Medical device designers should ensure they are not borrowing too heavily from consumer products.
As medical device consumers continue to evolve from highly specialized experts to engaged users and patients, designers have increasingly turned to the consumer electronics market for what can euphemistically be described as inspiration. But those designs could border on patent infringement.
Medical device manufacturers may need to start asking with increasing frequency and increasing urgency what percentage of these designs might be encroaching on the IP of companies such as Samsung and Apple, to name a few.
Author and futurist, Jim Carroll (who will be speaking at MD&M Chicago) says “Silicon Valley has the medical device industry in their sights.” His intention is to point out that Silicon Valley could reenergize the medtech space. But with such attention comes increased competition, hinting at other, possibly less welcome aspects of the consumer approach to medical.
It hasn’t happened yet.
“Off the top of my head, I don’t know any specific examples of these firms going after medical device companies, but it’s potentially a huge deal,” says Bill Betten, a member of MD+DI’s editorial advisory board, and teardown expert. However, he adds that companies in the wireless space have begun to look closely at how medical device firms are using wireless technologies. Further, the entry of nonpracticing entities (NPEs) into the medical device area is also of particular note. NPEs complicate the issue because their primary focus is on licensing of intellectual property.
The practice of borrowing design from the consumer or other industries isn’t new. Betten recalls an example when his own design team was working on a display that would show O2 levels of a patient during surgery. The team had to come up with a way to ensure the right leads went to the right place on the body and back to the display. Ultimately, the solution came from the oscilloscope industry. “The design for that device was best when it came from another field that had already dealt with a similar issue,” Betten says.
Still, companies need to cautious when using product elements that might be patented, and should ensure they have a good handle on what can be considered free use.
“Traditionally, medical devices were low-volume,” says Betten. They escaped the notice of big (and powerful) consumer products. But that dynamic is changing, particularly as consumer companies start to examine how they might capitalize on the growing healthcare market and new technologies that bring healthcare directly to consumers. A sophisticated blood glucose monitor, for example, can potentially have hundreds to thousands of patents, related to the user interface, software, battery, memory, power-management system, integrated circuits (ICs), and wireless connectivity.
“The phrase ‘It looks just like a iPhone’ could become particularly dangerous.” Betten warns.
One big pitfall, Betten says, could occur if medical device firms purchasing the design or wireless technology from a vendor assume that the vendor is securing IP. “That might not be the case,” he says.
The best advice Betten can give to companies about protecting themselves is, “Do your homework.” Companies should be practicing due diligence for patents—even those outside the traditional scope of other medical devices.
—Heather Thompson is editor-in-chief of Medical Device & Diagnostic Industry magazine.