#387: The case for Real World Evidence Studies

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation.

Simon breaks down NEST's critical role in catalyzing the use of RWE to streamline submissions, accelerate time-to-market, and lower costs for MedTech companies. With a focus on post-market data, off-label use, and pivotal test cases like pediatric devices and robotic surgery, this conversation reveals the immense potential of RWE to improve patient outcomes and advance medical innovation.

Simon also touches on the evolution of NEST since its creation under the FDA's MDUFA commitment and provides real-world examples of how RWE has led to FDA clearances, including collaborations with industry giants like Johnson & Johnson and Intuitive Surgical.

Key Timestamps:

• [00:02:05] – Introduction to Simon Mason and NEST's mission.
• [00:06:30] – The importance of real-world evidence in medical device submissions.
• [00:10:50] – NEST's relationship with FDA and industry stakeholders.
• [00:18:25] – Real-world examples: How RWE led to device clearances.
• [00:25:10] – Challenges in using real-world data for submissions.
• [00:32:45] – NEST's role in pediatric devices and the potential for off-label approvals.
• [00:38:30] – The financial and time-saving benefits of using real-world evidence.
• [00:50:00] – How companies can engage with NEST to accelerate device approvals.

Quotes:

• Simon Mason: “Real-world evidence has the potential to accelerate device approval and save millions in clinical trial costs. It's all about leveraging existing data to support regulatory submissions.”
• Etienne Nichols: "The opportunity to use off-label real-world data to expand indications opens a whole new world of innovation for MedTech companies."
• Simon Mason: “Speed is everything in business and in patient care. RWE is all about moving faster while maintaining safety and effectiveness.”

Key Takeaways:

Latest MedTech Trends:

1. Real-World Evidence (RWE) Revolution: RWE is transforming regulatory pathways by utilizing data already being collected in real-world settings, reducing the need for costly clinical trials.
2. Off-Label Use for Approvals: NEST is helping companies harness off-label data, particularly in pediatric and robotic surgery, to expand product indications.
3. FDA Collaboration: NEST serves as a bridge between the FDA and industry, simplifying the regulatory process for device companies.

Practical Tips for MedTech Innovators:

1. Engage Early: Medical device companies should consider engaging with NEST early in their product lifecycle to identify potential RWE opportunities.
2. Data Accessibility: Companies should explore existing registries or datasets that could support their submissions, saving time and resources.
3. Clear Project Goals: When approaching NEST, companies should have a clear understanding of their product claims and the available data to support them.

Questions for Future Development:

1. How will the widespread adoption of RWE change the landscape for early-stage MedTech startups?
2. Can RWE become the default pathway for medical device approvals, replacing traditional clinical trials?
3. What role will AI play in streamlining data collection and analysis for real-world evidence?

References:

• MDIC (Medical Device Innovation Consortium) – NEST's parent organization, which coordinates efforts between FDA and industry stakeholders.
• MDIC Innovators Forum, held April 8-9, 2025 in Washington, D.C. This is the annual event discussing the latest developments in real-world evidence and device approvals.
• Etienne Nichols' LinkedIn – Connect with Etienne for insights on MedTech innovation.

MedTech 101:

What is Real-World Evidence (RWE)?

Real-world evidence refers to the clinical evidence regarding the usage and potential benefits or risks of a medical device, derived from analysis of real-world data (RWD) gathered outside of traditional clinical trials. RWE is often collected from registries, electronic health records, and off-label device use, and can significantly speed up regulatory processes by leveraging data already in existence.

NEST: The National Evaluation System for Health Technology, under MDIC, is a non-profit initiative funded by FDA and MedTech companies to enhance the use of RWE for medical device regulatory submissions.

Audience Poll:

What do you think is the biggest advantage of using real-world evidence for medical device approval?

1. Faster time-to-market
2. Lower costs
3. More accurate data

Email your responses to podcast@greenlight.guru!

Discussion Question:

With real-world evidence becoming a critical part of regulatory pathways, how do you see the future of medical device approvals evolving? Will traditional clinical trials become obsolete?

Feedback Call-to-Action:

We’d love your feedback! Leave us a review on iTunes, or send your thoughts and suggestions to podcast@greenlight.guru. Your input helps us improve and bring more valuable content to the MedTech community.

Sponsor Segment:

Today's episode is brought to you by Greenlight Guru and Rook Quality Systems.

Greenlight Guru is the quality management (QMS) and electronic data capture (EDC) software designed specifically for medical device companies. From design controls to post-market surveillance, Greenlight Guru helps you stay compliant with FDA and ISO standards, ensuring your device reaches the market faster and safer. Visit greenlight.guru to learn how their QMS can help your MedTech innovation thrive.

Rook Quality Systems offers customized Quality-as-a-Service solutions for MedTech companies. Whether you need compliance support, process optimization, or help with regulatory submissions, RookQS tailors their services to meet your unique needs. Learn more about how they can elevate your quality management system by visiting rookqs.com.

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