Between government stimulus packages, an aging population, exploding healthcare costs and increasing need for better remote diagnostics, it's understandable that engineers looking for the next big opportunity would look up and cry: "Thars gold in them thar [medical] hills." But not so fast.
They may be right, but mining this particular mother lode has proven difficult at best, to downright stomach wrenching at worst, and the medical-device landscape is littered with the dried-up carcasses of what at one time seemed like a good idea .
Why? The reasons are many, which is why we've convened a panel of experts in the field to discuss medical Trends and Opportunities at ESC Boston this coming Tuesday, but the general issues are not so much technical as they are systemic: changing FDA rules and approval delays and lack of reimbursement models.
Take remote patient monitoring, for example. Along with implantables and diagnostic imaging, it is one of the three hottest spaces in medical electronics, yet is mired in a race to the bottom because of a lack of insurance reimbursement models. "Our system is based on people going to see a doctor [and getting billed accordingly], not on doctors reading in-coming data," said Steve Dean, medical marketing director at Texas Instruments, one of the medical panel members.
This lack of reimbursement relegates remote monitoring devices to consumer price points, while still having to meet FDA requirements for everything from connectors to firmware. Not a strong business model.
Speaking of the FDA: it has recruited 1,000 more approvers in the past year, yet the process is still bogged down in red tape as those approvers have ditched the principle of predicate technology and are looking at designs from scratch. This doesn't help anyone looking to develop implantable devices, which already has high barriers to entry, according to Mir Imran, serial medical entrepreneur, chairman and CEO of InCube Laboratories and ESC medical panelist. "Only a handful of people have the stomach for it [the approvals process]."
So yes, mining medical is indeed difficult, but the opportunities exist, given the strong drivers at play. Imaging, remote diagnostics, ultrasound, molecular sensing all have potential. To identify and explore those opportunities, Dean and Imran will be joined on the panel at ESC by Newton De Faria, business development manager, National Instruments, Charles Sodini, professor of electrical engineering at MIT, Al Wegener, CTO and founder of Samplify Systems and Steve Ohr, research director at Gartner Dataquest.
Together, the group will look at everything from where the technology and device gaps lie and how designers can go about targeting those market opportunities, to specifics such as low-power design to extend product life spans and firmware partitioning and other design techniques to secure FDA approval. More on the outcome of this discussion and where you should be putting your medical design energy in my follow-up posting.
In the meantime, join the pre-panel discussion and pose your own questions on EETimes at Where's the money in medical design? Join the conversation. See you on Tuesday!
Update: The full panel is now online, view it here.