Conversation with Pamela Gwynn: Emerging trends shaping the medical device industry

Q: What key trends do you see shaping the medical device testing and certification industry over the next five years?

We will see more and more devices in what is currently considered the consumer wellness market, such as heart rate measurement capabilities on a watch, become the devices used by the medical industry to monitor and treat patients. This change will cause these devices to be governed and regulated by the U.S. Food and Drug Administration (FDA) more like Class II medical devices are today.

The home healthcare trend is also likely to continue to expand, reducing hospital stays and increasing telemedicine and medical professional home visits for more complicated tasks. Another exciting trend is the involvement of AI in medicine. Organizations are designing algorithms that can help look at X-rays or digital images to observe anomalies that the radiologist may not have seen, prompting them to pinpoint and take a closer look at areas they may not have considered.

Also, adaptive AI components are being created to help stroke patients and those with mobility issues rehabilitate. Another example that comes to mind is adaptive exoskeletons, where the AI algorithms can gauge the terrain or adjust to the user’s gait so they can move around more easily.

Due to increased connectivity, the medical device and healthcare industry will need to be more diligent on the topic of cybersecurity. It is still a work in progress, but the need for it will grow.

Lastly, medical device manufacturers are starting to look at sustainability, and the time will come when they need to start considering circular economy principles. They will need to consider the viability of component reuse and how that factor plays into the performance of second-generation devices.

Q: How do you see the IEC 60601-1-2 Ed. 4.1 en:2020 standard for medical electrical equipment impacting medical device design and testing requirements?

Device developers have been looking at this for a while. There’s awareness that different levels of evaluation need to be done depending on where the device will be used. It comes down to considering the patient environments you see in facilities and the home. For example, how will a wearable heart monitor perform in a radiological room, or can devices used at home withstand voltage variances and power outages?

Now that medical devices are leaving the hospital environment and traditional wellness devices may be entering it, these environmental factors will need to be integrated into product design.

Q: Are there any upcoming changes to medical device standards or new regulations on the horizon that manufacturers should be preparing for?

The biggest question marks regarding regulations are cybersecurity and AI since regulations for these are in the works. Medical device companies will need to pay close attention to what’s going on in these areas over the coming years.

Q: What is your perspective on the U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA)? How is the industry responding to this approach?

Now that ASCA is no longer a pilot program, manufacturers are beginning to understand the value of the program. When submitting data from an ASCA-accredited laboratory, reviews tend to go quicker. The reports are smaller and less burdensome to produce, and the FDA has already approved the safety and performance of the accredited laboratory. The program makes this part of the approval process more succinct and reduces questions about how tests were conducted. It has also been beneficial for small and new companies in terms of development and testing by providing a clearer path to compliance. While adoption of the program is growing, broader awareness of its efficiencies could further streamline the approval process.

Q: How do you see considerations for medical electrical equipment (MEE) and medical electrical systems (MES) progressing?

With up to 100 different standards, the most common challenge for manufacturers is truly understanding which standards apply to their products. Once they know which standards apply to their product, they have to understand the requirements for risk management and how they apply. For instance, determining adequate creepage and clearance distances early in design mitigates costly revisions later.

However, a customer new to medical device manufacturing will rarely run an initial test and not need to do some revision. The best thing manufacturers can do is hold off on initiating mass production, like ordering 1,000 widgets, before running a prototype by a laboratory that can help them understand if they’ve picked the right standards and compliance issues. This way, issues can be addressed before heavily investing in something that will need to be changed later.

These ideas tie into MES as well. An MES is a collection of devices and equipment connected to produce the desired output. Systems integrating multiple devices — like a monitor paired with a therapeutic device — require holistic testing to prevent issues like leakage currents or environmental vulnerabilities. Take a monitor, for example; it’s in the room with a patient, and an IV bag bursts over the monitor, causing the medical device to fail. Developers have to consider how individual components interact under real-world conditions, including moisture exposure or power instability.

Q: From your experience, how does the shift toward home healthcare influence medical device development and regulatory requirements?

Current standards anticipate medical devices being used in a professional healthcare environment by trained users. They anticipate a controlled environment with ambient temperatures, humidity and so on. The infrastructure at home may not be as stable as in a healthcare facility. In the home, you have voltage fluctuations, varied temperatures, dust and other environmental factors to consider. Additionally, in a home setting, caretakers are not always trained health professionals. Usability testing must now account for these new environments and caregivers without medical expertise, requiring intuitive designs and clearer instructions.

Looking ahead, we may see regulatory updates to design codes like NFPA 99 – Health Care Facilities Code, for non-traditional facilities, such as mobile clinics or outpatient hubs in retail spaces. The pandemic highlighted the need for agile deployment, and these lessons could shape future standards for portable or modular care solutions.

Q: How will the industry’s transition to A2L refrigerants in 2025 affect laboratories that rely on refrigerated equipment? What compliance or safety considerations should they be aware of?

Retesting will be mandatory for components, sub-assemblies and devices. Manufacturers will have to investigate their supply chains for the use of these refrigerants. It's important to note that the same manufacturers are and will be facing the same challenges with other chemicals being phased out for environmental reasons. While chemical bans usually come with some lead time, there will still be challenges. From my experience, awareness and proactive collaboration between manufacturers and suppliers have been the most efficient way for organizations to avoid disruptions.

Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.

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