Improving Patient Care at the Heart of Rhythmlink’s Medical Device Innovation

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As Columbia, S.C.-based Rhythmlink International, LLC (RLI) prepares to turn 20 years old this year, co-founder and CEO Shawn Regan is reflective on just how far the organization has come since “the early days.”

After spending more than a decade in the medical device and medical services fields, Shawn and his partners created Rhythmlink in 2002 to meet the needs of neurophysiologic end-users whom they discovered were underserved by both large and small medical device companies. Shawn’s passion to apply innovative engineering solutions to address customer needs while improving patient care and reducing medical costs set him—and Rhythmlink—on a growth path that today has reached over 325 employees worldwide and has landed the organization on the Inc. 5000 list of America’s Fastest-Growing Companies nine times.

Of greater pride to Regan is the company’s ten straight years on South Carolina’s Best Places to Work list — a testament to Rhythmlink’s culture and the commitment of the organization to valuing the contributions and talents of its associates… whatever their role.

RLI is in the business of connecting patients to machines to record or elicit physiology information. It designs, manufactures, and distributes medical devices that go on or in a patient to help monitor the brain and the nervous system to identify and prevent serious neurologic conditions such as paralysis, seizures, and strokes. Rhythmlink’s products are commonly used in operating rooms, intensive care units, and other neurological clinical settings in hospitals. The company is now recognized as a leader within its field at providing the important physical connection between patients and the diagnostic equipment to record or elicit neurophysiologic biopotentials.

Originally founded by neurodiagnostic technicians and engineers, Rhythmlink is resolutely focused on continuous innovation and delivering superior quality in all of its products – and its advancements and improvements in technology and branding have brought national and international recognition to the former South Carolina start-up.

Indicative of the company’s focus on innovative product development are two notable recent offerings developed and marketed by the company: its MR Conditional/CT Compatible Quick Connect Electrodes and its Guardian Needle Electrode.

Rhythmlink was the first company in the world to achieve FDA approval for MR Conditional EEG electrodes. Rhythmlink’s FDA-cleared MR Conditional/CT Compatible Quick Connect Electrodes help eliminate the need and cost to have staff available to remove and reapply electroencephalography (EEG) electrodes each time a patient requires magnetic resonance (MR) imaging during critical care continuous EEG monitoring, long term epilepsy monitoring or in many other situations.

Electroencephalography is the recording of brain activity (i.e., brain waves) to help identify dangerous brain activity such as seizures. Prior to Rhythmlink’s MR Conditional products, any time a patient needed to have their brain monitored and needed to get an imaging study done, caregivers had to take off the electrodes, image the patient and then re-apply the electrodes. Getting electrodes on the head is time-consuming, qualified staffing in hospitals is limited, and application and reapplication can result in skin breakdown at the site of the electrodes. Applying the electrodes once and keeping them on during a patient’s stay saves time and cost while improving patient safety.

RLI achieved full FDA clearance on its MR Conditional EEG electrodes and the Quick Connect Electrode product line built upon the previous clearance. The product can also be used in a CT without having to take the electrodes off the head and re-apply them, furthering its potential use. 

Rhythmlink’s Guardian Needle Electrode is a subdermal needle electrode designed to reduce accidental needle sticks and reduce the risk of exposure to cross contamination. Commonly used in the operating room for real-time monitoring and protection of a patient’s nervous system, this subdermal needle can be used for critical care environments, the ICU, Emergency Room or anywhere a needle electrode is called for. Additionally, the Guardian Needle combines to work perfectly with RLI’s EEG template for quick and accurate electrode placement. 

The product was originally conceived of by Medical University of South Carolina (MUSC) Health clinicians, developed by the Zucker Institute of Applied Neurosciences (ZIAN) engineers and is today manufactured and sold by Rhythmlink, a testament to the power of collaboration in medical device innovation. The effort — ten years in the making — will make the operating room a safer place for health care team members the world over.

Traditional subdermal needle electrodes are used during surgery to monitor a patient’s nervous system during dangerous cases to identify and prevent paralysis, stroke and other dangerous conditions and outcomes during surgery. The small needles can become dislodged and accidently stick health care personnel during the surgery, whereas the new Guardian needle aims to reduce or eliminate the accidental needle sticks. Following extensive talks, licensing, contribution of additional IP to the patent and obtaining FDA clearance, Rhythmlink launched the product just over one year ago.

Twenty years of hard work and growth have come and gone quickly at Rhythmlink, yet the founders’ original passion still rings true today: improving patient care is — and always will be — at the very heart of Rhythmlink’s success.

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