P1.2 Prescribing direction

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 [...]

Medical devices are increasingly built around software. Of course, almost any medical device with a battery or power cord has a software component of some kind. But as more and more tech [...]

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 [...]

Let’s say one of your competitors introduces a successful new medical device to the market that would make sense as part of your suite of products. If you’re like most medical device companies, [...]