High Tech Materials and Rapid Response for a New Device
Situation
Upon the FDA’s request, a customer was fast-tracking the development of a pediatric heart valve. Their current supplier could not provide material that could meet the stringent demands for elongation and contraction that would be required for both the novel device and procedure.
Background
The FDA had identified that there was an unmet pediatric clinical need that our customer wanted to address. This unmet need was due to low market size making pediatric devices often unavailable or simply smaller versions of adult devices that are not ideal for small yet growing anatomy. This device manufacturer already had a successful adult version of the valve device but knew that a wholly unique product, engineered specifically for a child, was what the market needed.
Procedure:
Upon our customer’s request, we assisted in the development of a custom solution to meet the device requirements. To do so, ATEX deployed a development team to work closely with the customer and gather requirements for the substantial elongation and contraction unique to this pediatric valve. ATEX quickly realized that engineering the perfect solution would also require a custom yarn extrusion process, component shape construction, and fabrication all at once.
Result:
Development efforts for this project were completed much faster than a typical concept to commercialization timeline would take and was achieved through the work of dedicated teams from customer & ATEX. ATEX and the customer established productive project team calls multiple times per week. The project also included multiple visits to each other’s facilities to further enhance communication and the development to commercialization process. In the end, the customer was able to commercialize a novel product, addressing an unmet clinical need in a relatively short time frame as a result of this intense and productive collaboration.