Healthcare Innovation Cycle for "Biomarker Diagnostic" Solutions

Biomarker Diagnostics is a broad term for diagnostics that utilize biomarkers. Tracking data has been added that shows an example of an early stage team at risk due to a focus on technology and clinical to the exclusion of Market/Business and Regulatory issues. 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.

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MaturityDisplay

Requirement

Institutional Approval Request(s)

A justification and proposed protocol for testing your solution with patients at an institution if clinical data is required.
In cases that require clinical data, institutional groups (i.e. IRBs) approvals are necessary to conduct your studies and represent another source of validation for your idea. Even if the regulatory bodies do not require it, check with potential funders to see if they will require proof that the solution provides economic value in the intended setting.
Follow the rules established by your institution.

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Resource Type
Regions/Markets