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.

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checklist.

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MaturityDisplay

Requirements

Essential Experiment Results
Documentation of results from essential experiments that prove feasibility
Key In-Sourcing plans
Key items (data, parts, code, infrastructure, etc.) that are needed from external organizations
Preliminary BOM and Manufacturing-QMS Plan
A preliminary bill of materials (BOM) and plan for manufacturing as well as quality assurance. What will be done in-house, what will be outsourced and how will you ensure quality?
Product Requirement Document (PRD)
A description of what the desired product should be capable of doing - avoiding how the product will actually do it - that comes later.
Provisional IP filing and formal FTO review
A provisional patent application filed with the US Patent office or equivalent agency in another country with a study of prior art and assessemt of the freedom to operate (FTO)
Works-Like and Looks-Like Prototypes
A prototype that works like the proposed solution, with all the key functions, but not necessarily in the final form along with experimental data documenting the performance