Driving Patient Safety Throughout the Development Process

Wed, 10/16/2013 - 4:02pm
Jonathan Martha, Medical Segment Manager, Portescap

Q: How are supply partners to medical device OEMs aiding in ensuring patient safety with home healthcare devices?

At Portescap, we supply motors and gearing that go into critical care home medical devices. To ensure patient safety, we use prevention, containment, and OEM feedback.

During product design, we use a stage-gate system that incorporates multiple failure mode and effects analyses at different points in development to gauge the severity and impact of a single point failure. We use analysis results to drive to failure root cause and determine preventative corrective actions via design and poka-yoke in order to ensure our products have the highest level of quality and reliability built into the design prior to entering production.

Once in production, we focus on our quality system and control processes to contain deviations that may occur during manufacturing. At Portescap, we incorporate 100% inspections of critical mechanical dimensions and electrical performance requirements. We also utilize statistical based AQL product inspections prior to shipment to capture any possible deviations.

Lastly, we use data driven return analysis and customer inputs to integrate kaizen (continuous improvement) into our design, development, and quality systems. We frequently use statistical data and customer feedback to drive next generation product development and individual product quality and reliability improvements that make end devices safer.


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