Reliability and medical device manufacturing

Reliability is like quality-it has many definitions, and means different things to different people. To effect reliability, we must establish clear communications, use a common language and learn to set expectations. We must work toward a language upon which all agree. Reliability must be defined and specified in measurable terms. Realistic, achievable goals (defined in terms set by the customer) must be set and agreed upon. They must also be validated. In this manner, reliability expectations on both the part of the manufacturer and the end user can be fulfilled. The result is a satisfied customer and increased chances of gaining market share. In the medical device manufacturing arena, there are three primary reasons that a high degree of reliability is vital. First and foremost is customer satisfaction. Secondly, a highly reliable product that carries with it a high reliability reduces the amount of overhead and capital dollars required to maintain it in the field. The third factor (which unfortunately vies with the first one) is the notion of public and federal scrutiny. The author discusses these reliability issues.