MEDxD is one of the most content-rich events on digitalization in medical technology. It is organized by the AVASIS Group, a Swiss Siemens partner. PROSTEP took part for the second time this year and was also represented with its own booth. The exhibition is deliberately kept compact so that software and consulting companies can easily exchange ideas with the participants.
At our booth this year, we had many interesting conversations, for example about the often-underestimated effort of data migration when switching ALM/PLM systems. We also discussed the pain points of integrating the Siemens tools Teamcenter and Polarion with other PLM systems or platforms. Additionally, many discussion partners raised the question of how seamless traceability between requirements engineering and systems engineering processes can be ensured in an automated manner in heterogeneous tool landscapes.
Cross-domain continuity is important not only for regulatory reasons, but is also a prerequisite for the efficient use of data, for example for AI applications. We discussed possible use cases such as the detection of anomalies in test results or the AI-supported creation of documentation with numerous interested parties, in order to make it clear to them that they have to tidy up their data inventory before introducing AI.
As an exhibitor, we had our own Company Session, in which we were able to present our portfolio of services. We used two illustrative customer projects for this that we have recently implemented. We advised the dental technology manufacturer Dentsply Sirona on a vendor-neutral basis during the system selection and then also accompanied the system implementation. Together with BHC, we are supporting the manufacturer of heart assist systems Berlin Heart in the implementation of the new ALM system Polarion, the migration of existing requirements and test cases from IBM DOORS Classic, and the integration of two development partners for a cross-company Digital Thread. Both customer examples met with great interest from the audience.
A Sector with Major Digitalization Needs
We ourselves also used MEDxD to find out first-hand what is currently driving the industry. The two-day event is characterized by workshop-like sessions and plenty of opportunity for networking. Just how great this need actually is became apparent in several workshops. Although companies are no longer at the very beginning of their digital transformation, the lack of digital continuity of the processes – for example between requirements engineering, risk management, and regulatory affairs – often leads to inefficiencies and complicates change management, among other things.
One of the highlights this year was the presentation of a uniform data and information model for the documentation of medical technology products. It is based on DIN SPEC 91509, initiated by MDKU e.V., which was published in the first version in the spring of this year in order to implement the requirements of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The aim of the data model is to simplify communication between specialist departments and the notified bodies and thereby accelerate the market introduction of medical technology products.
The MDKU is an association of various industry associations, medical technology companies, and experts that has set itself the goal of easing the industry’s pain with regard to the ever stricter regulatory requirements. Regulation not only causes high costs but also leads to fewer innovations. Between 2017 and 2023 alone, the volume of documentation has increased sixfold. The growing complexity also makes traceability more difficult. In order to master these challenges, medical technology companies would have to make the transition from document-oriented to data- and knowledge-based processes, the MDKU recommends.
As Digital Thread Experts, we can provide support on many levels of digital transformation. Our Digital Thread Platform offers the possibility of linking product data across systems and in an automated way along the data processes. This saves time and relieves the burden on specialist departments. As a result, the effects of changes can also be assessed more quickly, and their implementation can be tracked transparently. The platform also supports the creation of Digital Data Packages (DDP), with which information from different data sources – including the relationships between them – can be combined in a compact container and made available in encrypted form to the parties involved (e.g. partner companies or notified bodies).
Conclusion
MEDxD has once again shown how well the PROSTEP Group’s portfolio of services fits the challenges of medical technology. With our expertise in Digital Thread, migration, systems engineering, and ALM processes, we address precisely the topics that are currently preoccupying the sector. It also helps that we have for years been accompanying the build-up of digitally continuous, regulatorily robust processes in other highly regulated industries – such as the automotive, aerospace, and shipbuilding industries. These proven methods can be transferred on a vendor-neutral basis to the requirements of MDR and IVDR and make technology transfer concretely usable for medical technology.
Would you like to know how this can be implemented in your company? Get in touch with us – we look forward to the exchange. You can learn more about our offering for the industry on our Medtech topic page.