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 -

https://www.linkedin.com/in/bruce-ramshaw-70195215/

Dr. Richard Scranton -

https://www.linkedin.com/in/richard-scranton-md-mph-489a12a/

Lyndra Therapeutics -

https://lyndra.com/

"Blind Spots: When Medicine Gets it Wrong, and What it Means for Our Health" by Marty Makary, MD -

https://www.martymd.com/

TED Talk: "Choice, Happiness, and Spaghetti Sauce" by Malcolm Gladwell -

https://www.ted.com/talks/malcolm_gladwell_choice_happiness_and_spaghetti_sauce?utm_campaign=tedspread&utm_medium=referral&utm_source=tedcomshare

Renowned pioneer in medical advancements and innovation – Robert (Bob) Langer -

https://en.wikipedia.org/wiki/Robert_S._Langer

FDA Premarket Approval (PMA) -

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma

European Union (EU) Medical Device Regulation (MDR) -

https://health.ec.europa.eu/medical-devices-sector/new-regulations_en

FDA Investigational Device Exemption (IDE) -

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide

and IDE Approval Process -

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process

Additional Resources

Contact the podcast team with comments and questions for Dr. Bruce Ramshaw -

[email protected]

Subscribe to the Caresyntax SmartSurgery Blog -

https://smartsurgerylp.caresyntax.com/blog-subscription

Learn more about Caresyntax and its mission to make surgery safer and smarter -

https://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 - https://smartsurgerylp.caresyntax.com/blog-subscription

#MedTech #SmartSurgery #SurgicalTech

In this episode of Data Nerds in the OR, Dr. Bruce Ramshaw sits down with Dr. Tripp Buckley, Associate Professor of Surgery, Director of Elective General Surgery, Co-Director of The Texas Center for Digestive Health, Dell Medical School at the University of Texas at Austin, to explore his experiences leading value-based care initiatives. The conversation highlights the transformative power of real-world data in surgical practice, focusing on how it can drive better patient outcomes and reduce costs. Dr. Buckley emphasizes the importance of cross-specialty collaboration and continuous learning, advocating for a healthcare system that leverages data-driven insights to enhance both quality and efficiency in real time.

Key Topics Discussed:

• Introduction to Dr. Tripp Buckley: Overview of his background and leadership in foregut surgery at Dell Medical School.
• Value-Based Care Initiatives: Dr. Buckley’s approach to implementing value-based care and its impact on patient outcomes.
• Real-World Data in Surgery: How real-world data is transforming surgical practices and improving decision-making.
• Collaboration Across Specialties: The critical role of interdisciplinary cooperation in optimizing patient care.
• Cost Reduction and Quality Improvement: How data-driven care can simultaneously reduce healthcare costs and enhance quality.
• Continuous Learning in Healthcare: The need for real-time feedback loops to drive ongoing improvement in surgical outcomes.

Resources Mentioned:

Dr. Tripp Buckley -

https://www.linkedin.com/in/trippbuckley/

Dell Medical School at the University of Texas at Austin -

https://www.linkedin.com/company/dell-medical-school-at-the-university-of-texas-at-austin/

Research Electronic Data Capture (REDcap) -

https://projectredcap.org/

American Foregut Society -

https://www.americanforegutsociety.org/

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) -

https://www.sages.org/

American College of Surgeons (ACS) -

https://www.facs.org/

 Redefining Health Care: Creating Value-Based Competition on Results by Michael E. Porter and Elizabeth Olmstead Teisberg -

https://www.amazon.com/Redefining-Health-Care-Value-Based-Competition/dp/1591397782

Value-Based Health Care in Orthopaedics by Eric C. Makhni, Benedict U. Nwachukwu, and Kevin J. Bozic -

https://www.amazon.com/Value-Based-Health-Care-Orthopaedics-Makhni-ebook/dp/B0CQQ3KYXK

Additional Resources:

SmartSurgery blog link -

https://smartsurgerylp.caresyntax.com/blog-subscription

Comments and questions -

[email protected]

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 Smart Surgery blog in the link below.

SmartSurgery Blog Link: https://smartsurgerylp.caresyntax.com/blog-subscription

#MedTech #SmartSurgery #SurgicalTech

In this episode of Data Nerds in the OR, Dr. Ramshaw and Henrik Hjorth, CEO of Novus Scientific AB, discuss the importance of real-world data in advancing healthcare technologies. They discuss the evolution of Novus Scientific's innovative product, Tiger Matrix, a long-term absorbable surgical mesh, and the critical role of data in validating its effectiveness. Henrik shares insights on the challenges and opportunities in medtech, the regulatory landscape, and the significance of continuous quality improvement (CQI) in ensuring better patient outcomes. The conversation also touches on the importance of collaboration between medtech companies and clinical teams to refine and improve medical devices through real-world feedback.

Key Topics Discussed:

- Introduction to Henrik Hjorth and Novus Scientific: Overview of Henrik's career from engineer to CEO.

- The Role of Data in Healthcare Innovation: Discussion on how real-world data is essential for validating the effectiveness of new medical technologies.

- Challenges in Medtech Development: Exploration of the difficulties faced in bringing new medical devices to market, including regulatory challenges and the importance of post-market surveillance.

- Continuous Quality Improvement (CQI): The value of CQI methods in improving patient outcomes and refining medical products based on real-world evidence.

- Collaboration with Clinical Teams: The importance of early and ongoing collaboration between medtech companies and clinical teams to ensure that products meet the needs of healthcare providers and patients.

- Regulatory Landscape: Insight into the differences between the U.S. and European regulatory environments and their impact on medtech innovation.

Resources Mentioned:

Henrik Hjorth -

https://www.linkedin.com/in/henrikmagnusson/

Novus Scientific AB -

https://www.linkedin.com/company/novus-scientific-ab/

Gapminder -

https://www.gapminder.org/

Factfulness: Ten Reasons We're Wrong About the World - and Why Things Are Better Than You Think -

https://www.amazon.com/Factfulness-Reasons-Wrong-Things-Better/dp/1473637465/ref=asc_df_1473637465/?tag=hyprod-20&linkCode=df0&hvadid=693372870690&hvpos=&hvnetw=g&hvrand=17252642663804766884&hvpone=&hvptwo=&hvqmt=&hvdev=c&hvdvcmdl=&hvlocint=&hvlocphy=9031008&hvtargid=pla-311714139973&psc=1&mcid=2b61a590e61d3d039dbeeabc7af35cb7&gad_source=1

The best Hans Rosling talks you’ve ever seen -

https://www.ted.com/playlists/474/the_best_hans_rosling_talks_yo

SmartSurgery Blog Link -

https://smartsurgerylp.caresyntax.com/blog-subscription

Comments and questions -

[email protected]

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 Smart Surgery blog in the link below.

SmartSurgery Blog Link: https://smartsurgerylp.caresyntax.com/blog-subscription

#MedTech #SmartSurgery #SurgicalTech

In this episode, Bruce is joined by Dr. Peter N. Nau, Surgical Director of the Digestive Health Center and Program Director, Bariatric Fellowship at the University of Iowa, to discuss the transformative role of data in healthcare and surgery. They delve into the complexities and frustrations of working with healthcare data, the impact of data-driven decision-making on patient outcomes and the integration of financial data with clinical outcomes to measure value. Dr. Nau shares insights from his experience with video data for surgical training and the potential of prehabilitation through data science. The conversation also touches on the challenges and opportunities presented by new weight-loss medications and the importance of transparent, meaningful data in improving healthcare practices.

Key Topics Discussed:

- Introduction to Dr. Nau: Background and experiences in bariatric, abdominal wall and esophagus surgery.

- Data Challenges: Frustrations with the lack of transparency and usefulness in healthcare data.

- Video Data in Surgery: How video data is used for training and improving surgical outcomes.

- Financial Data Integration: The importance of combining financial data with clinical outcomes to measure value.

- Impact of New Weight-Loss Medications: Concerns and opportunities related to GLP-1 medications.

- Sarcopenia and Surgery: Using data to predict patient outcomes and improve prehabilitation.

- Personal Journey: Dr. Nau’s transition from a pediatric cardiology interest to a surgical career.

- The Future of Data in Healthcare: Leveraging data science to transform healthcare practices and improve patient outcomes.

Resources Mentioned:

MBSAQIP (Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program) -

https://www.facs.org/quality-programs/accreditation-and-verification/metabolic-and-bariatric-surgery-accreditation-and-quality-improvement-program/

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) -

https://www.sages.org/

Additional Resources:

SmartSurgery Blog link -

https://smartsurgerylp.caresyntax.com/blog-subscription

Comments and questions -

[email protected]

https://caresyntax.com/blog/data-driven-surgical-education-a-conversation-with-dr-peter-nau/

https://medicine.uiowa.edu/surgery/profile/peter-nau

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 Smart Surgery blog in the link below.

SmartSurgery Blog Link: https://smartsurgerylp.caresyntax.com/blog-subscription

#MedTech #SmartSurgery #SurgicalTech

(Note: We apologize for the audio quality in this episode. The discussion was so insightful and valuable that we felt it was important to share it with you. Thank you for your understanding and enjoy the episode.)

In this episode, Bruce is joined by the Co-Founder of Platypus, Leigh McCormack, PhD, a distinguished data scientist and entrepreneur, to explore the intersection of data science and healthcare. Leigh shares her extensive experience in population health and AI, emphasizing the importance of equity in healthcare solutions. The discussion delves into the complexities of using AI in healthcare, addressing biases and the need for continuous updates to AI models. Leigh introduces Platypus Health, her company focused on identifying and mitigating bias in healthcare AI, and highlights the benefits of federated learning and ensemble modeling. 

Key Topics Discussed:

- Focus on Health Equity: The importance of diverse data in AI in improving healthcare outcomes.

- Addressing AI Bias: The inevitability of bias in AI and strategies to mitigate and address it.

- Importance of Context: The need for data scientists to understand healthcare context and collaborate with clinicians.

- Data Aggregation Challenges: Potential harm to marginalized populations due to data aggregation.

- Platypus Health: Introduction to the company’s mission to identify and mitigate bias in healthcare AI.

- Federated Learning and Ensemble Modeling: The benefits of these methods in enhancing AI effectiveness.

- Continuous Model Updating: The necessity of regularly updating AI models with new data to reflect current realities.

- Collaboration: The significance of collaboration between clinicians and data scientists for better AI models.

- Ensemble Modeling: Explanation and benefits of leveraging diverse data for improved AI predictions.

Resources Mentioned:

Leigh McCormack -

https://www.linkedin.com/in/leigh-mccormack/

Platypus | LinkedIn -

https://www.linkedin.com/company/platypushealth/

Platypus Health | Website -

https://www.platypus.health/

“Weapons of Math Destruction” by Cathy O'Neil -

https://www.amazon.com/Weapons-Math-Destruction-Increases-Inequality/dp/0553418815

White paper: The ASA Statement on p-Values: Context, Process, and Purpose -

https://www.tandfonline.com/doi/full/10.1080/00031305.2016.1154108#d1e167

Many analysts, one dataset: Making transparent how variations in analytical choices affect results -

https://www.researchgate.net/publication/320041452_Many_analysts_one_dataset_Making_transparent_how_variations_in_analytical_choices_affect_results

SmartSurgery Blog Link -

https://smartsurgerylp.caresyntax.com/blog-subscription

Comments and questions -

[email protected]

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 Smart Surgery blog in the link above.

#MedTech #SmartSurgery #SurgicalTech

In this episode, Bruce is joined by Shirin Towfigh, MD, FACS, a renowned hernia specialist with a private practice in Beverly Hills, to discuss the complexities and nuances of healthcare data, gender disparities in medical diagnosis and treatment, and the importance of patient-centered care. Dr. Towfigh shares her extensive experience and insights on how data can transform medical practices and improve patient outcomes, particularly in hernia treatment.

Key Topics Discussed:

- Introduction to Shirin Towfigh, MD, FACS: Background in hernia surgery and her patient-centric approach.

- State of Healthcare Data: Differences in data management between personal databases, national quality collaboratives, and hospital databases.

- Gender Disparities in Medicine: How men and women present differently with conditions like heart attacks and hernias, leading to delays in diagnosis and treatment for women.

- Importance of Data Granularity: The need for detailed and accurate data collection to improve medical outcomes.

- Challenges in Implementing Data Systems: The complexities of data science in healthcare and the importance of local environments in data accuracy.

- Personalized Patient Care: The significance of understanding and addressing individual patient needs and symptoms.

- Research and Machine Learning: Development of predictive tools for hernia diagnosis using machine learning algorithms.

Resources Mentioned:

Shirin Towfigh, MD, FACS -

https://www.linkedin.com/in/shirintowfigh/

Cedars Sinai Hospital -

https://www.cedars-sinai.org/home.html

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) -

https://www.sages.org/

European Hernia Society -

https://europeanherniasociety.eu/

SmartSurgery blog link -

https://smartsurgerylp.caresyntax.com/blog-subscription

Comments and questions -

[email protected]

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 Smart Surgery blog using the link above.

#MedTech #SmartSurgery #SurgicalTech

In this episode, Bruce is joined by Dr. David Earle, Director of the New England Hernia Center - Associate Professor of Surgery at Tufts University School of Medicine, to explore the evolving role of data in surgical practice. The discussion covers the challenges and skepticism faced in the early adoption of laparoscopic techniques, the importance of data-driven decision-making in improving patient outcomes, and the need for legislative changes to improve access to medical data. Dr. Earle also highlights the shift towards real-world data in regulatory processes and the importance of personalized patient care. This episode offers valuable insights into the transformative power of data in healthcare and the future of surgical practices.

Key Topics Discussed:

- Introduction to Dr. David Earle: Background and experiences with laparoscopic surgery and the challenges faced.

- Evolution of Minimally Invasive Surgery: The early skepticism and hostility towards laparoscopic techniques.

- Data in Surgical Practice: The importance of data in guiding medical practices and improving patient outcomes.

- FDA and Real-World Data: The shift from randomized control trials to real-world data.

- Legislation and Data Access: The need for legislative changes to improve access to medical data.

- Patient-Centered Care and Data: The importance of understanding patient preferences and tailoring treatments accordingly.

- Future of Data Science in Healthcare: The importance of continuous improvement and feedback loops in achieving better health outcomes.

- Changing Mindsets in Medicine: The need to move away from a single “right answer” approach in medical training and encouraging a shared decision-making process with patients.

Resources Mentioned:

Dr. David Earle -

https://www.linkedin.com/in/david-earle-md-facs-7b52a95a/

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) -

https://www.sages.org/

Trusted Exchange Framework and Common Agreement (TEFCA) -

https://www.healthit.gov/topic/interoperability/policy/trusted-exchange-framework-and-common-agreement-tefca

Additional Resources

Malcolm Gladwell’s TED Talk on Howard Moskowitz and spaghetti sauce -

https://www.ted.com/talks/malcolm_gladwell_choice_happiness_and_spaghetti_sauce?utm_campaign=tedspread&utm_medium=referral&utm_source=tedcomshare

Book: "Deep Survival" by Laurence Gonzales -

https://www.laurencegonzales.com/ds.html

SmartSurgery Blog Link -

https://smartsurgerylp.caresyntax.com/blog-subscription

Comments and questions -

[email protected]

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 Smart Surgery blog at the link below.

SmartSurgery Blog Link: https://smartsurgerylp.caresyntax.com/blog-subscription

#MedTech #SmartSurgery #SurgicalTech

In this inaugural episode, Dr. Bruce Ramshaw, Chief Medical Informatics Officer of Caresyntax, shares his transformative journey from a data-loving sports enthusiast to a pioneering surgeon integrating data science into healthcare. Bruce delves into the challenges and innovations reshaping surgical practices and highlights the critical role of emotional complexity in patient outcomes.

Key Takeaways:

(02:07) Early inspiration through analyzing NFL football injuries using data science.

(05:45) Bruce’s mother influenced his choice to follow the path of healthcare. 

(08:36) The ability to alleviate people’s pain quickly steered Bruce toward surgery. 

(14:50) The importance of continuous improvement and innovation in healthcare.

(17:16) Moving toward patient-centered teams and involving engineers for better healthcare delivery.

(20:57) Developing a complex hernia program to improve outcomes and lower costs.

(21:49) Recognizing emotional complexity as a significant factor in surgical outcomes.

(24:00) Transition to a value-based care model in healthcare.

(26:36) The pandemic highlighted the flaws in the healthcare data infrastructure.

(27:46) Validating the CQI method through successful FDA approvals.

(28:59) Fragmentation in healthcare data systems creates inefficiencies.

(30:00) Measuring outcomes should be context-specific to each patient process.

(33:00) Data accuracy is crucial for effective healthcare improvement.

Resources Mentioned:

Dr. Bruce Ramshaw -

https://www.linkedin.com/in/bruce-ramshaw-70195215/

Caresyntax | LinkedIn -

https://www.linkedin.com/company/caresyntax/

SmartSurgery Blog Link -

https://smartsurgerylp.caresyntax.com/blog-subscription

Comments and questions -

[email protected]

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 Smart Surgery blog in the link above.

#MedTech #SmartSurgery #SurgicalTech