{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F3a2566fb-4e81-4eb9-9406-80b990be1867","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"The Best of Jon & Mike Through the Years\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/3a2566fb-4e81-4eb9-9406-80b990be1867\"></iframe>","title":"The Best of Jon & Mike Through the Years","description":"<p>Today\u2019s episode is a little different than usual. This will be Jon Speer\u2019s last podcast for Greenlight Guru, as he\u2019ll be moving on to future ventures as of December 31st.</p><p>In honor of many podcast episodes featuring Jon and Mike Drues, this episode is a tribute to some of the best episode topics that the two of them have tackled. They review some of their favorite episodes and throughlines of their discussions throughout the time they\u2019ve been podcasting together. Listen to Jon and Mike discuss how they met, which episodes stuck out for them, and what thoughts they want to leave the audience with.&nbsp;</p><h3>Some of the highlights of this episode include:</h3><ul><li>How Mike and Jon met</li><li>Interpreting regulations</li><li>Communicating with the FDA</li><li>FDA plans to modernize 510K</li><li>Developing a regulatory strategy</li><li>The most important thing to remember</li><li>Understanding all your pathways to market</li><li>Usability testing and how it applies in the real world</li><li>The Emergency Use Authorization for medical devices</li></ul><h3>Memorable quotes from Mike Drues:</h3><p><em>\u201cWhen the rules make sense, follow them, but when they don\u2019t make sense should we follow them?\u201d&nbsp;</em></p><p><em>\u201cRegulation is about two things: it\u2019s about the interpretation of words and our ability to defend our interpretation.\u201d</em></p><p><em>\u201cYou need to know what all of your options are.\u201d</em></p><p><em>\u201cTell don\u2019t ask, lead don\u2019t follow.\u201d&nbsp;</em></p><h3>Links:</h3><p><a href=\"https://www.linkedin.com/in/jondspeer/\" rel=\"noopener noreferrer\" target=\"_blank\">&nbsp;Jon Speer LinkedIn</a></p><p><a href=\"https://www.linkedin.com/in/michaeldrues/\" rel=\"noopener noreferrer\" target=\"_blank\">Mike Drues LinkedIn</a></p><p><a href=\"https://www.greenlight.guru/academy\" rel=\"noopener noreferrer\" target=\"_blank\">Greenlight Guru Academy</a></p><p><a href=\"https://community.greenlight.guru/\" rel=\"noopener noreferrer\" target=\"_blank\">MedTech Excellence Community</a></p><p><a href=\"https://www.greenlight.guru/\" rel=\"noopener noreferrer\" target=\"_blank\">Greenlight Guru</a></p><p><br></p>","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/027515d4-aa2f-4fb0-a248-d47daa673bd7/9785476b-2a29-4578-b392-be121c9e2734.png"}