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AI in Regulated Medical Solutions: Overcoming the Risk, Embracing the Benefit

Tuesday, March 21, 2023 (1:00 PM - 2:00 PM) (EDT)


AI has become a much more common element of medical devices in the past few years, with submissions increasing rapidly over the last 3 years. This significant growth is being fueled by many factors that indicate this trend will continue for quite some time. Two factors that stand out are 1) the availability of data through connected systems and wearables has exploded and 2) access to elastic and seemingly limitless processing power and storage capacity with cloud computing now used at scale. 

AI has demonstrated value, such as in its use as a tool for radiological image analysis. This is just the beginning; consider, for example, the life and cost saving value of recognizing a meaningful signal from the noise of wearable’s data to achieve early detection of cardiac disease. There is significant additional value ahead as our ability to train more sophisticated algorithms improves and we navigate how to incorporate them effectively and safely into more new and existing systems.  

With our panel of industry experts, we will look the engineering challenges and strategies associated with the connected, often distributed systems that incorporate AI. Carlos Galmarini, CEO and founder of Topazium, will discuss some of the challenges and common pitfalls associated with developing the algorithms themselves.  Dave Vogel, Founder of Intertech Engineering Associates and author of the authoritative textbook, Medical Device Software, will cover the current regulatory framework for AI and how that impacts development approaches and decisions.  Lastly, Adam Hesse, former product lead for BD’s connected insulin pump and Medtronic’s cardiac CareLink backend, and current EVP of Engineering at Full Spectrum will talk about the architectural approaches required to support the development and update systems with widely varying speeds of evolution and significant regulatory expectations in a practical and balanced way. 



Matt Eisendrath, President and Chief Commercial Officer, Full Spectrum

Matt is an innovative leader within the Life Sciences and Medical Device industry, joining Full Spectrum after leading Medical Device and Life Sciences in the Americas for Capgemini. A proven strategic thinker and leader with over 20 years in the healthcare industry, Matt has experience leading and growing businesses and divisions that maintain high and differentiated value in the market. An entrepreneur at heart, Matt understands the interplay and impact of technology, industry challenges/opportunities, and regulatory evolution and has worked throughout the industry forging the creative teaming relationships required to develop market changing products. Matt earned in BS in Neuroscience from the University of Colorado and has done graduate work business at Babson University.


Adam Hesse, Executive Vice President of Engineering, Full Spectrum

A seasoned technical leader and entrepreneur, Adam brings more than 20 years of Medical Device, Healthcare Information systems, and machine vision experience to Full Spectrum. Adam comes most recently from leadership roles in BD’s Diabetes division and a major modernization program of Medtronic’s CareLink platform before that. Adam has direct and deep experience developing architectural solutions supporting connected medical devices, artificial intelligence, and imaging applications.  These experiences span from concept and business case development through the full product lifecycle.  Adam earned in BS in Computer Science from University of Minnesota.

David Vogel, Regulatory and Quality Advisor

David Vogel was the founder and president of Intertech Engineering Associates, Inc. from 1982 to 2020. Intertech had served the medical device industry by providing medical device development and validation engineering services for a large variety of device manufacturers. During that tenure, he participated in hundreds of medical device projects for clients. David was also an active participant with a joint AAMI/FDA workgroup to develop a standard for Critical Device Software Validation which was subsequently included in the IEC 62304 Software Lifecycle Standard. He worked with other joint AAMI/FDA workgroups to develop Technical Information Reports (TIR32:2004) for Medical Device Software Risk Management, and TIR36:2007 on the Validation of Software for Regulated Processes. As the author of Medical Device Software: Verification, Validation, and Compliance (2010, Artech Publishing), and as an AAMI instructor, Dave created and taught an AAMI workshop based on his textbook for nearly 10 years. David received a bachelor’s degree in electrical engineering and computer science from Massachusetts Institute of Technology, and from the University of Michigan he earned a master’s degree in bioengineering, a master’s degree in electrical and computer engineering, and a doctorate in bioengineering. Dave has been honored with an Outstanding Achievement Award in Biomedical Engineering from the University of Michigan, and was named as one of MD&DI Magazine’s “100 Notable People in the Medical Device Industry”.

Carlos M. Galmarini, Founder and CEO, Topazium Artificial Intelligence

Carlos is an imaginative entrepreneur and biomedical researcher with over 30 year of experience in the healthcare field. As CEO of Topazium, he leads a multidisciplinary team in developing and delivering transformational and innovative AI-based healthcare solutions in pharmaceuticals, medtech, and healthcare. From his early days as a physician in Argentina, Carlos found inspiration by focusing on how healthcare can improve patients’ lives. By working across multiple geographies and functions, he developed a deep understanding of what’s needed to achieve the global goal of "Health for All". A believer in the power of technology to accelerate progress in healthcare, Carlos is devoting his work to the application of artificial intelligence in the generation of diagnostic assistance and predictive tools (virtual biomarkers and synthetic patients) to solve the world’s toughest health challenges. Carlos earned an MD from University of Buenos Aires, Argentina, and a PhD in Oncology and HDR from the University of Lyon, France.

Tuesday, March 21, 2023 (1:00 PM - 2:00 PM) (EDT)
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