Global Medical Device Podcast powered by Greenlight Guru The Best of Jon & Mike Through the Years
Today’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31st.
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’ve 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.
Some of the highlights of this episode include:
- How Mike and Jon met
- Interpreting regulations
- Communicating with the FDA
- FDA plans to modernize 510K
- Developing a regulatory strategy
- The most important thing to remember
- Understanding all your pathways to market
- Usability testing and how it applies in the real world
- The Emergency Use Authorization for medical devices
Memorable quotes from Mike Drues:
“When the rules make sense, follow them, but when they don’t make sense should we follow them?”
“Regulation is about two things: it’s about the interpretation of words and our ability to defend our interpretation.”
“You need to know what all of your options are.”
“Tell don’t ask, lead don’t follow.”