In-Person Event: The AI Competency Crisis: Clinical & Regulatory Innovation
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Location
Fred Hutch
Thomas Building
SZE Conference Room
1100 Fairview Ave. N.
Seattle, WA 98109
USA
Category
Regular Monthly Meeting
Registration Info
Registration is required before Thursday, July 30, 2026 at 11:59 PM
Payment In Full In Advance Only
RSVP by 11:59pm, Thursday, July 30, 2026
Meeting: 5:30pm – 8:00pm PT
PAID FEES ARE NON REFUNDABLE
Credit card payments can only be accepted online prior to the meeting. No payments or registration is accepted at the door.
About this event
TOPIC:
Closing the AI competency gap in regulated healthcare: training professionals to work responsibly with AI, and building regulated, validated, and adoptable healthcare AI solutions
TOPIC DESCRIPTION:
As AI systems become increasingly embedded in healthcare, medtech, regulatory affairs, quality systems, clinical operations, and product development, organizations face a dual challenge: a growing competency gap among professionals asked to evaluate, govern, or deploy AI-enabled tools, and the practical difficulty of moving AI solutions from promising concepts to safe, validated, and adoptable clinical products.
This event brings together two complementary perspectives on responsible AI in regulated healthcare environments. Alexander Cutler will examine the emerging AI competency crisis, offering a UW faculty perspective on how educators, employers, and regulatory professionals can better prepare students and teams to work responsibly with AI — including practical training priorities such as regulatory reasoning, evidentiary discipline, validation thinking, cybersecurity awareness, documentation quality, and the distinction between fluent AI output and trustworthy professional judgment.
Marco Daoura will then explore the practical bridge between AI innovation, clinical value, and regulatory readiness, sharing real-world experience at the intersection of clinical workflow, regulatory strategy, validation, data and AI governance, information security, and adoption. His session highlights why successful healthcare AI requires more than model performance in a pilot: it demands clear use cases, trustworthy data, risk management, human factors, and real-world evidence that supports clinical and operational value.
Together, the sessions aim to help students and professionals move beyond generic AI enthusiasm or fear and toward concrete, teachable competencies and practical strategies for building and using AI safely, critically, and effectively in medtech and biomedical regulatory contexts.
SPEAKERS:
Alexander Cutler and Marco Daoura
SPEAKER BIOGRAPHY:
Alexander N. Cutler is an Affiliate Assistant Professor in the University of Washington Biomedical Regulatory Affairs M.S. Program and Principal Consultant at Cutler Consulting, LLC. His work focuses on high-stakes regulatory affairs, quality systems, AI governance, cybersecurity, medical devices, digital health, consumer products, combination products, and SaMD in regulated life-science environments. He has advised companies across AI, medtech, biotech, digital health, consumer products, dietary supplements, cosmetics, drug, and combination-product contexts. He is a member of the AI@UW Advisory Council.
Marco Daoura is a digital health, MedTech, and AI strategy leader with experience translating connected devices, software, data, and analytics into regulated healthcare products and scalable commercial solutions. He has held leadership roles across AIM Consulting, Sysmex, Latham BioPharm Group, Premera Blue Cross, Philips Healthcare, Fujifilm SonoSite, UltraLinq, and Novuson Surgical, with work spanning AI/ML-enabled diagnostics, clinical decision support, population health analytics, SaMD, product strategy and development, regulatory pathways, and commercialization.
Marco advises and supports health-tech and MedTech startups including Optiscan Imaging, OptHealth, and Emagine Solutions on product strategy, regulatory readiness, clinical validation, go-to-market planning, and digital transformation. He is also active in the innovation community through volunteer and mentoring roles with UW CoMotion, WTIA, Life Science Washington, HIMSS Washington, Keiretsu Forum, and University of Washington programs. Marco holds B.S. and M.S. degrees in engineering from the University of Washington.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification.
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