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.

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checklist.

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MaturityDisplay

1.
Need
Clinical
Disease State Characterization
50% Complete
50%
9/18/2020 9/18/2020
Clinical
Unmet Need Statement
100% Complete
100%
9/18/2020 9/18/2020
Market/Bus
Existing Solutions Characterized
100% Complete
100%
9/18/2020 9/18/2020
Market/Bus
Needs Screening and Selection
30% Complete
30%
9/18/2020 9/18/2020
Regulatory
Regulation familiarization
50% Complete
50%
9/18/2020 9/18/2020
Technology
State of the Art Summary
50% Complete
50%
9/18/2020 9/18/2020
2.
Idea
Clinical
Envisioned Benefit Statement
50% Complete
50%
9/18/2020 9/18/2020
Clinical
Feedback from 5+ Clinical Stakeholders
100% Complete
100%
9/18/2020 9/18/2020
Clinical
Updated Need Statement
0% Complete
0%
Clinical
Workflow Scenario
0% Complete
0%
Market/Bus
Competitive Landscape
10% Complete
10%
9/18/2020 9/18/2020
Market/Bus
Envisioned Value Proposition
30% Complete
30%
9/18/2020 9/18/2020
Market/Bus
Key stakeholders identified
30% Complete
30%
9/18/2020 9/18/2020
Market/Bus
Reimbursement Familiarization
30% Complete
30%
9/19/2020 9/19/2020
Regulatory
Comparables Identified
100% Complete
100%
9/18/2020 9/18/2020
Regulatory
Intended Use and Medical Device Determination
100% Complete
100%
9/18/2020 9/18/2020
Technology
Idea Screening and Selection
100% Complete
100%
9/18/2020 9/18/2020
Technology
Institutional IP Disclosure
0% Complete
0%
Technology
Interface Mock-Ups
100% Complete
100%
9/18/2020 9/18/2020
Technology
System and Module Requirement Specification
100% Complete
100%
9/18/2020 9/18/2020
3.
Proof of Concept
Clinical
Feedback from Clinical Stakeholders in 5+ settings
0% Complete
0%
Clinical
Target Outcomes
0% Complete
0%
Clinical
Updated Need Statement and Workflow Scenario
0% Complete
0%
Market/Bus
Business Protection Model
0% Complete
0%
Market/Bus
Competing Solutions Characterization
0% Complete
0%
Market/Bus
Preliminary Path-to-Payment Plan
0% Complete
0%
Market/Bus
Preliminary Value Proposition
0% Complete
0%
Market/Bus
Stakeholder Map
0% Complete
0%
Regulatory
Preliminary Indications for Use
0% Complete
0%
Regulatory
Preliminary Regulatory Classification and Pathway
70% Complete
70%
9/18/2020 9/18/2020
Regulatory
Preliminary Risk and Hazard Analysis
0% Complete
0%
Technology
Demonstration Results
100% Complete
100%
9/18/2020 9/18/2020
Technology
Key In-Sourcing Requirements
30% Complete
30%
9/18/2020 9/18/2020
Technology
Key Module PoC Prototypes
100% Complete
100%
9/18/2020 9/18/2020
Technology
Preliminary System and Software Architecture
100% Complete
100%
9/19/2020 9/19/2020
Technology
Updated Institutional IP Disclosure
0% Complete
0%
4.
Proof of Feasibility
Clinical
Feedback from Clinical Stakeholders in 20+ Settings
0% Complete
0%
Clinical
Updated Need and Workflow Descriptions
0% Complete
0%
Clinical
Updated Target Outcomes
0% Complete
0%
Market/Bus
Business Advisory Board
0% Complete
0%
Market/Bus
Development Plan
0% Complete
0%
Market/Bus
Feedback from 5+ Economic Buyers
0% Complete
0%
Market/Bus
Key Relationships Identified
0% Complete
0%
Market/Bus
Preliminary Business Model
0% Complete
0%
Market/Bus
Secure Access to Core IP
0% Complete
0%
Regulatory
Cyber Security Plan
0% Complete
0%
Regulatory
Draft Essential Requirements Checklist
0% Complete
0%
Regulatory
Draft Instructions For Use
0% Complete
0%
Regulatory
Draft Product Claims
0% Complete
0%
Regulatory
Institutional Approval Request(s)
0% Complete
0%
Regulatory
Submission Pathway Defined
0% Complete
0%
Technology
Essential Experiment Results
100% Complete
100%
9/19/2020 9/19/2020
Technology
Key In-Sourcing plans
50% Complete
50%
9/19/2020 9/19/2020
Technology
Product Requirement Document (PRD)
0% Complete
0%
Technology
Provisional IP filing & initial FTO review
0% Complete
0%
Technology
Risk Mitigation and Interoperability Plan
70% Complete
70%
9/19/2020 9/19/2020
Technology
Software and Hardware Architecture
90% Complete
90%
9/19/2020 9/19/2020
Technology
Works-Like Prototypes
100% Complete
100%
9/19/2020 9/19/2020
5.
Proof of Value
Clinical
Clinical Pilot
0% Complete
0%
Clinical
Clinical Trial Endpoints
0% Complete
0%
Clinical
Feedback from 100+ Clinical Stakeholders
0% Complete
0%
Clinical
Feedback from 5+ KOLs
0% Complete
0%
Clinical
Medical Advisory Board
0% Complete
0%
Market/Bus
Feedback from 10+ Economic Buyers
0% Complete
0%
Market/Bus
Incorporation and Founders Agreement
0% Complete
0%
Market/Bus
Initial seed investment
0% Complete
0%
Market/Bus
Investor Ready Business Plan
0% Complete
0%
Market/Bus
Key Management Team Committed
0% Complete
0%
Market/Bus
Key Relationships Formalized
0% Complete
0%
Regulatory
Application to Regulatory Authority Submitted
0% Complete
0%
Regulatory
Clinical Investigation Approval(s)
0% Complete
0%
Regulatory
Electronic Protected Health Information (ePHI) Plans
0% Complete
0%
Regulatory
Essential Requirements Checklist
0% Complete
0%
Technology
cGMPs Medical Software and Production Environment(s)
0% Complete
0%
Technology
Essential Technical Experiments Results
0% Complete
0%
Technology
Interoperability Validation
0% Complete
0%
Technology
IP search report
0% Complete
0%
Technology
Key In-Sourcing Requirements Committed
0% Complete
0%
Technology
Works-Like-Looks-Like prototypes
0% Complete
0%
6.
Initial Clinical Trials
Clinical
Demo Feedback From 20+ Clinical Stakeholders
0% Complete
0%
Clinical
Endpoints Achieved in Feasibility Clinical Trials
0% Complete
0%
Clinical
Peer Reviewed Publication(s) Submitted
0% Complete
0%
Market/Bus
1st Institutional investment
0% Complete
0%
Market/Bus
Feedback from 20+ Economic Buyers
0% Complete
0%
Market/Bus
Validated Quantification
0% Complete
0%
Regulatory
Data Requirements Confirmation
0% Complete
0%
Regulatory
GDPR-HIPAA Compliance
0% Complete
0%
Regulatory
Pre-Submission Filed
0% Complete
0%
Regulatory
Security and Vulnerability Certifications
0% Complete
0%
Technology
All In-Sourcing Requirements Achieved
0% Complete
0%
Technology
Full IP Application
0% Complete
0%
Technology
Updated specification & experimental validation
0% Complete
0%
7.
Validation of Solution
Clinical
Endpoints Achieved in Pivotal Clinical Trials
0% Complete
0%
Clinical
Peer Reviewed Publication(s) Accepted
0% Complete
0%
Market/Bus
2nd Round of Institutional Investment
0% Complete
0%
Market/Bus
Purchasing Intent From 10+ Buyers
0% Complete
0%
Regulatory
Submission of Technical File to Regulatory Body
0% Complete
0%
Technology
Quality Assured Process Validation (cGMP)
0% Complete
0%
Technology
Updated Specification and Experimental Validation
0% Complete
0%
8.
Approval & Launch
Clinical
Specialty Medical Group(s) Review in Place
0% Complete
0%
Clinical
Training Materials & Support Established
0% Complete
0%
Market/Bus
Initial Sales/ Deployment
0% Complete
0%
Market/Bus
Regionalization Plan
0% Complete
0%
Regulatory
Public Coverage and Code Determination
0% Complete
0%
Regulatory
Regulation and Listing
0% Complete
0%
Technology
Finalized cGMP Production Environment
0% Complete
0%
Technology
Regionalization Requirements
0% Complete
0%
9.
Clinical Use
Clinical
Included in local practice guidelines
0% Complete
0%
Clinical
Peer Reviewed Publication(s)
0% Complete
0%
Market/Bus
New Markets Launched
0% Complete
0%
Market/Bus
Profitable Sales
0% Complete
0%
Regulatory
Monitoring and Inspections
0% Complete
0%
Technology
Improvement Plan
0% Complete
0%
Technology
Regionalization Implemented
0% Complete
0%
10.
Standard of Care
Clinical
Recommended Practice by Medical Specialty
0% Complete
0%
Market/Bus
Dominant Market Share
0% Complete
0%
Market/Bus
Health Economics Study
0% Complete
0%
Regulatory
Product Obsolescence Plan
0% Complete
0%
Technology
Component Obsolescence Plan
0% Complete
0%