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.

Note: Download and open the PDF so that it is fiilable

MaturityDisplay

Milestone
Domain

Requirements

Draft Essential Requirements Checklist
The regulatory pathway will determine what information is required.
Draft Instructions For Use
Instructions for Use
Draft Product Claims
A draft of the claims that company wants to make about its product/service
Institutional Approval Request(s)
A justification and proposed protocol for testing your solution with patients at an institution if clinical data is required.
Submission Pathway Defined
An updated version of the preliminary regulatory pathway you expect will be used to approve your solution.