Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezers touched the side. Neurophysiology is a lot like that game.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Shawn Regan, CEO and Co-founder of Rhythmlink International, at the South Carolina Biosciences (SCBIO) Conference.From startup to industry leader, Rhythmlink is a company that designs, manufactures, and distributes medical devices that physically connect patients to machines to elicit or record neurophysiologic information.  Rhythmlink’s products are used during risky surgeries to help prevent or reduce paralysis, identify tumors, map the nervous system, and monitor brain waves. Its devices were the first of their kind to be cleared by the FDA to work specifically in MRIs.Some of the highlights of this episode include:Shawn describes neurophysiology as electrodes put on or under a patient’s skin to monitor their nervous system in real-time to identify dangerous situations.As a startup, Rhythmlink recognized the need to change from reusable to disposable products. Although the company did not know when that was going to happen in the medical industry, they knew it would and why.Early on, Rhythmlink experienced several challenges as a medical device company. It didn’t have any money, patentable technology, or intellectual property (IP). Co-founders had an idea, figured out how to create it, and bootstrapped it. Collaborating with the FDA 20 years ago was easy and straightforward. Rhythmlink wanted to know how to submit a 510(k) to get FDA clearance.Rhythmlink’s electrodes can be put on and left on during an imaging study to allow the brain to be monitored more often, which results in much better clinical information quicker and consistently to find and treat dangerous situations.Rhythmlink decided to automate some of its products because shipping rates changed, led to higher quality products, and customers liked the products better.Rhythmlink makes its products in China and sells its products in the United States, European Union (EU), and nine other countries.Cost-Benefit Analysis: Rhythmlink’s regulatory strategy is to identify all the different regulatory requirements for all the different countries the company wants to be in and make sure there is enough of a market to be worthwhile.Memorable quotes from Shawn Regan:“If you remember the game operation when you touch the side and the nose buzzes and goes off, it really is a lot like that.” “With our electrodes, the ability to put the electrodes on once and keep them on and leave them on during an imaging study allows the brain to be monitored more often.” “You get much better clinical information quicker and consistently all the time. So, you’re able to find those dangerous situations and then treat them.” “For our products, not every country has made the switch from reusables to disposables. All of the products that we make are disposable products, none of them are reusable at this point.” Links:RhythmLinkShawn Regan EmailSouth Carolina Biosciences Organization (SCBio)South Carolina Research Authority (SCRA)FDA - Medical Device OverviewCenters for Medicare & Medicaid Services (CMS)Plan, Do, Check, Act (PDCA) CycleEuropean Union Medical Device Regulation (EU MDR)EU Medical Devices Directive (MDD)The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email