International MedTech Safety Conference (IMSC26)
Boston, MA, USA
2-5 June 2026
Day of
Conversations, Connections, and Collaborations
05-Jun-2026
A participant-driven day focused on conversation, connection, and collaboration.
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Propose topics you care about throughout the conference (June 2–4)
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Informal, highly interactive discussions (no slides, no formal talks)
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Move freely between sessions (“law of two feet”)
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Open Q&A with experts
Introduction of the Risk Management Maturity Model (RM3) Initiative
Description: The newly finalized FDA Quality Management System Regulation (QMSR) underscores the central role of effective risk management. Yet despite widespread adoption of standards such as ISO 14971 and ICH Q9, real-world risk management practices across medical device and combination product organizations continue to vary significantly in both effectiveness and efficiency.
The Risk Management Maturity Model (RM3) initiative was launched to close this gap taking a first-principles approach to define a practical, scalable framework for assessing and advancing risk management capabilities across the industry.
This panel introduces the goals, structure, progress, and vision of the RM3 initiative. Panelists from the working group will present the guiding principles, core maturity domains, and initial assessment concepts, and highlight how the model supports patient safety, sound product decision-making, and regulatory alignment. Global regulators (e.g., FDA) will be invited to offer perspective and feedback.
Attendees will gain insight into how the model is being collaboratively developed with input from industry leaders, and how they can participate in shaping a framework that promotes shared learning, benchmarking, and continuous improvement in risk management practices.
Panel Speakers
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Fubin Wu – Chair of RM3 Initiative; Co-Founder & President, GessNet
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Dr. John Pracyk – Co-Chair; Chief Medical Safety Officer, Olympus
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Dr. Darin Oppenheimer – Co-Chair; VP of Regulatory, BD
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Dr. Anya Harry – Co-Chair; Chief Medical Officer, West Pharma
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Dr. Olaf Hedrich – Co-Chair; Chielf Medical Safety Officer, Medtronic
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Dr. Weiping Zhong - Co-Chair; Global Leader Risk Management, Medtronic
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FDA and other global regulators
John Pracyk, MD
Olaf Hedrich, MD
Weiping Zhong, PhD
PROPOSED TOPICS
Career Advice for Students and Early-Mid-Career MedTech Professionals
Description: Meet leaders. Hear real stories. Gain practical wisdom.
Career paths rarely unfold in straight lines. Join four seasoned MedTech leaders for a candid and engaging conversation about the unexpected turns, pivotal moments, lessons learned, and opportunities that shaped their professional journeys.
Together, Kathy de Padua, Fubin Wu, Steve Gompertz, and Roxanne Skowran Brule bring perspectives spanning executive leadership, entrepreneurship, consulting, product risk management, quality systems, and patient safety. Through personal stories and reflections, they will explore not only how careers evolve, but also the deeper questions of purpose, patient impact, leadership, and what it means to build a meaningful life and career in MedTech.
Students and early-mid-career professionals will gain practical insights on mentorship, standing out early in a career, navigating uncertainty, adapting in an AI-driven future, and the qualities that matter most in a rapidly evolving industry.
Whether you are just beginning to explore the field or preparing to launch your own professional journey, come ready for honest conversation, thoughtful reflection, and words of wisdom from leaders who have walked many different paths.
Kathy de Padua
SVP, Chief Quality &
Regulatory Officer
Steve Gompertz
Partner
Roxanne Brule
Sr. Global Product
Risk Manager
Fubin Wu
President & Co-Founder
Physicians in Transition: Clinical Expertise Driving Medical Device Safety in Corporate Environments
Description: This panel brings together physicians who have transitioned from clinical practice to corporate roles, offering a unique perspective on medical device safety. The discussion will highlight how their clinical backgrounds inform and enhance safety strategies across the product lifecycle. Panelists will share insights on their involvement in key areas, including:
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Clinical Study and Real-World Evidence (RWE): Designing and interpreting clinical trials, leveraging RWE to identify and mitigate safety risks.
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Regulatory Submissions: Navigating complex regulatory pathways and ensuring robust safety documentation.
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Risk Management: Applying clinical judgment to hazard identification, risk analysis, and proactive mitigation strategies.
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Launch Strategies: Integrating safety considerations into product launch planning and execution.
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Post-Market Surveillance: Establishing effective monitoring systems, adverse event reporting, and trend analysis for ongoing safety assurance.
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Escalations: Managing safety escalations and implementing corrective actions based on clinical and market feedback.
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Cross-Functional Collaboration: Working with medical affairs and other departments to align safety objectives and foster a culture of patient-centric risk management.
Attendees will gain practical insights into the evolving role of physicians in corporate medical device safety, the value of clinical expertise in cross-functional teams, and strategies for improving patient outcomes through collaborative, data-driven approaches.
Use-Related Risk — The Linchpin Between Risk Management and Human Factors Engineering
Description: Medical device standards and regulations have evolved considerably over the past few decades, often requiring companies to expand their quality systems to address new expectations. In many cases, new requirements were added as separate processes rather than being fully integrated into existing ones. Risk management, for example, was often bolted onto quality systems years after they were established. Later, Human Factors Engineering gained prominence, and many organizations once again responded by creating parallel processes instead of truly integrated ones.
This guided round-table discussion will explore the operational challenges that arise at the intersection of Risk Management and Human Factors Engineering. Although these disciplines are closely related, companies often maintain separate procedures, separate teams, and separate documentation, which can lead to inefficiencies, duplicated effort, and difficulty presenting a clear and consistent story during regulatory submissions or audits.
Participants are invited to join an open, interactive conversation on how to make Human Factors an integral part of risk management rather than a parallel activity. The goal is to share practical experiences, identify common obstacles, and discuss approaches that lead to more efficient, sustainable, and defensible implementations.
QMSR success – FDA/Stakeholder Action to Assure that the QMSR Thrives
Description of focus points of discussion:
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The QMSR transition is now complete, but implementation is just beginning. What does success look like, and how will we know if the QMSR transition is working?
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Challenges facing FDA and stakeholders during the transition
- Loss of FDA institutional knowledge and staff changes
- Training and consistency of investigators under the new model
- Alignment between QMSR, ISO 13485, MDSAP, and current inspection practices
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Risks to the success of the transition
- Centralization and generalization of the field force
- Reduced resources and competing priorities
- Potential gaps between policy, guidance, and real-world execution
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What needs to happen next?
- What work remains to ensure the QMSR functions as intended?
- What role should FDA, industry, standards bodies, and trade organizations play?
- How can stakeholders collaborate to avoid unintended consequences?
The Patient Impact of Medical Device Safety: A Patient’s Story
Description of focus points of discussion:
What does medical device safety look like from the patient’s perspective?
This roundtable offers a rare opportunity to step outside technical frameworks and experience safety through the lived experience of a patient. At the center of the session is a personal story, an account of life before and after a medical technology became part of care, and how it shaped safety, confidence, and quality of life.
Rather than a formal presentation, this session is designed as an interactive, small-group conversation. Participants will have the opportunity to engage directly with the patient’s story, ask questions, and reflect on what it reveals about the realities of safety in practice.
Together, we will explore questions such as:
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What does “feeling safe” mean from the patient’s point of view?
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Where do gaps in safety become most visible in real-world care?
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How can patient perspectives more meaningfully inform design, development, and risk management decisions?
This session is intentionally open and reflective, creating space for honest dialogue across disciplines. It is particularly relevant for clinicians, engineers, human factors specialists, and safety leaders who are committed to keeping the patient voice at the center of their work.
Participants will leave with a deeper appreciation of how safety is experienced, not just estimated, and with insights that can inform more patient-centered approaches to medical device development and use.
Stefan Leitenberger
Risk Management Engineering Leader
- Philips
Mayur Patel
Head of Regulatory, Quality, and Compliance
- PA Consulting
From Static Risk Management Files (RMF) to Living Risk Systems – Reimagining Medical Device Risk Management in the Age of AI
Description of focus points of discussion:
Can a static Risk Management File remain effective in a world of connected, AI-enabled medical devices? As MedTech systems grow increasingly interconnected, software-driven, and data-centric, traditional risk management approaches are challenged by ongoing updates, evolving system behaviours, AI integration, and real-time post-market insights. This panel will explore whether conventional RMFs are still adequate, or if the future demands more dynamic, continuously adaptive approaches to medical device safety and risk management.
Stay Tuned for Other Suggested Topics