Deloitte’s 2023 Global Health Care Outlook report, the global market for remote monitoring devices is expected to grow to more than $101 billion in 2028, and almost 440 million consumer health and wellness wearable devices are forecasted to ship worldwide by 2024. To capitalize on this market opportunity, medtech companies must deliver complex devices at an unprecedented scale, quickly. That is why many companies are looking for new capabilities—and partners—to capitalize on innovation cycles and help execute their technology roadmaps more reliably with greater speed and reduced risk.
 
Perspective on 2024: The healthcare industry is experiencing unprecedented disruption, from the rise of chronic illness to shifting healthcare delivery models to exciting technological advancements that are ushering in a new era of digital health. To win in this fast-paced market, companies must tap into advanced manufacturing capabilities and Industry 4.0 technologies to scale faster and more reliably. Rather than designing and manufacturing all products in-house, many companies are turning to global, diversified manufacturers like Flex to accelerate time-to-market, better manage risk, provide greater scalability, and improve market responsiveness. Over the next year, companies will continue to redesign their in-house operating models to tap into deep domain expertise and shift business to larger trusted partners to optimize operations across the product lifecycle, from design and manufacturing to supply chain and sustainable after-market services.
 

Geary A. Havran, Board Chairman and President of NDH Medical Inc.

2023 Significant Event: DATA! The year 2023 saw the rise of data in all aspects of the medical device industry, from supply chain through manufacturing and in all levels of healthcare. Using data to connect with suppliers to ensure continued supply of materials and products became the norm. At manufacturing facilities, ERP systems became more integrated with shop floor processes utilizing advanced machine controls, statistical process control, and data historians. This is leading to the adoption of artificial intelligence and machine learning, which is designed to improve efficiencies and help to alleviate the shortage of skilled and trained employees at all levels of the healthcare ecosystem.
 

Mark B. Leahey, President & CEO of the Medical Device Manufacturers Association (MDMA)

2023 Significant Event: As your readers know, every year in the United States, 20 billion medical devices representing half of all sterile, single-use devices are sterilized with ethylene oxide (EtO). The Environmental Protection Agency’s (EPA) proposals to modify the use of EtO sterilization of medical devices was the most significant headline in 2023, and if implemented as written, they would be devastating for patient access. As FDA noted after the EPA began to look into this issue, without an adequate availability of EtO as a sterilization method, the impact to patient care would be catastrophic. MDMA continues to share EPA’s commitment to public health and we support new regulations that are achievable while not impacting sterilization capacity, and we will continue to work closely with all federal agencies to help ensure any final regulations in 2024 do not create hurdles for patient access to safe and effective medical technologies.
 
Perspective on 2024: The creation of a new coverage pathway for innovative medical technologies that would improve patient access is our goal for 2024. MDMA and others continue to work with CMS to have as broad and robust of a Transitional Coverage for Emerging Technologies (TCET) program as possible, and there is ongoing bipartisan momentum in Congress for legislation that would do the same. MDMA remains committed to working closely with CMS, Congress and other policymakers to help ensure that our nation’s seniors get timely access to safe and effective medical technologies.
 

Brent Noblitt, Co-Founder and Senior Partner at Noblitt & Rueland

2023 Significant Event: There were several significant events that continued to be important this year alongside a number of new items. Among these are:
 

• Increased regulatory burden to market CE marked medical devices in European Union (EU) due to the advent and progression of Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation requirements.
• Artificial Intelligence (AI) including Machine Learning (ML) being implemented in healthcare settings for proactive/efficient care of patients, medical diagnostic imaging systems, robotic surgery, genomics, and other medical device technologies.
• Liquid biopsies and In Vitro Diagnostic testing for multiple types of cancer, Parkinson’s disease, Alzheimer's and dementia, and many other diseases, including DNA specific testing using next generation sequencing polymerase chain reaction molecular type testing.
• Medical Device Outsourcing to meet the needs of assisting medical device manufacturers with new technologies including AI/ML and molecular based testing, along with migrating to other new technologies implemented during product development and manufacturing of medical devices including electronic based Quality Management Systems with Enterprise Resource Planning (ERP) and Manufacturing Execution Systems systems.
• New cardiology minimally invasive surgical techniques such as Transcatheter Aortic Valve Replacement, which is becoming the common place alternative to open heart surgery and gene therapy.
• Brain Computer Interface to allow the disabled to communicate/move limbs, etc.
• Impact on ETO sterilization from EPA/OSHA environmental concerns due to the mainstream use of ETO sterilization as part of medical device manufacturing processes.

 
Perspective on 2024: From a regulatory perspective, something we will be keeping an eye on in 2024 (and even still for the rest of this year) will be the release of FDA's final rule and transition schedule for harmonizing ISO 13485 with FDA's current quality system regulation. This will impact all of the medical device industry selling in the U.S.
 

Dave Sheppard, CM & AA, COO and Principal at MedWorld Advisors

2023 Significant Event: While there are many important technology transitions taking place in medtech (including AI, robotics, etc.), one of those most important events in 2023 occurred in March of this year in Europe. On March 15, 2023, the European Union extended the EU MDR implementation deadline from May of 2024 to 2026 thru 2028 (depending upon classification of products).
 
The importance of this announcement cannot be understated as it literally saved patients’ lives in Europe as it allows viable and effective products to stay on the market longer in Europe. Prior to this announcement, some companies were planning to terminate some products rather than face the burdensome (and expensive) regulatory process to transition from MDD to MDR. Additionally, some smaller companies were considering giving up and retiring or selling their businesses due to these regulatory burdens and the unrealistic timelines.
 
In summary, this event was key for our industry as it saved products, companies, and patients’ lives in Europe, which is a very important market for medtech.
 
Perspective on 2024: The recent announcement of the FDA Draft Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions will have a significant impact on our industry. This guidance provides recommendations on medical device cybersecurity considerations and what information to include in premarket submissions.
 
I will be watching for the impact on new products and solutions and how companies manage these new regulations and market expectations. I will also be watching the impact on legacy products as these new regulations make it more difficult to simply update your software. If that’s the case, then it might be worth the challenge to update the entire product solution since it’s going to require regulatory scrutiny either way.
 
In summary, the companies that are already proactively addressing these issues will have a competitive advantage in the medtech markets for some time to come.