Insights From Our Team

Downsizing and reorganization are afflicting many in this industry. Flexibility in resourcing is important as you navigate this challenging economic landscape. Supporting your development teams with cross-functional industry experts can provide greater flexibility and efficiency, allowing you to drive excellence in innovation and improve your teams’ performance while keeping your fixed costs under control.

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.

New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. Who wouldn’t be excited about that? But these devices also carry varying levels of risk that must be carefully managed.

Developing a medical device starts with identifying every user need your final product will meet. Then, those needs are translated into actionable product specifications. These are called design inputs.  Why do design inputs matter? Because if you don’t satisfy your design inputs, your product won’t satisfy user needs. And if you don’t satisfy user needs, no one will want to use your product if and when it makes it to market. 

Today’s focus on VACs means that the modern market is made up of more medical device adopters — stakeholders serving as gatekeepers to market acceptance of your medical device — than ever before. So your product must be designed to galvanize more people than ever before as well.

If your human factors validation study is inadequate, the FDA can bounce your entire submission back. Consequently forcing you to revise your submission file — or worse, your actual design — and resubmit it for another chance at FDA approval. Learn how to make certain it’s the right time for your human factors study.