The medical device manufacturing industry has certainly been under a significant amount of pressure lately with increased regulations and the demands for more efficient, cost effective and higher quality production of their products. Additionally, more sophisticated devices are in development to utilize advanced materials, structures and design. As those innovations progress through the product lifecycle into the manufacturing phase, the industry continues to struggle with ways to adequately test product quality that meet FDA requirements but don’t break the bank. The NASA philosophy of “better, faster and cheaper” certainly would be a nice approach. However, within an FDA-regulated industry, and a highly competitive one, “better” is certainly an area where compromise is not allowed.
High-end image analysis software, integrated into the manufacturing process, is a relatively new and particularly strong way to improve the speed, quality and cost of producing medical devices. Imaging can be particularly valuable in two areas. The first area is in assessing structural integrity of manufactured parts. The second is the assessment and quantification of tolerance within the manufacturing process.
The introduction of advanced materials and sophisticated medical device designs demands that manufacturing achieve new levels of quality assurance with consistent runs in the manufacturing line—avoiding cracks and ensuring that fine structures are intact. The use of advanced imaging and analytical software in ensuring structural continuity can provide a consistent and cost-effective real-time way to identify issues, quantify the number of issues, and in some cases, provide causative information.
Take, for example, production of a cardiac stent, in which the manufacturer needs to determine if the fine mesh is connected and if not, discern what errors may have taken place in the manufacturing process. One way is to manually visually inspect it—the current state of art. Conversely, conducting high-resolution CT scans of these devices as they emerge from the assembly line brings a new dimension to the ability to detect the integrity of the device. Using the CT technology, it is possible to create a three dimensional view of the inside of each part, including the structure and consistency of the materials. Once you have this full scan of the part, it is possible to introduce automated software that can easily detect if there are any breaks in the structure or if material looks out of specification somewhere in the part. The output of the software can then be used to provide a “score” or a priority rating for the newly created part. This score can be used to quantify the overall acceptability of the part based on a number of key parameters that are critical to the quality. Structure can be assessed, material thicknesses can be measured, material consistency can be quantified, or many other key metrics can be automatically used in grading of the part. The output of this analysis can be used to prioritize a human-based inspection and QA process, so that the parts that seem to be most troublesome can be inspected first and thoroughly, while the parts that are more in line with expectations can be given a more rudimentary assessment. This analysis can be performed on every part that rolls off the manufacturing line, all while providing clear and concise documentation and audit history.
Of course, looking inside a part for such non-destructive testing is a very sophisticated technique. and therefore may not be required for every type of device that is being manufactured. However, if you don’t need to assess the inside of the device, it is almost assured that you will have a need to measure manufacturing tolerance of the dimensions of the device. Keeping products within manufacturing “tolerance” can be a real challenge for medical device manufacturers, because often the specifications are quite strict. This is not assessing the internal structure of the device, necessarily, or looking to see if it’s cracked or consistent, but rather a technique that will help the manufacturer determine if what was built lies within the manufacturing tolerance required by the designers.