Regulations and a shortage of skilled workers, fragile supply chains, new market players, and increasing cost pressure—medical technology companies face many challenges. Digital transformation promises solutions. Fresenius Medical Care explains how these can be realized.
When it comes to digitalization in medical technology, the focus is usually on products and processes such as digital healthcare solutions and telemedicine. However, the digital transformation of the companies themselves is at least as important. But this means more than just converting paper-based processes into digital ones. Manufacturers can only create the basis for resilient and sustainable business models if they exploit the new opportunities offered by digital technologies. "We have digitalized our company from end to end—and by that I don't just mean the products, but the entire value chain," explains Vogelei.
A digital thread through the entire value chain
To this end, Fresenius Medical Care has created a digital thread based on PTC's PLM software Windchill. It connects R&D with production, products, and services. This breaks down data silos and enables Fresenius Medical Care to utilize the full value of its data to automate processes and achieve greater flexibility and speed with more variants and higher quality.
"The digital thread gives us transparency along the entire value chain," says Vogelei. "We gain insights into how our products are manufactured and used throughout their lifecycle. This, in turn, has an impact on product development. We can identify changes much earlier and our change management is faster and more transparent.”
Components of the Digital Thread
The yarn from which the digital thread is spun is product lifecycle management (PLM). PLM combines previously siloed product data from various systems such as computer-aided design (CAD), application lifecycle management (ALM), or manufacturing process management (MPM). PLM supports change, configuration and quality management, traceability, data integrity, and the automation of manual processes.
The digital thread gives everyone involved in the product life cycle access to precise, up-to-date, and context-related product data. This democratization of data and transparent flow of information increases product quality and efficiency while shortening time to market. "We no longer have top-down processes. Now the users of the data sets drive the evolution of the products," reports Vogelei.
Digital thread strategy
To achieve success, companies need a digital thread strategy. The strategy must define which data and technologies are required. Four steps have proven effective in defining the right strategy:
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Identify and prioritize use cases:
The most valuable use cases for a digital thread are unique to each company. It is important to ensure that the selected use cases solve real business problems and can be traced back to key performance indicators (KPIs). Once determined, the cases with the greatest business benefit should be prioritized for implementation. For Fresenius Medical Care, a leading case was to develop products in such a way that they could be produced flexibly at any location. This was previously not possible because the globally dispersed production sites each had their own processes and systems.
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Identify relevant data, systems and gaps:
The second step is to determine which data must be available and usable for the defined use cases. Focusing on prioritized use cases will ensure the scope remains manageable for those responsible. But to gain the support of all stakeholders, it is crucial that the initiative takes effect as quickly as possible. To this end, an internal audit is recommended to identify gaps and bottlenecks.
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Define success:
The most important KPIs should be determined for each use case. Targets should be set for individual KPIs based on current values. In this way, progress can be quantified, and support for the initiative can be encouraged.
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Creating the digital foundation:
The next step is to collect, manage, and control the data identified for prioritized use cases. The quality and consistency of the data must be guaranteed, and everyone involved must have access. It is crucial to create a digital foundation for the product data, ensuring that all designers work with the same CAD model, requirements are linked to the product definition, and that important PLM functions can be used. When the data is used by all departments, its value increases exponentially.
At Fresenius Medical Care, the digital thread has fundamentally changed the relationship between R&D and production. "There is a much better understanding between the departments, and our traceability has also improved," says Vogelei. "In terms of regulation, reliable configuration management is crucial. When this is set up properly, you can easily adapt to regulatory, or other changes. And once you have had the pleasure of creating a design history file (DHF) or a device master record (DMR) with just the click of a mouse in Windchill, you will never want to go back to another system."
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