Notable players like Google and Apple are rushing to bring their versions of ‘healthcare’ monitoring devices and Digital Health applications to market. All of this is very exciting and offers lots of value to those who embrace the technology.
They’re developing new and easy to navigate products that transfer the responsibility of managing an individual’s healthcare directly to end user – much like what has happened with banking and the booking of travel.
But is it as simple as that? Will the consumer electronic world engulf and make the medical device development community – with its rigorous testing and risk mitigation processes – obsolete? Let’s look into how both categories of products are developed… and the reasons behind those development choices.
Development of consumer electronic products is characterized by fast decision making…..and lots of risk. To be successful and meet very short ‘time to market’ requirements, decision making must be quick and decisive. There’s no time to excessively worry over the details. The Design and Development Process is: Drive a general consensus on what the product should be, assembly a basic ‘market requirements document’, and then get the thing designed and out the door! If there are problems with the product, rev. 2 will handle it. In short, the consumer electronic world is the Wild West.
Contrast this with the development of medical devices. Because of regulatory standards designed to protect the public, a medical device that’s used to diagnose a condition and/or proscribe a treatment requires a very rigorous development and testing process. Processes are all about establishing clear efficacy, stability and rock solid predictability. Unlike a consumer device, a person’s quality of life (or even worse their very existence) can be either enhanced or harmed by a device. Government agencies and financial liability require companies developing and producing the medical products to do all they can to prove out the design and make sure it does what it’s supposed to do each and every time it’s used.
Now, the big question many in the business community are trying to come to grips with; Will the consumer electronics industry attempts at creating health monitoring devices make the medical device development world obsolete? I doubt it.
I’m sure they will have a major impact in some areas, but we need to remember that there’s a big difference between a device that monitors and graphically illustrates generic healthcare measurements and conditions and those used to diagnose disease and proscribe treatments. This is the main dividing line.
Knowing how your body is performing is very different than knowing what must be done to treat it if it’s going in the wrong direction. Devices that diagnose disease and proscribe suitable treatments will always require more demanding product development, testing and regulatory approval processes. It’s in everyone’s best interest that they do so. Medical device companies that focus their efforts and build the necessary skills and experience will continue to serve the business community and the public with well thought out and defined product development services. The consumer electronic industry will most likely become a prime component supplier and partner to the medical device business.
I’d love to hear your experiences and views on the future of Medical Devices, Consumer Electronics and Digital Health.
David Dobson is Director of Business Development at StarFish Medical. He brings consumer electronics and medical device experience and lots of passion to help potential clients understand what it takes to turn ideas into medical devices. See the results of some of his efforts in Our Work pages.