P1.2 Prescribing direction

Other than clinical efficacy, a medical device’s ability to meet its users’ needs is the most important predictor of success. For that reason, medical device development should begin with an [...]

The business of introducing new medical devices requires us to address enormous technical challenges that require plenty of hard work. As we strive to meet these challenges, the FDA reminds us [...]

When we’re ill, a speedier diagnosis will help you get better faster by shortening the time between seeing a doctor and receiving treatment. To meet rising patient expectations for instant test [...]

The line between medical devices and consumer products used to be very clear. But with the development of new consumer technologies and the trend toward home health and wearable medical devices, [...]

When medical device companies start planning a new device, they often jump ahead and begin with the bells and whistles. They spec out flashy new features and plan out unexpected ways to execute [...]

For many companies, the first step in producing the right medical device is hiring the right design and engineering partner. In fact, hiring the wrong one can be catastrophic. The [...]