PRODUCT RISK ASSESSMENT
By Donald Esker and Robert Gauss
CLIENT: A developer and manufacturer of component parts used in medical devices
CHALLENGE: The client had an opportunity to supply component parts for an implantable device. Senior executives rejected the op-portunity, nervous that the situation was too similar to a previous problem: A part they had manufactured was used in another type of implant that ended up causing infections. The implant manufacturer was sued, and our client was also named in the lawsuits. The im-plant manufacturer eventually settled, but the client's defense costs were significant, and the decision was made to avoid all future im-plant applications. The client's risk manager asked us to evaluate the risk attached to this new opportunity.
EVALUATION: We began by systematically collecting and analyzing the litigation history for the implant product under consideration. Since it was a new type of device, we also looked at the ...
