The Impact of Fuzzy Requirements on Medical Device Software Development

Any software development project can experience difficulties with unclear or vague requirements. Unfortunately, this problem can be experience two fold in regulated environments such as the medical device software development industry. In the medical device software development industry, development organisations must contend with vague or “fuzzy” both the customer and regulatory bodies. As new requirements are introduced they can have a knock on effect on other requirements. These requirements should be analysed to determine if they are conflicting, cooperative, mutually exclusive and irrelevant. Only when the requirement is classified can a clear method be established as how to integrate that requirement with previous ones. Medical device software organisations could benefit from understanding the impact of fuzzy requirements as it could result in reduced rework at a later stage in the project.