This time, last month, we discussed the safety-driver development process for medical devices; now let’s take a short look at how these lead to improved reliability.
Along with Safety, reliability is a key consideration for medical devices. The measures used for safety will also improve the overall reliability of the device. Some salient ones among those include using trusted suppliers, considering potential misuse of the device, and active mitigation of bad results, etc.
Similar considerations apply to risk management and security, which will be the subjects of upcoming blogs in this series.
IEC 62304 defines the steps from the beginning of the software development process through completion and maintenance, including:
- Classify the software systems based on the patient impact if they were to fail
- Define requirements for the device covering every possible aspect of its operation
- Define the software architecture and design
- Develop the device’s software units and perform unit testing
- Integrate the device components, including “Software Of Unknown Provenance,” or SOUP
- Validate that all safety requirements are fulfilled
To create a reliable solution for medical systems, it is important to address current trends while also enabling medical device manufacturers to increase the competitiveness of their offerings, reduce product development time, and minimize effort and cost in realizing an internet-connected medical device. Achieving these goals will lead to a faster and more efficient time to market.
Third-party or open-source software may be used to help realize a medical device. However, it is important to manage risks associated with their use. When integrating components into a system, it is essential to pay attention to those that were not developed internally. For life-critical systems, trusted suppliers with certified solutions to support safety requirements should be used.
The higher quality, better maintained, and better understood the software is, the more likely that risks can be mitigated. Security issues are a major concern due to increased connectivity and the value of exchanged data, making it necessary to keep individually identifiable health information safe and secure to prevent HIPAA violations and protect brand reputation.
Developing and subsequently maintaining a medical device that addresses safety issues and adheres to all possible security requirements is of utmost importance. Not only will this save costs and run a more efficient operation, but also boost the company reputation, increase quality, and ultimately, lead to higher customer satisfaction.
Read more in this white paper on Building Functional Safety and Security into Medical Devices: IEC 62304 Conformance