Healthcare Innovation Cycle for "Digital Medicine" Solutions

Digital Medicine is a broad term for the subset of the Digital Health field that related to promoting wellness or providing medical care (see Digital Therapeutics Alliance Definition). Tracking data has been added that shows 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 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

Requirements

cGMPs Medical Software and Production Environment(s)
Compliance with current Good Manufacturing Practice regulations for medical software and the production environments on which it operates
Essential Technical Experiments Results
A description of the target performance specifications/goals and experimental results that demonstrate that the technology is capable of meeting/beating the desired performance levels
Interoperability Validation
Validation of the interoperability of the software across target platforms
IP search report
A search report is a report established by a patent office which identifies documents which may be taken into consideration in deciding whether the invention to which a patent application relates is patentable over the prior art.
Key In-Sourcing Requirements Committed
All key items (data, parts, code, infrastructure, etc.) that are being provided by external organizations are committed with at least a MoU
Works-Like-Looks-Like prototypes
Prototypes that work like and look like the intended product that are built under controlled conditions and can be used in testing.