The evolution of medical device safety has been in motion since 1968 when the U.S. Food and Drug Administration (FDA) first became responsible for medical device regulation. In the last three decades, technology-powered medical devices have exploded into clinical practice with a persistent need to evolve and become safer for a more diverse and less technically sophisticated range of users. As medical device technology matures and the technology becomes more capable, it also becomes more complex, requiring safety mechanisms that do more. Safety features iteratively improve, as implementations become more nuanced, sophisticated, and context-aware, but the underlying safety principles being applied remain surprisingly constant.
Navigating speed, safety
The Moore’s-Law-esque advance of technology (microprocessors doubling in power every 18 months for the same cost) has dumped many high-powered tools on developers and designers – multi-core processors, novel transducers, redundant electronics, and abundant communication connections. In parallel, the FDA and other regulatory bodies are elevating safety expectations of medical device manufacturers through guidance, initiatives, and standards such as IEC 14971 (risk management) and the recent recognition of IEC 62366 (human factors and user experience).
The confluence of these forces results in safety systems in medical devices trending away from piecemeal, ad-hoc solutions and toward coherently conceived, self-reinforcing, multi-tiered systems.
Common safety principles
Safety features in a medical device are often extensions of a core principle that’s fairly intuitive. Principles such as double-check your input and isolate what’s critical are very relatable, and in some cases, may be obvious. Principles such as fail safely are a little more forward looking, but obvious in retrospect. The application of these principles changes throughout time, commensurate with the toolset that the technology curve provides.
The sidebar (page 11) shows six common safety principles and descriptions of how they might be applied, referencing the technologies that make them possible. These principles tend to be application agnostic and are implemented in hardware and software. Each should be carefully evaluated when designing a new medical device.
With medical device safety, a few trends seem inevitable. Users’ expectations will elevate, technology will grow more complex and more capable, and safety solutions will evolve to become more comprehensive. While the implementations shift, these principles seem positioned to persist, as each is simply a categorical solution to the eternal question: “What happens if ___ fails?”
About the author: Milton Yarberry is the Director of Medical Programs at Integrated Computer Solutions, Inc (ICS). He is a certified PMP with a background in software architecture, medical device product development and program management. He spent a decade in consulting working with startup companies, and 15 years working with Class II and Class III medical device manufacturers. He can be reached at email@example.com.