Software as a medical device (SaMD) is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” SaMD is developed at a much faster pace than traditional medical devices, and may require frequent updates, as opposed to hardware devices that typically are updated every few years. While SaMD and medical devices are clearly different and evolve at completely different paces, the same regulatory approval process currently applies to both types of technology. Using the same process for both is akin to forcing a square peg into a round hole – it is not going to work because one size does not fit all, especially in healthcare.
In an effort to improve this process and foster digital health innovation, the FDA recently announced a pre-certification pilot program aimed at streamlining the SaMD regulatory approval process in response to the 21st Century Cures Act. I joined a webinar recently to learn more about the pilot’s components and goals, and ended up leaving the webinar with several questions unanswered. How will the reviews be conducted? What specific information will be reviewed and taken into account for each product? Will the industry have a chance to provide feedback or comments on the new process after the pilot is completed? What is the overall timeline to make this new process effective? The FDA’s efforts are valiant and necessary, but there is still a lot to sort out before this becomes regular practice.
Turning to Coalitions for SaMD Best Practices
While the FDA is making a concerted effort to improve the approval process and foster digital health innovation, software vendors need to pitch in to help define best practices. By collaborating effectively, we can create guidelines for ourselves that align with our needs and pace of innovation – without needing the FDA to oversee every aspect of our industry. The FDA has stated it currently does not regulate all types of SaMD. Industry coalitions, which aim to create best practices for the industry, are addressing the gap between what the FDA intends to regulate and not regulate. In addition to unifying vendors of all types and sizes, these coalitions also gather feedback from user groups such as clinicians, patient advocates, clinical societies and healthcare payers. Having a variety of stakeholders in the group enables the consideration of different perspectives and issues. This is an advantage that the FDA does not currently have as part of its review process as their focus is limited in scope.
Since coalitions allow voices from all areas of healthcare to contribute, these groups are also able to consider how products comply with other vital areas of operation that affect everyday workflow such as billing practices and HIPAA privacy regulations. By evaluating product standards from all different angles, coalitions can create solid best practices that will spur better product development. Additionally, coalitions have the advantage to be able to move at a quicker pace than FDA regulations and therefore are in closer alignment with the pace of software innovation.
The FDA is attempting to address the needs of the ever-evolving SaMD market, but coalitions with diverse interests also play a vital part in the mission to advance software in healthcare. We are experts in this space, with the knowledge and ideas that complement the speed of software innovation. As an industry, we stand ready and willing to help.
Kristen Hopewell is currently the Director of Quality Assurance and Regulatory Affairs at AirStrip. She specializes in quality assurance and regulatory compliance in the medical device industry. Kristen began her career as a Drug and Medical Device Inspector for the Texas Department of State Health Services as one of only two persons certified by the FDA to conduct inspections of medical device manufacturers. She performed many inspections under both state and federal jurisdictions. Kristen has worked in the medical device industry for over 12 years in various roles including CAPA, Regulatory Affairs, Internal / Supplier Auditing, Clinical Compliance, Risk Management / Post Market Surveillance.