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UID:11786-1776189600-1776196800@www.mfests.org
SUMMARY:INCOSE: Integrating AI into Systems Engineering for Medical Devices: A Case Study
DESCRIPTION:Overview\n\n\n\n\nFindings from Boston Scientific’s early practice with IntelliU’s ALEX implementation \n\n\n\n\nAgenda (Central Standard Time) \n6:00 – Network and socialize over pizza (provided) \n6:30 – Welcome & INCOSE Chapter Overview by Chapter President \n6:45 – Presentation\, Integrating AI into Systems Engineering for Medical Devices: A Case Study from Practice \n7:45 – Adjourn \nHybrid Microsoft Teams meeting \nMeeting ID: 290 561 832 063 94 Passcode: qJ7dC6L5 \nJoin: teams.microsoft.com/meet/29056183206394?p=cGnz114ed5Cej4fUFn \nSynopsis \nFollowing development discussed at an earlier presentation to the chapter\, of IntelluU’s ALEX platform\, Boston Scientific is exploring the future of medical device design through its stategic evaluation of AI capabilities. The engineering team is leveraging ALEX to augment and accelerate quality design while navigating the organizational and technical realities of AI adoption. \nThis presentation shares the methodology\, challenges\,and measurable impacts from deploying ALEX within Boston Scientific’s engineering workflows\, demonstrating how AI not only boosts productivity but also elevates design quality. Attendees will gain actionable insights into the future of AI in medtech\, including best practices for implementation and scaling AI-driven engineering. \nPresenters’ Biographies \nAaron Bowser is an experienced R&D leader with a background in systems engineering\, process development\, and technical team leadership. As Senior R&D Manager of Systems Engineering at Boston Scientific\, he leads teams developing implantable medical devices\, focusing on collabotration\, problem-solving\, and helping engineers grow in their careers. Aaron has been involved in integrating AI-driven tools into engineering workflows\, including efforts to improve requirements analysis and test scenario generation. He is particularly interested in how AI can enhance efficiency\, streamline development processes\, and support engineers in tackling complex challenges. With experience spanning both medtech and semiconductor industries\, Aaron has held engineering and leadership roles at Boston Scientific\, Seagate Technology\, and Cypress Semiconductor. He has guided teams through complex product development efforts\, balancing innovation with the realities of working in highly reglulated environments. Aaron holds a Bachelor of Science in Electrical Engineering from the University of Minnesota – Twin Cities. He enjoys working at the intersection of technology and teamwork\, applying new tools and approaches that help engineers do their best work. \nXiaofan Mai is a visionary leader\, fueled by growth and innovation. Her passion lies in developing digital techologies that advance patient care through customer-driven strategies and focused execution. \nAs the CEO and Founder of IntelliU LLC\, Xiaofan brings over 20 years of experience to the table. She has successuflly launched numerous new products and innovative technologies for Fortune 500 companies\, leading cross-functional teams across the globe. Her expertise spans strategy\, new product development\, and collaborative partnerships to drive business growth in regulated markets. Having spent two decades in the field before venturing into entrepreneurship\, she possesses a passionate vision of AI and a deep understanding of the industry. IntelliU addresses critical gaps in healthcare\, aiming to reduce risk to patients while expediting business commercialization and growth for its clients. \nXiaofan holds an MBA from the Carlson School of Management and an MA from the Education Department\, both from the University of Minnesota. She enjoys the beautiful four seasons\, rich culture\, and vibrant performing arts scene that Minnesota offers. As an international student from Beijing\, China\, who arrived 29 years ago\, she appreciates the diversity and “Minnesota Nice” culture that have allowed her to thrive. She considers Minnesota her second hometown.
URL:https://www.mfests.org/event/incose-integrating-ai-into-systems-engineering-for-medical-devices-a-case-study/
LOCATION:Augsburg Park Library\, 7100 Nicollet Avenue\, Richfield\, Minnesota\, 55423
CATEGORIES:INCOSE
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SUMMARY:ASQ: Program Meeting - First Pass Design Controls
DESCRIPTION:First Pass Design Controls –\nGetting it Right on your First Medical Device\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nIf you’re part of a new startup or an insulated development team in a larger company\, you probably know how daunting it can be to collect the evidence required to demonstrate to a regulatory body that design requirements have been met. \nFDA regulations require design controls to help ensure this\, which can translate into many hours of reviews\, oversized spreadsheets\, and enough signatures to slow a change assessment system to a crawl. \nBut when implemented correctly\, design controls enhance – rather than hinder – development efforts while providing the assurance needed to enter the submission process with confidence. \nThis presentation takes a practical look at design controls within FDA regulations and how they’ve been implemented across the medical device industry. And you’ll earn 0.2 RU’s (Recertification Units)! \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nClick Here for more info or to register!
URL:https://www.mfests.org/event/asq-program-meeting-first-pass-design-controls/
LOCATION:Webinar
CATEGORIES:ASQ
ORGANIZER;CN="ASQ-MN%20Section":MAILTO:info@mnasq.org
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