Eliminating Subjectivity And Guesswork With A Modernized Solution To Detecting Ear Infections
This is a podcast episode titled, Eliminating Subjectivity And Guesswork With A Modernized Solution To Detecting Ear Infections. The summary for this episode is: 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.
Quality in the Medical Device Industry