The move of a former US Food and Drug Administration (FDA) employee to one of the world’s biggest pharma companies signals a recognition at a very senior level in the industry that the breadth and depth of Human Factors activities needs to dramatically improve.

Molly Story, a member of the FDA’s CDRH Human Factors team, is leaving the FDA to head Sanofi’s Usability & Risk Management team for Medical Devices in Frankfurt. The move occurs against an industry backdrop of combination products experiencing setbacks during the submission review stage, resulting in costly delays, re-designs and project cancellations.

It has been suggested that this move signals a turning of the tide for the status of Human Factors in product development, and reflects the challenges and questions that companies are facing when submitting approval dossiers to the regulatory authority.

As well as smoothing the path to regulatory approval, effective use of Human Factors helps medical devices complete their development sooner – speeding up time to market, maximising the amount of patent life available for sales, reduces development process costs and maximises product uptake.

We can help you do this quickly and cost effectively, by either:

  • An audit of your device development, improving and changing your processes and systems so you can fulfil regulators expectations,
  • A tailored service to help you get the benefits outlined above,
  • Outsourcing of device development activities to us.

Talk to us today about how we can help you.