International MedTech Safety Conference (IMSC26)
Boston, MA, USA
2-5 June 2026
Fubin Wu - GessNet Co-founder & President
Fubin Wu is the Co-founder & President of GessNet and creator of QMSpace, a CGMP-compliant digital platform that provides a single source of truth for medical product development and lifecycle management, integrating design controls, risk management, Quality by Design, cybersecurity, and safety assurance case into one model-based system.
With 25+ years of experience, Fubin has guided 40+ organizations in bringing a broad range of medical technologies to market—including drug-device combination products, infusion pumps, robotics, and SaMD—and has led more than 30 safety assurance cases submitted to the FDA. He previously held leadership roles at Medtronic and Hospira and began his career as a software engineer at Intel.
Before founding GessNet in 2011, Fubin held leadership roles at Medtronic and Hospira, where he served as Quality Director and Manager. He began his career as a software developer at Intel.
Fubin holds a Master’s degree in Electrical and Computer Engineering from Oregon Health & Science University.
Naveen Agarwal - Creative Analytics Solutions Principal & Founder
Dr. Naveen Agarwal is the visionary creator and host of Let’s Talk Risk!, a community-driven platform dedicated to advancing the understanding and application of medical device risk management. Through expertly curated content and engaging conversations, Let’s Talk Risk! has built a global audience of over 4,000 professionals, offering a robust library of practical resources, including case studies, podcasts, and webinars. Dr. Agarwal's mission is to elevate the collective capability of the medical device industry in risk management, driving improvements in patient safety, accelerating innovation, and reducing costs.
An engineer by training, Dr. Agarwal brings over 15 years of experience in the MedTech sector, having held diverse roles in R&D, Product Quality, and Business Analytics. His extensive consulting work focuses on innovative solutions to integrate complex documentation systems seamlessly while streamlining procedures, making compliance both efficient and effective.
Dr. Agarwal is a passionate advocate for bridging the gap between technical expertise and operational excellence, empowering professionals across the medical device industry to address risk with confidence and purpose.
https://www.linkedin.com/in/naveenagarwal/
Shannon Hoste - Hoste Consulting Principal & Founder
Shannon is a cognitive systems engineer, with a 27+ year career in the medical device and combination product space. This includes four years as a Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and reviewer within the Center for Drug Evaluation and Research (CDER). At the FDA she led reviews of Human Factors data for medical device premarket submissions through 510(k), PMA, and De Novo pathways; combination products through NDA, BLA, and ANDA pathways; as well as data to support IND and IDE requests. In industry she held roles in R&D, Quality, Risk Management and Human Factors. She has been the Global Risk Management Process owner within the IVD industry, a Design & Development Process Owner in the surgical instruments space and President of a Human Factors CRO.
Shannon holds a BS in Mechanical Engineering, MS in Cognitive Systems Engineering, MS in Management and as a lifelong learner is working toward a graduate certificate in epidemiology in 2026.
Previous speaking experience (include links to slides, videos, or talks)
MEDevice Boston, AFDO/RAPS MedCon, AFDO/RAPS Combination Products Summit, RAPS, AAMI, MedTech Intelligence, The Pack-Out, various webinars and course sessions.
LinkedIn profile link
https://linkedin.com/in/shannonhoste
Matt Hazelett - MedSec COO, CQO, Ex-FDA Cybersecurity Policy Analust
Matt Hazelett is Chief Operating Officer and Chief Quality Officer at MedSec, responsible for ensuring operational excellence, while also guiding the development of consistent quality processes. Matt supports the organization in meeting both client and regulatory expectations. His role is multifunctional and includes the direction of MedSec's training initiatives designed to enhance the knowledge base across the industry and set manufacturers up for success in developing and maintaining more secure medical devices.
Prior to MedSec, Matt worked at the Food and Drug Administration (FDA) for over 8 years. He most recently served as the Senior Cybersecurity Policy Analyst in the Office of Product Evaluation and Quality (OPEQ). His role focused on premarket and postmarket cybersecurity policy development and implementation across the clinical review offices including the recent requirements under Section 524B of the Food, Drug, and Cosmetic Act and the 2023 final premarket guidance. He also served as a Digital Health Center of Excellence Program Director for the OPEQ Cybersecurity Focal Point Program.
LinkedIn profile link
https://www.linkedin.com/in/matthew-hazelett-8690a455/
Instructor
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Abstract
Instructor
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