What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to regulatory affairs professionals and regulatory affairs attorneys? Those are just a few of the items covered in today’s live discussion with Mark DuVal.
Mark is the founder and president of Duval & Associates. He’s been in healthcare marketing and advertising for over 20 years and is a leading expert in medical device promotion. In today’s episode, you’ll learn his tips for creating “appropriately aggressive, yet compliant” ad campaigns. Learn from Mark’s expertise as he discusses the four buckets of knowledge for information sharing, the different perspectives between regulatory and legal, and how to think about the information provided with a medical device.
Some of the highlights of this episode include:
- The difference in perspectives between a regulatory affairs professional and a regulatory affairs attorney
- Best recommendations for regulatory affairs professionals when approaching off-label
- Examples of when the dissemination or communication of on and off-label information comes into play
- General and specific use, and being specific with your indication for use
- Whether a case study could be built around a physician’s off-label use
- How compliance monitors sales for off-label promotion
- Ad promo enforcement action
Memorable quotes from Mark DuVal:
“The regulatory affairs professionals are, a lot of times, they’re biomedical engineers and scientists, and they are much more steeped in the medicine and the science as we would be as lawyers.”
“It’s kind of a mantra I make everyone repeat when I do a training exercise – I make them repeat after me, truthful, not misleading, fairly balanced.”
“You have every right to participate in social media. But again, you’re still regulated.”
“We don’t feel people should unnecessarily leave money on the table, nor should they foolishly aggravate FDA and receive a warning letter and get told to cease and desist.”
“When you’re in the trenches day-to-day, trying to convince them to use something that’s real-world data is work. It can be done, though!”
Links:
Mark DuVal
DuVal & Associates
Cardiac Arrest: 5 Years as a CEO on the Feds Hit List (book)
Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers
Washington legal foundation case
General/Specific Intended Use - Guidance for Industry
Etienne Nichols LinkedIn
Greenlight Guru
