Medical device manufacturers spend big dollars on research and development of new products. In many cases, the manufacturer relies on a series of vendors to produce the devices that are used in a variety of surgical procedures. One of the biggest challenges for a medical device maker, then, is to ensure that products are properly manufactured and meet very precise specifications. Thus, who does the medical device manufacturer trust to inspect the product before it is packaged, distributed and into the hands of a surgeon? In most cases, the manufacturer enlists a mechanical inspection team to complete a detailed and thorough evaluation of a product before a launch or as part of a continuous process of checks and balances.
Defining Advanced Mechanical Inspection
Mechanical inspection comprises tools, gauges and machines that enable professional inspectors to compare a product to an engineer’s print and verify that the product was manufactured to design dimensions and functional specifications. Mechanical inspection can be conducted by a cell operated within a medical device manufacturer, or by an outsourcing service provider. Advanced mechanical inspection involves highly skilled professionals and sophisticated equipment and tools.
The purpose of advanced mechanical inspection is to deliver objective evidence that a product meets the design and functionality standards required by the medical device manufacturer in order to best serve its customers. The inspection cell, whether internal or external, is the final check before a device is packaged and distributed. Moreover, the feedback that a mechanical inspection cell is in the position to provide can help the medical device manufacturer make important business decisions about suppliers and vendors. For example, if a medical device manufacturer receives objective data that indicates that one vendor’s ability to meet specifications is substandard, then the manufacturer can provide feedback to the vendor—or switch vendors.