Device description
The Nuubo System provides non-invasive, remote electrocardiograph (ECG) patient monitoring. It consists of three core components: the NuuboREC—a wireless medical device that registers the ECG data; the Nuubo30—a wearable textile that senses the ECG signal from the patient's skin and houses the monitoring device; and the Leonardo software—a program that facilitates healthcare professionals' related data analysis and management.
Challenge
Apply HF expertise to confirm that the Nuubo System and its associated instructional materials meet users' needs in a manner consistent with FDA's expectations (i.e., ensuring its use-safety and effectiveness). Additionally, evaluate the system's electrode performance according to terms described in the ANSI AAMI EC 12 standard.
Notably, the independent use by patients (i.e., without healthcare professional supervision) of the Nuubo System presented an even greater challenge from an HF perspective. The HFE process required design and research teams to collaborate to build a device that not only performed accurately, but also served as one that patients could operate safely on their own. The complexity increased when considering the intended patient's age (e.g., elderly population) as well as other potential physical and cognitive disabilities.
Solution
First, we conducted an expert review of Nuubo's instructional materials with a focus on identifying strengths and opportunities for improvement. Next, we drafted an HF validation test protocol, which we then executed during a series of pre-HF validation testing as well as HF validation testing. During these tests, we evaluated representative patients', caregivers', and healthcare professionals' interactions with the system, including tasks such as textile application and data comprehension.
Following the HF validation test, we also conducted two supplemental studies of the system to evaluate the recording quality of the system's electrodes. Specifically, lay patients wore the wireless cardiac monitoring device for a period of 12 hours either during the day or overnight. Following the recording period, we leveraged the system's Leonardo software to evaluate the electrodes' overall performance.
Impact
Following our close collaboration with Nuubo between 2016 and 2018, FDA issued 510(k) clearance of the Nuubo System in August 2018.
Trust built on industry knowledge and first-hand experience
“As a small startup with no experience in HFE regulations, UL was the right partner to help us go one step at a time and successfully complete our FDA submission. The learning from the process has proven critical in the market, as now more than ever before, the product's usability is key for hospitals to adopt your product. UL's capability to adapt to a startup company was impressive.”
Nuubo®
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