While medical equipment thrives on technological innovation for the betterment of patient safety, the speed at which the equipment is evolving can introduce challenges for those who use them everyday.
The medical device landscape is changing fast in part due to new technology including IoT hardware. These modifications are creating opportunities and challenges for products designers.
New medical devices must be safe, practical and valuable to providers and their patients. At the same time, regulations and ongoing supply shortages create additional challenges for manufacturers.
The right approach is needed for businesses that want to design medical devices effectively. Preparing for the current challenges will enable manufacturers to take full advantage of emerging technology.
Read the full article at Fierce Electronics.
There is nothing particularly wrong in the article. And it touches on nothing new. But it ignores an elephant in the room: the impact of introducing functional changes to independent devices in complex clinical environments.
As I read the article I wax reminded of two quotes from Henry Petroski that I often cited in my work:
“Things work because they work in a particular configuration, at a particular scale, and in a particular context and culture.”
“Any design change…can introduce new failure modes or bring into play latent failure modes. Thus it follows that any design change, no matter how seemingly benign or beneficial, must be analyzed with the objectives of the original design in mind.”
These warnings do not only apply to the internals of any one device but also, and I believe more importantly, to the systems in which they are applied.
When I entered clinical engineering in 1979, the importance of user training was already well recognized. That was an era without the internet let alone the concept of interoperability. The functionality of devices could only be changed by changing the hardware design, which effectively precluded changes until devices were replaced or recalled.
I’m not yearning for the good old days, but I’d really like to see evidence that the rate of change of technologically complex clinical environments is independent of the quality of care delivery.