P1.2 Prescribing direction

The FDA requires user interface specifications for medical devices. But your user interface specification can and should be more than a requirement or regulatory box to check.

From a medical device development perspective, the goal of human factors engineering, usability, and user experience activities is the same: To release a product that meets users’ needs in a [...]

Risk management is a crucial aspect of medical device development. You need to account for and mitigate the risks associated with your product early on, so it’s safe for users and passes [...]

As a medical device marketer, you go to great pains to identify a unique value proposition for each new device your company creates. But — and here's the rub — by the time a medical device goes [...]

For several decades, the medical and healthcare industry has undergone a transformation in its adoption of digitally enabled tools. Whether it's an embedded user interface within a device or a [...]

It doesn't matter if your medical device company is a hungry new startup or a seasoned industry leader: There are times when you need to augment your in-house team’s capabilities. Whether you [...]