“It’s important to make things clear and also look at it from the lens of public health not just from the lens of business.” – David Rutledge
“Don’t let the place you begin dictate the place you end up” – David Rutledge
My guest on today’s podcast is David Rutledge. David is a Regulatory Affairs Director at Abbott Vascular.
David is an expert in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) which form the foundation of medical product approvals and license renewals worldwide.
In his previous role as a Clinical Research Director, David has led publications strategy for Abbott’s medical products including the blockbuster XIENCE V drug eluting stent. David has also served on the FDA advisory committee for four years prior his industry experience.
David is my go-to person for advice on interpretation of Meddev regulations and the Medical Device Regulation (MDR). He is also a regulatory and quality expert presenting at many conferences and providing input on draft regulatory guidance documents.
Enjoy my interview with David!
Selected Links from the Episode:
- Connect with David Rutledge
- Six Sigma
- CFDA demonstrates the wisdom of Confucius. He said, “By three methods we may learn wisdom: First, by reflection, which is noblest; Second, by imitation, which is easiest; and third by experience, which is the hardest.”
- Food and Drug Administration
- Harvard Business Review
Books Mentioned:
- Simple: Conquering the Crisis of Complexity by Alan Siegel and Irene Etzkorn
- Steve Jobs by Walter Isaacson
- Chess Not Checkers: Elevate Your Leadership Game by Mark Miller
- The Art of Asking: How I Learned to Stop Worrying and Let People Help by Amanda Palmer
- Kiss, Bow, Or Shake Hands: The Bestselling Guide to Doing Business in More Than 60 Countries by Terri Morrison and Wayne A. Conaway
Show Notes:
[09:45] How to pierce through clinical study reports and making insightful comments
[17:05] About Six Sigma certification
[21:59] Three basic skills that will make you a better CRO or medical writer
[31:05] Developing competency in quality systems
[34:40] Paying for certifications and training
[37:00] Guidance for productive one-on-one meetings with managers
[40:18] Learning from the mistakes of others
[42:41] Keeping current with latest developments in clinical research industry
[52:20] Working in China and the CFDA
[1:02:45] Taking ownership of your career
QUESTION: What was your favorite lesson from this episode?
Leave me a comment below and thanks for listening.
6 Thoughts on "CTP 001: Becoming an Intelligent Clinical Researcher with David Rutledge"
Velma Priest
August 18, 2017Thank you Kunal for asking insightful and inquisitive questions. David shared his vast knowledge and great ideas on overcoming obstacles through learning, patience and understanding. My favorite part was learning how David’s personal tips and tricks worked for him. Thank you David for sharing your experiences.
Kunal Sampat
August 18, 2017Awesome Velma. I’m glad to hear you found this interview with David of much value.
Weiying Zhao
August 27, 2018Thank you, David and Kunal. It was a great interview. The story of the dinner toast was very inspirational. Living in the global environment, it is important to show our respect and appreciation of difference culture and history. I am very impressed by how David took the extra steps to connect with local people from a different culture. Thanks for sharing such a great story.
Kunal Sampat
August 27, 2018Hey Weiying! Glad you enjoyed this special episode with David. Thanks so much for the kind words. I continue be to amazed and humbled David’s story. Thanks for tuning in 🙂
Venky Mutyam
July 16, 2020Kunal, Thanks for this amazing interview. Thoroughly enjoyed David’s insights. Lot of powerful quotes. Few that stood out for me were-” You need to be responsible for your own development and invest in it”. “Learn to reflect from the mistakes of others and be observant”. ” Don’t underestimate the power of just talking to people”
Kunal Sampat
July 18, 2020Thank you, Venky for sharing your insights from David’s interview.