The development and current status of Medi SPICE

There is increasing demand for effective software process assessment and improvement in the medical device industry. This is due to the expanding and complex role that software now plays in the operation and functionality of medical devices. This paper outlines the development and current status of Medi SPICE a software process assessment and improvement model which is being developed to meet the specific requirements of this safety-critical domain. This includes the selection of the most appropriate software process improvement model on which to base Medi SPICE. Its initial development and restructuring to conform to ISO/IEC 15504-5:2012 and ISO/IEC 12207:2008. The structure and content of its process reference model is outlined and an industry based trial assessment of 11 of its processes discussed. Current and future work is considered including the timeframe for the release of a full version of the Medi SPICE model

Pacing technology: advances in pacing threshold management

Over the last five decades, pacemaker therapy has undergone remarkable technological advances with increasing sophistication of pacemaker features. However, device longevity has remained one of the major issues in pacemaker design ever since the first endocardial pacing lead implantation in 1958. In addition to various hardware design to enhance device longevity, software-based solutions to minimize pacing energy and yet with good safety margin have also been developed. Together with desire and need of fully automatic pacing system in increasingly busy pacemaker clinic, several manufacturers have introduced different automatic threshold management algorithm. This article summarizes the current state-of-the-art management in pacing threshold in the modern pacemakers