The Medtronic Bakken Research Center (BRC) was founded in Maastricht, the Netherlands, in 1987, starting as a research facility with 45 employees. Clinical study activities have grown substantially and now range from small exploratory studies with one physician-investigator and just a few patients to multinational, randomised trials intended to demonstrate superior clinical and economic outcomes with new device therapies and the number of patients now in the hundreds, and sometimes thousands. The BRC hosts the Benelux Therapy and Procedure Training Center, where advanced simulator training is offered to physicians, nurses and technicians.
Most of the BRC’s 300 employees are designing and managing clinical studies, generating data for regulatory and reimbursement dossiers in Europe, Japan and the US, and generating scientific publications in peer-reviewed journals. The Medtronic Cardiac Rhythm & Heart Failure (CRHF) Division is represented at the BRC by three departments: Clinical Research, Clinical Operations, and Research & Technology. The cardiovascular activities at the BRC are structured in three departments: Coronary Vascular, Endovascular and Structural Heart Disease. CRHF Clinical Operations offers biostatistical and monitoring support to clinical groups outside the BRC.
Around 55 scientists, engineers and technicians are working closely with medical innovators in European hospitals and universities to develop, build and study new devices or methods to alleviate pain, restore health, and extend life. In addition, the BRC Research & Technology Department designs and builds custom-made devices for CRHF as well as for the neuro and diabetes divisions, addressing the needs of individual patients according to the specifications provided by a physician.
Although the number changes on a monthly basis, an average of around 50 linguistic specialists manage the translation of Medtronic’s product manuals and the texts on the displays of our products into some 25 languages. Around 25 quality and regulatory affairs professionals ensure that our products and services exceed all applicable requirements inside and outside the EU, while the management team makes sure that all BRC employees recognise quality and service for patients and customers as their number one priority.