MEDHF AT DIA 2018
MEDHF TO PRESENT AT DIA EUROPE 2018
We will present on Thursday 19 April, 2018 between 10:30-12:00 in the session:
IMPACT OF HUMAN FACTORS ON THE DEVELOPMENT OF COMBINATION PRODUCTS.
The session will be chaired by Dr. Muriel Didier, Human Factors Team Head, Novartis, Switzerland.
Speakers at the event are:
- Lee Wood, Co-Founder, medHF
- Chin-Wei Soo, Global Head, PTR Combination Products/Devices, Genentech
- Andrew Warrington & Edward Oakeley , DayOneLab
Lee Wood will present on Human Factors Validation.
Medication error reduction is a key imperative for drug and drug-device combination product development, and human factors engineering is the discipline that is intended to improve the design of medical products to minimize potential use errors and resulting harm. Human Factors data demonstrating acceptable usability are now a critical part of the regulatory review of combination products, and manufacturers falling short of requirements have suffered delays, non-approvals, compliance observations and warning letters. One critical element is the Human Factors Validation study; a study conducted to demonstrate that the final finished combination product user interface can be used as intended by intended users without serious use errors or problems. Such studies are commonplace for combination products, and can also be requested to support new drug/ biologic filings. The regulatory basis, technical considerations for study design, when testing may not be required and typical issues/ pitfalls of such studies will be presented.