LTR 112: Overcoming organizational barriers to risk management through collaboration

Summary“We still see companies having difficulty in accepting risk management as a tool for better decision making. Risk is often seen as a blocker rather than an enabler.”In this Let’s Talk Risk! conversation, host Naveen Agarwal and Brett Travaglio discuss the challenges and opportunities in risk management within the medical device industry. Key themes include cultural resistance to risk management, the importance of clear roles and responsibilities, the integration of project management principles, and the evolving role of AI in enhancing risk management practices. The discussion emphasizes the need for training and collaboration among cross-functional teams to effectively navigate the complexities of risk management in a dynamic regulatory environment.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing Brette Travaglio01:10 Organizational Barriers in Risk Management03:46 Training for Improved Team Collaboration08:34 Applying Project Management Skills for Excellence in Risk Management10:39 Improving Basic Understanding of Risk Management13:09 Navigating the Current Regulatory Chaos15:42 How AI-Assisted Reviews will Impact FDA Reviews19:17 Using AI to Prepare Regulatory Submissions24:12 Handling Device Deficiencies in Clinical Trials25:32 Using Ambient AI to Improve Healthcare Delivery26:49 Announcements, Key Takeaways and Closing CommentsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Collaboration that drives innovation, not delays.LTR: Tips for improving collaboration in risk management. ACHIEVE: FMEA Workshop.Key Takeaways* Cultural resistance is a significant barrier to effective risk management.* Risk management is often perceived as a tedious exercise.* Clear roles and responsibilities are crucial for effective risk management.* Training for collaboration is essential in cross-functional teams.* Project management principles can enhance risk management practices.* Understanding risk management standards is vital for compliance.* Companies should build internal strength to navigate regulatory challenges.* AI can provide valuable insights for risk management.* Training is necessary for effective AI integration.* Collaboration must be a conscious effort, not assumed.KeywordsRisk management, medical devices, regulatory affairs, AI in healthcare, project management, collaboration, training, quality assurance, risk assessment, industry challengesAbout Brette TravaglioBrette Travaglio is the President and Consultant for Drug, Medical Devices, Biologics and Combination Product Manufacturers at Quality Solutions Now (QSN). She has over 25 years of industry experience at leading organizations with expertise in R&D, quality, regulatory affairs, and process improvement. At QSN, she leads a team to provide hands-on project management and consulting services to drug, medical device, biologics, and combination product manufacturers. QSN’s proprietary process, qsnFLOW™, enables them to quickly deploy highly skilled professionals to tackle challenges with flexibility, scalability, and cost-effectiveness. She holds a Bachelors degree in Aerospace Engineering, and Masters in Business Administration and Industrial Engineering. Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe