The unexpected benefits of using the Digital Enterprise for compliance

By Riccardo Consonni

James B. (Jim) Thompson, Ph.D.

Jim has worked in the Product Lifecycle Management (PLM) industry for 30 years. Initially in R&D roles for development of CAD/CAM and PLM software, and then as a leader responsible for technology consulting with customers in a variety of industries. Since 2006, Jim has focused exclusively on the Medical Device and Pharmaceutical industries.

At Siemens PLM Software, Jim is currently responsible for Siemens PLM’s global business strategy for the Medical Device and Pharmaceutical industries.

What are the key considerations that MedTech companies need to think about as they architect an end-to-end digital enterprise infrastructure?

Here’s what Jim had to say:

As far as key considerations, probably number one is maintaining a regulatory compliant process. We must always keep our customers in a state of compliance. Almost always, the medical device manufacturers we work with are compliant, just in a less automated way. When we get engaged, they transition from more manual processes to digital processes.

The interesting shift that happens when medical device manufacturers embark on the digital enterprise journey for compliance reasons is that they very quickly see some unexpected benefits – some very strategic benefits. The ultimate payback is that the digital processes we implement provide a more error-proof process from the beginning, and a faster, more efficient process that takes waste out of their operations. We typically see dramatic reduction in errors as well as costs through the enforcement in controls that digital systems deploy.

This is striking in light of initiatives specifically at the FDA that reveal a shift of mindset and direction. Maintaining regulatory compliance is the bare minimum that they expect. The goal of the regulators isn’t for manufacturers to do the bare minimum, but to adopt and utilize best practices that are above and beyond compliance. The digital enterprise approach as a manufacturing planning process as well as product controls is a good example. Regulators don’t say you MUST use these systems, but we know that the end results of using them provides manufacturers a platform to optimize the quality of their products. And, of course, from a business perspective, it also improves margin and creates a clear competitive advantage with speed to market.

As manufacturers become more familiar with the benefits of moving toward a digital enterprise approach, their key considerations are expanding beyond mere compliance. From the product quality angle, they are moving from a focus of testing to find quality leaks to a more proactive approach of building quality into products in a planned and enforced way. From an overall business perspective, designing in quality is an overarching imperative.

We are on a journey in this industry. Many customers who have been working with us for many years have recognized these benefits. Using Camstar, really the de facto standard for medical device manufacturers, they can’t imagine putting products out without it. Other companies are earlier on the journey. They are adopting MES technology in an incremental way in their various plants. You can’t adopt a new system overnight.

Large manufacturers are typically farther along on the journey. But mid-market companies are catching up. They have the same challenges and problems, and, while they have limited capital to invest in enterprise automation systems, they are quickly seeing that that investment needs to be prioritized. The payback in quality and efficiency, with manufacturing compliance as a natural outcome, more than pays for the investment.

Because the production and design controls inherent in the digital enterprise are so critical, especially for industries like medical device where product quality can mean life or death, Siemens is working alongside these smaller manufacturing companies to make the path to the digital enterprise possible.

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This article first appeared on the Siemens Digital Industries Software blog at