Maintaining product quality is one of the most important issues that medical device manufacturers face. Stringent controls are put on the industry by governmental bodies, such as the FDA which proposed a “Case for Quality” program in 2011 to ensure that medical device manufacturers are meeting the highest levels of device quality and safety throughout a product’s design, manufacture, and service.
Confounding this issue to stay compliant to quality regulations is the fact that product information – including information from parts suppliers, non-conformances, and corrective actions -- changes rapidly. If, for instance, the stakeholders in manufacturing aren’t able to see updates to the product information immediately -- as they are made -- serious consequences can result including injury or death of the patient who uses the device.
In response to the market’s need for real-time access to product data, KPIT Technologies recently announced that it is developing a set of PTC Navigate apps that is specifically aimed at the Medical Device industry. PTC Navigate is an application that consolidates product information from various enterprise systems – i.e. ERP, PLM, Quality Management Solutions (QMS) – together into an intuitive, easy-to-use dashboard app. PTC Navigate is role-based meaning that information in the app is available to users depending on their needs – whether supplier, engineer, manufacturer, service or sales. KPIT’s Medical Device apps are built on both the PTC Navigate solution as well as PTC’s Thingworx platform.
KPIT’s first app for the industry focuses on Supplier Quality Management (SQM) which allows Medical Device manufacturers to evaluate and audit suppliers on a consistent basis with a trusted output. Not only that, it will provide quick visibility of real-time performance, supplier corrective actions, non-conformances, and percentage of on-time delivery within a specified period.
It is exciting that KPIT is using PTC Navigate to develop an application specifically for the Medical Device industry. PTC has been increasingly prioritizing the delivery of solutions for the Medical Device industry over the past few months. At this year’s Liveworx, for example, we announced the release of the Medical Device Industry Value-Ready Deployment (VRD) – a set of pre-configured best practice processes deployed in Windchill to build in product and process quality. We look forward to seeing what other PTC Navigate-based applications KPIT deploys to preserve quality standards.
See for yourself how easy it is to unleash your product data to the entire organization