Cybersecurity has become a major concern over the years as technology has advanced. Device manufacturers are searching for ways to keep security up to date with the demand for stricter scrutiny for users and patients alike. There are no particular processes as specified by current safety standards and regulatory guides such as IEC 62304; this lack is meant to give developers the flexibly to find the most efficient processes dedicated to their products, so long as they meet standards.

 

The approach to developing safer and more secure software heavily overlaps with the current required models for hazard and risk management that are already practiced by medical device manufacturers. Through this process, the level of potential harm a medical device may pose becomes clearly defined and assessed. Sterling’s hazard analysis processes look at both top down and bottom up approaches to consider every possibility of cause and effect through the entire lifecycle. Sterling also uses software FMEA risk management in conjunction with the additional measures required of ISO 14971 to create secure systems.

 

The reapplication of safety hazard analysis to cybersecurity is regarded as security vulnerability management of a software’s functions and designs. These enhancements are made while considering the extent to which security should be specifically integrated into the device, as well as the external practices during development, production, and use. Specific functions are algorithmically developed to monitor and detect where vulnerabilities appear, in addition to what kind of risks they pose, and what software updates may be necessary. Additional hardware components can be embedded into devices to create external system-on-chip architectures. Following the exposure of vulnerabilities, each is assessed for mitigation and rehabilitation, which returns to the guidelines set by existing regulations. Archival systems aid in creating references when compiling the required documentation for verification and validation at the end of production.

 

Although it can be intimidating to attempt to regulate innovations that are constantly changing, it is important to maintain composure. By staying focused and recalling the standards that have been set for medical device development for years, as well as reaching out to experienced consultants like Sterling, a fluent transition into cybersecurity is ensured.