Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

Evaluating DDCP’s in Human Factors and Usability Studies Commonly, DDCP’s are either studied or tested. Formative Usability Studies focus on user interfaces, design and development of these user interfaces if the device is novel – not if “Off-the-Shelf”.  Summative Usability Studies focus on performance of the intended users with the device and test the safety and usability of the DDCP.  The focus is to ensure that the intended users can use the device in the intended manner, in the intended use environment using the intended user interfaces.  DDCP’s now include more than just a device – apps, software, integration with other devices, packaging, smart-instructions etc.  Comparative Human Factors Studies focus on just the performance of the intended users with the device – not safety. Risk Assessment is the tool for showing evidence of safety.

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

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Evaluating DDCP’s in Human Factors and Usability Studies Key elements that studies and tests look at –  The intended users  The use environments  The user interfaces Most studies and tests are performed with –  Nurses (Hospital, Care-Home, Community, Specialist etc.)  Patients with the conditions/injuries/medical condition  Personal/professional Carers who manage the patient(s)  Pharmacists Most studies and test are performed focusing on how the DDCP’s interact with the patient's body:  Orally  Through surgery/intervention  By injection/infusion  By inhalation  Through absorption

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

34

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