The requirements for medical devices have increased dramatically in recent years – this starts with the design and documentation and does not end with approval. It is no wonder that suppliers of medical devices are moving towards having these devices developed and approved externally. Seleon offers precisely these services. The company uses PTC Creo and Windchill in a product development environment managed by Inneo.
“We specialise in medical devices in which gases and liquids are transported, portioned, measured and mixed,” explains Uwe Schwerdtfeger, Head of Mechanical Design. For example, a mixing device for artificial nutrition or a contrast medium injector for cardiology were developed at Seleon, as well as devices for eye operations, ventilators or a vacuum therapy unit that draws secretions from wounds. Depending on customer requirements, Seleon supplies assemblies or complete product developments, manufactures small series and takes care of the entire approval process in various countries and regions.
Efficiency is important
“Unfortunately, the regulations for medical devices are becoming increasingly complex,” explains Schwerdtfeger. “Whereas we used to spend 80 per cent of our time on design and 20 per cent on approval, the proportion of design work has now fallen to 40 per cent. This makes the efficiency of our tools in this area all the more important to us.” Seleon has been using Creo for many years, mainly due to a customer requirement at the time. Depending on the order and customer, a second system is now also used or work is carried out directly in the customer’s system.
PTC Windchill was introduced for document management in 2014. Windchill is certified for the development of medical devices and contains the necessary processes and functions to fulfil the regulations of US, Asian and European authorities, for example. “As we carry out development in Heilbronn and Dessau, it was important for us to be able to work with the same database at both locations,” adds Schwerdtfeger. “Initially, we managed the CAD data in the ERP system, but that didn’t work out and we then decided in favour of Windchill.”
Precise and clean work
“Creo doesn’t allow any errors,” Schwerdtfeger reports from practical experience. “Other systems are more forgiving, but Creo teaches you to work accurately and cleanly. This may sometimes be exhausting, but the models are then absolutely stable and can be opened again and again.” It is also important to the designer that the change history is documented in Creo, so you can see exactly how a development was created.
Electronic components are imported from the ECAD system into Windchill as STEP files and can be integrated into Creo models from there. The requirements management system is also linked to Windchill. In the near future, the data from the second CAD system will also be managed in Windchill so that all data flows together in one place. Two servers at the two development sites in Heilbronn and Dessau synchronise their databases automatically so that all data is available at both sites.
“We use Windchill to derive the engineering parts list as the basis for the device parts list,” says the design manager. “We are supported by Inneo’s Genius Tools, including the Genius Tools Parameter module for entering model parameters such as name, designation, drawing number or material selection. In the assemblies, we use Genius Tools Assembly Report to structure the components in the model tree in Creo. This structure is the basis for generating the design parts list according to the assembly sequence, which is then exported from Windchill.” Schwerdtfeger adds: “We have been pursuing the approach of managing all data in one system for several years with the support of Inneo. One of the reasons this has failed so far is the licence costs that would have to be incurred to connect many more employees to Windchill. Switching to a rental licence model has made this much easier.”
Document management system for the entire company
The Creo extension GD&T Advisor Extension, which supports the creation of shape and position tolerances, is currently being tested. The Windchill area is also to be expanded, as Schwerdtfeger explains: “We want to use Windchill as a document management system for the entire company, including for electronics development and complete with electronic signatures. The system has integrated functions for this that are certified by the US FDA, which would save us a lot of paper.”
The administration of Windchill is almost impossible to manage on the side, as Schwerdtfeger says: “Inneo regularly checks the system and rectifies problems, which is a very practical service. We also use the Genius tools for Windchill, which simplify administration.” On the Creo side, the corresponding start-up tools are used, which, like the Genius tools, simplify administration; for example, all CAD system settings can be managed centrally, as can the user interface and library access. “This makes administration centralised and simple,” adds Schwerdtfeger.
The seleon developers use Ansys for simulation, so far mainly for static-mechanical simulation. However, there are plans to extend the use of Ansys, for example to analyses of dynamic and non-linear processes. Inneo is providing support here with training and has already invested in connecting the simulation system to Windchill. The implementation is planned together with Inneo.
“The collaboration with Inneo is very good,” concludes Schwerdtfeger. “We are in regular contact and discuss the next steps. They always help us promptly with any problems and we send new employees to the nearby Inneo branch in Leipzig for training. We also use training courses for new topics such as ISO GPS. Inneo helps us to stay up to date and use the systems as efficiently as possible.”
Please note that all details and lists do not claim to be complete, are without guarantee and are for information purposes only.
