Introduction
Every year, medical device, equipment and supplies manufacturers pay close attention to the FDA to look for signals about shifts in regulatory standards. 2023 is an especially unique year because COVID-19 is still impacting the medical landscape, but it is not in its peak like it was a few years ago. This year, there are a lot of anticipated shifts that could impact cybersecurity, software validation, the use of artificial intelligence and machine learning, and more. Here is what leading industry professionals are saying about what the FDA will focus on for medical device regulation in 2023:
The Growth of Software
Software is becoming increasingly important in the medical device industry, but this presents its own set of challenges. The FDA is very aware of the obstacles of regulating and approving software use, especially when it comes to software validation and digital health applications. Roz Burke, Senior Vice President of Global Quality and Regulatory at Boston Scientific, describes, “We’re optimistic about the Agency’s commitment to agility…the use of real-time, real-world data and advanced algorithms is turning traditional paradigms on their heads, and we need a more agile approach to maintain strong, effective oversight” (MedTech Dive). Because of these advanced systems, the FDA is actively reviewing ways to assess software and medical devices faster, which we will talk about more in a moment. If your organization is eager to maximize new software but struggles with issues like software validation, data management or disaster recovery, consider turning to a long-term partner like Datix. As software consultants with experience working with all of the major software applications, we can help our customers no matter what they need. At Datix, we will do what it takes to support you so you can be confident in the direction of your business.
Artificial Intelligence and Machine Learning
There are a lot of new technologies that the FDA is keeping an eye on, but two major ones are artificial intelligence and machine learning. Andrew Fish, President and CEO of the Medical Device Innovation Consortium, says:
The FDA has wrestled with how to regulate machine learning software in medical devices because its regulatory review approach is rooted in a one-time approval of a static, unchanging device that often requires a new review of any device modifications. That’s not an approach that moves quickly and doesn’t easily accommodate the great potential benefit of machine learning in medical devices in making fast-paced iterative improvements (MedTech Dive).
The FDA appears interested in adapting its review approach for the sake of supporting innovations that can help consumers. One of the guidance document priorities for the year appears to be about the use of algorithm change protocols. Such a guidance would outline types of changes which could be implemented without the need to file an additional review submission in certain circumstances (MedTech Dive). For AI/ML technologies, this type of allowance would make it significantly easier to maintain approval while fostering innovation.
Striving for Agility
The pandemic caused the FDA to face a huge amount of pressure in the medical sector. This influx of demand has decreased somewhat, but the Agency is still actively working on staffing, training and retraining its employees to stay up to date and allow for maximum agility as an organization. In addition to hiring more workers, the FDA may be considering the option of incorporating automated inspection systems into their methodology. Burke explains:
In the U.S., the FDA’s willingness to look at new technologies and rethink traditional submission periods has helped the industry to move much more quickly toward superior quality technologies. Machine-based and automated inspection have the potential to offer more robust safeguards than human inspection for certain tasks, and FDA has been thoughtful in how they validate and expedite traditional review periods in light of new technologies becoming available (MedTech Dive).
For the medical device industry, the FDA is taking specific steps to ensure they can meet application demands and keep up with new technologies. The Medical Device User Fee Amendments was recently reauthorized for five years to provide sufficient funding to support the Agency’s medical device review function (MedTech Dive).
Cybersecurity
Cybersecurity is another increasing concern for the FDA. In addition to increasing the FDA’s budget in general by 6.5%, the recently passed Omnibus spending bill expanded the FDA’s authority to enforce cybersecurity for medical devices (MedTech Dive). Agata Anthony, Vice President for Global Regulatory Affairs at GE HealthCare, explains that the increased authority “will enable the Agency to verify that new technologies submitted after the law comes into force contain cybersecurity protections, and that manufacturers have a plan to manage those devices and provide patches throughout the product life cycle” (MedTech Dive). If you need a plan for managing cybersecurity and your products throughout their product life cycle, Datix can help. With 25 years’ experience in software solutions, we understand how difficult it is to utilize your technology to best serve your organization. Our team of experts will work with you to understand your unique business needs and maximize your software.
Wrap Up
It is hard to know what 2023 will bring for the medical device industry, but it is clear the FDA is focusing on software and improving its own agility. If regulatory processes become faster, you want your organization to be able to keep up. At Datix, our experts understand the importance facilitating innovation for medical manufacturers and adapting to whatever regulatory changes the new year brings.
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About Datix
For medical manufacturers, Datix is the software consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.
