The role of modern MES in the Digital Enterprise strategy for Medical Device

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.

Considering your extensive experience working with MedTech companies on their digital enterprise plans, and specifically with MOM/MES, what is the role played by a modern MES within the overall digital enterprise strategy? What is the right time to implement an MES system during the journey towards the digital enterprise concept?

Here’s what Jim had to say.

We like to talk about three product lifecycle phases: Ideation, where R&D focuses on the conception and design of a product; Realization, the actual production of the product; and Utilization, in this case the use of medical devices in the healthcare delivery environment. The importance of bridging ideation and realization through digital twins and digital threads have significant impact on time to market, time to clearance, error proofing and quality improvement. Connecting ideation and realization makes those things available to medical device manufacturers.

Optimizing the product early from a design and manufacturing process is far superior to finding out a problem in utilization. That is a late stage response in which a consumer may have been adversely affected. Our strategy at Siemens is to focus the attention of a digital enterprise earlier in the lifecycle to optimize product and processes – to hit the market with the “perfect product” from the start.

Other vendors in the market are looking at bridging realization and utilization through the Internet of Things, or IoT. The idea here is that we’re going to build sensor technology into the medical device itself so that when it’s produced and delivered, and that medical device is being used, it can “phone home” so the manufacturer can figure out how the device is working. The manufacturer can observe it, and use those sensor outputs to identify quality issues in the field.

While that’s great, it’s is a suboptimal time to be thinking about whether the medical device is behaving properly. Our strategy is to move first towards emphasizing the early phases of the lifecycle, and focus on getting it right from the beginning. The worst time to be optimizing the performance of your product is when it is being used by the consumer.

Focusing on proactive quality means the connection of design and production, operating with feedback as the product is being manufactured – what we call “closed-loop manufacturing.” We use the digital twin to anticipate how the product will be manufactured and used in the physical world, and the digital thread to ensure that design is executed properly on the shop floor. That requires a tight coupling of PLM and MES/MOM – the foundational elements of the digital enterprise for manufacturing.

We are hearing a lot about the IoT. I think of the IoT as part of the digital enterprise – one component for medical devices. The IoT is an element, but today tends to ignore the ideation phase. It doesn’t currently fit well for the medical device industry, because we need high quality, perfected medical devices in the first place. I believe as the concept of the IoT becomes more of a reality within the walls of the manufacturing enterprise, as well as the extended supply chain, that may change. But that is a longer way off.