Fast Failure Testing in Medical Device Development

Challenge:

Medical device design is a complex and expensive business – the stakes are high, both financially and otherwise. Early, rigorous testing of device components, even as the design process evolves, can reveal flaws at a stage where solutions are still manageable and cost-effective. This type of early detection can save device inventors and manufacturers a great deal of time and money. Proven Process Medical Devices, a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, refers to its early testing procedures as a “Fast Failure” program. Its purpose is to uncover potential problems before they derail product development or feasibility, or exhaust available resources.

Design Concept:

Proven Process was retained to assist a client developing vascular access ports with a range of specific design parameters and objectives. Flexibility was essential: the final design needed to be both power injectable and non-power injectable, valved and non-valved, with metal and plastic port bodies. Pressure and flow characteristics were optimized with computational fluid dynamics (CFD) and the final design required proprietary interconnects.

Solution:

Proven Process conducts risk assessments through a series of smaller, “batch” studies to test individual component-level aspects of the device design. This can involve lab work, prototyping, and even animal and cadaver testing at different process stages. Sometimes product development leads to parallel development of new technology and processes in pursuit of specific solutions. It is an adaptive process, morphing as new technologies and demands emerge.

For Proven Process’ client, the final vascular access port design was developed with a series of tests to identify and eliminate any potential for design flaws or irregularities. Models were developed in multiple iterations for CFD testing, and prototypes were built using stereolithography (SLA) before being custom machine built and tested. From here, Proven Process’ engineering team created soft mold designs that were then process-tested before being locked and moved to commercialization.

No matter what end-use the device serves, meticulous and thorough testing must be conducted to ensure 100% reliability in meeting design specifications, and the design itself must define rigorous performance standards. Certain types of medical devices are required to meet specific standards; for instance, Class III medical devices must meet a known set of protocols as outlined by the FDA. Proven Process’ “Fast Failure” testing will help meet those requirements with minimal redesign – while delivering exceptional peace of mind.