Manufacturers and developers of medical devices and software, get ready for straight talk from one of UL Solutions’ most experienced and connected principal engineers. Pamela Gwynn talks global harmonization and variations and how market access starts with comprehensive regulatory knowledge.
Q: What challenges do manufacturers face in supporting clinical-grade performance for home-use devices?
A: Maintaining a clinical-grade performance in the home environment rather than in a controlled healthcare setting is always a challenge, as manufacturers must account for greater variability, from user expertise to environmental conditions, that can affect accuracy, reliability and safety.
Q: Consumers have access to so many new devices to support better health outcomes. Are these classified as home-use devices?
A: There are two types of home health products: regulated medical devices and wellness devices. Regulated devices must comply with standards, but regulatory bodies such as the U.S. Food and Drug Administration (FDA) offer little clear direction regarding wellness devices other than accuracy and some monitoring of concerns. Manufacturers should anticipate future regulation of wellness devices because consumers really don’t perceive a difference between medical devices and most wellness devices.
Q: For Software as a Medical Device (SaMD) developers and manufacturers, what is the best approach to designing and developing a device that can meet safety requirements and earn certification across regions?
A: It all starts with knowing which standards apply in what markets — a constant challenge for manufacturers trying to enter many (or even several) markets at once. However, harmonized global standards like IEC 60601 can help streamline the process significantly.
What developers and manufacturers should do is prioritize target markets, starting with those using harmonized standards, and gain a full understanding of how regulations deviate from nation to nation. Common deviations include voltage, such as requirements about dual voltage power supplies, low-voltage motors and products designed for variable voltage.
Additionally, it’s critical for developers and manufacturers to know how regulators in their target markets classify their devices. For example, the FDA classifies breast pumps as a medical device, but in the EU, these products are considered household appliances.
Q: What kind of clinical evidence is typically required to support safety claims for SaMD?
A: The evidence required will vary depending on the claims made and market requirements, and is outlined in each requirement. However, the clinical evidence required for SaMD is similar to what’s required for medical devices. Developers must show results from actual use in a healthcare setting. Additional data may be required to demonstrate biocompatibility, for example.
One area we’re actively working on and are excited about is how modeling and simulation can be used to evaluate SaMD and devices. Using these tools can yield insights that lead to better design and operation but could also augment clinical data for review by regulators. Stay tuned.
Q: What trends are shaping the future of SaMD certification and safety expectations?
A: We’re seeing an increase in the use of artificial intelligence (AI) used to review or assist in clinical decisions. The imaging world, for example, increasingly uses AI-driven software that highlights areas of concern for review by a physician, but perhaps soon AI will be used to make medical judgments.
Also, with more medical care offered outside of a traditional healthcare setting, telemedicine relies on cloud-based solutions that help stretch the idea of “point of care.” It’s exciting to think about the ease with which patients and clinicians can connect with each other, and with experts around the world, but data security and confidentiality must be paramount.
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Q: How does IECEE CB certification support global market access, and what are its limitations?
A: The CB scheme was originally designed for you, as a manufacturer, to have your product tested at one location and shared across the world to get another agency's mark, eliminating the need for multiple tests. As the regulatory landscape has changed, the use of a harmonized standard has really helped ensure a common understanding of testing requirements and documentation. The CB scheme is based on peer assessment and mutual recognition and is held in high esteem in some markets and can facilitate clearance. In fact, even countries that do not participate in the scheme welcome reporting in the consistent formatting style according to its requirements.
Q: What are the most common national deviations manufacturers should watch for in the CB Scheme?
A: This is an important question and something manufacturers and developers should certainly understand. Let’s look at the EU, for example. Standards here are typically written as EN, but will feature variations outlined in an annex, such as Annex ZA, ZA or ZZ. These addenda will feature additional regulatory requirements that can pertain to testing or risk management procedures. Another example is a country such as Brazil, which outlines specific language requirements or in-country testing processes. But each market may have unique directives beyond standards and understanding these deviations are crucial for market access.
Q: What are the most impactful ways you’ve seen medical device manufacturers reduce environmental impact during product design?
A: Sustainability isn’t a consistent goal among all medical device manufacturers yet. However, there is some information in the IEC 601 series of standards that offers basic guidance regarding “environmentally conscious designs.” What we need is a common vocabulary around circular design and develop guidance for medical device manufacturers regarding greater sustainability from a life cycle perspective. Here’s an example: an X-ray machine may be refurbished to extend its useful life, and testing can be done to validate the performance of the refurbished machine according to a standard.
There’s a lot of promise around reuse, refurbishment and recycling among medical devices. We have finite materials, and even the reuse of components typically considered “single use” should be explored. Of course, evaluating and mitigating risk to patients must be centered.
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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