The MedTech approach to the Digital Enterprise strategy

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.

How are Medical Device Manufacturers Approaching their Digital Enterprise Strategy?

Here’s what Jim had to say:

First, let’s define what we mean by “digital enterprise strategy.” The “digital enterprise” is a concept. It is the idea that we can digitally represent products and processes to create proactive visibility into performance – quality product performance and efficient process performance.

We use “digital threads” to connect information and models that help plan product development as well as the product’s manufacturing and utilization. It is the chain of information connecting all participants with the application and information they need to design, build and support innovative products. We also use “digital twins” – an accurate virtual representation of the product, its manufacturing processes, and its intended use to predict and optimize performance in the physical world.

The digital twin and the digital thread come together to create a highly efficient digital manufacturing enterprise. We can identify any quality issues or manufacturability problems in the virtual world before we make commitments to prototypes or early production ramp up. We work out those problems digitally in advance. The digital enterprise is thus highly resource and time efficient – we reduce waste, reduce time to market, and deliver higher quality products the first time.

As an industry, Medical Device manufacturers are moving towards becoming digital enterprises rapidly. As a highly regulated industry, most medical device companies readily understand and appreciate the value of digital enterprise concepts because they are already required through regulatory mandates to keep careful track of this kind of traceability. While regulatory requirements don’t dictate that they maintain traceability digitally, when we approach medical device manufacturers with the digital concept, they get it right away. They see how transformative it is to move to a digital approach rather than manual processes, or “digitized” processes – which is really a paper-based process in which the documents have been moved to digital format, or what we call “paper on glass.”

I am seeing some commonalities among the many medical device manufacturers I work with. The areas we typically see moving to the digital enterprise concept first are design controls and production controls.

Design controls are in the earlier product development activity. They specify digitally the product and the manufacturing process, ensuring that user needs are addressed, and keeping track of all the testing to prove that the user needs and technical requirements are being met by the product definition as it is designed as well as the manufacturing process as it is designed and built. Production controls enter once you are in the production scenario to make sure that the pre-approved process and quality controls are being properly enforced on the shop floor.

Of course, I am most familiar with the Siemens’ MES for medical device manufacturers – Camstar. As an MES system, it maps onto the need companies have for a digital approach for production control. However, it also participates in design control. It is being used by medical device manufacturers to detail out the manufacturing process, the methods, the quality controls, the actions that need to be taken to successfully build the product on the shop floor. So, our MES offering is not only a production offering, it also gets used in modeling the manufacturing process digitally, and coming up with the specification of what the manufacturing processes are going to look like in advance of production.

The advice I give to medical device manufacturers is that an MES is one of the first things that customers should implement in their journey towards a digital enterprise. They should also look to invest in design controls with a PLM system in R&D. Siemens is in a unique position in the market with our ability to offer solutions for both design controls and production controls, providing seamless integration between the two that allows the combined use of technologies to create a true digital enterprise.