The Importance of Design Validation in Global Health Surgical Innovation

Introduction. Medical technology development requires an understanding of user needs and environmental requirements. Accurately capturing market requirements, user needs, and design specifications are multifactorial and challenging. On-site observation and design validation may lead to development of more effective solutions to improve health care. This study was designed to evaluate the value of design validation for medical devices developed to address global medical needs. Methods. Observational comparative analysis and survey studies were used to collect data involving multiple stakeholder viewpoints. User needs, market requirements, and design inputs were created using standard operating procedures in accordance with US FDA—21 CFR 820. Design requirements included user needs, product description, regulatory standards, functional requirements, performance and physical requirements, use environment, human-system interfacing, conceptual designs, and market analysis. A random population-based cohort sample in India was used to conduct a semi-longitudinal assessment of exposure-outcome relations from device prototype use and design validation. Seventy-two subjects were observed for a 4-week duration. After validation, each component of the traceability matrix was either marked “no change,” “significant change,” or “new addition” as defined in the methods section. Results. A total of 198 design requirements and specifications were evaluated for each device. Eleven percent of the final design requirements and specifications were “new additions” and 12% were “significant changes.” Conclusion. Assessment of design requirements and specifications in the global environment improves medical device design quality and safety. This study validates environmental immersion in the target use environment early to ensure validation of user needs and design specifications during design conception.