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.

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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MaturityDisplay

1.
Need
Clinical
Disease State Characterization
100% Complete
100%
9/21/2020 9/21/2020
Clinical
Unmet Need Statement
100% Complete
100%
9/21/2020 9/21/2020
Market/Bus
Existing Solutions Characterized
70% Complete
70%
9/21/2020 9/21/2020
Market/Bus
Needs Screening and Selection
30% Complete
30%
9/21/2020 9/21/2020
Regulatory
Regulation Familiarization
70% Complete
70%
9/21/2020 9/21/2020
Technology
State of the Art Summary
100% Complete
100%
9/21/2020 9/21/2020
2.
Idea
Clinical
Envisioned Benefit Statement
100% Complete
100%
9/21/2020 9/21/2020
Clinical
Feedback from 5+ Clinical Stakeholders
100% Complete
100%
9/21/2020 9/21/2020
Clinical
Updated Need Statement
100% Complete
100%
9/21/2020 9/21/2020
Clinical
Workflow Scenario
100% Complete
100%
9/21/2020 9/21/2020
Market/Bus
Competitive Landscape
0% Complete
0%
Market/Bus
Envisioned Value Proposition
0% Complete
0%
Market/Bus
Key Stakeholders Identified
0% Complete
0%
Market/Bus
Reimbursement Familiarization
0% Complete
0%
Regulatory
Comparables Identified
0% Complete
0%
Regulatory
Intended Use and Medical Device Determination
0% Complete
0%
Technology
Biological Mechanism of Action Identified
100% Complete
100%
9/21/2020 9/21/2020
Technology
Idea Screening and Selection
100% Complete
100%
9/21/2020 9/21/2020
Technology
Institutional IP Disclosure
100% Complete
100%
9/21/2020 9/21/2020
Technology
Preliminary Target Product Profile (TPP)
70% Complete
70%
9/21/2020 9/21/2020
3.
Proof of Concept
Clinical
Feedback from Clinical Stakeholders in 5+ settings
100% Complete
100%
9/21/2020 9/21/2020
Clinical
Target Outcomes
90% Complete
90%
9/21/2020 9/21/2020
Clinical
Updated Need Description and Workflow Scenario
100% Complete
100%
9/21/2020 9/21/2020
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
0% Complete
0%
Regulatory
Preliminary Regulatory Pathway
0% Complete
0%
Technology
Key In-Sourcing Requirements
100% Complete
100%
9/21/2020 9/21/2020
Technology
Key Mechanism of Action Validated
90% Complete
90%
9/21/2020 9/21/2020
Technology
Preliminary Freedom to Operate (FTO) Assessment
70% Complete
70%
9/21/2020 9/21/2020
Technology
Updated Institutional IP Disclosure
0% Complete
0%
Technology
Updated Target Product Profile (TPP)
0% Complete
0%
4.
Proof of Feasibility
Clinical
Feedback from Clinical Stakeholders in 20+ Settings
70% Complete
70%
9/21/2020 9/21/2020
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
0% Complete
0%
Technology
Key In-Sourcing plans
0% Complete
0%
Technology
Preliminary Manufacturing-QMS Plan
50% Complete
50%
9/21/2020 9/21/2020
Technology
Provisional IP filing & formal FTO review
0% Complete
0%
Technology
Works-Like and Looks-Like Packaging Prototypes
0% Complete
0%
5.
Proof of Value
Clinical
Animal/First in-with man experiments
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 20+ 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
cGMP Compliant Pilot Manufacturing Process
0% Complete
0%
Technology
Conference/poster session/paper submitted
0% Complete
0%
Technology
Finalized TPP & Essential Technical Experiments Results
0% Complete
0%
Technology
IP Search Report
0% Complete
0%
Technology
Key In-Sourcing Requirements Committed
0% Complete
0%
Technology
Works-Like, Looks-Like, Made-Like Packaging 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) Accepted
0% Complete
0%
Market/Bus
1st Institutional investment
0% Complete
0%
Market/Bus
Feedback from 25+ Economic Buyers
0% Complete
0%
Market/Bus
Validated Quantification
0% Complete
0%
Regulatory
Data Requirements Confirmation
0% Complete
0%
Regulatory
Pre-Submission Filed
0% Complete
0%
Technology
All In-Sourcing Requirements Achieved
0% Complete
0%
Technology
Full IP Application
0% Complete
0%
Technology
Updated TPP & Experimental Validation
0% Complete
0%
7.
Validation of Solution
Clinical
Endpoints Achieved in Pivotal Clinical Trials
0% Complete
0%
Clinical
Peer Reviewed Publication(s) Published
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
cGMPs Compliant Manufacturing Process
0% Complete
0%
Technology
Final TPP & Experimental Validation
0% Complete
0%
Technology
Quality Assured Process Validation (cGMP)
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
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
IP for Improvements Filed
0% Complete
0%
9.
Clinical Use
Clinical
Included in local practice guidelines
0% Complete
0%
Clinical
Peer Reviewed Publication(s) by Others Published
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
Key Patents Issued
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 Planning
0% Complete
0%