About

Adam Shames is a human factors expert and the Founder and Chief Executive Officer of Core Human Factors. He has an MBA in international business from the Fox School of Business and Management at Temple University (US) and a BS in human factors engineering and psychology (double major) from Tufts University (US), where he received the De-Florez Prize in Human Engineering. Mr Shames also has a Certificate in Applied Ergonomics Training from the US Army Center for Health Promotion and Preventive Medicine.

He spent almost two decades conducting usability research, has been the Principal Investigator on hundreds of usability studies with tens of thousands of participants in cities around the world and has worked as a consultant for more than 15 years. Mr Shames has been a member of the US Association for the Advancement of Medical Instrumentation (AAMI) Human Factors Committee, is appointed by the American National Standards Institute (ANSI) as an Expert on the IEC Joint Working Group on Human Factors, which publishes IEC 62366-1, and is a contributing author on numerous international human factors standards for medical devices.

Contributions

RESPIRATORY

FDA ISSUES FINAL GUIDANCE ON MEDICAL DEVICE HUMAN FACTORS STUDIES

Michael Gross and Adam Shames discuss US FDA draft recommendations on human factors validation which are part of the design validation requirement of device design controls.

More contributions

INJECTION

US FDA ISSUES GUIDANCE ON HUMAN FACTORS STUDIES FOR COMBINATION PRODUCTS

Adam Shames and Michael Gross summarise the US FDA’s recently released draft Guidance: “Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development”.

PREFILLED SYRINGES

QUALITY & SYSTEMS USABILITY REQUIREMENTS

Michael Gross and Adam Shames discuss US FDA quality system requirements for combination products, especially Design Controls, which includes the requirement to validate the design of the medical device constituent part of a combination/borderline product.