Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

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Episode 246 • 16th February 2022 • Global Medical Device Podcast powered by Greenlight Guru • Greenlight Guru + Medical Device Entrepreneurs

They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emotions. But what can the eyes reveal in a neurological sense, particularly when tracking abnormal eye movement?

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Scott Anderson, Chief Clinical Officer (CCO) at SyncThink about the groundbreaking work the company is doing in advancing neurological assessments by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.

You’ll hear how Scott went from his position as Head of Sports Medicine program at Stanford University, where he was part of a multidisciplinary research collaborative studying the natural history of head injuries. Though the technology was initially developed to aid in concussion protocol and the clinical care of athletes with head injuries, the potential of EYE-SYNC technology is now used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.

Some of the highlights of this episode include:

SyncThink specializes in neurological assessment by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.
Besides concussions, EYE-SYNC technology is used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.
Verbal or motor actions are the result of real-time brain function using the eyes to orient yourself to what’s happening and respond in real-time. Neurological deficits in performance occur across one’s lifespan due to disease or impairment.
SyncThink’s EYE-SYNC technology has the potential to proactively prevent health problems in the future. It could facilitate the migration of hospital-based care to consumer-based driven care to preserve brain health.
If used as a surveillance or monitoring tool, EYE-SYNC can identify improvement in brain function based on medication deployment. It helps clinicians learn to better titrate medication to specific individuals, such as children with ADHD.
Scott admits that he faced logistical challenges and obstacles when doing clinical trials to get the first FDA clearance for following concussion patients.

Memorable quotes from Scott Anderson:

“There’s a whole host of neurological disorders that have a high prevalence of abnormal eye movements associated with it.”

“Your eyes actually serve as the window to the brain. It allows you to orient yourself to the things that are happening around you.”

“Your brain uses your eyes to select content it wants to interact with.”

“Our bread and butter is the software and analytics and the eye tracking measurement, and there’s a whole host of these cases for this.”

“As technology evolves, too, as well, there will be, I think, several opportunities in order to accelerate the clinical utility of something like eye tracking for a whole host of neurological conditions.”