Fast Failure Testing in Medical Device Development
Fast Failure Testing
The design of medical devices is a difficult and costly business. The stakes are high, both financially and otherwise. Early, thorough testing of system components will expose defects at a point where solutions are still manageable and cost-effective, even as the design process progresses. This method of early detection will save a great deal of time and money for system inventors and manufacturers. “A global leader in the design, production, validation, and manufacture of Class II and Class III medical devices, Proven Process Medical Devices refers to its early testing procedures as a Fast Failure program. Its aim is to discover potential problems before they derail the production or viability of products or exhaust the resources available.
To help a client build vascular access ports with a variety of unique design parameters and goals, the Validated Method was retained. Flexibility was vital: with metal and plastic port bodies, the final design required to be both power injectable and non-power injectable, valved and non-valved. With computational fluid dynamics (CFD) and the final design required proprietary interconnects, pressure and flow characteristics were optimised.
Via a series of smaller “batch” tests, Proven Method performs risk assessments to evaluate individual aspects of the system design at the component level. At various process levels, this may include laboratory work, prototyping, and even animal and cadaver research. In pursuit of unique solutions, product development often leads to the simultaneous development of new technologies and processes.
The final vascular access port design was developed for Proven Process’s client with a series of tests to detect and remove any potential for design defects or irregularities. Models were created for CFD testing in multiple iterations, and prototypes were designed using stereolithography (SLA) before being constructed and tested by custom machines. From here the engineering team of Established Process produced soft mould designs that were then process-tested before locking and moving to commercialization.
No matter what end-use the system serves, it is important to conduct careful and detailed testing to ensure 100% reliability in meeting design requirements, and stringent performance standards must be specified by the design itself. Some types of medical devices are needed to follow strict standards; for example, a known set of protocols as outlined by the FDA must be complied with by Class III medical devices.