Life Science Startup Medical Device Playbook

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Feasibility Stage

Concept Validation Stage

1 FILE INITIAL PROVISIONAL PATENT 6 DEFINE MINIMUMALLY VIABLE PRODUCT (MVP) 5 FORM COMPANY INITIAL IDEA - EXIT - ABANDON PROJECT PREPARE FOR AND RAISE SUFFICIENT FUNDS TO GET THROUGH PROOF OF... 7 WRITE FEASIBILITY REPORT IS CHANGE NEEDED? 4 TEST/ VALIDATE ASSUMPTIONS
By doing research & Talking to:
Customers, Physicians, Providers, Patients,
Other Influencers, Experts, Researchers, Etc.
PATENT SEARCH & FILE PROVISIONAL PATENTS PROPOSED PRODUCT
Features and Benefits
Drawings
Models
Etc.
CUSTOMERS AND VALUE PROPOSITIONS
Patients
Clinicians
Providers
Payers
Distributers
Others
REGULATORY AND REIMBURSEMENT
FDA Requirements?
Clinical Trials Requirements?
Reimbursement?
OTHER
Competition?
Technically Viable?
Other considerations
BUSINESS MODEL
Market Size?
Sales Price?
COGS?
Time Line
3 OUTLINE/REFINE CRITICAL ASSUMPTIONS 2 FORM INITIAL TEAM COMPELLING UNMET NEED MEDICAL ADVISORY BOARD REIMBURSEMENT STRATEGY CLINICAL AND REGULATORY STRATEGY OBTAIN LICENSES TECHNICAL EXPERTS -DIRECTORS -BUSINESS ADVISORS CEO & TEAM 8 PREPARE FOR AND RAISE SUFFICIENT MONEY TO GET THROUGH... PROOF OF CONCEPT ESTABLISHED FREEDOM TO OPERATE OBTAIN PATENT ON DEVICE PEOPLE WITH BUSINESS EXPERTISE 7 PRODUCE BUSINESS PLAN -LUMINARIES -CUSTOMERS -PHYSICIANS -PATIENTS -PROVIDERS -PAYERS 1 DEMONSTRATE TECHNICAL FEASIBILITY RUN P.O.C. (CHICKEN) EXPERIMENT 6 INVESTABLE MANAGEMENT UNMET NEED SOLUTION MARKET SIZE COMPETITION VALUE... 5 INTELLECTUAL PROPERTY NOT AN ISSUE 4 OUTLINE REGULATORY CLINICAL AND REIMBURSEMENT 3 SHOW IT IS A GOOD BUSINESS (FOR INVESTMENT) 2 DEVELOP EXTERNAL CREDIBILITY BUILD PROTOTYPE 5 DEFINE MINIMUMALLY VIABLE PRODUCT (MVP) 7 FORM COMPANY INITIAL IDEA - EXIT - ABANDON PROJECT 6 WRITE FEASIBILITY REPORT IS CHANGE NEEDED? 3 TEST/ VALIDATE ASSUMPTIONS
BY DOING RESEARCH & TALKING TO:
Customers, Physicians, Providers, Patients Other Influencers Experts, Researchers, Etc
4 REVIEW IP STRATEGIES & FREEDOM TO OPERATE PROPOSED PRODUCT
Features and Benefits
Mock Ups/Wireframes
Etc.
CUSTOMERS AND VALUE PROPOSITIONS
Patients
Clinicians
Providers
Payers
Health Systems
Others
REGULATORY CONCERNS
HIPAA Compliance
State Privacy Law Requirements
FDA or Other Agency
Cybersecurity
OTHER
Competition & Substitutes
Technical Viability
Market Density
Other considerations
BUSINESS MODEL
Market Size
Market Strategy
Stickiness
Sales Price
Reimbursement Potential
Timeline
2 OUTLINE/REFINE CRITICAL ASSUMPTIONS
Is there a real need?
Does Product/Service satisfy the Need?
Is the Solution Economically & Technically viable?
Can the Solution’s Competitive Advantage be protecte
1 FORM INITIAL TEAM COMPELLING UNMET NEED CYBERSECURITY FDA OR OTHER APPLICABLE AGENCY RULES PRIVACY LAWS / HIPAA 1st MOVER STICKINESS TECHNICAL EXPERTS -DIRECTORS -BUSINESS & MEDICAL ADVISORS CEO & TEAM 8 PREPARE FOR AND RAISE SUFFICIENT MONEY TO GET THROUGH... PROOF OF CONCEPT ESTABLISHED IDENTIFY TRADE SECRETS OBTAIN COPYRIGHT AND/OR TRADEMARKS PEOPLE WITH BUSINESS EXPERTISE 7 PRODUCE BUSINESS PLAN -LUMINARIES -CUSTOMERS -PHYSICIANS -PATIENTS -PROVIDERS -PAYERS 1 DEMONSTRATE TECHNICAL FEASIBILITY BETA TESTING 6 INVESTABLE MANAGEMENT UNMET NEED SOLUTION MARKET SIZE COMPETITION VALUE... 5 OUTLINE COMPETITIVE ADVANTAGE 4 ADDRESS COMPLIANCE ISSUES 3 SHOW IT IS A GOOD BUSINESS (FOR INVESTMENT) 2 DEVELOP EXTERNAL CREDIBILITY BUILD PROTOTYPE 1 FILE INITIAL PROVISIONAL PATENT 6 LEAD PRODUCT CANDIDATE IDENTIFIED 5 FORM COMPANY INITIAL IDEA - EXIT - ABANDON PROJECT PREPARE FOR AND RAISE SUFFICIENT FUNDS TO GET THROUGH CONCEPT... 7 WRITE FEASIBILITY REPORT IS CHANGE NEEDED? 4 VALIDATE ASSUMPTIONS AND OPTIMIZE TECHNICAL POTENTIAL
Talk to Payers, Physicians, Providers, Patients, Other Influencers, Technical Experts, Researchers, etc
PATENT SEARCH & FILE PROVISIONAL PATENTS PROPOSED PRODUCT
Features
Benefits
Limitations
CUSTOMERS AND VALUE PROPOSITIONS
Patients
Clinicians
Providers
Payers
Distributers
Others
REGULATORY AND REIMBURSEMENT
FDA Requirements
Clinical Trials Requirements
Reimbursement
TECHNICAL VIABILITY
Lead Compound Optimization
Testing in Small Animal Models
BUSINESS MODEL
Market Size
Competition
Sales Price
COGS
Timeline
Other Considerations
3 OUTLINE/REFINE CRITICAL ASSUMPTIONS
Is the Unmet Medical Need real?
Does the product satisfy this need?
Is your solution economically & technically viable?
Can it be protected by patents?
2 FORM INITIAL TEAM COMPELLING UNMET NEED ANIMAL PHARMOKINETICS PHARMACOLOGY MEDICAL ADVISORY BOARD REIMBURSEMENT STRATEGY CLINICAL AND REGULATORY STRATEGY OBTAIN LICENSES TECHNICAL EXPERTS -DIRECTORS -BUSINESS ADVISORS CEO & TEAM 8 PREPARE FOR AND RAISE SUFFICIENT MONEY TO GET THROUGH INITIAL... CONCEPT VALIDATION ESTABLISHED FREEDOM TO OPERATE OBTAIN PATENT ON COMPOUND BIOPHARMA BUSINESS EXPERTISE 7 PRODUCE BUSINESS PLAN KEY OPINION LEADERS (KOLS) PHYSICIANS PATIENTS PROVIDERS PAYERS 1 DEMONSTRATE TECHNICAL FEASIBILITY MAKE COMPOUND 6 INVESTABLE MANAGEMENT UNMET MEDICAL NEED SOLUTION MARKET SIZE COMPETITION VALUE... 5 INTELLECTUAL PROPERTY NOT AN ISSUE 4 OUTLINE REGULATORY CLINICAL AND REIMBURSEMENT 3 SHOW IT IS A GOOD BUSINESS (FOR INVESTMENT) 2 DEVELOP EXTERNAL CREDIBILITY TARGET PRODUCT PROFILE (TPP) DEFINED