How Real-World Data Is Transforming FDA Approvals and Healthcare Decisions with Dr. Richard Scranton

In this episode of “Data Nerds in the OR,” Dr. Bruce Ramshaw, Chief Medical Informatics Officer at Caresyntax, talks with Dr. Richard Scranton, 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.
Key Topics Discussed:
Introduction to Dr. Richard Scranton: From Navy clinician to biotech executive, Dr. Scranton shares his unique career path and early exposure to healthcare data systems.
Real-World Data for Regulatory Innovation: Examples of leveraging RWD to expedite FDA approvals and demonstrate safety and efficacy, especially in pediatric care.
Shifting the Regulatory Focus: Moving beyond harm identification to identify and quantify unexpected treatment benefits through RWE.
The Role of AI in Surgery: Opportunities for artificial intelligence and machine learning to streamline clinical trials, optimize workflows and enhance decision-making in the OR.
Iterative Quality Improvement: Continuous data collection drives iterative improvements in surgical techniques, patient outcomes and cost management.
Advancing Pediatric Care: The untapped potential of RWD to support pediatric surgical innovation, expanding access to life-saving interventions.
Resource Mentioned
Dr. Bruce Ramshaw -
/ bruce-ramshaw-70195215
Dr. Richard Scranton -
/ richard-scranton-md-mp...
Lyndra Therapeutics -
lyndra.com/
"Blind Spots: When Medicine Gets it Wrong, and What it Means for Our Health" by Marty Makary, MD -
www.martymd.com/
TED Talk: "Choice, Happiness, and Spaghetti Sauce" by Malcolm Gladwell -
www.ted.com/ta...
Renowned pioneer in medical advancements and innovation - Robert (Bob) Langer -
en.wikipedia.o...
FDA Premarket Approval (PMA) -
www.fda.gov/me...
European Union (EU) Medical Device Regulation (MDR) -
health.ec.euro...
FDA Investigational Device Exemption (IDE) -
www.fda.gov/me...
and IDE Approval Process -
www.fda.gov/me...
Additional Resources
Contact the podcast team with comments and questions for Dr. Bruce Ramshaw -
[e-mail]
Subscribe to the Caresyntax SmartSurgery Blog -
smartsurgerylp...
Learn more about Caresyntax and its mission to make surgery safer and smarter -
rb.gy/4oteq2
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 SmartSurgery blog - smartsurgerylp...
#MedTech #SmartSurgery #SurgicalTech