Authentication Software as a Medical Device (SaMD) All You Need to Know

Software development has stimulated a new era of the healthcare industry as compared to the scenario 20 years back. Medical device manufacturers and life sciences companies have earlier been skeptical of integrating or automation into processes. However, that has changed drastically as Software has now become a ubiquitous trend in the healthcare industry.

For instance, treatments including insulin pumps and pacemakers were heavily reliant on physical devices incorporated with Software to run smoothly. Now, these devices run simply via Bluetooth. Cochlear implants are a good example of Bluetooth-enabled devices. The rapid adoption of digitization across medical devices has led to emerge as a medical device itself.

Proper authorization of Software is crucial in ensuring compliance, regulatory aspects, patient safety, and product quality. SaMD is therefore undergoing a systematic process monitored by government agencies to determine the regulatory factors. The United States Food and Drug Administration deployed the Artificial Intelligence and Machine Learning-Based SaMD Action Plan. However, this strategy displays compromised validation.

Medical device companies should much rather focus on validating specific areas posing the highest risk instead of all functionality of a Software. According to the FDA, the highest risk components that need to be addressed are the ones affecting patient safety and product quality.A proposed solution is the utilization of a continuous integration or continuous deployment (CI/CD) approach. It will allow fixing the weak areas of code quicker and is functionally enhanced with the application of AI. FDA’s CDRH plans on updating the CSV, replacing it with CSA.