Whether it’s an insulin pump, respirator or pacemaker, medical devices obviously require extremely high quality. Therefore, manufacturers must always make sure to have a solid supply chain and a commitment to quality throughout production in that supplier chain.
While the medical device manufacturers themselves may be aware of the inherent risks in manufacturing, often suppliers may be manufacturing components for a variety of applications. Pat La Londe says that it is important to explain the stakes to suppliers. If the supplier’s staff knows that a component is going into a respirator, they will be more likely to monitor the quality carefully. La Londe, chair of the ASQ World Conference Board, has been in the quality field since the late 1970s and in medical devices since 1991, and has seen this happen firsthand on supplier visits. In fact, during one such presentation to suppliers when she would bring in the actual medical device and clinician to show the product in use in the field, two people left the room. She later found out they both had family members in the hospital at that time.