Developing a Diagnostic for Home Use? Assemble the Right Team and Consider These Issues

Diagnostics is becoming the “darling of the medical industry because of potential growth,” says Josh Blackmore, global healthcare manager at thermoplastics resin supplier M. Holland Co. “Patients have been using simple but accurate devices at home for years—think of the pregnancy test. We are used to seeing high-quality testing devices in laboratory settings, but it wasn’t until the Fitbit proved to the world that patients would spend a significant amount of non-deductible money to monitor vital health markers.” Start-ups are now looking to take sophisticated tests from the laboratory and bring them into the home, Blackmore told MD+DI. “An entire industry is popping up for lab-quality, reliable testing that can be miniaturized in a point-of-care (POC) reader,” he says. “These tests utilize the same test methods as lab-scale equipment —they have to be reliable. If they are wrong, people’s lives may depend upon the results. Doctor visits, prescriptions, and treatment are often based on these test results.” To bring such products to market, it is important that product developers assemble cross-functional teams. “They do a good job by involving the molder for DFM, for instance, but, they don’t always get representatives from regulatory departments involved—and those experts know what regulatory hurdles have to be passed,” he said. Material suppliers should also be involved because “not all engineers know the full breadth of medical-grade plastic...
Source: MDDI - Category: Medical Devices Authors: Tags: MD & M West (Anaheim) Materials Source Type: news