*co-funded by the European Regional Development Fund, the Ministry of Economic Affairs, and the Provinces of Limburg and Brabant in the context of the Operational Program South Netherlands (OPZuid)
The core of further developing and validating the matrix lies in the modular design of a learning-work environment, which allows you to configure the development process using exactly those elements you need. These can be lab facilities, special equipment, or even specific knowledge in quality management and legislation and regulations. ‘Education is one of the pillars of InSciTe, and this is reflected in BEAM-NL,’ says Filip. ‘Project members are given the necessary tools to learn what steps they need to take to effectively get from idea to patient. They appreciate this approach, as they can immediately learn how they need to organize it for themselves this time and next times. I think that self-steering capacity is an important strength of the matrix.’
This working model proved attractive not only for the InSciTe research projects but also for start-ups, of which four of them soon joined InSciTe with the aim of developing themselves using the model. In 2018, the InSciTe team received a crucial quality recognition for their way of working with the ISO 13485 accreditation of the model, the highest European quality standard in medical devices. The team further professionalized the model to accommodate even more projects and companies on their way to the patient. In 2019 the spin-off Medace was established to meet this growing demand, which proves the commercial viability of the matrix.
Thanks to BEAM-NL, rapid and important progress has also been made in two research projects using the matrix, including PoSTuRE (Patient Specific Scoliosis Treatment). Rigid constructions of metal – mainly titanium – are currently used to surgically correct scoliosis (curvature of the back). PoSTuRE introduces a new procedure in which the metal wires are replaced by wide woven polyethylene cables sliding on bars. Vertebral fractures can be prevented by winding these cables around the bone instead of using screws as a fixture, which leads to better results and fewer repeat surgeries. This technology even allows children to continue to grow while their back is being straightened out – without repeat surgery.
‘We’ve gone through all the test phases and expect to operate on the first adult patient in the second half of 2020,’ says Paul Willems, orthopaedic surgeon at Maastricht University Medical Centre. ‘That’s a huge milestone. For the first time in our hospital’s history we perform a ‘first in man’ trial and offer patients a product that we have developed ourselves, with the help of partners. By setting up a project consortium within BEAM-NL, we have acquired the knowledge that we as doctors don’t have, such as information about legislation and regulations. This is also very important and useful for our own clinical trial centre. We’re now familiar with the whole process and have built up a network, which helps us in future projects. We hope to be able to complete the study in our hospital in two to three years’ time, after which another multicentre study will have to be completed before we can really go to market.’
Filip adds: ‘Medtronic is also involved and wants to play a role in this. Thanks to our open innovation platform, this also offers opportunities for other interested companies to join. It is fantastic to see knowledge rapidly increasing within the matrix’, says Filip. ‘We can now complete a similar journey for the new WISE (wrist implants) project twice as fast. Our dedication to BEAM-NL is now paying off – it’s a huge motivation.’
Filip Maes is project manager of the biomedical research projects at Chemelot Institute for Science and Technology. He is responsible for the overall quality and outcome of the InSciTe biomedical program and reports directly to the board of InSciTe with representatives from Royal DSM, Eindhoven University of Technology, Maastricht University and University Medical Center, and the Province of Limburg. Filip facilitates, supervises and monitors the projects with regards to scientific progress, publications, inventions/IP, budget, quality and legal affairs. Before moving to InSciTe in 2017, Filip has gained several years of experience in pre-clinical and clinical product development of medical devices, working under Quality Management Systems (ISO13485 and ISO14155).
Paul Willems was trained as an orthopaedic surgeon with an additional 1-year certified AO-Spine Fellowship at the Sint Maartenskliniek, Nijmegen. He has devoted his clinical and research practice to Spine Surgery at the Maastricht University Medical Center (MUMC+). Paul is leader of the Spine Center Maastricht, a multidisciplinary setting for evaluation and treatment of patients with spinal disorders, and his clinical practice is devoted to the whole spectrum of instrumented spine surgery in first, second and third line of care. Scientifically he has a special interest in deformity and degeneration of the spine, osteoporotic fractures and translational research in scoliosis.
Since December 2016 he has been active as project leader of Posture, a translational InSciTe project that aims to improve and renew surgical techniques for the treatment of early onset scoliosis and adult spinal deformity with the use of Dyneema® sublaminar wires.