Tuttlingen – Support from the industry for the industry, from companies for companies: This is still the approach of the Med Alliance BW brought to life by MedicalMountains GmbH. Funded by the Baden-Württemberg Ministry of Economic Affairs, Labor and Tourism, the concept now opens up even more opportunities for participation for the years 2023 and 2024 in order to jointly master regulatory and transformative challenges in medical technology.
Basically, the story goes back to 2018. Under the pressure of the recently published EU-MDR, medical technology companies sat down at a table so that the open questions could be answered together - and the results could be used to help other manufacturers over the regulatory hurdle. "This form of openness and cooperation was and is a role model," says MedicalMountains Managing Director Julia Steckeler. "A lot of positive things have emerged from this for the industry." The ExpertTable developed into the Med Alliance BW in 2021; the questions became more diverse, the results more extensive - and trust further deepened. "It works because the network works," summarizes Julia Steckeler, "because we also contribute with our skills as coordinators and bridge builders."
“The releases have passed their baptisms of fire in the certification process”
Master templates for quality assurance agreements and distributor contracts, frameworks and practical templates for clinical evaluations, post-market surveillance and PMCF, checklists for material compliance and international approvals have been designed in recent years. The results are closely linked to day-to-day implementation. "What is created is intended for direct use in the company," says Julia Steckeler. In the meantime, many of the documents are known to the notified bodies, some of which have been checked and approved by them in advance: "The publications have passed their baptism of fire in the certification process."
However, the work doesn't stop. “Even if important topics have already been dealt with, more than enough questions remain. About the MDR and beyond.” Questions that can be deepened, discussed and clarified together. Accordingly, the new concept of the Med Alliance BW provides for a strengthening and upgrading of the working groups. On the one hand, this means that the previous separation of active and passive companies will be abolished. "Anyone who registers in Med Alliance BW can choose the degree of participation themselves," says Julia Steckeler. As in the past, only results can be obtained or direct participation in working groups can be sought. These are advertised in the form of consortia. If there is a sufficiently large number of interested parties who can contribute (basic) expertise, time and human resources, implementation begins. The groups themselves determine which goals are to be pursued. "You can envisage a specific project, i.e. templates, checklists or guidance documents, or simply look for an informal exchange," explains Julia Steckeler.
“Practitioners meet here”
Julia Steckeler quickly finds an answer to the question of how the Med Alliance BW differs from other working groups. “Practitioners meet here. This is where companies meet that are not only looking for information, but also for active, pragmatic support, for resource sharing and expert cooperation.” In the Med Alliance BW, the work is divided among the companies, which are pragmatic and practical when dealing with current issues Challenges supported, experiences, tips and knowledge shared: "Very special values of cooperation are lived here."
What is new in the current phase, however, is that thanks to state funding, external support can also be called in for specific challenges for the first time. For example, to finalize content according to specifications from the working groups or to have your own results checked by third parties. "One mustn't forget one thing: anyone who is involved in working groups is doing this in addition to their day-to-day business," reminds Julia Steckeler. "It is all the more valuable to relieve the groups by outsourcing subtasks and thus to reach the goal faster."
“We are concerned with medical technology in the entire German-speaking area”
Another new module is the creation of generic module documents that can be used directly in technical documentation, for example. Here, the elaboration lies with external service providers from the beginning.
