Device development and manufacturing processes in translational biomedical engineering

We offer significant reduction of time in the development of innovative medical devices as well as for risks in terms of failure during technology transfer. This is done through device development with simultaneous development of custom-fit test systems and test methods. Products and test devices are developed at Fraunhofer ITEM to such an extent that they meet the requirements for use in initial clinical trials or as validated measuring devices. In this way, we offer a decisive contribution to the development chain: from the first research approaches to prototype production and verification up to the first clinical investigations. We support small and medium-sized enterprises in particular as well as spin-offs from research institutions in their developments.

Development of medical inhalers

Field of Competence "Medical inhalation devices": The development of medical inhalation devices is increasingly moving towards intelligent, breath-controlled combination products for the inhaled administration of drugs. In this context, the development of new processes and formulations for the generation of inhalation drugs is highly complex and heavily regulated.

Our expert competencies include novel techniques for the delivery of new active ingredients, including the ability to administer high-dose dry powder in a controlled, continuous manner. Likewise, techniques for breath-triggered, bolus-accurate aerosol administration are also available for premature infants, neonates, and young children.

Bringing medical devices into clinic: respiratory devices and drugs

  • Development of smart inhalation devices: Drug administration, especially in patients with ventilator support, is practically restricted to liquid formulations. Our innovative CPA technology (CPA = continuous powder aerosolization) enables continuous release and measurement of high doses of dry powder. This technology can be used not only in spontaneously breathing patients, but also under respiratory support.
  • Dry powder inhaler: Development of novel systems and formulations for the generation of medicinal aerosols is a complex process taking place in a highly regulated environment. Supporting our customers with a novel technology approach for the administration of medications at high doses is one of our areas of expertise.
  • Optimized humidification of aerosols for inhalation: Inhalation of therapeutics can result in adverse reactions like coughing, especially when inhaling dry-powder aerosols. Our novel humidification technology offers the possibility to continuously release high doses of dry powder without causing adverse effects during inhalation.

Field of Competence "Implants"

Our patented 3D printing process enables the production of personalized neuro-implants made of medical silicone with integrated conductive pathways for measuring or stimulating neuronal areas. This independence also enables the development of neurophysiological implants for research purposes.

In addition to patient-specific implants, we are developing durability tests for implants. In order to be able to evaluate the long-term durability of implants, we provide new test methods tailored to the specific requirements. These include methods for testing of osseointegration for orthopedic implants and, in particular, testing of active implants.

We are for example developing standardized methods for long-term functional tests of neural implants in vivo for objective evaluation.

Bridging the gap: from academic research to clinical trials 

Osseointegration and regulation of finger prostheses: Some 20 million people in Germany suffer from a rheumatic disease. With about 5 million people, the hand and sometimes also the finger joints in particular, are affected – the thin bones, which offer far less stability. Previous forms of therapy have very often resulted in stiffening of the joints.

The collaboration of 5 Fraunhofer Institutes in the project “Fingerkit” enables the development of a unique, new therapy, and thus the remobilization of finger joints through individually adapted joint implants. 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 MDR requirements. Within the scope of this project, Fraunhofer ITEM is evaluating osseointegration using test methods developed in-house for in vivo specimen.

Contact

Gerhard Pohlmann

Contact Press / Media

Dr. Gerhard Pohlmann

Division Director of Translational Biomedical Engineering

Phone +49 511 5350-116

Ulrich Froriep

Contact Press / Media

Dr. Ulrich Froriep

Deputy Head of Division Translational Biomedical Engineering

Phone +49 511 5350-294

Theodor Doll

Contact Press / Media

Prof. Dr.-Ing. Theodor Doll

Head of Department of Implant Systems

Phone +49 511 5350-248