Dear colleagues, hello! 👋
As we close on 2023, I want to take a moment to reflect on what we have accomplished so far and where we are headed in 2024.
Let’s Talk Risk! started in March of this year with a simple premise - when we connect and share, we all learn and grow together. The core idea behind Let’s Talk Risk! is to build a collaborative platform where risk practitioners feel safe and inspired to connect with each other, and openly share their unique perspectives and insights on risk-related topics. This is the best way to help elevate our collective capability in risk management, so we can significantly improve patient safety, accelerate innovation and reduce cost.
This is how we can best serve our patients and doctors, while also making a significant contribution to business goals.
We have come a long way in a short span of just 9 months! Our weekly Let’s Talk Risk! conversations on LinkedIn are connecting colleagues from all over the world as we share insights and perspectives on risk-related topics in a very casual and informal way. The spirit and intent of these conversations is nicely captured by Christie Johnson below, a frequent attendee herself, and a past guest speaker in one of our LTR conversations.
Our weekly newsletter is now read by a highly engaged, and rapidly growing community of over 1300 risk practitioners worldwide. We have published over 175 articles, now available in the archive section of the Let’s Talk Risk! website. We are gradually building a knowledge repository of lessons learned, practical tips, industry news, and case studies to help advance the practice of medical device risk management.
In August 2023, Let’s Talk Risk! began offering paid subscriptions to support a more dedicated, full-time focus on content development and community building. A vast majority of content continues to remain freely available to all subscribers but paid subscribers have access to premium content, exclusive monthly webinars and deep discounts on training courses on ACHIEVE. At less than $1 per article, and indirect cost savings of nearly $500 each year, paid subscriptions offer a great value while also providing an opportunity to support our the Let’s Talk Risk! mission.
Please consider upgrading your subscription today to help us continue building the Let’s Talk Risk! community and this valuable resource. Your support is essential to sustain these efforts and fuel our growth in 2024.
Group subscriptions are available at a discounted rate, and students receive a 50% discount on annual subscription.
The road ahead in 2024
A significant development in 2024 is expected to be the final rule by the US FDA that will transition the current Quality System Regulation (QSR) to a more risk-focused Quality Management System Regulation (QMSR). This will have a significant impact on medical device manufacturers in the United States, and those planning to gain access to the US market.
Let’s Talk Risk! is well positioned to help practitioners identify and bridge gaps at various interfaces within their Quality Management Systems (QMS) as they prepare for this transition. We will continue to share practical insights in case studies based on warning letters, recalls and other FDA actions. We will also focus on building a deeper understanding of risk management principles and best practices for integration within a QMS through Let’s Talk Risk! conversations and webinars.
Artificial intelligence and machine learning (AI/ML) will continue to advance rapidly, leading to development of software-based, smart medical applications. Software risk management, including information security and cybersecurity, will significantly challenge manufacturers in the currently uncertain, but rapidly evolving, regulatory environment. We will monitor industry trends, best practices, and regulatory developments next year to help you stay ahead of the curve to tackle these challenges and benefit from new opportunities they offer.
We also plan to launch a monthly podcast feature where we will record in-depth conversations with leading industry voices to provide deeper insights on key topics of interest.
Finally, we will continue growing the Let’s Talk Risk! community through our weekly conversations on LinkedIn. If you would like to help us grow, please refer your friends and colleagues to join our community. Each referral helps you earn rewards such as complimentary access to premium content. Click the button below to get your special referral link and monitor your rewards.
Your feedback is important
The future direction of Let’s Talk Risk! is in your hands! This is your platform, your community, your resource. That is why, your continued engagement and feedback is very important to us. There are many ways you can share your thoughts with us:
Reply to this newsletter email with your comments, questions or other feedback
Leave a comment on this post when it is published on the Let’s Talk Risk! website
Connect on LinkedIn and engage with our updates
Initiate a discussion on the Let’s Talk Risk! Chat (paid subscribers only)
Happy Holidays! See you in 2024.
LTR Weekly Digest #17 - 23rd December, 2023