Michael Drues's guest appearances

Michael Drues

Global Medical Device Podcast powered by Greenlight Guru

The Qualitalks Podcast

Meghan Alonso

Leo Eisner

Mike Drues

Peter Sebelius

Thomas McMann

Chris Maughan

Alex Hall

Gary Saner

Ronny Bracken

Mark Swanson

Mitch Levinson

Sara Naab

Matt Romey

Therese Graff

Mike Cremeans

OwlTail

In this episode, Yan Kugel talked to Dr. Michael Drues about medicinal combination products. Michael is an internationally recognized expert and featured keynote speaker on cutting edge medical technologies and regulatory affairs.  Listening to the podcast and reading the article, you will learn:  What is a combination product? What are some examples of combination products? What are the roles of the Office of Combination Products? How are combination products assigned for review? What types of marketing applications are required for a combination product? How are adverse events reported for combination products? A Three-Step Path toward Combination Product Approval Challenges with Combination Products   Watch the video talk on Qualistery.com

In this episode, <a href="https://www.linkedin.com/in/yankugel/" rel="nofollow" target="_blank">Yan Kugel</a> talked to <a href="https://www.linkedin.com/in/michaeldrues/" rel="nofollow" target="_blank">Dr. Michael Drues</a> about medicinal combination products. Michael is an internationally recognized expert and featured keynote speaker on cutting edge medical technologies and regulatory affairs. Listening to the podcast and reading the article, you will learn: <ol> <li><a href="https://podcast.qualistery.com/?p=1879&amp;preview=true#_What_is_a" rel="nofollow" target="_blank">What is a combination product?</a></li> <li><a href="https://podcast.qualistery.com/?p=1879&amp;preview=true#_What_are_some" rel="nofollow" target="_blank">What are some examples of combination products?</a></li> <li><a href="https://podcast.qualistery.com/?p=1879&amp;preview=true#_What_are_the" rel="nofollow" target="_blank">What are the roles of the Office of Combination Products?</a></li> <li><a href="https://podcast.qualistery.com/?p=1879&amp;preview=true#_How_are_combination" rel="nofollow" target="_blank">How are combination products assigned for review?</a></li> <li><a href="https://podcast.qualistery.com/?p=1879&amp;preview=true#_What_types_of" rel="nofollow" target="_blank">What types of marketing applications are required for a combination product?</a></li> <li><a href="https://podcast.qualistery.com/?p=1879&amp;preview=true#_How_are_adverse" rel="nofollow" target="_blank">How are adverse events reported for combination products?</a></li> <li><a href="https://podcast.qualistery.com/?p=1879&amp;preview=true#aThreeStepApproval" rel="nofollow" target="_blank">A Three-Step Path toward Combination Product Approval</a></li> <li><a href="https://podcast.qualistery.com/?p=1879&amp;preview=true#ChallangesWithCombination" rel="nofollow" target="_blank">Challenges with Combination Products</a></li> </ol> Watch the video talk on <a href="www.qualistery.com" rel="nofollow" target="_blank">Qualistery.com</a>

Medicinal Combination Products - Dr. Michael Drues

We’ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does consulting for medical device companies, the FDA, Health Canada and other regulatory bodies.Today Jon and Mike talk about 510(k)s and some of the major mistakes some companies make when they get 510(k) clearance. Specifically, they talk about companies that get 510(k) clearance but don’t have design controls, risk management and don’t have a quality system.And it’s chuck full of actionable advice and takeaways.“70-75% of 510(k) and PMA submissions are rejected the first time.”  -Mike DruesThe FDA’s mission is to make sure the products we bring to market are safe and effective. The 2 areas of 510(k) submissions that are getting the most scrutiny are the substantial equivalents argument and the risk mitigation strategy. If you don’t have a rock solid argument and a bulletproof strategy you will probably be rejected. Early and frequent communication with the FDA is the key to success. “Design controls are nothing more than a synonym for prudent engineering.” - Mike DruesToday Mike and Jon talk about:When a 510(k) isn’t necessaryReasons for rejection of a 510(k)“Lead don’t follow, tell don’t ask.”Design controlsMultiple Predicate Strategy / Split Predicate StrategyRisk MitigationRegulatory checksCorrective Action/Preventative Action Plan“Physicians can kill patients one at a time but an FDA reviewer can kill patients thousands at a time.” -Mike DruesWhat can a company do if they’ve been approved for market but aren’t prepared? Conduct a gap analysis, figure out what you have, figure out what’s missing, fill in what’s missing and be upfront about it. Ask for help if you need it. Go to the experts. There is so much more we can do to help before, rather than cleaning up problems later, but, “It’s never too late to do the right thing.” -Jon Speer

We’ve got a good one for you today. In episode #8 of the Global Medical Device Podcast we welcome back Michael Drues, president of Vascular Sciences. As many of our listen may recall, Mike does consulting for medical device companies, the FDA, Health Canada and other regulatory bodies. Today Jon and Mike talk about 510(k)s and some of the major mistakes some companies make when they get 510(k) clearance. Specifically, they talk about companies that get 510(k) clearance but don’t have design controls, risk management and don’t have a quality system. And it’s chuck full of actionable advice and takeaways. “70-75% of 510(k) and PMA submissions are rejected the first time.” -Mike Drues The FDA’s mission is to make sure the products we bring to market are safe and effective. The 2 areas of 510(k) submissions that are getting the most scrutiny are the substantial equivalents argument and the risk mitigation strategy. If you don’t have a rock solid argument and a bulletproof strategy you will probably be rejected. Early and frequent communication with the FDA is the key to success. “Design controls are nothing more than a synonym for prudent engineering.” - Mike Drues Today Mike and Jon talk about: When a 510(k) isn’t necessary Reasons for rejection of a 510(k) “Lead don’t follow, tell don’t ask.” Design controls Multiple Predicate Strategy / Split Predicate Strategy Risk Mitigation Regulatory checks Corrective Action/Preventative Action Plan “Physicians can kill patients one at a time but an FDA reviewer can kill patients thousands at a time.” -Mike Drues What can a company do if they’ve been approved for market but aren’t prepared? Conduct a gap analysis, figure out what you have, figure out what’s missing, fill in what’s missing and be upfront about it. Ask for help if you need it. Go to the experts. There is so much more we can do to help before, rather than cleaning up problems later, but, “It’s never too late to do the right thing.” -Jon Speer

How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues