Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

What are the benefits and future challenges of Human Factors and Usability Engineering for DDCP’s?

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

37

What are the benefits of Human Factors and Usability Engineering? Including Usability and Human Factors (Engineering) into the development of a DDCP’s can only enhance it and make it suited to its intended users, use environments and scenarios of intended use. Usability and human factors incorporated into DDCP’s :  Can improve the use-safety inherent in the design of the DDCP’s.  Can aid the long-term compliance of using the DDCP (very important for expensive DDCP’s, and for medicine / drug adherence).  Can show an economic benefit in using the DDCP against existing DDCP’s.  Can be clinically more effective and efficient than existing technologies.  Can enable a higher acceptance of the DDCP when launched and used for the first time.

 Can determine a higher level of ease of use than predicate DDCP’s.  Can enable a better user experience than with existing DDCP’s.

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

38

19