disrupting the healthcare systemA recent report that I noticed on the MedGadget website reveals how innovative companies are disrupting the healthcare system.

The Trak male fertility testing system is a device that can be used at home to test sperm count. It has received FDA clearance. The product page claims that, after 500 hours of testing and clinical trial, it has proven to be as accurate as the gold-standard laboratory test.

The Trak device is a leading indicator of what we can expect in a healthcare market that is shifting from one that relies on high-cost institutionalized professional services, to one that gives individuals much more control of (and responsibility for) their own healthcare. Devices that allow at-home testing and diagnostics are going to provide healthcare consumers with alternatives that provide convenience and significant cost-savings. At-home testing and point-of-care diagnostics is where we are headed. Medical device companies would be wise to take notice. This is a significant market change. Those that capitalize on it will be those that focus on designing products that are easy for the average consumer to use and – even more importantly – provide confidence that the device has been used correctly and that the user can rely on the results.

The healthcare landscape is changing rapidly. High-cost healthcare cannot be sustained. Many people will take advantage of opportunities for DIY healthcare that these new devices will enable. Many people will have no choice but to do so. In such an environment, robust, accurate functionality will not be enough. Companies will also have to carefully design their devices taking the user’s perspective.