Top MES for Digital Medical Technology Production

Global life expectancy has increased by around 40 years since 1900 – thanks in part to advances in hygiene and medical technology. ADMEDES contributes to this: As the world’s leading contract manufacturer of self-expanding nitinol components for medical technology, the Pforzheim-based company offers all the services required to accompany ideas from their inception to commercial success. The company produces medical components from a variety of metals in different shapes using state-of-the-art processes. It produces more than one million medical components every year. Production takes place at three locations: in Germany, the USA and Costa Rica.

Digital realignment at ADMEDES

Regardless of whether you are a start-up or a large multinational medical technology company: ADMEDES offers a customized development path tailored to the respective requirements. To accelerate these processes, the company provides rapid prototyping services, extensive project management experience, test lab services and quality system support. This ensures a rapid transition from the feasibility phase to large-scale commercial production. However, this posed increasing challenges for production control and manufacturing IT.

ADMEDES therefore decided to reorganize its IT structures and production processes. Hendrik Brod, Team Leader Lean Engineering at ADMEDES, explains: “Our previous ERP system had served us well for a long time, but was increasingly reaching its limits. The company therefore decided to switch to SAP S/4HANA – and to comprehensively digitalize production at the same time.”

Digital production processes without media disruptions

In addition to the new SAP system, the company also wanted to introduce a modern Manufacturing Execution System (MES) as SAP MES for medical technology companies. This was to be based on the principles of the company’s own production system “AOS” (ADMEDES Operating System) and beyond:

• enable end-to-end production processes without media discontinuity,
• provide a standardized, intuitive user interface (UI),
• can be easily connected to the new SAP landscape and
• closely dovetail quality management and production.

Marc Mierezek, Head of Special Projects at ADMEDES, explains: “To ensure maximum product safety in medical technology, many countries have very high quality standards. In the EU, for example, the Medical Device Regulation. We therefore needed a system that could handle this – and also offered potential for future digitalization steps.”

ADMEDES and top flow launch MES cooperation

While searching for the right solution, ADMEDES came across top MES from top flow – a manufacturing execution system that integrates seamlessly into a company’s SAP environment as an add-on, thus enabling flexible and modern production control.

“Finding a suitable solution for us was not easy given our high requirements. So we were all the more pleased when we finally discovered top MES. It seemed to be exactly the solution we were looking for – flexibly adaptable and easy to implement at the same time,” recalls Mr. Brod. The contact and subsequent discussions with top flow confirmed the high expectations. Both companies quickly agreed on a cooperation and were able to start the structured project design.

top MES as SAP MES for medical technology companies connects systems and creates an overview

Several workshops initially formed the starting point for the collaboration. This resulted in a joint project team, which standardized the level of knowledge and roughly outlined the project process. Building on the implementation of top MES, the team planned to optimize the processes in several steps:

• Introduction of the new user interface:

Until now, isolated IT systems and inconsistent user interfaces have made production processes more difficult. Media disruptions led to a loss of speed and rework.

The project team therefore networked SAP S/4HANA, top MES and document management to create a consistent system landscape. A standardized, MES-based interface now bundles all relevant information clearly in one place. Workers use it to document all relevant production steps – the basis for digital QM reports, stable processes and paperless production.

“The underlying logic remains invisible to the user. But as a result, everyone can now achieve results much faster, more easily and with fewer errors,” Marc Mierezek is convinced.

• Development of digital processes:

The new user interface also offers further advantages – particularly for quality assurance. For example, workers can now only start a job once they have completed all mandatory preparations – such as calling up a relevant document. If they want to use a specific machine, the system also automatically checks whether the employees have the necessary qualifications.

The system also ensures safety when using materials: for each production process, employees may only use components that are approved according to the parts list. To ensure this, the workers scan the batch of primary material using a barcode before starting the job.

• FDA-compliant documentation:
  The project team used SAP S/4HANA and top MES to introduce FDA-compliant electronic records and signatures. ADMEDES thus fulfills the strict requirements of the US health authority for the electronic documentation of medical products.

Marc Mierezek: “Electronic records and signatures not only ensure FDA compliance, they also significantly simplify our teams’ day-to-day work—because manual documentation is hardly necessary anymore.”

• Labeling, rethought:

ISO standard 13485 and the EU Medical Device Regulation require manufacturers in the medical technology sector to label their products precisely in order to improve traceability. ADMEDES also sought a modern, digitally supported solution in this area.

The project team implemented this request by adding a specially developed app to top MES. This uses mandatory fields to ensure that all labels are complete – with details of the manufacturer, company address, product name, country of origin and batch number.

Systematic Digitalization — With an International Perspective

Thanks to the close collaboration with top flow, ADMEDES is noticeably digitalizing its production and production-related quality management – making it more efficient, user-friendly and future-proof. The successful go-live at the headquarters in Pforzheim in spring 2024 was followed around 18 months later by the smooth launch at the US site in Livermore, California.

The new SAP MES for medical technology companies has already enabled the company to make six-figure savings in production costs. At the same time, there is also an ecological effect: in the USA alone, around 10,000 pages of paper were avoided in the first month – an important step towards paperless production. The plant in Costa Rica will also be converted shortly. Hendrik Brod is highly satisfied with the result:

“Our industry is subject to particularly strict regulatory requirements due to potential health risks. In order to meet these economically in the long term, we need well thought-out processes and a future-proof IT landscape. We have achieved both with the introduction of top MES in collaboration with top flow.”

“There is a high level of regulation in our industry. To master this efficiently, we need smart processes and a modern IT landscape. The joint project with top flow is an important building block for both aspects!”

Hendrik Brod, Lean Engineering Team Leader at ADMEDES