The portal is designed to reflect a phased or ‘stage-gated’ approach to medical device development as described by Pietzsch et al., 2009. It describes concurrent streams of device development activities to include regulatory, clinical or quality considerations with the aim of supporting developers to better anticipate process requirements from concept to clinic.
The device development process is described as a journey with information or material common to all phases linked across all paths whereas information or resources pertinent to a particular phase or category e.g. Regulatory, Clinical, Quality are set apart as single stops on route to market.
Medical Device Design
The device development journey as described by Medtech Translate builds upon an existing device development model which describes the product realisation process in five discrete stages interspersed with a set of critical ‘go – no go’ decision gates at the end of each stage 1.
This stage-gated model describes the activities performed by each function (e.g. regulatory, quality, clinical) of the business as well as the expected deliverables and key decisions to be made at each stage.
Stage 1
Initiation
Stage 2
Formulation
Stage 3
Design & Development
Stage 4
Final Validation
Stage 5
Post-Market
Select a point on the Medical Device Development Journey
Click below to see sample journey pages or sign up for full access
MedTech Translate membership and benefits
Access pertinent information on Medtech Translate membership and the Medtech Translate device development support programme.
