Swedish company Elekta provides radiation therapy, radiosurgery, related equipment and clinical management for the treatment of cancer and brain disorders. Due to new medical legislation and regulations (MDR) in Europe, the company must improve or supplement existing design and production documentation where necessary. They get help from six TMC employeneurs.
In this article Wilko van Erp (Director Applicators Elekta), Martin Golverdingen (employeneur TMC and System Requirements & Verification Engineer MDR project Elekta) and Thomas van der Heijden (Senior Business Manager TMC) share their thoughts and experience on the collaboration of Elekta and TMC. The goal is to obtain CE approvals for Elekta's products by May 2024 so the company can continue to serve customers with their state-of-the-art cancer treatment solution. Wilko: “Our challenge was – and still is – in delivering proof to show we meet all MDR requirements. This means existing products must be re-approved by DEKRA and for this we have to update drawings and test verification documents, among other things. This must take place in only four years for 20 product families. TMC came to our attention via a former colleague of the company - who now works for us. Thomas took the lead and took what he needed from introductory meetings. Thanks to his quick response and accuracy, we found the right people within a few weeks. Martin was the first of six to join through TMC.” Thomas: “By asking as well as the client's side as the candidate's, a match was made in an efficient and effective way.”
After a year of training, Martin was given the lead of the MDR system engineering project part at Elekta. The tasks within the team were divided according to everyone's qualities. Martin: “Of course you run into things that won’t go smoothly at first, but after two or three products we were able to standardize a lot of things. The person who worked on the engineering process created a structure which allowed us to generate any overview that was desired with only a few actions.” Wilko adds: “That led to a structured approach and really helped us. Within Elekta we have several engineering groups where they will adopt this working method.”
To show a product meets the requirements, Elekta sends documentation with test proofs to various authorities. First in Europe, later also worldwide. There they review the documentation after which they send back questions the company has to answer. Only after everything has been answered satisfactorily a product will be approved. This process takes about 9 months. Wilko: “All new certificates must be received by May 2024, otherwise we can no longer sell the products. The documentation of the first 2 product families has been sent, but we still have 18 left to do. An enormous challenge.”
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High level of knowledge
Despite the fact the collaboration between Elekta and TMC started during Covid-19, both parties look back positively on their collaboration. Wilko: “For a good start we always link one of our employees to new colleagues. The goal is to train someone within three months so he or she can work independently. In Martin's case it was much faster. After about six weeks, he was practically working independently at home.” Martin: “Elekta's buddy system works great. Especially in a different-than-different situation such as corona in which almost everyone works from home. You immediately have a buddy you can hang out with and who has the same activities. It allows you to find your way more quickly to the right department and person.”
Wilko: “This is only the first collaboration with TMC, but for me it positively stands out. Everyone is well educated and the knowledge of TMC’s people is above average. Because of this we could immediately focus on working methods of the MDR team. The only point of attention is people from another culture sometimes having difficulties with the Dutch culture. It takes time and effort adjusting to another culture.” Thomas: “In addition to a training budget for one-on-one coaching and courses aimed at hard and soft skills, we are working on the transition for employeneurs coming from abroad. We want to guide them even better so their adaptation to Dutch culture is as optimal as possible.”
Wilko: “The most important lesson I take from this project is Elekta should have gone to TMC earlier. They are a good match, on all levels, and they distinguish themselves by quickly profiling and finding the right candidates.”
Thomas: “TMC's strength lies in providing high-quality customization for our clients and realizing challenging projects for our employeneurs.” Martin: “I started at TMC in 2019 and wanted to work with medical devices from the start. Shortly before this project I was working on another MRD related project. Because of the great chemistry between Wilko, HR and future colleagues I wanted to join this project. For me also, this collaboration is - and feels - great.”
Thomas van der Heijden
Business manager Field Service | International Site Management, Netherlands
Tél. : +31 (0)6 83 16 07 56