P1.2 Prescribing direction

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 [...]

Over the past few years the FDA has increased their emphasis on the importance of applying sound human factors procedures during medical device development. That means they’ve increased their [...]

When medical device companies set out to produce a new product, they are often driven primarily by one of two things: business goals or technological innovation. These are necessary elements of [...]

Competition in the medical device industry is already cutthroat. But an influx of investor-backed startups means the pressure is only ratcheting up. The investors who back these startups often [...]