The medical industry is one of the fastest growing segments of US economy. Health care spending is increasing all over the world due to increased life expectancy and consequently the increased aging population. To maximize profits and increase market share in this ever expanding market, medical device manufacturers want to be first to introduce innovative products. However, device manufacturers need to get approval from the Food and Drug Administration (FDA) before they can sell a medical product in the USA. FDA is the U. S. Government agency that oversees and approves the introduction of most medical products into the market. Prior to getting approval from the FDA to market a device in the USA, a PMA (premarket approval application) or a 510(k) (pre-market submission) has to be made to the FDA. These submissions include a substantial amount of documentation, analysis and results of tests outlined in the FDA recognized consensus standards, which takes a fairly long time to perform and report on. Due to budget and schedule constraints, and the desire to be first to market, medical device companies tend to focus on performing only the FDA required compliance tests and then tend to incorrectly draw conclusions about the reliability of their product from the results of these compliance tests. Erroneously drawing reliability conclusions from compliance test results can negatively impact a medical device manufacturer's warranty program, part replacement stocking program at repair/service centers, and staffing levels at customer support centers. In the worst case scenario it can lead to product field recall and product liability lawsuits, especially in the US. This can have an adverse impact on company reputation, sales and profits. This paper describes the FDA approval process, the difference between compliance and reliability testing, the pitfalls of incorrectly drawing reliability conclusions from compliance test results and developing use-misuse model to drive reliability testing. It also provides real life examples that practicing reliability engineers can use to make a strong case for reliability testing in addition to compliance testing, in spite of budget and time constraints.
