Technical Risk Management for an Ensured and Efficient Product Development on the Example of Medical Engineering

Abstract

Nowadays, industry and trading companies are facing a lot of risks. These risks occur in a variety of different fields such as in the corporate strategy, the development of new products or in the introduction of new business and production processes. Due to external influences in particular technical risks are increasing, e. g. by regulations, increasing price and quality competition or shorter product life cycles, reasoned by innovative products. Therefore, an effective and efficient technical risk management system is crucial, to keep competitive advantages. A survey of the Fraunhofer Institute for Production Technology IPT, regarding technical risk management (TRM) in manufacturing companies, confirms the described importance, because 75% of the companies assign TRM a very high importance within the product and process development. Against the background of shown challenges, the Fraunhofer IPT developed an approach to make the assessment and control of technical risks more efficient.