The medical device industry has long relied on hydrogel electrodes, but this technology has inherent limitations: it dries out, requires costly packaging, and can cause skin irritation. Enter FLEXcon’s OmniWave—a dry electrode that is redefining what’s possible for medical wearables. Recently, we had the opportunity to speak with Amit Roy, Business Development Manager at FLEXcon, about the development and benefits of OmniWave.
1.What is OmniWave?
OmniWave is a dry adhesive electrode that solves many of the challenges associated with hydrogel technology. “Hydrogel requires expensive barrier packaging because it’s water-based and needs to stay wet. With OmniWave, we’ve eliminated the need for any packaging, drastically reducing costs and waste,” explained Amit.
2.Clinical Performance and Patient Comfort:
In a clinical trial conducted at UMass Memorial Hospital, patients overwhelmingly preferred OmniWave over traditional hydrogel electrodes. One key reason? Comfort. “Hydrogel electrodes can cause irritation, and at least 8% of patients are allergic to them. OmniWave showed no signs of such irritation,” Amit shared.
This breakthrough in comfort is critical, especially as medical devices become more integrated into patients’ everyday lives, requiring long-term wearability without discomfort.
3.Increased Efficiency for Manufacturers:
One of the standout benefits of OmniWave is its impact on manufacturing efficiency. Hydrogel rolls are typically around 300 feet long, but OmniWave can be produced in rolls up to 3,000 feet—ten times the length. This drastically reduces downtime in production. “You don’t have to stop and start as frequently, and there’s no need for specialized storage like freezing,” Amit explained.
Additionally, OmniWave can be laser-cut, which is impossible with hydrogel. This flexibility makes it a more versatile option for manufacturers.
4.Diverse Applications for OmniWave:
Although OmniWave was initially developed for ECG applications, its potential goes far beyond. “We’ve seen it used in everything from diagnostic devices to EDA (electrodermal activity) monitoring and muscle health assessments,” Amit noted. Other groundbreaking applications include detecting internal bleeding post-surgery and even shrinking tumors through electrical stimulation..
5.Regulatory Compliance and Safety:
OmniWave meets the highest standards for safety and regulatory compliance. It has passed ISO 10993 for sensitization and irritation and complies with the AAMI EC12 standards for disposable electrodes. FLEXcon already has customers using OmniWave in FDA 510(k) approved devices, with more on the way.
Conclusion:
FLEXcon’s OmniWave is poised to be a disruptive force in the medical wearables market. By addressing the limitations of hydrogel, OmniWave offers superior performance, comfort, and cost savings. As more medical device manufacturers adopt this technology, it’s only a matter of time before OmniWave becomes the new standard for dry electrode applications.