Bob’s deep expertise in medical human factors enables him to deliver value to clients in hours that would take almost anyone else days. He knows the device world and the regulatory world and most importantly, he knows how to help clients be successful where these two worlds converge. He is the dominant expert in this industry.

Patricia A. PattersonPresidentAgilis Consulting Group

Bob is truly an expert on human factors regulatory requirements not only for medical devices, but also for drug/device combination products. Because of our partnership with Human Centered Strategies, we were able to submit a comprehensive and robust human factors report to the FDA that produced no additional questions from the Agency.

Evan T. EdwardsVice President, Product Development & IndustrializationKaléo Pharma

Bob has provided my team sound advice on several occasions regarding our human factors study protocols that were being sent to the FDA for approval. I know of no one else with Bob’s depth of knowledge regarding the FDA human factors team’s pre-market review philosophy. This has made us much more efficient in conducting our human factors studies and saved us valuable time in preparing and finally obtaining regulatory clearances.

Edmond Israelski, PhD. Director Combination Product DevelopmentAbbvie Human Factors