Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

What is the Human Factors and Usability Engineering process? For most DDCP’s, a drug product will be used in an “ Off-the-Shelf ” device – an auto-injector, inhaler, infusion system etc. As such, the design of the device itself is verified (by that manufacturer).

So, what is required by the pharmaceutical product manufacturer for a DDCP?

1. Research and then Validation of the system – User Research and then a Summative Human Factors Study (or Validation Test if in the USA).

Research

Design

Develop

Verify

Validate

2. Comparative Human Factors Study (for generics, to show better use performance (non inferiority).

Only #1 or #2 are required – depending on the regulatory pathway – never both (in my experience)!

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

27

What is the Human Factors and Usability Engineering process? For most DDCP’s, a drug product will be used in an “ Off-the-Shelf ” device – an auto-injector, inhaler, infusion system etc. As such, the design of the device itself is verified (by that manufacturer).

So, what is required by the pharmaceutical product manufacturer for a DDCP?

1. Research and then Validation of the system – User Research and then a Summative Human Factors Study (or Validation Test if in the USA).

Research

Design

Develop

Verify

Validate

2. Comparative Human Factors Study (for generics, to show better use performance (non inferiority).

Only #1 or #2 are required – depending on the regulatory pathway – never both (in my experience)!

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

28

14