INNORISK - Innovative Risk Management for Medical Devices

Overview

In the framework of the AiF/FQS-project INNORISK, funded by the Federal Ministry of Economy and Technology (BMWi), a twofold strategy is used: 

  • The first strategy is to model the cause-and-effect chains of  safety-critical, technological and Man-Machine systems, in order to detect and avoid complex failures with non-linear dependencies 
  • The second strategy approaches the potential human errors in risk-sensitive Man-Machine interfaces using new methodologies for reliability and usability with relation to the clinical environment.  These methodologies are than evaluated and quantified after the fact 

Under management of the leading research establishments, the Chair of Medical Engineering at the Helmholtz-Institut for Biomedical Engineering at the University of RWTH Aachen (mediTEC/HIA) and the Fraunhofer Institut for Production Technology (IPT), a total of 12 industrial and academic project partners bring in their long-time expertise and knowledge to the field of risk management and usability engineering.

Manufacturers of medical products, especially small and medium-sized enterprises (SME) have to reach an adequate level of risk management in order to fulfil normative requirements (Figure 1).  In medical technologies, manufacturers of medical products are bounded to the DIN EN ISO 14971 norm (applying risk management to medical products). They are in need of systematic and effective methods alongside tools for risk analysis, minimizing not only effort but also allowing the best possible results.


Based on these approaches, early detection shall be used to enforce the appropriate risk-minimzing measures. Achieving an accurate and comprehensive risk analysis is analagous to long development cycles and costs. Therefore most SMEs apply as little risk management as normative requirements allow.

Application areas of medical technology are therefore an appropriate field for development and experimentation in risk analysis and usability assessment. The industry is affected by large amounts of small enterprises bringing highly innovative technologies to the market. Undetected risks in advanced developmental stages can only be corrected with large expenses and delays.
 

Objectives

The objective of INNORISK is to provide a progressive risk analysis method which can be applied to products out of various risk-sensitive areas. In the course of these analyses, especially those pertaining to complex technical errors which are yet to have been sufficiently condsidered, a better integration of Man-Machine-Interface evaluation in risk management process is to be conducted.

Contact

Dr.-Ing. Armin Janß
Phone: +49 (0)241-80 23867

Funding

The INNORISK project is funded by the German Federal Ministery of Economic Affairs and Technology.

(Project term: 2006-2008)

Funding and controlling agency is the Forschungsgemeinschaft Qualität e.V. (FQS)

Research centers

Fraunhofer-Institute for Production Technology (IPT) Aachen

Chair of Medical Engineering (mediTEC)

Methods

mAIXuse