January 10, 2025
How Real-World Data Is Transforming FDA Approvals, Healthcare Decisions and Drug Development with Dr. Richard Scranton
<p><span style="background-color: transparent;">In this episode of “Data Nerds in the OR,” </span><a href="https://www.linkedin.com/in/bruce-ramshaw-70195215/" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);"><strong>Dr. Bruce Ramshaw</strong></a><span style="background-color: transparent;">, Chief Medical Informatics Officer at Caresyntax, talks with </span><a href="https://www.linkedin.com/in/richard-scranton-md-mph-489a12a/" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);"><strong>Dr. Richard Scranton</strong></a><span style="background-color: transparent;">, an epidemiologist and healthcare leader, to explore the evolving role of real-world data (RWD) and evidence (RWE) in healthcare. The discussion spans Dr. Scranton’s career journey, innovative uses of RWD to support regulatory decisions and the future of data-driven surgical care. Together, they highlight the power of integrating RWD into surgical practice to enhance outcomes, accelerate innovation and make healthcare more efficient.</span></p><p><br></p><p><strong style="background-color: transparent;">Key Topics Discussed:</strong></p><p><strong style="background-color: transparent;">- Introduction to Dr. Richard Scranton</strong><span style="background-color: transparent;">: From Navy clinician to biotech executive, Dr. Scranton shares his unique career path and early exposure to healthcare data systems.</span></p><p><strong style="background-color: transparent;">- Real-World Data for Regulatory Innovation</strong><span style="background-color: transparent;">: Examples of leveraging RWD to expedite FDA approvals and demonstrate safety and efficacy, especially in pediatric care.</span></p><p><strong style="background-color: transparent;">- Shifting the Regulatory Focus</strong><span style="background-color: transparent;">: Moving beyond harm identification to identify and quantify unexpected treatment benefits through RWE.</span></p><p><strong style="background-color: transparent;">- The Role of AI in Surgery</strong><span style="background-color: transparent;">: Opportunities for artificial intelligence and machine learning to streamline clinical trials, optimize workflows and enhance decision-making in the OR.</span></p><p><strong style="background-color: transparent;">- Iterative Quality Improvement</strong><span style="background-color: transparent;">: Continuous data collection drives iterative improvements in surgical techniques, patient outcomes and cost management.</span></p><p><strong style="background-color: transparent;">- Advancing Pediatric Care</strong><span style="background-color: transparent;">: The untapped potential of RWD to support pediatric surgical innovation, expanding access to life-saving interventions.</span></p><p><br></p><p><strong style="background-color: transparent;">Resource Mentioned</strong></p><p><br></p><p><a href="https://www.linkedin.com/in/bruce-ramshaw-70195215/" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);"><strong>Dr. Bruce Ramshaw</strong></a> -</p><p>https://www.linkedin.com/in/bruce-ramshaw-70195215/</p><p><a href="https://www.linkedin.com/in/richard-scranton-md-mph-489a12a/" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);"><strong>Dr. Richard Scranton</strong></a> -</p><p>https://www.linkedin.com/in/richard-scranton-md-mph-489a12a/</p><p><a href="https://lyndra.com/" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);">Lyndra Therapeutics</a> -</p><p>https://lyndra.com/</p><p><a href="https://www.martymd.com/" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">"Blind Spots: When Medicine Gets it Wrong, and What it Means for Our Health" by Marty Makary, MD</a> -</p><p>https://www.martymd.com/</p><p><span style="background-color: transparent;">TED Talk: </span><a href="https://www.ted.com/talks/malcolm_gladwell_choice_happiness_and_spaghetti_sauce?utm_campaign=tedspread&utm_medium=referral&utm_source=tedcomshare" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">"Choice, Happiness, and Spaghetti Sauce" by Malcolm Gladwell</a> -</p><p>https://www.ted.com/talks/malcolm_gladwell_choice_happiness_and_spaghetti_sauce?utm_campaign=tedspread&utm_medium=referral&utm_source=tedcomshare</p><p><span style="background-color: transparent;">Renowned pioneer in medical advancements and innovation – </span><a href="https://en.wikipedia.org/wiki/Robert_S._Langer" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);">Robert (Bob) Langer</a> -</p><p>https://en.wikipedia.org/wiki/Robert_S._Langer</p><p><a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);">FDA Premarket Approval (PMA)</a> -</p><p>https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma</p><p><a href="https://health.ec.europa.eu/medical-devices-sector/new-regulations_en" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);">European Union (EU) Medical Device Regulation (MDR)</a> -</p><p>https://health.ec.europa.eu/medical-devices-sector/new-regulations_en</p><p><a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);">FDA Investigational Device Exemption (IDE)</a><span style="background-color: transparent;"> - </span></p><p>https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide</p><p><span style="background-color: transparent;">and </span><a href="https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);">IDE Approval Process</a> -</p><p>https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process</p><p><br></p><p><strong style="background-color: transparent;">Additional Resources</strong></p><p><span style="background-color: transparent;">Contact the podcast team with </span><a href="mailto:podcast@caresyntax.com" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">comments and questions</a><span style="background-color: transparent; color: rgb(17, 85, 204);"> </span><span style="background-color: transparent;">for Dr. Bruce Ramshaw - </span></p><p>podcast@caresyntax.com</p><p>Subscribe to the <a href="https://smartsurgerylp.caresyntax.com/blog-subscription" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);">Caresyntax SmartSurgery Blog</a> - </p><p>https://smartsurgerylp.caresyntax.com/blog-subscription</p><p><span style="background-color: transparent;">Learn more about </span><a href="https://caresyntaxcom-my.sharepoint.com/personal/elizabeth_bazarko_caresyntax_com/Documents/Desktop/WIP/Podcast/Data%20Nerds%20in%20the%20OR/Episode%208%20-%20Dr.%20Richard%20Scranton/Writing%20Deliverable%20Documents/caresyntax.com" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);">Caresyntax</a><span style="background-color: transparent;"> and its mission to make surgery safer and smarter - </span></p><p>https://rb.gy/4oteq2</p><p><br></p><p><br></p><p><span style="background-color: transparent;">Thanks for listening to Data Nerds in the OR: A Surgeon’s Journey Toward Value-Based Care. If you enjoyed this episode, please leave a 5-star review to help get the word out about the show. Be sure to subscribe so you never miss any insightful conversations. And, if you want more content like this from Caresyntax, please sign up for our </span><a href="https://smartsurgerylp.caresyntax.com/blog-subscription" target="_blank" style="background-color: transparent; color: rgb(0, 0, 255);">SmartSurgery blog</a> - https://smartsurgerylp.caresyntax.com/blog-subscription</p><p><br></p><p><br></p><p><span style="background-color: transparent;">#MedTech #SmartSurgery #SurgicalTech</span></p>