References – Projects

Here is a selection of our projects.

METEAN – Projects

Project INSYDE – Intelligent Care System for Pressure Ulcer Prevention and Treatment

The project INSYDE is developing a nursing bed that varies the distribution of pressure across the patient´s body using sensors and actuators to prevent the development of pressure ulcers. METEAN is advising the project consortium on regulatory questions that arise during the development process, is training the consortium and providing it with standardized documentation tools.

Provision of Support during a Developmental Project

METEAN has supported a research consortium during the introduction of developmental processes and the implementation of the technical documentation to accelerate the transfer process into a marketable medical device following completion of the project.

Data Protection and Data Security in the Praxisnetz Nürnberg Süd e. V.

Based on previous work carried out by METEAN, the Fraunhofer Institute for Integrated Circuits IIS in Erlangen and the Fraunhofer Institute for Digital Media Technology IDMT in Ilmenau, an investigation was commissioned by the Praxisnetz Nürnberg Süd e. V. on the safety concept and data protection concept of the practice network during the documentation, processing, storage, and transfer of personal data (evaluation). In addition, important suggestions on how to improve data and IT security were worked out, taking into consideration the upcoming changes in the healthcare and social services. Furthermore, a recommendation for action was made in relation to the implementation of potentially mandatory legal provisions and laws governing medical devices.

Process Analysis for Surgery – Field of Ophthalmology

Potential process optimization for the improvement of quality and cost-effectiveness in patient care has long been a focus of research at the Fraunhofer IIS. Within the scope of this project, multiple institutions were interviewed on their process sequences during cataract surgery and advised during patient hospitalization. The focus of the interview was on potential improvements to working processes, to ensure these were more efficiently organized and to facilitate individual working steps for the surgery teams, taking into consideration ergonomic perspectives, among other factors.

Data Collection for Pulse Wave Analysis

The aim of this project is the identification of characteristic properties of the pulse wave, based on which a so-called risk score (similar to the classic risk scores, such as PROCAM, Framingham) can be calculated as a measure of the personalized probability of developing cardiovascular disease. This probability is dependent on the condition (e. g. cholesterol, blood pressure or smoking) of the individual cardiovascular system and thus on a variety of individual factors. However, these factors do not remain constant over years, but are each subject to specific variation. These values may thus not be representative for past years and could therefore even falsify results. This project evaluates a method based on which a current and reliable condition of the cardiovascular system can be determined through analysis of the pulse wave curve. The classic risk scores were compared with the results of pulse wave analysis (e. g. duration, augmentation index, heart rate) in 40 subjects of all age groups. An algorithm was developed that calculates a probability of developing cardiovascular disease over the next ten years.

KARDIKOM Wireless Clinical Observation Study

KARDIKOM Wireless is a so-called Holter device for monitoring biosignals or vital data (e. g. ECG, breathing, pulse oximetry, movement). The data that are collected are stored on a microSD card for further analysis and for documentation purposes and transmitted in real time to a server with a smartphone using mobile phone technology. KARDIKOM Wireless has been certified as a medical device pursuant to Annex II of Directive 93/42/EEC. In a clinical observation study, the device was tested over 24 hours in 53 female and male subjects, aged at least 30, in their everyday environment and rated in a questionnaire. An average score of 2.8 (on a scale of 1 to 6, 1 being the highest possible score) was achieved across all criteria that were rated. The sensor device is to be used both in primary prevention and for follow-up outside the clinical environment after hospitalization or for secondary prevention.