Julia Steckeler

Julia Steckeler joined MedicalMountains in December 2014 as a cluster manager. In 2018 she was appointed as CEO. She is committed to the political representation of the cluster's interests with a particular focus on making the voices of the many SME's heard. She further focuses on developing and leading joint projects, trainings and alliances that aim on a more pragmatic but secure implementation of regulatory requirements. Julia holds a Masters degree in Marketing from the University of Sheffield and a bachelor's degree in International Business Administration which she obtained in a dual study programme at Karl Storz. 

On 26 th of May 2021 the EU Medical Device Regulation (MDR) became fully applicable. It is a modern piece of legislation that strives to ’ establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation’ . It further aims ’to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector’. ’ Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other ’, it states . I could not agree more with these phrases. There are two main objectives that are inextricably linked and need to be balanced: safety and innovation are mutually dependent. Fortunately, there are thousands of innovative ideas designed to improve people’s lives. The European Patent Office (EPO) [1] data for 2020 shows that the medical technology sector made the highest numbers of applications – 14,295 to be precise – putting it ahead of digital communication, electrical machinery, energy, transport, pharmaceuticals, and others. But the medtech industry is telling me a different story about the future! Many innovation projects in times of implementation of the MDR are being abandoned while improvements to existing products are no longer being made. Where manufacturers are seeking regulatory approval of medtech innovations, geographies beyond Europe with faster and more predictable pathways (e.g., in the US and others) tend to be preferred, at least for now. We are facing an imbalance between the above-mentioned goals of the MDR. More and more often I hear that products that are certified under the provisions of the old directives pose a...