New Ways to accelerate Translation - Briding academic and industrial research for optimal translation into clinic


The three projects CeramActive, FullSkin and Implant Lifecycle Mangement work together with the central project to develop the translation system (schematic) © BioTex

In the past, innovative university research has produced a large number of excellent ideas in medical technology. However, these often remain at a preclinical level and do not reach the level of industrial product development. This translation gap prevents continuous academic-industrial value creation. The aim of the joint project is to investigate and establish a continuous translation process that enables researchers and doctors to successfully progress from preclinical studies to clinical application.

The translation system to be developed developed by the central project using specific application examples. In this way, an application-oriented, practically-oriented system can be developed that can be validated during the development and adapted to practical requirements. The three different research projects CeramActive, FullSkin and Implant Lifecycle Management serve as application examples.



Schematic illustration of a multilayer biofunctionalized high-performance ceramic implant surface.

Osteoarthrosis is a widespread chronic disease in elderly people, which is characterized, among other things, by the progressive loss of articular cartilage. As a result, around 400,000 hip and knee endoprostheses are implanted annually in Germany alone, with an increasing number of surgical revisions of the implants due to aseptic loosening. Through a multi-stage organochemical process, specific biomolecules can be coupled to high-performance ceramics in a hydrolysis-stable manner (see figure). This biofunctionalization could clinically contribute to less aseptic loosening and thus to a significantly longer service life of an all-ceramic implant. The coating technology is to be further optimized with regard to hydrolysis stability and, in particular, to be examined in detail with regard to sterilizability. Further information on CeramActive can be found here.


Clinic for orthopaedics, trauma and reconstructive surgery - University Hospital Aachen

Teaching and research area of ​​dental materials and biomaterials research - University Hospital Aachen

Institute for Cell and Molecular Biology at Interfaces & Institute for Pathology - University Hospital Aachen



Schematic representation of the mode of action of the in vitro diagnostic device © Ruth Heise

The aim of the FullSkin research project is to replace frozen sections of animal tissue with frozen sections of standardized three-dimensional human full skin models in the diagnosis of severe blistering autoimmune diseases of the skin. In analogy to the established method of indirect immunofluorescence microscopy with frozen sections from animal tissue, the patient's serum is incubated on frozen sections of a 3D full-thickness skin model to detect the autoantibodies. The benefit of this research project lies in the fact that, the usage of animal tissue, in particular in the form of the monkey esophagus, can be terminated by replacing it with full-thickness skin models produced in vitro in combination with indirect immunofluorescence microscopy.


Clinic for Dermatology and Allergology - University Hospital Aachen

DWI - Leibnitz Institute for Interactive Materials


Implant Lifecycle Management

ILM covers development, manufacturing, implantation, interactions and end of life cycle.

When developing biologized medical devices, ensuring compliance with the guidelines for good working practice (GxP) and the regulatory and normative specifications has top priority in every life cycle phase. The implementation of the resulting requirements represents a major hurdle for researchers. In order to overcome this, we want to develop software as part of the Implant Lifecycle Management (ILM) project that supports researchers in complying with the necessary requirements. The ILM has the task of recording, managing and providing available information in a structured manner using the example of a biohybrid vascular prosthesis. At the same time it guides the researcher to create the necessary documents at the right time. The ILM thus represents an implant-oriented data collection that serves as exemplary manual which can model other medical products across the life cycle as well. The software is intended to support a systematic, accelerated translation from academic pre-development through validated (pre)clinical development to industrial development.


Institute for Applied Medical Engineering - RWTH Aachen University

Laboratory for Machine Tools and Production Engineering - RWTH Aachen University


Central project

Translation process of prototypes towards pre-competitive first-in-human applications © Susanne Golombek

The central project investigates the R&D processes in the satellite projects CeramActive, FullSkin and ILM and supports them in complying with the normative and regulatory requirements of the Medical Device Regulation (MDR 2017/745 2017) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). Structures, methods and competencies must be established for the translation process so that the basic safety and performance requirements can be implemented in the production of test and preliminary products in the academy. For this purpose, the central project is building a quality management system according to ISO 13485 as part of the NewTranslation joint project and establishes processes for the creation of technical documentation. Furthermore, expertise and methodical competence in the areas of risk management (ISO 14971), usability engineering (DIN EN 62366) and software development (ISO 62304) are implemneted in order to be available to scientists in the long term as a core facility for translational research. Part of the translation is the Institute for Laboratory Animal Science, which provides practical experience through the participation in the development of numerous medical devices and biomaterials. Thereby, clinic-related, animal experimental development is feasible while complying with risk and safety aspects in accordance with DIN ISO 9001:2015. Great importance is attached to working in accordance with animal welfare and the current state of scientific knowledge.


Translation center - Uniklinik Hospital Aachen

Institute for Laboratory Animal Science - University Hospital Aachen


This project supported by the Federal Ministry of Education and Research (funding number: 13GW0452A-C).

  This project is spnsored by the federal ministry of educationa and research