Services and expertise in Translational Biomedical Engineering

Development of medical devices is a complex process taking place in a highly regulated environment. Besides specific technical expertise in this area, compliance with the relevant regulatory requirements is of pivotal importance. In this environment, we conduct research, development projects, and device testing. Our Translational Biomedical Engineering team has many years of experience in the development of medical devices. The focus is on neuro-implants on the one hand, and on conducting and assisting the development of novel technologies for administration of medical aerosols on the other hand.

Close dovetailing with the institute’s other working groups with scientific or medical focuses allows the team to provide comprehensive support to clients in their development projects. By cooperating with both internal and external development partners from industry and academia, we quickly find flexible solutions for project-specific requirements. In the area of quality and risk management, we support qualification of external technology processes for medical devices.

Medical inhalation

For inhaled administration of medical aerosols, we develop novel technologies or assist our clients in their development activities. In addition, our scientists deal with issues arising during development of novel formulations. Our portfolio ranges from dealing with physical and physicochemical problems in the area of aerosol technology to providing assistance in the performance of necessary preclinical and early-phase clinical studies.

Implants

Testing and manufacturing of implants: Neuroimplants can restore lost body functions or alleviate neurodegenerative diseases. The development is a great challenge to experts. As part of the Medical and Pharmaceutical Technology Performance Center, Fraunhofer ITEM's Neuro Laboratory provides support for in vivo long-term functional testing of active neural implants to increase reliability in innovation transfer. With high resolution, recordings and stimulations up to closed-loop settings as well as impedance spectroscopic characterization, our neurolab offers a comprehensive service portfolio. Standardized procedures for data analysis and tissue response assessments complete the services of our interdisciplinary team.

Osseointegration and regulation of finger prostheses: About 20 million people in Germany suffer from a rheumatic disease. With about 5 million people, the hand – and often also the finger joints in particular - is affected, the thin bones, which offer far less stability. Previous forms of therapy have often resulted in stiffening of the joints. Fingerkit is a project, where 5 Fraunhofer Institutes collaborate, enabling the development of a unique, new form of therapy, and thus the remobilization of finger joints through individually adapted joint implants. In order to ensure rapid transferability to clinical and industrial applications, all institutes are working together during the project on cross-institute, standard-compliant, digital documentation of their processes in line with the requirements of the MDR. Within the scope of this project, Fraunhofer ITEM is evaluating osseointegration using test methods developed in-house for in vivo specimens.

The EU-wide Medical Device Regulation (MDR) sets out obligations for medical device manufacturers that require more effort and costs to comply with the legislation. Our pooled expertise at Fraunhofer ITEM offers comprehensive support in the implementation of the regulation.

These new regulations include safety and quality standards for medical devices that have to be complied with, before a product can be placed on the European market. In a defined process to assess compliance with the new legislation, manufacturers have to prepare a technical dossier demonstrating that general safety and performance requirements have been met. Well-documented risk management to assess and minimize potential risks and clinical evaluation of the product are subject to more detailed regulation and essential for compliance with the new legislation. For the entire life cycle of a product, processes for the identification and assessment of technical, biological, and chemical risks have to be in place.

The institute’s business area Translational Biomedical Engineering combines expertise in the medical device area – focused on neuroimplants and on conducting and assisting the development of novel technologies for administration of medicinal aerosols – with many years of experience in the assessment of chemicals, nanomaterials, and biocompatibility. This allows optimal support to be provided to medical device manufacturers in developing innovative biomedical engineering solutions in compliance with the new regulations and in implementing the new requirements.

Fraunhofer ITEM offers the definition of risk management measures in compliance with (DIN EN) ISO 14971, biological evaluation of the medical device as part of the risk management process, and performance of relevant in-vitro and in-vivo tests in compliance with the (DIN EN) ISO 10993 standards under one roof. Clinical evaluation is performed primarily based on scientific literature and can be complemented, if necessary, by clinical investigation.