Requirements Management is key to success in many industries, however it is even more so the case with the medical industry. This is due to the exponentially growing complexity of medical devices, with many of the medical devices produced today applying high technology including: nanotechnology, advance electromechanical and robotics elements. These medical devices all have one thing in common in that they include sophisticated software systems that govern the device, like a modern computer.
The first step is to define the requirements of those complex hardware software systems. After this, all the complex behavior of medical systems has to be understood in order to fulfill functional safety regulation and customer requirements. Furthermore companies have to estimate what level of effort will be required to develop and produce the system, to mitigate risk and produce it efficiently. By answering these fundamental questions, a precise definition of requirements can be made during the design phase of medical device.
The Requirements management process has to focus on the definition of complete/correct/feasible and prioritized requirements in the early stages of the development ideally in the design phase. Full traceability of requirements is the key for a successful implementation.
The benefits of Requirements Management are as follow:
- Reduced risk of health critical failures and ensure better compliance to standards.
- Cost savings during production and maintenance processes – There is strong evidence that effective requirements management leads to overall project cost savings. Requirements errors that remain undetected until test or deployment, for example, typically cost well over 10 times more to repair than other errors. The sum of these costs demonstrates that companies cannot afford to ignore the benefits of improved requirements management. The cost associated with repairing the requirement error increases drastically as the project moves further along in the process.
- Achieve better collaboration with the involvement of clients at the design phase, this greatly improves the likelihood that the product meet their needs, and as a byproduct, they will be more engaged in the process by having a higher level of understanding and direct input into the decision making process.
- Full traceability and requirements based verification. Requirements properly managed across the whole lifecycle of production results in traceability and transparency on all changes, and can also ensure that the testing and verification of all requirements are made before deployment.
codeBeamer ALM software solution provides improved Requirements Management for medical device producers. Intland Software also provides a medical project template to support IEC62304 compliance, by covering requirements management-software development and QA Test processes. The medical project contains customized risk management functionality as well.