Module 14 2022

22/03/2022

GOOD DESIGN PRACTICE

IDENTIFY THE UNMET NEED (I): ● What will the device do? – Is this a recognised unmet need? – Understand the disease state / physical condition

● Who is the user? – Patient? – Home carer? – Healthcare provider?

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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GOOD DESIGN PRACTICE

IDENTIFY THE UNMET NEED (II): ● How will it help support the patient? – Will it be used with other devices?

● Are there existing devices available that have a similar role? – …but which do not fulfil the required function completely?

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

6

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