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Table of contents
Acknowledgments
Executive summary
Focus on advanced medical devices
MedTech solutions scarce in LDCs
Lessons learned
Intellectual property
Regulatory systems
Financing
Training and skills development
Introduction
Objectives
Understanding the MedTech sector
Definitions
Demographic and epidemiological context of MedTech in LDCs
Methodology
Triple helix model of innovation
Translating lessons learned from case studies
Main challenges and enablers in the MedTech sector in LDCs
Intellectual property’s role
Patents for innovation
Patents vs. trade secrets
Utility models
Trademarks, copyright and industrial designs
International IP law and special treatment for LDCs
LDCs often overlooked
Technology transfer
Technology transfer for MedTech during COVID-19
Factors contributing to successful technology transfer
Patent pooling for technology transfer
Regulatory systems for MedTech
Simplify by streamlining regulatory process
MedTech regulatory guidance needed
Regulatory reliance
Harmonization creates uniform standards
Financial incentives
Long timelines may dissuade investors
Loss of operational control is a risk
Placement contracts and phased market entry in LDCs
Product-market fit of MedTech in LDCs
Availability
Appropriateness
Functionality and affordability
Spare parts
Personnel, infrastructure and medical training
Management/public policy
Culture
Workforce training
Local manufacturing challenges and use
Regionalizing manufacturing is inefficient
Bangladesh case study
Healthcare overview
Industrial policy
MedTech imports/exports
Addressing the lack of access
MedTech challenges and enablers in Bangladesh
Intellectual property
IP seen as key to advancement
Progress to date and suggested measures
Regulatory systems
Regulatory challenges
Financial incentives
Local MedTech industry capacity
Ending the “brain drain”
Potential to expand MedTech manufacture
Rwanda case study
Healthcare overview
Quadrupling the healthcare workforce
Industrial policy
MedTech imports/exports
Intellectual property
Commitment to support innovation
Embracing innovation
Filling the gaps
Regulatory systems
Financial incentives
Local MedTech industry capacity
Lessons learned: applicable to all LDCs
Intellectual property
Regulatory systems
Financing
Capacity
Country-specific opportunities and recommendations
Bangladesh
Intellectual property
Regulatory systems
Financing
Capacity
Rwanda
Intellectual property
Regulatory systems
Financing
Capacity
Study limitations and areas for further research
Annex 1. Open-ended interview questions
Annex 2. Interviewee profiles
Copyright
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Strengthening Medical Technology Innovation Ecosystems to address Non-Communicable Diseases in Least Developed Countries
Annex 2. Interviewee profiles
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