| Monday, January 01, 0001
Over the past 30 years, medical device and diagnostic technology has progressed along a predictable path.
Technologies commonly were launched into clinical and lab settings as large systems suited for larger, centralized workspaces (like hospitals and centralized laboratories), or complex procedures for more narrowly trained specialists. Then, over time and keeping pace with Moore's Law, diagnostic technology gets faster, accuracy and reproducibility increase, the form factor shrinks – and the moderate- to high-complexity system that was a $100,000 capital expenditure ten years ago now is CLIA-waived, sits on a counter in every Primary Care physician’s office and costs $6,000 (with ample margin for the manufacturer).
The disruptive nature of computing, though, has put Moore's law in the rear view mirror. Lab-on-a-chip is going from a concept in a PowerPoint presentation to reality – and “on-a-chip” will mean “on-a-smartphone” in the very near future.
Because of the enormous processing power packed into the chips that run today’s smartphone and tablets, mobile devices will become the analyzers of tomorrow. Perhaps the most celebrated example so far is the AliveCor Heart Monitor, the FDA-cleared ECG device-app combination includes a sensor that adheres to the back of an iPhone.
That processing power is making devices more widely available and less expensive is evident by the low, $199 price tag – and the lack of a need for a sales representative to detail the product.
These concepts were discussed by mobile health expert Eric Topol, MD, professor of genomics and director of the Scripps Translational Science Institute, in a recent interview with Clinical Laboratory Review.
“I actually think this is the next big wave of where the diagnostics field will go. It’s basically an outgrowth of the remarkable progress that’s been made in microfluidics. For example, if you connect lab-on-a-chip hardware to a smartphone, that smartphone can do a lot of the processing, display, and archiving of the data. Already the likes of thyroid function tests, liver tests, and electrolytes are in the pipeline. This is definitely happening.”
The path forward will not be as linear for all device-app companies because traditional market constructs still will govern market acceptance – notably the FDA’s role as regulator, the market making influence of reimbursement from 3rd party insurers, validation through clinical trials, product design, etc. For example, Biosense Technology’suChek semi-automated urinalysis application, which uses the iPhone’s camera to read Siemens and Bayer test strips, was flagged by the FDA in late May. FDA contends Biosense does not have the proper clearance to market the uChek in the U.S. despite its registration as a Class I device.
While the regulatory landscape is being shaped in real time, the progression from table top to hand-held is underway and unstoppable. Products like Telcare (wireless glucose meter with data visible to patients, family and caregivers), Nephosity (remote medical image viewing for physicians), Hubble Telemedical (real-time retinal imaging analysis for diabetic retinopathy monitoring) – and countless others – are all advancing into clinical practice at a pace the medical technology and physician practices have never before experienced.