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This talk on Configuration Engineering (= Configuration Management for Platform development) will discuss challenges, solution approaches and engineering experiences in invitro-diagnostic (IVD) product development. CE is an emerging discipline in various industries (such as medical devices, automotive, avionics/ space, …) which has developed from Configuration Management practices for single products. Further, examples presented will highlight the underlying CE concepts as well as address tool issues including observed benefits over the introduction.
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Medical device development is increasingly under market pressure to reduce deployment in critical care facilities. Further, budget cuts in critical care facilities drive process innovation mostly realized through a holistic integration of IT systems (hospital information systems, PACS and modalities). One important leverage to reduce development cycle time is to introduce learn/ agile requirements engineering approaches. Traditional V-model based development processes cannot cope with the pressure from the market. Given that the content of software in medical device has risen bigger than 60% (compared to 30% by end of the ‘90s), lean/agile RE is becoming a paramount discipline for a development organization to remain competitive. Our own experience and an underlying business case show concrete cost savings in the project planning, testing and complexity reduction of the imaging platform architecture. A comparison of traditional to learn/ agile requirements engineering rounds up the picture including key takeaways.
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