Welcome!

Dear colleagues, I am super excited to welcome you to this weekly newsletter.

In this first edition, I want to tell you a little about the kind of topics this newsletter will cover and how it will help you build a foundation of knowledge to significantly contribute to innovation and growth in your medical device business.

Our focus here is going to be on safety risk management of medical devices

Risk management is a very broad discipline with highly specialized practices targeting different types of risks across various business operations. Here, we are going to limit our scope to safety risk management because of two main reasons:

1. I have focused on safety risk management over the last 5 years in my consulting practice. I have helped multiple medical device clients, both large and small, in identifying gaps and inefficiencies in their risk management processes. My expertise in this area is both deep and broad. Therefore, I can offer you actionable insights to apply in your business.
2. I believe there are three major industry trends that are currently driving the need for better safety performance in medical devices: 1) Rising cost of healthcare is driving increased scrutiny by payors on the contribution of device-related safety issues on total cost of care; 2) public awareness of device related injuries and deaths is increasing due to social media influencers and highly acclaimed public reports and documentaries; and finally 3) the global regulatory environment is rapidly evolving to drive increasing focus on public safety and transparency. These are new forces that all medical device players need to overcome in order to achieve and maintain their competitive advantage. As a result, you need to have a renewed focus on safety performance beyond simply trying to achieve regulatory compliance.

Topics we will cover in this newsletter

• Key concepts, requirements and best practices related to safety risk management per ISO 14971, other relevant standards and guidance documents
• Industry trends and new product innovation, especially from a safety point of view
• Evolving regulatory expectations for safety and effectiveness, including use of real-world data to make regulatory decisions
• Analysis and lessons learned from recalls and warning letters
• Strategies for developing and implementing business processes that are both efficient and effective
• Strategies for enhancing team engagement and commitment in the Quality & Regulatory functions

Examples of how you will benefit from following this newsletter

• If you are an engineer/product developer, you will learn about safety-led innovations, evolving regulatory expectations and best practices for efficiently satisfying compliance (e.g. documentation) requirements throughout your product's lifecycle;
• If you are a Quality engineer/manager, you will gain insights on the why behind the requirements so you can help develop an efficient process that will not only reduce the development cycle time but also improve your standing in audits;
• If you are a project manager leading a new product development team, you will gain insights to help facilitate important trade-off decisions related to safety, performance and cost using a comprehensive risk-based approach;
• If you are a regulatory affairs professional supporting a new product development team, you will gain insights on evolving regulatory expectations to strike the right balance between pre- and post-market evidence generation;
• If you are a medical safety professional supporting your product development and quality/regulatory teams, you will learn about best practices to better integrate the voice of the patient and healthcare provider in the risk management process;
• If you are a senior executive in the Quality/Regulatory functions, you will gain insights on maximizing the business impact of your risk management and/or quality management processes, not just by productivity improvements but also through a more direct link to revenue growth

Are you ready to join me in this journey of shared learning?

I will be the first to admit that I don't have all the answers! I see this newsletter as an opportunity to engage with you and learn together. Together, we will share our collective knowledge, ask deep questions that challenge the status quo in our industry, and inspire each other to do more.

Our industry is unique as it strives for a higher purpose than just profit and loss! We are all driven by the ultimate vision of improving the lives of our patients and healthcare providers through safe and innovative products. This is a noble mission; one that requires cross-industry collaboration and exchange of knowledge and new ideas. This is the main driving force behind this newsletter.

I invite you to join me in this journey of shared learning. Share with me your thoughts, concerns and suggestions for improvement (in a non-proprietary way!). If you would like to talk one-on-one, please schedule a 15 minute call with me here.

I look forward to connecting with you!