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Bioabsorbable Solutions from the Aachen Technology Region
The RUBIN alliance reACT has set itself the goal of transferring degradable implants into medical use in the medium term and thus making a direct contribution to structural change in the Aachen Städteregion. The alliance aims to achieve this goal through a holistic approach and a sustainable utilization concept. For this purpose, the alliance networks medical technology companies and research partners from the Aachen city region in order to enable a smooth transition from research to application.
The joint projects and the subproject of the MSE
The Alliance is divided into three technical collaborative projects ("Soft Tissue Regeneration", "Bone Repair" and "Cardiovascular Intervention") and two superordinate collaborative projects ("Next Gen Innovation" and "Tech Education"). In the three technical collaborative projects, absorbable solutions from different application areas are to be researched and prototypically tested. In the overarching collaborative project "Next Gen Innovation", innovation-promoting processes for product development are to be researched and measures to strengthen the reACT alliance are to be developed. In the joint project "Tech Education", certified further training programs for "Medical Device Regulation Specialist for Resorbable Solutions" will also be developed.
The sub-project "Model-based system development for the innovation of absorbable implant concepts" of the Institute of Machine Elements and System Development is part of the overall project "Next Gen Innovation".
The motivation of the subproject
Absorbable medical solutions are one of the major goals in surgical, orthopedic and traumatological surgery. However, SMEs in the MedTech region of Aachen are faced with the challenge of prototyping absorbable and biocompatible implant concepts that not only have sufficient mechanical properties for their specific application, but are also absorbed in a balanced manner by the human body and stimulate and promote cell growth and the formation of new blood vessels. For successful treatment, the technology must be individually adapted to the respective patient. However, adaptation to individual requirements is not efficiently possible through a current document-based development approach, as the information and data required for the modification process, such as patient-specific geometry, load or degradation rate of the material, are available in numerous documents or independent models (e.g. 3D CAD model for macro- and microstructuring of the solution, MBS model for calculating the individual load of the solution or maps of the degradation behavior). Sub-process steps that allow the implant's shape to be changed and optimized, taking into account the individual stress and degradation, must also be run through in a structured and iterative manner, which leads to an enormous amount of time and costs in the development process. For ultimate approval, the absorbable solutions must also meet the stringent regulatory requirements for medical devices, which are currently being demonstrated in a certification process downstream of development. However, the regulatory requirements have been significantly tightened by the new Medical Device Regulation (MDR) 2017/745. Among other things, the MDR requires data from clinical trials to demonstrate safety, clinical performance and clinical benefit before CE certification of products can take place. Solutions that do not meet regulatory requirements after product development must be subsequently modified, their modification documented and clinically verified, resulting in additional time and costs. The technical documentation required for the certification process is also one of the biggest obstacles to medical technology development in Germany, according to the fall survey conducted by the German Medical Technology Association (Bundesverband Medizintechnologie e. V.).
The research objective of the subproject
The aim of the sub-project "Model-based system development for innovating absorbable implant concepts" is therefore to research and provide a model-based product development process (mPEP) that enables an efficient change process of absorbable medical solutions by using the MBSE approach and an early certification of absorbable medical solutions by extending the MBSE approach. To achieve the goal, the mPEP will be researched and validated using the example of an absorbable solution from the application area of orthopedics.
01.09.2022 - 31.08.2025
The alliance and joint project partners
A total of 21 partners belong to the RUBIN Alliance reACT. Characterised by a predominantly medium-sized core, the alliance combines the power and dynamism of young companies with the experience of established medical technology actors.Copyright: © Meotec GmbH
In the joint project "Next Gen Innovation", MSE is conducting research together with meotec GmbH, Medical Magnesium GmbH, AGIT - Aachener Gesellschaft für Medizinprodukte in Europa mbH, ecm - Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH and Medlife e.V. - Kompetenznetzwerk der Life Sciences and in close cooperation with the joint project "Bone Repair".
Here you will find the link to the project site.
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