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Life Science Startup Medical Device Playbook
Click here for the PDF version of the Startup Playbook.
Feasibility Stage
Concept Validation Stage
By doing research & Talking to:
Customers, Physicians, Providers, Patients,
Other Influencers, Experts, Researchers, Etc.
Features and Benefits
Drawings
Models
Etc.
Patients
Clinicians
Providers
Payers
Distributers
Others
FDA Requirements?
Clinical Trials Requirements?
Reimbursement?
Competition?
Technically Viable?
Other considerations
Market Size?
Sales Price?
COGS?
Time Line
BY DOING RESEARCH & TALKING TO:
Customers, Physicians, Providers, Patients Other Influencers Experts, Researchers, Etc
Features and Benefits
Mock Ups/Wireframes
Etc.
Patients
Clinicians
Providers
Payers
Health Systems
Others
HIPAA Compliance
State Privacy Law Requirements
FDA or Other Agency
Cybersecurity
Competition & Substitutes
Technical Viability
Market Density
Other considerations
Market Size
Market Strategy
Stickiness
Sales Price
Reimbursement Potential
Timeline
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
Talk to Payers, Physicians, Providers, Patients, Other Influencers, Technical Experts, Researchers, etc
Features
Benefits
Limitations
Patients
Clinicians
Providers
Payers
Distributers
Others
FDA Requirements
Clinical Trials Requirements
Reimbursement
Lead Compound Optimization
Testing in Small Animal Models
Market Size
Competition
Sales Price
COGS
Timeline
Other Considerations
Is the Unmet Medical Need real?
Does the product satisfy this need?
Is your solution economically & technically viable?
Can it be protected by patents?
Marketplace
Resources
Accelerators/Incubators
Consultants
Contract Laboratory Organization (CLO)
Contract Manufacturing Organization (CMO)
Contract Research Organization (CRO)
Core Services
Equipment
Funding
Government Resources
Legal
Product Development
Service Providers
Workspace
Playbook
LSWI Website
Search
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