Our AI Summit Core Team is made up of the following FDA and industry experts:
Consultant – Global Device Quality Assurance
In his current role, Bob authors global medical device quality standards and common quality practice documents. He also provides oversight to changes to the Lilly device QMS in order to support Lilly digital device initiatives (including Mobile Medical Applications). Bob also provides global device quality support with respect to medical device QMS auditing, risk management governance including medical device cybersecurity risk governance, product lifecycle management (PLM), and device regulatory surveillance. He has twice presented at past FDA/Xavier University Global Medical Device Conferences on MMA QMS and risk management.
He is a member of the AAMI Device Security Working Group responsible for drafting TIR97/Ed.1 Principles for medical device security – Post-market security management for device manufacturers. He has worked for Lilly for the past 15 years with prior extensive experience as a technical communication specialist in software, aerospace and manufacturing. He holds a bachelor of arts in journalism from Indiana University—Bloomington.
Vice President, Quality and Regulatory Affairs
IBM Watson Health
John joined IBM in May of 2016 and is responsible for ensuring Watson Health’s portfolio complies with all relevant lifescience related regulations. Prior to joining Watson Health, John was with Boston Scientific for nine years and had a number of positions there including the head of International Quality, Distribution and Supply Chain and management board level positions for their Endoscopy and Urology and Women’s Health. Prior to Boston Scientific, John worked for Johnson & Johnson and held quality related positions in their device, diagnostic, and pharmaceutical sectors. John has over 20 years of experience with FDA regulated industries and has special expertise in Design Control, Software Quality, and Quality Systems.
Founder and CEO
Cindi Linvill is the Director of Quality for Best Sanitizers, and has worked at Best Sanitizers for nine years. Prior to working at Best Sanitizers, Cindi was the Facility Quality Assurance Manager for Avnet. She has a degree in IT Security, Electrical Engineering, Organizational Management, and a Masters in Business Management. Overall, Cindi has worked in Quality for over 20 years. Cindi also has ASQ certifications as a Quality Engineer, Biomedical Auditor and in Pharmaceutical GMPs.
Kumar Madurai has 35 years of IT experience in Life Sciences, Healthcare, and Manufacturing environments. He currently works for CTG as a Principal Consultant and a Solutions Delivery Manager, responsible for advising clients on strategic planning and selection of technology and infrastructure and for developing and implementing custom solutions to solve today’s complex business problems.
He has experience designing, developing, and implementing ontology-based solutions using advanced semantic technologies for predictive quality assurance and knowledge engineering by linking enterprise data from multiple structured and unstructured data sources. As Data Scientist for the Medical Informatics Products team, he has used exploratory data analysis and applied machine learning algorithms for population health predictive analytics.
Prior to joining CTG in 2009, he spent 25 years at Fisher-Price/Mattel, serving as Director of Technology group leading applications, infrastructure and technical teams. He is currently working on his Ph.D. in the healthcare area at University at Buffalo.
Fellow, Regulatory Science
Boston Scientific Group
Mac McKeen has over 25 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study, and regulatory approvals of cardiovascular devices and is currently a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize.
He also serves as an Adjunct Professor at the University of Minnesota instructing a 4000 level course on medical device development and is also a Faculty Director within the College of Continuing and Applied Professional Studies. He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed, MDIC and Medical Alley. He holds a B.S. in industrial technology from Iowa State University and an M.B.A. from the University of Dallas and is RAC certified.
Head of Enterprise Analytics
Walt is the driving force for Data Analytics at Shire. His vision for an Enterprise Analytics Marketplace is unique to the industry and has positioned Shire to be a leader in Digital Health for rare diseases. The Analytics Marketplace allows all Shire employees that ability to analyze data to make data-driven decisions and integrate data into a model for connected care. Prior to joining Shire, Walt was a Senior Partner with CSC Consulting where is was known as a leader in Data. In 2010, Walt conducted a special research project for CSC’s Leading Edge forum to look at the future of data. His 2011 report, “Data rEvolution,” foreshadows the explosion in Data Analytics that we all see today. Walt received his Ph.D. in neuroscience from the University of Pennsylvania where he conducted Vision Research and studied brain physiology and microcircuitry.
Associate Center Director for Digital Health
Bakul Patel is a digital-health visionary and entrepreneurial leader focused on creating, shaping, and implementing national and international public health strategies. He has over 28 years of experience in leadership business development, marketing, product management, assessing long and short term needs, establishing objectives, improving organizational performance, and resource management.
Patel is an excellent collaborator, experienced in building effective cross functional teams by establishing and maintaining working relationships with diverse set of internal and external stakeholders. He has strong management, technical and regulatory skills in identifying, analyzing, managing, and solving highly complex issues, policies, procedures, federal regulations, and legislative matters in relation to Food Drug and Cosmetic Act. Patel has a detailed understanding of the regulatory infrastructure needed to balance regulatory requirements with national needs while developing policies and regulations.
He has expertise in medical device regulations, product development processes, software engineering, embedded systems, wireless communication systems, and robotics and control systems. Patel holds a master's degree in electronics engineering, M.B.A. in international business, Six Sigma, and Black-belt certified.
Director, Xavier Health
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in chemistry from Xavier University, and a Ph.D. in organic chemistry from the University of North Carolina – Chapel Hill.
Associate Vice President, Technology and Regulatory Affairs
Zach Rothstein is Associate Vice President for Technology & Regulatory Affairs at AdvaMed. In this position, Zach advocates for medical device regulatory policies that are transparent, predictable, consistent, timely, and science-based. Zach’s particular areas of focus include digital health, medical device software, cybersecurity, labeling, and postmarket surveillance.
Prior to joining AdvaMed, Zach was Deputy Senior Counsel for Public Policy at Samsung Electronics where he was responsible for the company’s medical device and healthcare regulatory and policy issues. In this position, Zach counseled Samsung’s global business units through all stages of product development on U.S. regulations affecting digital health, Health IT, and medical devices. Zach also planned and executed the company’s FDA and healthcare regulatory and legislative policy objectives.
Prior to joining Samsung, Zach was an Associate Attorney in the FDA and Healthcare practice at the law firm of Morgan, Lewis & Bockius LLP.
Cincinnati Children's Hospital Medical Center
Dan Santel is a biomedical informatics Research Fellow at Cincinnati Children’s Hospital, researching applications of artificial intelligence in healthcare with Dr. John Pestian. After receiving his Ph.D. in high energy physics at the University of Cincinnati in 2013, he worked at Certica Solutions (née Cincinnati-based Academic Benchmarks) using AI to help academic publishers match materials to state education requirements. From there, he joined Dr. Pestian’s team at Cincinnati Children’s. Amongst other things, the Pestian research group is currently developing an iPhone app that detects suicidal language in spoken conversations. Dan's current research includes the use of AI and natural language processing in identifying other psychiatric disorders from conversational language.
Senior CPV Engineer
Matt Schmucki began working in the pharmaceutical industry in 2008 supporting the startup of Amylin Pharmaceuticals. He later joined Patheon Pharmaceuticals supporting granulation production before joining AstraZeneca in 2013. He is still with AstraZeneca and is responsible for the West Chester site's Continued Process Verification Program. Matt is a graduate of the University of Cincinnati where he earned his B.S. in mechanical engineering. He later returned to also earn his M.B.A. as well as his M.S. in business analytics.
AI Research Technologist
Michael is a Technical Evangelist providing vision and leadership through transformational AI initiatives. His experience in supply chain, manufacturing and services is foundational in communicating that contextualized analytics is key to #datamonetization. Michael’s passion is demonstrating real-world scenarios with the Dell SupportAssist Intelligence Engine to explain that predictive and proactive AI platforms running at the “speed of thought” are feasible for every industry. Michael has been granted 12 hardware and software patents in eight countries.