Quality, timeliness and reliability in software medical devices-experience

Quality, Timeliness and Reliability are key parameters to meet the business goals of any organization. Each parameter plays an important role in terms of making the product effective, reliable and is released to market for use on time. Quality, Timeliness and Reliability (QTR) are the most important KPIs (key performance indicator) used for improving operational excellence. Various measures (e.g. schedule variance, defect density, rework effort etc.) are used to improve predictability and ability of products in meeting time to market with required quality and reliability. In a regulated industry like medical devices, it is important to ensure high degree of Quality and Reliability as they touch human lives. Timeliness or time to market is not just important from the business perspective but also from end user perspective as the primary intent of any medical device is to improve health and well-being of people. There are some studies for systematic approach to achieve reliability goals in software intensive medical devices, however research on achieving overall QTR at both product as well as Organization level specifically for software intensive medical devices is not well covered. In this paper, a systematic approach to define and achieve QTR (Quality, Timeliness and Reliability) goals in software medical devices is developed.