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FDA Reduces Regulatory Barriers

Written by Nicholas Lesniewski-Laas, Sr. Director of Sunrise Systems

FDA Reduces Regulatory Barriers

The new FDA guidance maintains design standards but lowers regulatory barriers, making it a good time to enhance medical devices by adding connectivity and smartphone interfaces.

The FDA reduced regulatory barriers for remote patient monitoring devices during the COVID-19 crisis

On June 02, 2020, the FDA released a guidance document dramatically reducing regulatory barriers to designing and deploying in-home medical monitoring devices to help alleviate high hospital utilization and potential infections while at the hospital. This enables medical device manufacturers to modify physiological monitoring devices to include remote monitoring capabilities or to adapt their hospital-use devices for in-home care. Over the last few years, we have seen the medical devices market shift to more in-home care and monitoring. This announcement from the FDA is likely to accelerate this trend. Sunrise Labs has helped many medical device manufacturers expand their product portfolios into the in-home market and hopes to help address the COVID-19 crisis by enabling medical device manufacturers to rapidly address the changing market needs. We advise that firms evaluate the opportunity that this FDA announcement presents with their regulatory experts in regards to getting their medical device FDA approved.

The novel coronavirus pandemic has changed the way we live, the way we work, the way we socialize, and the way we manage our healthcare. Many in-clinic services, such as routine physicals, cancer screenings, and other preventative care measures have been nearly eliminated during this public health emergency. The reduction in preventative care is due to limited hospital capacity and the fear of infections while at the hospital. The delay in addressing non-COVID-19 issues may also be hurting overall public health. The public health emergency is expected to last for months, maybe even more than a year, during which time patients may suffer and even die from health issues that could have been prevented with proper preventive care.

In response to this very serious concern, the FDA released a number of guidance documents detailing relaxed enforcement policies for devices that address remote healthcare needs. One of the recent policy updates (https://www.fda.gov/media/136290/download) opens the door for medical device manufacturers to modify physiological monitoring devices to include remote monitoring capabilities or to adapt their hospital-use devices for in-home care. This new policy applies specifically to a range of non-invasive monitoring devices related to respiratory, cardiovascular, and neurological monitoring, and includes oximeters, cardiac monitors, EEG, and thermometers. The FDA’s goal is to create an ecosystem of tools that combat the COVID-19 threat while also reducing the need for in-clinic visits.

This new policy enables medical device manufacturers to quickly adapt their devices for in-home remote patient monitoring and eliminates the often significant delays associated with gaining regulatory clearance. The policy allows for a broad range of product modifications, including form factor changes for usability, hardware and software changes to enable Bluetooth or Wi-Fi communications, new smartphone apps, and new cloud data management infrastructure. The policy also allows modification to existing indications, claims, and functions; however, the policy only allows modifications that do not pose an undue risk. The FDA provides some examples of what does and does not constitute an undue risk.

Years ago, Sunrise identified remote monitoring as a technology area that was ripe for growth and invested in developing tools and know-how for end-to-end remote monitoring systems. This investment proved wise because the industry shifted so strongly in this direction that it seems like all new medical devices include either Bluetooth or Wi-Fi connectivity, store and process data in the cloud, and communicate to the user through their smartphone. Sunrise is also aware that some medical device manufacturers have not yet added connectivity to their devices because the barriers to adding all of this infrastructure, both technical barriers and regulatory barriers, are so high. The new FDA guidance does not reduce the design requirements, but reduces the regulatory barriers significantly, making this a good time to improve the usability of medical devices by adding connectivity and smartphone app interfaces.

Whether adding an app or just modifying a hospital-use device for in-home care, the biggest challenge is likely to be usability engineering per IEC 62366. Adding connectivity and an app dramatically affects how the user interacts with the device, creating new workflows that need to be designed and tested. Similarly, many hospital devices are designed to fit into workflows familiar to trained technicians. When updating these devices for a home setting, the user is likely to change to an untrained patient with different workflows and different foreseeable use errors.

In addition to the significant usability challenge, electrical and mechanical changes are likely required to support the new user modes. From an electronics standpoint, adding basic Bluetooth LE or Wi-Fi capability is relatively straightforward with pre-qualified off-the-shelf modules; however, adding high-speed digital and RF components to the system has implications on EMC and may affect other subsystems such as precision analog front ends. Additionally, the electrical and mechanical design updates need to be tested against the 60601-1 family of safety and EMC standards, including 60601-1-11 for the home healthcare environment. IEC 60601-1-11 has stricter requirements because a user’s home is a less controlled environment than a hospital.

Software updates will also be required, ranging from minor UI edits to adapt a hospital device for in-home care, to a major software effort to add connectivity, an app, and cloud-based data management. Importantly, adding connectivity to a device requires careful consideration for cybersecurity at all levels of the software stack.

Sunrise Labs regularly designs in-home wireless remote health monitoring devices, with associated apps and back-end or cloud services. Sunrise Lab’s User-Centered Design Group are experts at navigating the usability and human factors issues presented by connected devices. Similarly, Sunrise’s systems, software, electrical, and mechanical engineers have extensive experience developing and deploying connected medical devices and associated apps. Sunrise’s medical device design team is very cohesive and effective, enabling rapid design iteration and a shorter time to market. Please contact us today to learn more. Our team members are experts in navigating the issues associated with MedTech at home, and we are passionate about improving patient care!

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