T. Schwab1,3, B. Fassl2, R. Patel2, J. Langell1,3 1University Of Utah,Department Of Surgery,Salt Lake City, UT, USA 2University Of Utah,Pediatrics,Salt Lake City, UT, USA 3University Of Utah,Center For Medical Innovation,Salt Lake City, UT, USA
Introduction: Creating high-quality new clinical technology solutions requires an in-depth understanding of user needs and environmental constraints. Accurately capturing market requirements, user needs, and design specifications for medical device innovation is multifactorial and challenging. Through on-site observation and design validation, innovators may develop better solutions to unmet medical needs and provide products with tremendous potential to impact healthcare delivery. Our study objective was to determine the effectiveness and value of design validation in medical devices designed to address the global healthcare needs.
Methods: An observational comparative effectiveness study and survey were used to collect data involving multiple stakeholder viewpoints (provider, patient, regulatory, industry, academic and societal). The study setting consisted of a community hospital in rural India. A random population-based cohort sample was used to conduct a semi-longitudinal assessment of exposure-outcome relations from device prototype use and design validation. Medical device prototypes were exposed to potential users ranging from ages 1-92 years old. Sixty-two subjects were observed for a 4-week duration. User needs, market requirements, and design inputs were created using standard operating procedures for a novel non-invasive hemoglobin detection device according to the code of federal regulations governing the US FDA—21 CFR 820. Design requirements included user needs, product description, regulatory standards, functional requirements, performance and physical requirements, use environment, human and system interfacing, conceptual designs, and market analysis. 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: The study evaluated 156 original design requirements and specifications. Ten percent of the final design requirements were considered “new additions” and 12% were considered “significant changes.” Sixteen percent of the final design specifications were considered “new additions” and 22% were considered “significant changes.” Overall, 22% of the original marketing requirements and 38% of the design specifications changed significantly (Figure 1)
Conclusion: All of the changes and additions to the design requirements and specifications increased medical device design quality and safety, while reducing potential risk of lost time and investment. We strongly recommended environmental immersion for early validation of user needs and design specifications during design conception, and continue through prototyping process.
