Quick links

Stage – ID2: Design the Solution

Design is a vital part of the product development process, and can be defined as the formulation of an idea as a solution to a problem, or as a way of doing things better. In this context companies providing project, business or technology management services can be said to be involved in design.

Select a task name below for more information

Task Overview

Before you write your design specification you should consider the following.

What you need to do:

  • Check your design doesn’t infringe on existing designs or patents
Write your product specifications, including:

  • A definition of the clinical need
  • A functional analysis (what will it do?)
  • Performance requirements (what will it achieve?)
  • Regulatory classification (e.g. is it a medical device?)
  • Details of how to use it, how it will perform and how to maintain it and dispose of it
You should also decide:

  • How to test whether the product meets design specifications and manufacturing capabilities
  • How to make any changes required, for example, if it needs to be sterile
  • How to develop a demonstrator (e.g. a non-functional mock-up), to help with fundraising and enable potential users to influence the design
  • How feedback from users could help you develop and market your product
  • How the product could fit into the payment systems of target healthcare markets

Finally, conduct an initial risk analysis using formal methods such as failure mode and effect analysis (FMEA):

  • Are you using new or unusual materials?
  • What risks do they pose?
  • Is any material likely to cause an adverse reaction (e.g. fracture, corrosion, allergy)?
  • Can end-users offer advice on any of these issues?