LTR is launching premium features for paid subscribers

But don't worry, you will still have access to a lot of free educational content on risk management.

Dear colleagues, hello! 👋

I have an important update to share with you.

Beginning August 1, 2023, Let’s Talk Risk! (LTR) is going to offer paid subscriptions to help you deepen your knowledge of risk management and build hands-on skills.

👉Let us face it - the global regulatory environment for medical devices is increasingly getting more focused on risk management. Medical device regulation in the European Union (EU-MDR¹), for example, includes references to risk management more than 250 times! The US FDA is also working on harmonizing the Quality System Regulation (QSR²) with ISO 13485:2016³, which has a much higher emphasis on risk management.

ISO 14971⁴ is the state of the art, international standard for application of risk management to medical devices. Regulatory authorities across the world expect medical device manufacturers to effectively implement ISO 14971 requirements to ensure continuing safety and effectiveness.

It is one thing to simply learn about ISO 14971 requirements through one of the many “certification” courses out there. But to actually implement an efficient and effective risk management system in practice requires a totally different level of competence.

👉This is the promise of LTR - to help you build a solid, practical knowledge of risk management and hands-on skills through real-world examples, case studies and industry trends.

👉My long term mission is to help elevate our collective capability in risk management across the global medical device industry so we can significantly improve patient safety, accelerate innovation and reduce cost.

👉LTR helps me deliver on this long-term mission by:

• serving as a credible source of information, insights and guidance for risk management of medical devices;

• building a vibrant global community of risk practitioners for sharing best practices; and

• facilitating access to highly affordable learning and coaching opportunities to practitioners worldwide for career advancement.

👉Consider this - at less than $1 per article, and indirect cost savings of nearly $500 each year through webinars and training courses, your paid subscription returns an amazing value in a single year!

➡️Note: you can use this email template to get support from your manager to expense your paid subscription.

👉How your subscription delivers a significant return on investment

With a paid subscription, you are not only contributing to the advancement of risk management in the medical device industry, you are also investing in your own career growth:

• Affordable training and certification: risk management of medical devices is a highly specialized field. There are only a handful of training and certification courses focusing on medical device risk management, but they are simply out of reach for most individuals. Unless you are able to get support from your employer, be prepared to pay over $1000 out of your own pocket.
  
  Your LTR subscription offers deep discounts on already low-cost, world-class training courses via my ACHIEVE portfolio. As an example, you could save up to $200 on a Live ISO 14971 certification course, which can provide an immediate payback on your annual subscription!
  

• Skill building: certification can help you access a full time role, but it is only a starting point in your career as a risk practitioner. You gain basic knowledge, but you need continued learning and practice to build hands-on skills. Knowledge helps you learn the what, but not the why and the how. This is where currently available training offers falls short. There are practically no credible opportunities for continued learning and skill building in risk management.
  
  Your LTR subscription offers access to a live webinar each month where you can go deeper in a specific topic and get your questions answered. As an example, check out this hazard analysis made easy webinar. Plus, you will also get my proven templates. You will build practical knowhow through premium content that includes analysis of warning letters, recalls and industry trends. It is only through such continual learning that you can build a strong competence in risk management and fuel your career growth!

• Community and networking: when you are a part of an engaged community of practitioners, you have access to a powerful human resource. You can find solutions to your specific challenges, share best practices and build collaborative, professional relationships for long term career success. Professional societies such as ASQ, RAPS or AAMI cater to the needs of a much broader audience, and risk management is only a small part of their overall scope. Plus, you will pay over $100 to join these societies.
  
  Your LTR subscription offers access to a highly engaged community focused exclusively on risk management. Our weekly Let’s Talk Risk! with Dr. Naveen Agarwal conversations offer an opportunity to engage with colleagues in a casual and informal way. As an example, listen to a recording of a recent LTR conversation about using a risk-based approach to auditing quality systems. Here is another discussion about risk-based thinking and collaboration. Each week, you can join these conversations, learn about practical issues and build new connections with other like-minded colleagues.

➡️Note: you can use this email template to get support from your manager to expense your paid subscription.

👉Here is what some of our early subscribers are saying why they support LTR

This is a valuable community that's a pleasure to be a part of. I am looking forward to supporting the development of a Safety mentality into engineering processes, and I'm committed to being a part of the evolution of Safety thinking and methods. Being a part of this group, able to exchange experiences and opinions, is a privilege.

I want to support your work because I think you bring focus, and value to the medical device risk management community.

Thank you for bringing valuable information to your circle and creating a platform to engage. Though I am a rookie in Medical device industry, your content made me move a step forward in how I think Quality and risk. Good luck with your future endeavors.

Because of the key position of risk management now, I think it is my duty to encourage and support all the important work that Naveen has been doing so far. Beyond this, I appreciate and share his vision of our work in the industry, and how we can all make a strong impact in the lives of patients and doctors we aim to serve. This is my little contribution to support this vision, and it is a pleasure to make it.

Join this growing community and take advantage of the premium benefits!

➡️Note: you can use this email template to get support from your manager to expense your paid subscription.

👉If you are not ready or can’t afford a paid subscription

I understand that it may not be possible for some of you to pledge a paid subscription even at a discounted price.

Please know that I still value your engagement with LTR and remain deeply committed to helping you achieve success in risk management.

As a free subscriber, you will continue to have access to these features:

• 2 weekly articles: a quick tip every Monday and highlights from our weekly LTR conversations every Friday.

• Occasional access to premium content at no cost: you will be able to access some of the premium content occasionally.

• Access to full archive of past articles: you will have full access to the archive of past articles. Premium content may be only partially accessible or delayed, but you can access free articles anytime.

• Access to monthly webinars at low cost: you can still join individual webinars of interest at a low cost (generally $25 or less).

• Early access to discounted pricing on courses: you will get early notification of occasional promotions on ACHIEVE training courses. Live certification courses are generally limited to 15 attendees at a time.

If you are not yet ready to pledge a paid subscription, you can still support me by participating in my referral program. Invite friends to join LTR and help me grow our LTR community. You will also be earning rewards that will give you access to premium content:

• Just 1 referral gets you 1 month of free access to paid content

• 5 referrals get you 3 months of free access to paid content

• 20 referrals get you 1 full year of free access to paid content

🙏Thank you for your support! 🙏

In a short span of 3 months, LTR has grown significantly with a highly engaged community and a large archive of newsletter articles.

It is now ready to get my full time commitment to continue this growth and deliver on the long-term promise.

But I can’t do it alone. I need your financial support.

I do not want to rely on advertisements or sponsorships. I want to maintain full editorial independence to provide you an unfiltered perspective on risk management. This will ensure that LTR remains true to your specific needs and not serve any commercial interests.

Think of this as the NPR of risk management! It can work only with your sustained financial support.

➡️Note: you can use this email template to get support from your manager to expense your paid subscription.

1. EU-MDR: Regulation (EU) 2017/745 of the European Union

2. QSR: Quality System Regulation for medical devices/current good manufacturing practices

3. ISO 13485:2016 - Medical devices - Quality management systems -Requirements for regulatory purposes

4. ISO 14971:2019 - Medical devices - Application of risk management to medical devices