The Customer Need. A medtech company approached Lake Region Medical with concepts for an embolic protection system designed for capturing and removing emboli. This company desired a partner that could supplement its design initiatives with wire-based technologies and manufacturing capabilities to reduce their internal development timelines and resource requirements.
The Challenge. The clinical requirements necessitated the miniaturization of a very complex device that functioned both as a guidewire and as an embolic capture device. This miniaturization inherently created some design and processing challenges. Additionally, the design called for a hybrid polymer and metal wire creating challenges associated with effectively combining the two dissimilar materials.
The Design. The final device used a hybrid design of a thin polymer membrane with laser cut holes over a metal wire-formed structure. A high-tech thin film analyzer, capable of measuring down to a half micron, insured precision of the membrane. Computational flow dynamics assisted in the development of the precision laser-cut membrane holes. An array the development manufacturer’s processes and sub-assembly competencies were used to make this project successful.
The Result. The customer’s clinical testing indicated that the device achieved a relative stroke reduction rate. The polyurethane membrane proved to capture clinically relevant emboli and reduce the rate of stroke. Additionally the low profile design facilitated crossing difficult lesions and substantiated the need for a dual guidewire-embolic capture device design.
Customer Value Profile:
? Expedited development timeline
? Reduced internal resources
? Provided value-added design and process expertise
? Engineered products for ease of manufacturing
Return to main article: "Changing Vendor Roles In Research and Development"