Healthcare Innovation Cycle for "MedTech" Solutions

MedTech is broad term for electro/mechanical medical devices. Tracking data has been added to show an example of an early stage team at risk due to a focus on technology. Select any Maturity Level to see the core Requirements or select the Requirements themselves to see a description of what is involved in completing a requirement and curated resources.

Note:To access the Resources that describe each Deliverable, use the Sign-in button above to create an account and then click on the Deliverable or the Innovation Maturity Level to see all Deliverables at that level and click on the one of interest.

Download a complete 
checklist.

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MaturityDisplay

Requirements

Preliminary Indications for Use
A description of the way the solution is intended to be used and indications for when it is to be used.
Preliminary Regulatory Classification
Regulatory body (FDA in the US) classification of your product based on products or services that work in similar ways.
Preliminary Regulatory Pathway
The regulatory pathway you expect will be used to approve your solution.
Preliminary Risk and Hazard Analysis
An initial assessment of the potential risks and hazards associated with the results of using the solution