International MedTech Safety Conference (IMSC26)
Boston, MA, USA
2-5 June 2026
Keynote Speaker
Michelle Tarver, M.D., PhD
FDA - Director, Center for Devices and Radiological Health (CDRH)
Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health. She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture. Dr. Tarver has held various leadership positions while at FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement. Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials, and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. Dr. Tarver has extensive policy experience in crafting regulations, guidances, and conducting premarket and postmarket reviews. She most recently served as the Deputy Center Director for Transformation, steering the development, implementation, and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the healthcare ecosystem, and stimulate creative evidence generation pathways. Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health. As a dedicated clinician, she continues to care for people living with inflammatory eye conditions.
Naveen Agarwal, PhD
Principal & Founder - Creative Analytics Solutions
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 3,000 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.
Bassil Akra
CEO & Founder - Akra Team
Experience in R&D, Manufacturing and Testing, Conformity Assessment Activities as a Notified Body Reviewer and Auditor, and finally preparation of Standards and Guidance Documents. I support medical device and in-vitro diagnostic device manufacturers preparing and executing a compliant regulatory, clinical and quality strategy in the EU. I can speak the language of legislators, notified bodies and manufacturers.
Brent Bailey, PhD
Systems Engineer - 8i Robotics, Inc.
Dr. Brent Bailey is a Systems Engineer and Technical Lead with over 20 years of experience designing and developing advanced robotic and medical systems. After early work in space-exploration projects with the Canadian Space Agency, he joined a startup to develop a robotic assistant for brain surgery, an experience that redirected his career after seeing his work used in saving a patient’s life. Since then, Dr. Bailey has worked with multiple medical‑device startups, contributing to the development of CT machines for breast cancer, wearable pulse oximetry devices, dental‑implant robotics, and, most recently, a robotic assistant aimed at transforming spine surgery at 8i Robotics. He promotes systems thinking by incorporating Model‑Based Systems Engineering (MBSE), Value Proposition Canvas (VPC), and System‑Theoretic Process Analysis (STPA) into the design process to deliver medical products that are safe, effective, and commercially successful.
Pat Baird
Sr. Regulatory Specialist - Philips
Pat Baird is the Co-chair of the AI committee that created AAMI TIR34971: Application of ISO 14971 to AI/ML Devices. He is also a lead person in the creation of ISO/TS 24971-2, the successor to AAMI TIR34971. He works at Philips as a Sr. Regulatory Specialist, with a focus on the use of AI in healthcare. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, whitepapers, and training to meet those needs. He co-chairs multiple committees related to artificial intelligence, is an industry rep for IMDRF AI committee, and current standards projects include risk management for ML systems and cybersecurity considerations for ML systems.
Marguerite (Meg) Brackley, M.D.
Medical Safety Consultant - Independent
-A board-certified internist with proven leadership ability and over twenty years of health science industry experience -Former Vice President of Global Medical Safety and Patient Safety Officer for Boston Scientific -Proven strategic and analytic thinker -Establishes global strategies that drive innovation, improve compliance and promote patient safety -Dedicated advocate for patient safety with medical expertise and the ability to resolve unclear and complex issues -Demonstrated success in product development, clinical trials, safety, post market surveillance and risk management -Long history of team development and leadership that promotes continuous improvement, efficacy and efficiency -Leadership style with a focus on collaboration, mentorship, communication and global process development
Bettina (Hoover) Brant
Sr. Director, Medical Safety - Medtronic
Inspirational Senior Medical Safety Director with a solid foundation of change management experience in the medical device industry as well as clinical healthcare settings. Critical care bedside nurse for over a decade before beginning in patient safety in 2014. Motivator, team-builder, education and program development with excellent communication and problem-solving skills. Transparency with patients and teams, processes, projects and performance ensures everyone understands the vision and strategy which is obtained through clarity and conciseness, teamwork, and simplification. Ensuring the voice of the patient is at the table when making critical decisions as a team.
Devon Campbell
CEO - Prodct Studio, Inc.
Devon C. Campbell is the co-founder and CEO of Prodct Studio, where he works with early-stage MedTech and Life Science teams to turn promising concepts into responsible, buildable products. An experienced design engineer and MedTech leader, Devon focuses on helping startups align clinical intent, usability, requirements, and system architecture so that design and development decisions hold up under regulatory, quality, and commercial scrutiny, as well as the real-world pressures of developing and launching world-class products. With more than 25 years in medical device and diagnostics development and three successful exits, Devon has seen how early product choices, documentation habits, and team culture either accelerate progress or create expensive rework later. His work spans system and hardware architecture, design controls, verification and validation planning, and quality strategy for small teams operating under pressure, evolving requirements, and constrained budgets. He emphasizes approaches that are practical for startups while still standing up to FDA, notified bodies, and due diligence. Devon is particularly focused on attacking waste and making meaningful product development more accessible to small teams. At Prodct Studio, he explores and builds tools that help teams understand risk sooner, write better requirements, connect engineering work to quality records, and reduce the friction of doing things “the right way” from the start. He regularly writes and speaks about early MedTech strategy, fundraising, design controls, and the ways interconnected requirements and risk management ultimately support safer, more reliable medical products that make an impact.
David Cronin
CBO, Biotech - Cognition Corporation
Throughout my life I’ve always enjoyed technical things, building things, and making something work in a new way. The majority of my career has been in helping people use “systems-thinking” to add value to a variety of different types of science and engineering projects. This holistic perspective helps identify patterns, optimize system performance, and anticipate potential issues by considering feedback loops, emergent behaviors, and the relationships between various system elements. It also empowers teams to maximize creating, managing, and wrangling complicated data and relationships to be readable by both humans and machines, achieving more efficient and effective product development and lifecycle management outcomes. Areas of activity include: Systems Engineering & Systems Thinking Pharmaceutical Structured Content/Dossier Authoring Medical Device Safety Risk Pharmaceutical Process Risk Integrated Risk Management between device and drug Mr. Cronin is a co-chair of the INCOSE (International Council On Systems Engineering) Healthcare Working Group, whose mission is to bring together systems engineers and systems thinkers to identify, develop, and tailor best practices for the MedTech and Healthcare industry. He is also an active member of the Northeastern University Department of Bioengineering Industrial Advisory Board in Boston, MA. In addition, Mr. Cronin is a guest lecturer for the Drexel University Biomedical MS program in Philadelphia, PA. He holds a BSEE and an MBA, both from Northeastern University, Boston, MA.
Domenic Di Francesco, PhD
Turing Research Fellow - The Alan Turing Institute
Domenic Di Francesco is a Turing Research Fellow at The Alan Turing Institute, where he has worked with partners including Lloyd's Register, the Health & Safety Executive (HSE) and the Cambridgeshire and Peterborough Integrated Care Board (ICB). These projects have focused on guidance for engineers and clinicians on the use of computational statistics, and AI assurance. Domenic is also a chartered mechanical engineer who has previously worked in the energy industry. Dr. Rozelle Kane is an NIHR academic clinical fellow, Dept. Public health and Primary care, University of Cambridge. She is a clinical safety officer with expertise in implementing digital health tools and leading teams. CHIME and FCI registered.
Taylor Dieringer
Senior Staff Quality Engineer; Risk Management - iRhythm Technologies, Inc.
Taylor Dieringer, B.S. Biomedical Engineering, CQE, CRE, is a medical device risk management professional with over a decade of experience applying ISO 14971 across the product lifecycle. Taylor specializes in integrating risk management with post-market surveillance, translating real-world performance and post-market feedback into actionable insights that strengthen safety, support regulatory compliance, and improve decision-making. In his current role as Senior Staff Quality Engineer, Risk Management, Taylor connects post-market learnings to new product development and residual risk monitoring. This work helps ensure risk assessments remain current, risk controls remain effective, and patient safety remains the central outcome. Taylor’s credentials as an ASQ Certified Quality Engineer and ASQ Certified Reliability Engineer complement a strong biomedical engineering foundation and bring a rigorous, data-driven perspective to risk-based thinking in the medical device industry.
Leo Eisner
Founder & Principal Consultant - Eisner Safety Consultants
Leo Eisner, known as “The IEC 60601 Guy,” is Founder and Principal Consultant at Eisner Safety Consultants (est. 1997) and a licensed Professional Engineer in Safety. He brings 30+ years in medical devices, 40+ years in product-safety testing, and 20+ years in global standards development. Leo has worked with three Notified Bodies (TÜV SÜD, NSAI, Pre-Safe) as an auditor and a product reviewer at NSAI. He also held roles in test laboratories at UL and TÜV SÜD. Leo and his team of experts lead complex compliance programs across product safety, EMC, software lifecycle, usability, risk management, labeling, and technical documentation, helping companies of all sizes operationalize standards, laws, regulations, and guidances into traceable design controls and clear, easy-to-understand evidence packages. Leo is an expert in the standards development process, staying at the forefront of evolving medical device standards. His leadership includes: • Co-convener, IEC/TC 62/SC 62A/WG39 (User Interface hazards, IEC 60601-1, 4th Ed.) • Advisory Group member, IEC/TC 62/SC 62A/AG50 (IEC 60601-1, 4th Ed. editing team) • Committee member, IEC/SC 62A/WG37 (General requirements) • US co-chair, AAMI TAG 62D on electromedical equipment • Member, IEC/SC 62A/AG33 and IEC/SC 62D/AG32 (Chairman’s advisory groups) • Convener, IEC/TC 62/SC 62D/JWG9 & US chair, AAMI EV-WG13 (Lens removal and vitrectomy equipment) • Member of numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years Beyond standards writing, Leo contributes to the IECEE CB Scheme, an international mutual-recognition system for safety test reports and certificates, as a member of the CB Scheme ETF-17 Medical (formerly ETF-3 Risk Management Group). He was also named one of the Top MedTech Leading Voices of 2025 by MLV, recognized for sharing expertise on evolving standards, product-safety testing, and compliance strategy.
Kerry Flecknoe
Sr. Manager, Global Quality, HHE - Getinge
Kerry Flecknoe, BSE, BCMAS, is a senior quality leader with over 20 years progressive experience across multiple disciplines in the medical device industry, specializing in post-market risk-based decision making in the framework of Health Hazard Evaluation and Correction & Removal decisions. In her current role as Senior Manager, Global Quality – Health Hazard Evaluation (HHE) at Getinge, Kerry serves as the global business process owner for HHE, overseeing enterprise-wide strategy, governance, and implementation across more than 15 global manufacturing sites. She pioneered the development and optimization of Getinge’s HHE process, ensuring alignment with ISO 14971 and regulatory expectations, while embedding risk-based decision-making into organizational culture. Kerry has led training initiatives on HHE and risk management fundamentals for internal cross-functional teams worldwide, established a Community of Practice to harmonize global field action and HHE activities, and maintains consultative partnerships with executive leadership to embed a culture of compliance and patient safety into operational routines. With a unique background that includes over a decade in a hospital-based patient-facing commercial role, Kerry brings a unique lens through which she views patient safety and user experience, offering a patient-centered perspective to risk management and corrective action decision-making.
Pujitha Gourabathini
Quality Assurance Manager - Becton Dickinson and Co.
Pujitha Gourabathini is a Quality Assurance Manager at BD Medication Management Solutions, where she leads safety and regulatory strategy for infusion pump systems across the full product lifecycle. With over a decade of experience in engineering, risk management, and standards development, she specializes in applying ISO 14971 principles and leveraging Safety Assurance Cases to strengthen risk frameworks, enable engineering-for-safety, and drive regulatory confidence. An active contributor to global standards committees (AAMI), Pujitha helps shape policies on post market surveillance, change configuration and risk management for medical technologies. Her work bridges total product lifecycle, ensuring risk is continuously assessed and mitigated from concept through field performance. She is passionate about advancing quality culture through cross functional collaboration, systems thinking, and evidence based decision making.
Matt Hazelett
COO, CQO - MedSec; Ex-FDA Cybersecurity Policy Analyst
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.
Shannon Hoste
Principal and Founder - Hoste Consulting; Ex-FDA
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.
Terry Irwin
Sr. Distinguished Engineer - Edwards Lifesciences
Terry is a recognized leader in medical device quality engineering and risk management. As the Risk Management Business Process Owner at Edwards Lifesciences, he drives enterprise-wide strategies that ensure patient safety, regulatory compliance, and operational excellence to deliver novel lifesaving devices and therapies to patients. His leadership spans the development and governance of global risk management frameworks, integrating ISO standards and emerging regulations including the EU AI Act into Edwards’ Quality Management System. He has held pivotal roles across top-tier organizations and startups, including Edwards Lifesciences, Boston Scientific and NUVAIRA, where he developed quality systems from the ground up and advanced risk assessment methods and principles. He also leads initiatives that harmonize risk management with best-in-class product development practices across product lifecycles, from concept through commercialization. Terry’s academic foundation includes a Bachelor of Science in Mechanical Engineering from the University of Iowa and a Masters in Business Administration from the University of Saint Thomas, equipping him with a unique blend of technical and business acumen. His philosophy centers on simplicity, respect, and engagement to foster a culture of collaboration and innovation. He is also a contributor to industry forums including ISO technical action groups for TC 176, TC 210 and AAMI standards development where he co-chaired and co-authored AAMI TIR42. With a proven track record of delivering compliant, high-quality solutions in highly regulated environments, Terry is a trusted voice in shaping the future of medical device quality and risk management.
Yu Jin, M.D., PhD
EU MDR Expert - Former Notified Body Clinical & Regulatory Leader
Dr Yu Jin is a Medical Doctor by education and specialized in Cardiology. She received her Ph.D. and training in cardiovascular epidemiology at the University of Leuven, Belgium. With over 20 years of expertise in the medical and clinical sector, Dr. Yu Jin has deep knowledge of cardiovascular diseases, clinical evaluation, clinical investigation, and post-market clinical follow-up (PMCF) of medical devices. In the past five years, she played a key role in a large European notified body, leading a team of clinician and clinical reviewers, overseeing the clinical assessment of technical documentation, and ensuring compliance with regulatory requirements (EU-MDR). She is the author of 12 first-author and 39 co-authored peer-reviewed publications. She is passionate about advancing patient safety, MedTech innovation, and regulatory excellence.
Christie Johnson
COO - Prodct Studio, Inc.
Christie Johnson is the co-founder and Chief Operating Officer of Prodct Studio, where she works closely with medical device and diagnostic startups to build products responsibly within real-world constraints. A mechanical engineer by training, she leads risk management, quality strategy, and regulatory/clinical operations with a focus on helping teams make sound safety decisions early, when they still have flexibility in design and development. With 15 years in medical device development, Christie has seen how risk management is often introduced too late or treated as a compliance exercise disconnected from product decisions. Her work is grounded in ISO 14971, but shaped by the realities of small teams, limited budgets, and evolving designs. She emphasizes practical, defensible approaches to safety that directly support engineering and development work. Christie is deeply focused on the responsible use of AI to improve how medical devices are developed. She explores how intelligent tools can help teams identify risk patterns sooner, reduce rework, and lower the overall cost of rigorous product development. She regularly writes and speaks on medical device risk management, quality systems, and emerging tools that support better decision-making in safety-critical products.
Aaron Joseph
Principal Consultant - Sunstone Pilot, Inc.
Aaron Joseph is a biomedical engineer, systems engineer, and design quality assurance consultant at Sunstone Pilot, Inc. where he helps medical device companies implement modern processes and tools for development of complex, software-intensive medical devices. Aaron has over 25 years of experience in medical device development over a wide range of products: surgical robotics systems, laser eye surgery system, digital x-ray fluoroscopy system, drug inhaler devices, x-ray catheter for brachytherapy, heart-lung bypass machine, and multiple IOT and SaMD products (in total, over 50 product development projects and over 25 quality systems at large and small companies). With this broad experience, Aaron guides clients in optimizing their design control and risk management procedures, implementing software tools to automate compliance documentation, and training R&D staff. He is an avid promoter of lean and agile methods for medical device development and is always looking for new ways to make it faster and cheaper to bring new medical devices to market. Aaron has a BS in Electrical Engineering from Rice University and an MS in Bioengineering from the University of Washington.
Michelle Jump
CEO - MedSec
Michelle L. Jump is the CEO of MedSec, LLC, where she leads a team of experts focused on regulatory strategy and technical analysis of cybersecurity for medical devices. With over 15 years of experience across the MedTech sector, she is a recognized leader in digital health, regulatory compliance, and product security. Michelle has held senior roles at Stryker, Carestream Health, and Nova Leah, where she developed global regulatory programs and advanced industry-wide cybersecurity initiatives. She has contributed to international standards through her work with AAMI, ISO, IEC, UL, IEEE, and IMDRF, and regularly speaks at global conferences and FDA workshops. She holds an M.S. in Regulatory Science from USC, an M.S. in Biotechnology, and a B.S. in Biology from UC Santa Barbara. Michelle is RAC certified and a Certified HIPAA Administrator.
Pooria Kashani, PhD
Chief Product Officer - Horizon Surgical System
Pooria Kashani, PhD is Chief Product Officer at Horizon Surgical Systems, where he leads product strategy and execution for next-generation robotic platforms in ophthalmic surgery. He brings 20+ years of experience in eye care, digital health, product development. Previously, he was Head of R&D Digital Solutions at Alcon, where he founded three global centers of excellence in Software as a Medical Device, Product Security, and Data Science And AI. Dr. Kashani is an inventor on 20+ patents and holds a PhD/MS from UCLA. His current focus lies at the intersection of AI, robotics, real-time imaging, and surgical autonomy, translating advanced computation into safe, scalable clinical impact.
Nikhil Khadabadi, M.D.
Chief Medical Officer - Eclevar Medtech
Dr. Nikhil A. Khadabadi is a medical professional with extensive expertise in orthopaedics, medical devices, and healthcare innovation. As Chief Medical Officer at Eclevar Medtech, he oversees global clinical research initiatives, regulatory strategies, and post-market clinical follow-up (PMCF) activities, contributing significantly to advancing patient safety and medical device innovation. During his tenure at TÜV SÜD, he played a pivotal role as a Clinical Reviewer, evaluating high-risk Class IIa, IIb, and III devices under EU MDD and MDR regulations. His work encompassed critical assessments of prosthetic joint replacements, spinal implants, and dental devices, ensuring compliance with global standards and fostering innovation. In addition to his contributions to Eclevar Medtech, Dr. Khadabadi leads the clinical team at Milo AI Healthcare, a pioneering platform that leverages artificial intelligence to revolutionize medical decision-making in clinical trials. Under his leadership, Milo AI Healthcare has developed cutting-edge solutions that integrate clinical insights with advanced AI technologies, transforming the healthcare landscape. His dual focus on clinical excellence and technological innovation exemplifies his commitment to improving patient outcomes and driving meaningful progress in the healthcare and medtech sectors
Jonathan Kendler is a leading expert in product design and human factors engineering for medical technology. For over two decades, he has specialized in creating safe and intuitive user interfaces for a wide range of safety critical medical products, including dialysis machines, surgical robots, patient monitors, infusion pumps, and glucose monitors. Jonathan is a prominent voice in the field, having co-authored the books “Usability Testing of Medical Devices,” “Designing for Safe Use,” and "Designing Simple Instructions for Medical Products." He is also a seasoned educator who has taught graduate-level courses at Tufts University and delivered usability engineering workshops to professional audiences across the globe. He co-founded the successful consultancy Wiklund Research & Design, which was acquired by UL (Underwriters Laboratories) and evolved to become Emergo by UL's Human Factors Research & Design team. At UL/Emergo, he lead the European usability engineering group and kick-started the development of the RAMS software platform. Since 2018 served as Curiolis' Principal Consultant, helping medical device teams develop safe and user-friendly medical technology. In addition, he is leading the development of Segurra - a digital platform for managing use-related risk analysis.
Tina Krenc
Principal - KTA Compliance Consulting
Tina is the Principal Consultant for KTA Compliance Consulting. She has over 40 years of medical device experience in a variety of organizations and functions including IVD’s, software, hardware, and implantable medical devices. She has led employees in research and development, clinical research, operations technical support, and has over 25 years of quality assurance experience in multiple quality organizations. Tina serves as member of ISO/TC 210 Joint working group on Application of risk Management to medical devices, and IEC SC 62A - Common aspects of electrical equipment used in medical practice. In addition, she is the ISO TC210 liasion for risk management subject expertise to ISO/TC212 - In-vitro Diagnostics Technical Committee. Tina received a Master of Science in Product Design and Development from Northwestern University McCormick School of Engineering in 2006. Tina has taught risk management for several organizations including Northwestern University Master of QARA program. She served on the Board of Directors for AAMI and teaches several of the courses for AAMI including those related to Design Control, Quality Systems, and Risk Management.
Jayet Moon
Director, Risk Management Global - Agilent Technologies
Holds a Master’s degree in Biomedical Engineering from Drexel University and a Bachelor’s degree in Electrical Engineering. Certifications and Professional Credentials: • PMI-RMP (Project Management Institute – Risk Management Professional) • ASQ Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), and Certified Quality Improvement Associate (CQIA) • Chartered Quality Professional (UK CQI/IRCA) • Fellow of the International Institute for Safety and Risk Management (FIIRSM) • RIMS-CRMP (Risk & Insurance Management Society – Certified Risk Management Professional) Books and Publications: • Foundations of Quality Risk Management: A Practical Approach to Effective Risk-Based Thinking • Mastering Safety Risk Management for Medical and In Vitro Devices (ASQ Quality Press, 2023) • Artificial Intelligence Fundamentals (ASQ Quality Press, 2025) • Numerous technical and opinion articles on quality, risk, and regulatory science published in professional outlets. Awards and Recognition: • ASQ “40 Under 40” Rising Star honoree • Australian Organization for Quality “Passion for Excellence” Award recipient • Recognized for contributions to the advancement of Quality Risk Management and AI in regulated industries • Volunteer assessor for Communities of Excellence recognition programs Research and Technical Work: • Developed and published new statistical methods such as “J Charts” for risk-based adverse event trending • Research on emotional intelligence, leadership styles, and their influence on risk-based decision-making • Published work connecting risk management with data analytics, quality systems, and regulatory frameworks Professional Roles: • Quality and Risk Management leader in the medical device and life sciences sector • Experience includes Post-Market Surveillance, Vigilance, and Design Control environments • Contributor and reviewer for professional quality and risk publications and communities
Susan Neadle
President & Principal Consultant - Combination Products Consulting Services
Susan W. Neadle, MS, BS, FRAPS, FAAO, is a recognized international authority in combination products, medical devices and digital health, with over 35 years of industry experience. After retiring from a distinguished 26-year career at Johnson & Johnson in strategic and technical roles, she founded Combination Products Consulting Services LLC, where she leverages her extensive expertise to provide strategy, quality, regulatory affairs, and technical design excellence services to the bio/pharma, biotech and medical device industries. Susan chairs the AAMI Combination Products Steering Committee and plays leading roles in numerous industry-working groups, including Combination Products Coalition, ISPE, TOPRA, AFDO/RAPS and MediPhorum. She is also a respected educator, teaching combination products, integrated risk management, and quality system curricula through her consulting business and at UMBC, AAMI, and DIA, among others. Her significant contributions to the industry have earned her several prestigious awards, including Fellowships in the Regulatory Affairs Professional Society and American Academy of Optometry, 2022 ISPE Joseph X. Philips Professional Achievement Award, 2021 TOPRA Finalist in the Futures category for Regulatory Excellence, and the Johnson Medal for Research & Development Excellence from Johnson & Johnson. In 2023, Susan published “The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems,” through Taylor & Francis/ CRC Press. This comprehensive guide provides helpful information and best practices on combination product lifecycle from pre-market development and regulatory pathways, through post-market, making it an essential resource for professionals in the field. Through her consultancy and active participation across industry forums, presentations and workshops at numerous venues, and authorship of chapters, books, whitepapers, and technical standards, Susan continues to advance the field, driving innovation and leading critical conversations in the industry.
Mathias Sander, PhD
Senior AI Certification Manager - TÜV AI.Lab GmbH
Dr. Mathias Sander is Senior AI Certification Manager at TÜV AI.Lab, a joint venture founded by some of the largest and most important companies in the certification industry in Germany and beyond. The TÜV AI.Lab is paving the way for trustworthy AI by developing conformity criteria and test methods for AI systems. Dr. Mathias Sander leads the certification work package in the European research project TEF Health. He previous was responsible for the regulatory and clinical strategy for AI-based software as a medical device in a startup company. His focus was on the implementation of quality and information security management systems, as well as on regulatory aspects related to AI, software, and cybersecurity in the MedTech environment.
David Simon, J.D., LL.M., PhD
Associate Professor of Law - Northeastern University School of Law
David A. Simon, J.D., LL.M., Ph.D., is an Associate Professor of Law at Northeastern University School of Law, where he teaches courses on tort law, administrative law, and drug & device regulation. He is the Principal Investigator on The Project on Medical Device Safety and co-director of the Amy J. Reed Collaborative for Medical Device Safety, funded by Arnold Ventures. He is also a member of the UIUC CLASSICA research team, a project funded by the European Union. He has previously served on the faculties of Harvard Law School, George Washington University Law School, and the University of Kansas School of Law. Professor Simon’s research focuses on innovation in healthcare, with an emphasis on prescription drugs and devices. His work has appeared or will appear in a variety of publications, including the Texas Law Review, the Boston College Law Review, the Emory Law Journal, the Georgia Law Review, the Oxford Journal of Legal Studies, the Yale Journal of Law & the Humanities, the Journal of Law & the Biosciences, JAMA, Nature Biotechnology and the Journal of Law, Medicine, & Ethics. A complete list of Dr. Simon’s publications is available on his CV. Professor Simon has served on the law faculty at Harvard Law School, George Washington University School of Law, and the University of Kansas School of Law. During his time at Harvard Law School, he led a three-year project at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics dubbed Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health, and funded by the Gordon and Betty Moore Foundation. Professor Simon is also a founder of two nonprofits—Harmed Americans for Reform in Medical-Device Safety and Project TCF20—and a practicing member of the Bar in both Illinois and Massachusetts. You can learn more about Professor Simon at his website: www.davidasimon.us.
John Thomas, PhD
Co-Director, Engineering Systems Laboratory - MIT
Dr. John P. Thomas is Co-Director of the Engineering Systems Laboratory (ESL) in MIT’s Department of Aeronautics and Astronautics. His work centers on developing and applying systems-theoretic safety methods for complex systems. He leads research that bridges aerospace, automotive, and healthcare domains. Dr. Thomas’s research integrates model-based approaches to safety, requirements development, and analyzing human–system interactions for critical applications ranging from autonomous flight to healthcare technology infrastructure. In the healthcare sector, his work has pioneered modern approaches for ensuring safety of medical-devices, diagnostic laboratory systems, and other equipment in healthcare. His recent collaborations include an FDA study on Safety of Laboratory Data Exchanges, IVD Devices, over-the-counter (OTC) and point-of-care (POC) diagnostic systems, and other healthcare equipment.
Mike Walsh
Distinguished Engineer - Medtronic
As a Distinguished Engineer at Medtronic with more than nineteen years of expertise in medical device quality assurance and safety risk management, I have consistently served as a subject matter expert and key driver in advancing organizational risk management strategies. My work has centred on fostering a proactive safety culture, implementing standardized methodologies to strengthen the clarity, uniformity, and effectiveness of risk analysis, benefit-risk evaluation, and residual risk assessment. In addition to my technical leadership, I am dedicated to mentorship and the dissemination of knowledge through forums I have developed to enhance technical capabilities and encourage professional development across the organization. My academic credentials include a Bachelor’s degree in Computer Engineering, a Master’s degree in Biomedical Science, and recognition as a Technical Fellow at Medtronic.
Fubin Wu
President and Co-founder - GessNet
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.
Yu Zhao
President - Bridging Consulting LLC
Yu Zhao is the Founder and President of Bridging Consulting LLC, a leading regulatory, quality, and clinical consulting firm that supports AI startups and medical device companies worldwide. Under Yu’s guidance, the firm has grown to include over 25 expert consultants, serving clients across North America, Europe, and Asia Pacific. Since founding Bridging Consulting in 2020, Yu has focused on guiding organizations of all sizes—from early-stage ventures to multinational corporations—through complex regulatory pathways, ensuring they achieve both innovation and compliance. Yu brings more than three decades of experience in the life sciences and technology sectors, including a 16-year tenure at Medtronic. There, he held multiple leadership roles in regulatory affairs, culminating in positions as director and interim vice president for several multi-billion-dollar business units. Over the course of his career, Yu and his teams have secured more than 150 U.S. FDA approvals and clearances, spanning PMAs, PMA supplements, IDEs, 510(k)s, and De Novos. Yu holds a BS in Electrical Engineering from Zhejiang University in China, along with an MBA and an MSc from Washington University in St. Louis, Missouri. His extensive background and passion for healthcare innovation drive his commitment to helping companies successfully navigate the rapidly evolving regulatory landscape.
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