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New (Feb 2024): There is a new set of expert interviews recorded for the needs of the Yale Certificate Program in Medical Software and Medical AI (2023-4). These are available on YouTube -- or in audio podcast form on Apple, Spotify, and directly from Yale.
About These interviews
About These interviews
These interviews with experts from industry, academia and regulatory agencies were conducted over zoom during the summer of 2021. Parts of these interviews (37 short clips) were embedded in our Coursera class "Introduction to Medical Software." The whole (slightly edited) videos were then uploaded on YouTube as supplementary material for this class. We hope you willfind them an interesting and useful resource. (Total time=8 hours and 48 minutes)
An Interview with Mr. Michael Nilo: FDA Regulation and Process
An Interview with Mr. Michael Nilo: FDA Regulation and Process
Mr. Nilo is president and principal consultant at Nilo Medical Consulting. (40:15)
Additional Links:
An interview with Dr. Andrea Biasiucci: An Introduction to the European Regulatory Process
An interview with Dr. Andrea Biasiucci: An Introduction to the European Regulatory Process
Dr. Andrea Biasiucci is a competence cluster lead & senior consultant at Confinis AG, Switzerland. (40:00)
Additional Links:
An Interview with Ms. Sara Li: Medical Software Regulation in China
An Interview with Ms. Sara Li: Medical Software Regulation in China
Ms. Li RAC, MS is a Senior Regulatory Affairs Consultant at the consulting company China Med Device. (18:54)
Additional Links:
An Interview with Mr. Rich Wynkoop QMS, ISO 13485 Certification and Risk Management
An Interview with Mr. Rich Wynkoop QMS, ISO 13485 Certification and Risk Management
Mr. Wynkoop is the president & CEO of Vision28, Redmond, Oregon. (46:29)
Additional Links:
An Interview with Dr. Phan Luu: Setting up and using a quality management system
An Interview with Dr. Phan Luu: Setting up and using a quality management system
Dr. Luu is the chief science officer of the Brain Electrophysiology Company. (32:40)
Additional Links:
An interview with Prof. Alka Menon: An Introduction to Organizational Theory for Engineers
An interview with Prof. Alka Menon: An Introduction to Organizational Theory for Engineers
Dr. Menon is an assistant professor of Sociology at Yale. For more information about her work see her personal webpage. (47:14)
An Interview with Mr. Tom Renner: Cybersecurity and Medical Devices
An Interview with Mr. Tom Renner: Cybersecurity and Medical Devices
Mr. Renner is a quality, efficiency, and regulatory affairs consultant at Vision28, Redmond, Oregon. (19:01)
Additional Links:
An interview with Dr. Lynn Fiellin: Creating Video Game-based Digital Health Interventions in Youth
An interview with Dr. Lynn Fiellin: Creating Video Game-based Digital Health Interventions in Youth
Prof. Fiellin is the founding director of the play2PREVENT lab at Yale. She is a professor of Medicine (General Medicine) Yale Child Study Center, and Public Health at the Yale School of Medicine. She is also Chief, Fitkin Firm, Yale-New Haven Hospital. (44:20)
Also joining us are Bryce Bjork and Ting Gao, who graduated from Yale College in 2020 and currently spearhead the work of the Chase Bjork Foundation to create Brain Health education programs.
Additional Links:
An Interview with Dr. Saradwata Sarkar: Understanding Users and Requirements
An Interview with Dr. Saradwata Sarkar: Understanding Users and Requirements
Dr. Saradwata Sarkar is a medical software designer and developer with over 10 years of experience developing software in the medical device industry. (21:59)
An Interview with Dr. Andinet Enquobahrie: Open Source, Open Science and Medical Software
An Interview with Dr. Andinet Enquobahrie: Open Source, Open Science and Medical Software
Dr. Andinet Enquobahrie, Ph.D., MBA, is the director of medical computing at Kitware, Inc. (60:48)
Additional Links:
An Interview with Dr. Steve Pieper: Software Engineering and Medical Software
An Interview with Dr. Steve Pieper: Software Engineering and Medical Software
Dr. Pieper is the CEO of Isomics Inc. He is affiliated with the Surgical Planning Laboratory at BWH, Harvard Medical School, in which role he serves as the lead maintainer of 3D Slicer. (47:53)
Additional Links:
An Interview with Dr. Rajesh Venkataraman: Medical Software Design, Implementation and Testing
An Interview with Dr. Rajesh Venkataraman: Medical Software Design, Implementation and Testing
Dr. Venkataraman is the director of research and development at Eigen Health Services LLC. (40:13)
Additional Links:
An interview with Dr. Nicholas Petrick: How the FDA Reviews Software and Related Issues
An interview with Dr. Nicholas Petrick: How the FDA Reviews Software and Related Issues
Dr. Petrick is the deputy director Division of Imaging, Diagnostics and Software Reliability, Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), U.S Food and Drug Administration (FDA) -- http://www.fda.gov (38:45)
An interview with Prof. Christian Kästner: Machine Learning and Software Engineering
An interview with Prof. Christian Kästner: Machine Learning and Software Engineering
Dr. Kästner is an associate professor at the Institute for Software Research, Carnegie Mellon University, Pittsburgh, PA. (32:04)
See his resources page for more information.
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