1.
Need
Clinical
Disease State Characterization
100%
9/21/2020
9/21/2020
Clinical
Unmet Need Statement
100%
9/21/2020
9/21/2020
Market/Bus
Existing Solutions Characterized
70%
9/21/2020
9/21/2020
Market/Bus
Needs Screening and Selection
30%
9/21/2020
9/21/2020
Regulatory
Regulation Familiarization
70%
9/21/2020
9/21/2020
Technology
State of the Art Summary
100%
9/21/2020
9/21/2020
2.
Idea
Clinical
Envisioned Benefit Statement
100%
9/21/2020
9/21/2020
Clinical
Feedback from 5+ Clinical Stakeholders
100%
9/21/2020
9/21/2020
Clinical
Updated Need Statement
100%
9/21/2020
9/21/2020
Clinical
Workflow Scenario
100%
9/21/2020
9/21/2020
Market/Bus
Competitive Landscape
0%
Market/Bus
Envisioned Value Proposition
0%
Market/Bus
Key Stakeholders Identified
0%
Market/Bus
Reimbursement Familiarization
0%
Regulatory
Comparables Identified
0%
Regulatory
Intended Use and Medical Device Determination
0%
Technology
Biological Mechanism of Action Identified
100%
9/21/2020
9/21/2020
Technology
Idea Screening and Selection
100%
9/21/2020
9/21/2020
Technology
Institutional IP Disclosure
100%
9/21/2020
9/21/2020
Technology
Preliminary Target Product Profile (TPP)
70%
9/21/2020
9/21/2020
3.
Proof of Concept
Clinical
Feedback from Clinical Stakeholders in 5+ settings
100%
9/21/2020
9/21/2020
Clinical
Target Outcomes
90%
9/21/2020
9/21/2020
Clinical
Updated Need Description and Workflow Scenario
100%
9/21/2020
9/21/2020
Market/Bus
Business Protection Model
0%
Market/Bus
Competing Solutions Characterization
0%
Market/Bus
Preliminary Path-to-Payment Plan
0%
Market/Bus
Preliminary Value Proposition
0%
Market/Bus
Stakeholder Map
0%
Regulatory
Preliminary Indications for Use
0%
Regulatory
Preliminary Regulatory Classification
0%
Regulatory
Preliminary Regulatory Pathway
0%
Technology
Key In-Sourcing Requirements
100%
9/21/2020
9/21/2020
Technology
Key Mechanism of Action Validated
90%
9/21/2020
9/21/2020
Technology
Preliminary Freedom to Operate (FTO) Assessment
70%
9/21/2020
9/21/2020
Technology
Updated Institutional IP Disclosure
0%
Technology
Updated Target Product Profile (TPP)
0%
4.
Proof of Feasibility
Clinical
Feedback from Clinical Stakeholders in 20+ Settings
70%
9/21/2020
9/21/2020
Clinical
Updated Need and Workflow Descriptions
0%
Clinical
Updated Target Outcomes
0%
Market/Bus
Business Advisory Board
0%
Market/Bus
Development Plan
0%
Market/Bus
Feedback from 5+ Economic Buyers
0%
Market/Bus
Key Relationships Identified
0%
Market/Bus
Preliminary Business Model
0%
Market/Bus
Secure Access to Core IP
0%
Regulatory
Cyber Security Plan
0%
Regulatory
Draft Essential Requirements Checklist
0%
Regulatory
Draft Instructions For Use
0%
Regulatory
Draft Product Claims
0%
Regulatory
Institutional Approval Request(s)
0%
Regulatory
Submission Pathway Defined
0%
Technology
Essential Experiment Results
0%
Technology
Key In-Sourcing plans
0%
Technology
Preliminary Manufacturing-QMS Plan
50%
9/21/2020
9/21/2020
Technology
Provisional IP filing & formal FTO review
0%
Technology
Works-Like and Looks-Like Packaging Prototypes
0%
5.
Proof of Value
Clinical
Animal/First in-with man experiments
0%
Clinical
Clinical Trial Endpoints
0%
Clinical
Feedback from 100+ clinical stakeholders
0%
Clinical
Feedback from 5+ KOLs
0%
Clinical
Medical Advisory Board
0%
Market/Bus
Feedback from 20+ Economic Buyers
0%
Market/Bus
Incorporation and Founders Agreement
0%
Market/Bus
Initial Seed Investment
0%
Market/Bus
Investor Ready Business Plan
0%
Market/Bus
Key Management Team Committed
0%
Market/Bus
Key Relationships Formalized
0%
Regulatory
Application to Regulatory Authority Submitted
0%
Regulatory
Clinical Investigation Approval(s)
0%
Regulatory
Electronic Protected Health Information (ePHI) Plans
0%
Regulatory
Essential Requirements Checklist
0%
Technology
cGMP Compliant Pilot Manufacturing Process
0%
Technology
Conference/poster session/paper submitted
0%
Technology
Finalized TPP & Essential Technical Experiments Results
0%
Technology
IP Search Report
0%
Technology
Key In-Sourcing Requirements Committed
0%
Technology
Works-Like, Looks-Like, Made-Like Packaging Prototypes
0%
6.
Initial Clinical Trials
Clinical
Demo Feedback From 20+ Clinical Stakeholders
0%
Clinical
Endpoints Achieved in Feasibility Clinical Trials
0%
Clinical
Peer Reviewed Publication(s) Accepted
0%
Market/Bus
1st Institutional investment
0%
Market/Bus
Feedback from 25+ Economic Buyers
0%
Market/Bus
Validated Quantification
0%
Regulatory
Data Requirements Confirmation
0%
Regulatory
Pre-Submission Filed
0%
Technology
All In-Sourcing Requirements Achieved
0%
Technology
Full IP Application
0%
Technology
Updated TPP & Experimental Validation
0%
7.
Validation of Solution
Clinical
Endpoints Achieved in Pivotal Clinical Trials
0%
Clinical
Peer Reviewed Publication(s) Published
0%
Market/Bus
2nd Round of Institutional Investment
0%
Market/Bus
Purchasing Intent From 10+ Buyers
0%
Regulatory
Submission of Technical File to Regulatory Body
0%
Technology
cGMPs Compliant Manufacturing Process
0%
Technology
Final TPP & Experimental Validation
0%
Technology
Quality Assured Process Validation (cGMP)
0%
8.
Approval & Launch
Clinical
Specialty Medical Group(s) Review in Place
0%
Clinical
Training Materials & Support Established
0%
Market/Bus
Initial Sales
0%
Regulatory
Public Coverage and Code Determination
0%
Regulatory
Regulation and Listing
0%
Technology
Finalized cGMP Production Environment
0%
Technology
IP for Improvements Filed
0%
9.
Clinical Use
Clinical
Included in local practice guidelines
0%
Clinical
Peer Reviewed Publication(s) by Others Published
0%
Market/Bus
New Markets Launched
0%
Market/Bus
Profitable Sales
0%
Regulatory
Monitoring and Inspections
0%
Technology
Improvement Plan
0%
Technology
Key Patents Issued
0%
10.
Standard of Care
Clinical
Recommended Practice by Medical Specialty
0%
Market/Bus
Dominant Market Share
0%
Market/Bus
Health Economics Study
0%
Regulatory
Product Obsolescence Plan
0%
Technology
Component Obsolescence Planning
0%
Filters