Brian Holly heads up Human Factors Engineering at Pfizer’s Devices Centre of Excellence within the BioTherapeutics Research and Development Division, based in Cambridge UK. Brian has 28 years’ experience in the healthcare sector and has been at Pfizer for the past 17 years. Brian has worked on a wide variety of drug delivery system development programs including management of post market product activities. Brian has developed expertise in human factors engineering including user interface design, risk management, design controls, and regulatory activities for combination products and medical devices, and he is no stranger to FDA interactions regarding human factors.