Today’s guest is Mike Drues, the president of Vascular Sciences and a world-renowned expert on all things pertaining to regulatory topics in medical device development and production. Mike is a frequent guest, so I’m sure you’ve heard them talk about various regulatory and design topics in the past.
Today they are actually going to be giving you a sneak-peek of subjects that both Jon Speer and Mike Drues will be talking about live at MD&M East in New York on June 14. They'll be talking about when design inputs go wrong, as well as designing your labeling like you design your device.
Some of the highlights of the show include:
- What design inputs are and why they are important.
- Who comes up with the design inputs and why it’s a mistake to rely only on the technical people to create the elements of the device.
- Why it might be inaccurate to say that a clinician knows exactly what they need in terms of a device design, as well as why it’s vital to ask the right questions of clinicians.
- The importance of thinking ahead to the verification and validation processes during your design process.
- Why companies need to spend more time designing their labeling.
- What labels need to include and why it’s so important to carefully consider everything that goes on it when you create your design.
- Using caution when determining what the FDA says about advertising off-label uses of a product and how a mistake in this area could end up involving the FBI in addition to the FDA.
“The underlying assumption is that the end user actually knows what it is that they need. I’ve learned not to make that assumption.”
“Answers are only as good as the questions that we ask.”
“Companies and engineers spend a lot of time designing their physical widget, but they don’t spend very much time designing their labeling.”
“It’s not what you say that matters; it’s what people hear.”
About The Global Medical Device Podcast:
The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.