The Importance of Design Validation in Global Health Surgical Innovation

Area of Science:

• Biomedical Engineering
• Medical Device Design
• Global Health Technology

Background:

• Medical technology development necessitates a deep understanding of user needs and environmental contexts.
• Accurately defining market requirements, user needs, and design specifications presents significant challenges.
• On-site observation and design validation are key to creating effective healthcare solutions.

Purpose of the Study:

• To evaluate the value of design validation for medical devices targeting global health needs.
• To assess the impact of environmental immersion on the design process for medical technologies.
• To improve the quality and safety of globally developed medical devices.

Main Methods:

• Employed observational comparative analysis and surveys with multiple stakeholders.
• Generated user needs, market requirements, and design inputs following US FDA-21 CFR 820 standards.
• Conducted a 4-week semi-longitudinal assessment with 72 subjects in India to evaluate prototype use and design validation.

Main Results:

• A total of 198 design requirements and specifications were assessed per device.
• Eleven percent of final design requirements were identified as 'new additions'.
• Twelve percent of final design requirements were categorized as 'significant changes'.

Conclusions:

• Assessing design requirements in the target global environment enhances medical device quality and safety.
• Early environmental immersion validates user needs and design specifications during the conception phase.
• This approach ensures medical devices are better suited for their intended global use.