Transitioning an innovative product to high-volume manufacturing
A start-up medical device company had developed an innovative wound clamp device to rapidly control severe bleeding. Their FDA-cleared, first generation device demonstrated the effectiveness and life-saving potential of this technology for use by first responders. However, the design needed to be optimized for manufacturability and the cost-of-goods reduced to transition the product to higher volume manufacturing.
Develop design for the first-generation device
The challenge was developing a scalable design that would significantly reduce the cost-of-goods while still maintaining the proven clinical performance of the first generation device. The clamping mechanism used high-cost, precision components that added significant cost to the product but were believed to be necessary to meet performance requirements.
Create and manufacture a custom, low-cost mechanism
The MPR development team rapidly brainstormed concepts for cost reduction and developed a concept for a unique, custom mechanism. This creative mechanism leveraged injection-molded components to allow the design to be scaled-up at a low cost, and was ultimately patented by MPR’s customer. Our team then integrated this concept into functional prototypes which were optimized for usability through simulated use studies. MPR helped our customer identify a manufacturing partner and managed the successful transfer of the second generation design into production.
Award winning design optimized for scalability
MPR’s creative design solution resulted in a 60% cost reduction in the device cost of goods. At the same time, MPR delivered a solution that was optimized for usability and could be scaled to meet the target production volumes. MPR successfully led the project through development, verification and validation, design transfer, and regulatory clearance. MPR’s design was a gold winner in the 2016 Medical Design Excellence Awards.