Many of us in science have this "Aha!" moment when the mental puzzle is put together and you get a clear picture of a product, which will change the world. Moreover, you have a clear understanding of how it can be a commercial success. So, you decide to start a new company, a startup, and have a clear path to success. However, soon you come face to face with reality, where things are much more complicated. Only a minute fraction of startups survives and becomes successful. This is particularly true in the complex world of medical devices. There are many good books on startups but this book is specifically about startups specializing in medical devices, which are very different from other ones. It is written by a MedDev entrepreneur for first-time MedTech entrepreneurs.
Author(s): Gennadi Saiko
Publisher: Jenny Stanford Publishing
Year: 2022
Language: English
Pages: 314
City: Singapore
Cover
Half Title
Title Page
Copyright Page
Table of Contents
Preface
Chapter 1: Introduction
1.1: Startups
1.2: Customer Discovery
1.3: Market Size
1.4: Patent Filing
1.5: Paths to Commercialize
1.6: Technology Transfer Office
Part I: Road to Market
Chapter 2: Regulatory Environment
2.1 US Regulatory Environment
2.1.1: Exempt Devices
2.1.2: Premarket Notification [510(k)]
2.1.2.1: Types of the 510(k) submission
2.1.3: Premarket Approval (PMA)
2.1.4: Humanitarian Device Exemption (HDE)
2.1.5: De Novo Classification
2.1.6: Breakthrough Devices
2.1.7: Medical Device Classification
2.1.8: Predicate Device
2.1.9: 513(g) Request
2.1.10: Special Cases
2.1.10.1: Digital health
2.1.10.2: Software as a medical device
2.1.10.3: Mobile medical apps
2.1.10.4: Artificial intelligence and machine learning as a medical device
2.1.10.5: Medical device accessories
2.1.10.6: Pre-Cert program
2.1.10.7: Emergency use authorization
2.1.11: Closing Remarks
2.2: European Union
2.3: Canada
2.4: Australia
2.5: Japan
2.6: Other Countries
2.6.1: China
2.6.2: Asia Pacific
Chapter 3: Prerequisites
3.1: Quality Management System
3.1.1: Design Control
3.1.2: Core Components of QMS
3.1.3: Software Development
3.2: Risk Management
3.2.1: Risk Management Process
3.2.2: Risk Management Procedures
3.2.3: Risk Management and Design Controls
3.2.4: Risk Management Roles and Responsibilities
3.3: Biocompatibility
3.4: EMC and Safety Testing
3.4.1: Electromagnetic Compatibility Testing
3.4.2: Electrical Safety Testing
3.4.3: Special Cases
3.4.3.1: Wireless technology
3.4.3.2: Portable batteries
3.4.4: Standards and Accredited Labs
3.4.5: CB Schema
3.5: Performance Testing
3.5.1: Non-clinical Laboratory Studies
3.5.2: Clinical Studies
3.5.2.1: Investigational device exemptions
3.5.3: Human Factors Engineering (HFE)
3.5.3.1: Analysis and evaluation
3.5.3.2: Elimination or reduction of use-related hazards
3.5.3.3: Human factors validation testing
Chapter 4: Product Development Process
4.1: Product Development Methodologies
4.1.1: Stage-Gate Model
4.1.2: Agile Methodologies
4.2: Integration of Product Development Process with Regulatory Requirements
4.2.1: Waterfall Models in MedDev PDP
4.2.2: Agile Methodologies in MedDev PDP
4.2.3: MedDev PDP: Waterfall or Agile?
4.3: PDP Phases
4.3.1: R&D and Product Development
4.3.2: Clinical Phase
4.3.2.1: Regulatory requirements for MedDev
4.3.2.2: Clinical trial design considerations
4.3.3: Regulatory Phase
4.4: Other Helpful Considerations
4.4.1: Prototyping
4.4.2: Customer Development
4.4.3: MVP
4.4.4: Pivoting
4.4.5: TRL
Chapter 5: Timelines and Capital
5.1: How Long Does It Take?
5.1.1: 510(k) Product
5.1.2: PMA Product
5.2: How Much Money Do You Need?
5.2.1: Class II Devices
5.2.2: Class III Devices
5.3: Exits
5.3.1: IPOs
5.3.2: M&As
5.3.3: Regulatory Stage at Exit
5.3.4: Probability of a Successful Exit
5.4: Conclusions
Part II: Important Ingredients
Chapter 6: Funding
6.1: Types of Funding
6.2: Sources of Funding
6.2.1: Grants
6.2.1.1: Research grants
6.2.1.2: Industrial research
6.2.1.3: Academia–industry collaboration
6.2.1.4: Translational grants
6.2.1.5: Commercialization grants
6.2.1.6: Other grant opportunities
6.2.2: Equity Funding
6.2.2.1: Friends and family
6.2.2.2: Incubators and accelerators
6.2.2.3: Crowdfunding
6.2.2.4: Angel investors
6.2.2.5: Family offices
6.2.2.6: Government organizations
6.2.2.7: Foundations, venture philanthropy, and patient groups
6.2.2.8: VCs
6.2.2.9: Corporate venture capital
6.2.2.10: Big Pharma and biotech
6.2.2.11: Pension plans and endowments
6.2.2.12: Hedge funds
6.2.2.13: Private equity
6.2.3: Other Sources
6.2.3.1: Wage subsidies
6.2.3.2: Tax incentives
6.2.3.3: In-kind contributions
6.3: Funding and Startup Lifecycle
6.3.1: Angel and Seed Stage
6.3.2: Early Stage
6.3.3: Late Stage
6.4: Final Considerations
Chapter 7: IP and Other Moats
7.1: IP
7.1.1: Types of IP
7.1.1.1: Patents
7.1.1.2: Industrial designs
7.1.2: Considerations for Software
7.1.3: Patent Infringement
7.1.3.1: Defenses to patent infringements
7.1.4 Patent Search
Country-specific requirements:
7.2: Regulations
7.2.1: Time
7.2.2: Money
7.3: Data
7.4: Conclusions
Chapter 8: Business Model
8.1: Lean Canvas
8.1.1: Customer Segments
8.1.2: Problem
8.1.3: Unique Value Proposition
8.1.4: Solution
8.1.5: Channels
8.1.6: Cost Structure
8.1.7: Revenue Streams
8.1.8: Key Metrics
8.1.9: Unfair Advantage
8.2: B2C Model
8.3: B2B Model
8.3.1: Out-of-Pocket Payments
8.3.2: Payers
8.3.2.1: Universal healthcare
8.3.2.2: Public insurance and compulsory private insurance
8.3.2.3: Voluntary insurance
8.3.3: Reimbursement
8.3.3.1: Coding
8.3.3.2: Payment
8.3.3.3: Coverage
8.3.3.4: Regulatory approval vs. reimbursement approval
Chapter 9: Other Considerations
9.1: Team
9.1.1: Skin in the Game
9.1.2: Knowledge Transfer
9.1.3: Tacit Knowledge
9.1.4: Balanced Team
9.1.5: Believers
9.1.6: Setting Expectations
9.1.7: Aligning Incentives
9.1.8: Solo Founders
9.2: Degree of Innovation
9.3: Timing
9.4: Therapy vs. Diagnostics
9.5: Founder’s Age
9.6: Market Size
9.7: In-House vs. Outsourcing
9.8: Location… Location… Location
Chapter 10: Silver Lining
Instead of Afterword
Appendix A: Premarket Notification [510(k)] Process
Appendix B: SaMD: Software as a Medical Device
Appendix C: Technology Readiness Levels in MedDev
Appendix D: Useful Resources
Index
