Security, Usability & Sustainability: Navigating Responsible Design Principles for Medical Devices
Today’s engineers are embracing the concept of responsible design, a broad framework encompassing everything from usability and security to reducing the vast volumes of electronic waste accumulating across the globe.
Designers are concerned about the impacts of their products not only at the drawing board, but well after they are released. In a recent Molex and Digi-key global survey, “Design Engineer Tell-All: Advancing Innovation in an Era of Disruption,” 85% of design engineers said they feel responsible even after their design is approved, and 80% find it painful to release a design when they know they could do better with a bit more time.
Few feel design responsibilities more acutely than the creators of medical devices, in which a small glitch can impact patient health outcomes. In this post, we talk to Iain Simpson and Tony Bedford, co-directors of platform management and innovation for Phillips-Medisize, about the challenges of leveraging responsible design principles for medical equipment and how engineering teams are evolving to manage them.
The Security Conundrum
For medical devices, safe, secure and private operation has always been a top priority. But, in today’s environment of increasingly complex software-driven processes and connected devices, ensuring it has become a far greater challenge.
Indeed, every new portal gives cybercriminals the opportunity to launch a new attack. And device makers have doubled down on security in kind. But these measures come at a cost, Simpson says.
“We’ve tried to keep devices locked down with cybersecurity controls, but in doing that, we’re also taking away some benefits. For example, it would be great to remotely update a device with new features, or change the dose of a patient’s medication, but doing these things comes with risks. You have to be very careful about positioning yourself along the spectrum of technology innovation.”
Another challenge is interoperability. When devices share information securely and effectively, they can improve patient care, reduce errors and adverse events, and encourage innovation. But devices and components don’t always communicate well without a common set of standards, and those haven’t been fully developed. Components, especially, fall into a gray area.
The FDA is currently seeking comments on a proposed regulation for manufacturing standards, but because there are so many types of medical devices, its recommendations are deliberately broad and general, leaving it to designers to work out the details.
Collaboration is crucial. In the Molex survey, 92% of design engineers said collaboration skills are just as important as technical expertise.
To move forward in the absence of clear standards, many medical device engineers are creating a software bill of materials (SBOM), or a detailed list of all the software components included in their devices. Comparing SBOMs allows manufacturers, buyers, and operators to work together to identify and mitigate software compatibility problems and security vulnerabilities.
The ease-of-use consumers experience with their cellphones and laptops has created a high bar for medical device manufacturers. In fact, the Molex survey shows that 43% of design engineers said higher customer expectations are complicating design efforts. “The user experience has suddenly become much more important. If people don’t like the way a device works or find it difficult to use, they won’t use it. It’s really challenging for medical device makers,” Bedford says.
In addition, medical designers are often starting from ground zero, rather than iterating based on years of user study. Even established, widely-available devices are not always up to par. In a 2020 academic study examining consumer operation of blood pressure monitors and pulse oximeters, researchers found “a lack of usability for both devices.”
The study was conducted with healthy volunteers. But remember, outcomes could be even worse for acute patients, researchers warned: “Indeed, the patient will be in a postsurgical context, with pain, nausea, and stress, and will often need the help of family members to use the devices at home.”
Another wrinkle is the propensity to experiment with devices, which could be dangerous in a medical setting. “With a phone, you can play around with the settings to make it work. Doing that with a medical device, you may find you’ve given yourself a wrong injection,” Bedford says.
To pick up the pace of usability improvements, engineers are increasingly adopting agile development processes. In the Molex survey, more than half of design engineer teams said they have adopted agile methods, continuous innovation/continuous delivery processes, or both.
Agile development and continuous integration allow designers to make more frequent code changes, enhancing collaboration and improving designs. The process also enables regular cybersecurity reviews to avoid last-minute pressures and bug-ridden initial releases.
Having a diversified team also helps improve design. Engineers with different types of expertise can share insights, improving the overall product. The recent Molex survey indicates that in recent years, nearly half of designers have added engineers with deep expertise in specialized areas.
At Phillips-Medisize, a Molex company, engineers from diverse backgrounds have helped UX teams expand their points of view.
“We have trained and qualified user experience designers, including people who have worked in the design of consumer products and are bringing that knowledge across,” Simpson says. “Consumer products are designed to create an engaging experience. Why wouldn’t we want to see more of that in medical devices?”
Sustainability, Recycling, and Disposal
The third pillar of responsible design is fostering environmental sustainability. In the medical device arena, that often means recycling devices that have traditionally been consigned to the incinerator.
“The industry has grown up. There’s a lot of emphasis on eliminating single-use, disposable products,” Simpson says.
Recycling has been on the upswing in recent years. One hundred percent of hospitals used reprocessed single-use medical devices in 2020, removing nearly 32 million devices from the waste stream, according to the Association of Medical Device Reprocessors. Reusing materials allows designers to develop more sustainable solutions that can also lower costs on a per use basis and support the implementation of new features.
“By adding electronics and connectivity, we can create better products with more features that have the potential to improve patient engagement and support based on actionable data that is gathered and shared in real time,” Simpson says. “But in doing so, we need to consider the impact on sustainability.” Recycling isn’t always possible or economically feasible for devices that contain electronics and manufacturers should follow environmental regulations for proper disposal, including IEC 60601-1-9, which was created to protect the environment and human health from hazardous substances and minimize waste and its adverse environmental impacts. Integrating electronics into single-use disposable devices increases their environmental impact in a way that may significantly outweigh the benefits this brings. But for a reusable device, the burden is shared across multiple uses reducing cost and significantly improving sustainability on a cost per injection basis.
Responsible disposal of smart devices also means ensuring the proper destruction of sensitive data. Though HIPAA doesn’t define requirements for disposing of physical devices, it does require the protected health information they contain to be controlled at all times during the device’s lifecycle, including end-of-life.
Following responsible design principles is complicated for medical device makers, who work in an environment of hefty regulation and hazy standards. The resulting uncertainty can slow progress at a time when consumers are demanding upgrades. But by assembling diverse teams and employing agile design principles, designers can find ways to balance security, usability, and sustainability, forging a path to innovation with small but continuous improvement.