Medtronic founded the Bakken Research Center (BRC) in Maastricht in 1987. Starting with 45 employees, it nowadays employs more than 400 international talents of 35 different nationalities.
BRC is unique because of the multiple specialties and expertise at one location – which stimulates things happening at the intersection, such as working across multiple Medtronic business units which enables knowledge sharing and sharing of best practices. But also unique because it has a leading role in driving access to Medtronic therapies – from idea to market adoption.
BRC is one of the largest Medtronic R&D campuses outside the United States. Over the past several years, the BRC has been at the start of key medical innovations such as dual chamber pacemakers, sacral neuromodulation, cardiac resynchronization therapy and deep brain stimulation. We excel in therapy innovation, clinical and economic evidence, data science, regulatory approval and translations.
Medtronic Bakken Research Center
Medtronic founded the Bakken Research Center (BRC) in Maastricht in 1987. Starting with 45 employees, it nowadays employs more than 400 international talents.
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As experts in the EMEA region for regulatory clinical, CE market access, country support & planning and radio frequency, Regulatory Affairs (RA) provides centralized regulatory support and advice for clinical studies and clinical data needs, CE marking including notified body key account management, and product registrations.
Regulatory provides cross-business regulatory solutions, strategy and support, to secure and sustain the availability of therapies and services to patients, taking into account all relevant country regulations. Radio frequency registrations take place worldwide to fulfil cross-business unit needs. The Regulatory Affairs EMEA pre-market team based at the Bakken Research Center (as well as other European Medtronic sites) facilitates its services by partnering with notified bodies, competent authorities and agencies.
Clinical Research plays a vital role in the development of products and therapies that help Medtronic to fulfill its mission of alleviating pain, restoring health and extending life.
We offer a comprehensive portfolio of clinical expertise: from strategic evidence planning to clinical operations services resulting in clinical and economic evidence, to better serve patients, physicians, hospitals and all other stakeholders around the globe.
Data and scientific publications generated at BRC support regulatory and reimbursement dossiers in Europe, Japan, China and the USA, as well as generate scientific publications in peer-reviewed journals.
With services ranging from document translations, user interface localization and interpreting to consultancy on stylesheet development, globalization strategy and design reviews, Medtronic Translations is the partner in globalization for content creators across Medtronic. Based at the BRC, Mounds View and California, the team partners with Medtronic business units to create content with a global mindset in more than 34 languages.
Medtronic is committed to being a frontrunner and leader in Value-Based Health Care (VBHC).
Currently our business models are based on supreme technologies which are supported by their outcomes. In the near future, Medtronic’s revenue will be based on patient outcomes generated by our technologies and services.
In order to implement VBHC at a large scale, Medtronic acknowledges that it needs to deploy its talents and resources that are familiar with outcomes data and analytics, to support different value-based initiatives to become successful. These resources are residing in our clinical, research and scientific organization. Via our Center of Excellence in Outcomes Evidence, Analytics & Research, different regions and business units already receive outcomes-specific VBHC support. The Center of Excellence helps to deploy our talents, skillsets, knowledge and resources at the BRC to enable VBHC initiatives.