In order to guarantee safety as well as progress, the medical technology sector is subject to increasingly complex standards. A leading medical technology manufacturer in Tuttlingen demonstrates how to master the rising challenges.
The health economy in Germany has been expanding for years, with an export volume of around €131 billion. Medical technology and its innovations play a particularly important role and are a driving force behind this economic development. The high quality of medical instruments made in Germany is appreciated around the world, and DANNORITZER Medizintechnik GmbH & Co. KG – DANmed for short – contributes to this from its location in Tuttlingen in the federal state of Baden-Württemberg.
From DANmed’s humble beginnings as a precision mechanics business and medical technology supplier run by master craftsmen in 1975, the family-run business has become one of the leading global manufacturers of repair parts for the medical technology sector. Today, it also acts as a manufacturer and dealer of surgical instruments as well as a repairs service partner for hospitals and distributors. Quality is the company’s leading principle and the foundation for its continuous expansion as well as the trust of its partners, suppliers and customers. The high complexity of the medical products the company manufactures demands high-quality work and precision down to the last detail.
Standards: Mastering the Challenges
To ensure flawless quality, the medical technology sector is subject to strict international standards. The requirements for quality management have risen sharply in the past three years, and gained considerably in complexity. This is partly due to the new Medical Device Regulation (MDR) that became effective in 2017 and becomes applicable from May 2020 onwards. This regulation contains extensive new requirements and puts a high strain on smaller companies within the medical sector in particular. In addition, DIN EN ISO 13485 is applicable to medical technology; DANmed has been certified in accordance with this standard since 2004. It includes requirements for a comprehensive management system related to the manufacture and design of medical products and is a prerequisite for approval as a manufacturer on key markets.
When a revision of the standard was announced in 2016, DANmed took the opportunity to completely realign its quality management. Until then, the company had handled its quality management using Majesty, an ERP program developed specifically for the medical technology sector, as well as Excel. However, DANmed increasingly found that the company reached its limits using this solution. To be able to guarantee the quality of its manufactured products in future, the company needed a CAQ system that could help them retrieve and evaluate production data efficiently, among other tasks, and that could also monitor incoming goods, for example.
DANmed first became aware of the BabtecQ quality management software on the ERP provider’s website. The company then took part in one of Babtec’s Q.Events, where DANmed obtained further information, had the opportunity to ask questions and talked in depth with other users and experts. The software made a good first impression and, after comparing several providers, DANmed ultimately selected the CAQ expert with a branch in nearby Villingen-Schwennigen. To provide the best possible support for its quality planning, assurance and management tasks, DANmed chose to introduce an extensive module package from the BabtecQ range.
This decision was mainly based on the scope of service and the convincing user friendliness and was further influenced by the fact that the cooperation was professional from the start. However, what ultimatleyl won DANmed over was the package offer, which allowed the company to realize quality-related tasks using software from a single source: The company was happy with several modules from day one, among them the “Gage Management”, “Task and Action Management”, “Complaints Management” and “CAPA” modules. The individual modules each met DANmed’s expectations, and so did the level of interconnectivity and consistency of data across all tasks. The latter especially made it easy to gradually introduce employees to the new system, as the intuitive design and functions of the various modules go hand in hand.
First Impression Confirmed in Daily Use
After the introductory phase, during which Babtec supported DANmed by providing product trainings, the CAQ system quickly became an established part of the company’s day-to-day business. DANmed had great expectations where the new software was concerned. The decision to launch almost every BabtecQ module at the same time was unusual and courageous. Unusual – and in hindsight, a great success, as the company quickly achieved its objectives. Today, one thing is certain: The software has met the expectations, and even exceeded them in parts.
Two modules in particular have been extremely beneficial – including from an economic point of view: the “Complaints Management” module, which reliably covers quality-relevant areas, as well as the “Incoming Goods Inspection” module. In the past, faults in supplied parts occasionally went undiscovered, which led to unnecessary hassle. Now, deliveries consistently undergo planned inspections. Now, if a delivery contains faulty products, DANmed immediately sends a complaint to the supplier via “Complaints Management”. The seamless correspondence among the two modules ensures an efficient work process. The 8D report – which originated in the automotive industry – is also used in this context. It was adapted for the company according to the needs in the medical technology sector, and its simplicity ensured that it soon became a routinely used part of the CAQ software. The report also contributed to one of the key measurable successes: a visible improvement in the quality of the products.
Gage Management is another key factor that contributes to a more professional quality management within the company. BabtecQ provides a clear and structured overview of where gages are located, which gages are currently being calibrated and which gages will need to be calibrated in the immediate future. Furthermore, proofs and certificates have now been organized and are always accessible – a process that required a much more elaborate administrative effort in the past.
QM Impacts the Company – and It Doesn’t Stop there
The “Task and Action Management” module helps DANmed meet a key requirement stipulated in the regulations as it ensures that immediate and long-term corrective actions are implemented effectively in the event of deviation. The module therefore handles necessary tasks that are distributed, tracked and implemented throughout the company and across departments. Since the introduction of BabtecQ, DANmed has established Task and Action Management throughout the entire company; it is now used constantly by employees in various departments.
DANmed has also received positive feedback from third parties, for example from a QM consultancy based in Mannheim that regularly visits the company. The consultancy was impressed by the way DANmed used the software to optimize processes, which in turn contributes to customer satisfaction and the company’s economic efficiency. BabtecQ was recently connected to the existing MES, which also contributes to these factors.
To be well-equipped in the age of digital factories and smart communications, DANmed began working with the BabtecQube, the cloud solution developed by Babtec, in as early as 2016. This innovative platform actively involves key suppliers and partners in quality management. Together, they master the challenges of medical technology and can face the future with confidence in their innovative approach.