Eliminating Subjectivity And Guesswork With A Modernized Solution To Detecting Ear Infections

If you or your child have ever experienced ear infections, you know how difficult (and painful) they can be to diagnose and treat with prescribed medicines and procedures. Today’s guest is Ryan Shelton, CEO and founder of PhotoniCare, whose team has developed TOMi Scope, a non-invasive handheld imaging platform that uses light to see through ear tissue. PhotoniCare’s TOMi Scope looks directly at the disease, not the eardrum. Some of the highlights of the show include: ● Middle ear infection is the leading cause of hearing loss, surgeries, and antibiotic use, especially in children. ● Traditionally, an otoscope is used that results in a 50% misdiagnosis rate. ● TOMi Scope looks like the otoscope, but optical coherence tomography (OCT) images of middle ear increase accuracy, eliminate subjectivity and speculation. ● TOMi Scope is simple to use by nurse practitioners, physician’s assistants, and technicians. It’s not anymore complicated than a flashlight or magnifying glass. ● Parents and patients feel helpless due to limitations of standard care for middle ear disease. ● MedTech startups experience challenges, obstacles, successes, and barriers with fundraising, compliance, regulatory, quality, design, and testing. ● Trying to avoid being on FDA’s radar? Embrace the regulatory landscape. ● A picture is worth a thousand words, a prototype is worth a thousand pictures.

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This is MedTech True Quality Stories, hosted by Jon Speer, founder and VP of QA/RA at Greenlight Guru. Each week, we embark on a new storytelling journey with different MedTech executives as they share real-world, actionable best practices for medical device leaders. Listeners will gain invaluable insights into how these industry pioneers are successfully imagining, implementing, and improving True Quality medical devices.