Navigating Product Data in the Medical Device Industry

Written By: Swapan Jha
  • 10/27/2016

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.  

Click here to learn more about what PTC is doing in the Medical Device space and learn more about KPIT’s Supplier Quality Management application here.     


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About the Author

Swapan Jha

Swapan Jha is Vice President Global GTM of the Product Lifecycle Management (PLM) segment at PTC. A seasoned technology executive with broad expertise in developing and executing enterprise software sales, product and go-to-market strategies, he has 15+ years of PLM domain experience across Medical Device, Hi-Tech and Manufacturing industries. Mr. Jha joined PTC in 2015 from Oracle Corporation where he most recently served as Global Client Advisor to P&G’s Key IT and business stakeholders, with responsibilities including working with cross pillar teams within Oracle and across all divisions and geographies at P&G. He previously held several leadership positions within Oracle, including Industries Business Unit, where Mr. Jha was responsible for driving growth in Oracle’s supply-chain, including PLM offerings. He holds a bachelor of Engineering, and a Masters of Business Administration (M.B.A.), Finance, Entrepreneurship from the University of Chicago - Booth School of Business.