Plastics in Medical Devices 2012: Rick Stearns

Biomaterial suppliers need to take measures to minimize liability exposure during the design and production of medical devices, legal expert Rick Stearns told the audience at the Plastics in Medical Devices 2012 conference in Westlake. Stearns, a partner at Washington-based law firm Keller and Heckman LLP addressed liability issues, as well as Food and Drug Administration regulations and risk management during the conference. Despite a supplier’s desire to take a hands-on approach in the design and production of a product, Stearns cautioned that becoming too involved those processes increases a firm’s exposure to risk. "The more you as a supplier become involved in the designing of the finished device, the weaker your argument that you’re just supplying the material," he said. Stearns urged suppliers to develop supply agreements that clearly outline responsibility. "Leave no questions in the contract," he said. The conference, hosted by Plastics News, was held June 12-13.