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Medical Device Development from Ideation to Regulation and Technology Transfer in Low- and Middle-income Countries.
Roxanne P De Leon1, Lourdes Marie S Tejero2,3
1Electrical and Electronics Engineering Institute, University of the Philippines Diliman, Quezon City, Philippines.
Acta Medica Philippina
|November 1, 2024
Summary
Innovators in low- to middle-income countries (LMICs) face unique challenges developing medical devices. This paper outlines these hurdles and proposes solutions for navigating the process from idea to market.
Area of Science:
- Biomedical Engineering
- Medical Device Innovation
- Global Health Technology
Background:
- Low- to middle-income countries (LMICs) possess a strong drive for local medical device innovation due to unmet health needs.
- Developing medical devices in LMICs involves standard stages like ideation, design, validation, and market entry.
- These stages present distinct and significant hurdles within the LMIC context compared to developed nations.
Purpose of the Study:
- To identify and describe the specific challenges encountered by innovators in LMICs throughout the medical device development lifecycle.
- To delineate practical mechanisms and strategies for overcoming these identified hurdles.
- To provide guidance for navigating the complex processes from initial ideation to final technology transfer and market access.
Main Methods:
- Analysis of the standard medical device development pathway.
- Identification of unique challenges faced in LMIC settings at each stage (ideation, design, validation, regulation, technology transfer).
- Delineation of potential solutions and supportive mechanisms for LMIC innovators.
Main Results:
- Key hurdles identified across the innovation pipeline, including funding, infrastructure, procurement, testing, regulatory affairs, and technology transfer.
- Specific challenges are amplified in LMICs due to resource limitations and differing regulatory landscapes.
- Proposed mechanisms offer pathways to mitigate these challenges for successful medical device commercialization.
Conclusions:
- Addressing the unique hurdles in LMICs is crucial for fostering local medical device innovation.
- Strategic interventions and supportive mechanisms can facilitate the journey of medical technologies from concept to market in resource-limited settings.
- This work provides a framework to assist innovators in successfully bringing essential medical devices to their local populations.
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