7th EDITION US MEDICAL DEVICE HUMAN FACTORS AND USABILITY ENGINEERING CONFERENCE
Boston | 2026
From Insight to Impact: Transforming HF into Measurable Value
key information
- Boston, MA, USA
- 20th – 22nd October 2026
Conference Insights
Join human factors and usability engineering leaders for a transformative three-day experience designed to elevate best practices, strengthen collaboration, and advance human-centered innovation across the medical device industry.
What to Expect:
- Workshops – Interactive, hands-on sessions focused on practical skills and real-world application
- Fireside Chat – Open, candid conversations with industry trailblazers sharing experiences and lessons learned
- Panel Discussion – Collaborative dialogue across functions to exchange perspectives, insights, and proven approaches
- Roundtable Discussions – Interactive group sessions encouraging open dialogue, peer exchange, and practical insights on shared challenges
Connect with the minds shaping medical innovation and return with the insights to influence decisions at every stage of development.
3 DAYS OF INSIGHTS & INNOVATION
PRE-CONFERENCE WORKSHOP DAY
DIVE DEEP WITH EXPERT-LED WORKSHOPS
WORKSHOP A:
- Defensible Critical Task Frameworks
- Classification Decisions Under Scrutiny
- Linking Critical Tasks to Risk & Validation
- Addressing Common Deficiency Triggers
WORKSHOP B:
- URRA to Risk File Integration
- HF, Risk & QA Traceability
- Post-Market Signal Integration
- Audit & Inspection Readiness
DAY 1
LEARN FROM REAL-LIFE CASE STUDIES, PANEL AND ROUNDTABLE DISCUSSIONS
REGULATORY & VALIDATION
- FDA Deficiency & Remediation Strategies
- Critical Task Classification & Validation Gaps
- HF Validation Reporting for Submissions
PRODUCT DESIGN & USABILITY
- Combination Product Usability
- Multi-Site Validation & Data Integrity
- Complex Use Environments & Scenarios
POST-MARKET & RISK
- Complaint Data & Risk Mitigation
- Use Error Trending & Signal Escalation
- HF & Risk Integration
DAY 2
CONNECT THROUGH EXPERT-LED PRESENTATIONS AND ENGAGING FIRESIDE CHAT
DIGITAL & ADVANCED SYSTEMS
- AI, SaMD & Connected Devices
- Robotic & Complex System Validation
REGULATORY & INSPECTIONS
- US vs EU HF Submission Alignment
- Inspection Readiness & Documentation
- FDA Review Expectations
STRATEGY & INNOVATION
- Engineering vs HF Alignment
- HF in Breakthrough Device Programs
- From Compliance to Competitive Advantage
Our Industry Specialists
Mingxiang Xu
Selman Iqbal
Jeongpyo (JP) Hong
Braden Haws
Joe Cesa
Rhonda Johnston
Prabhu Ramachandran
Pasha Javadi
Kay Sim
Michelle Dowell
Nicholas Child
Mor Vardi
Amanda Masotta
Katrina Hansen
Matt Marber
Leah Swanson
Matt Chen
Shreya Sridhar
WHY TAKE PART
- Master Validation & URRA Excellence - Strengthen use-related risk analysis and validation strategies to reduce costly failures.
- Navigate AI & Software Complexity - Address transparency, trust, and usability challenges in AI-enabled and software-driven devices.
- Align HF with Business Strategy - Demonstrate ROI through metrics-driven approaches and cross-functional integration.
- Prepare for Regulatory Evolution - Stay ahead of FDA expectations and post-market usability requirements.
- Design for Real-World Complexity - Improve simulation environments, multi-user testing, and representative clinical scenarios.
- Learn from Industry Leaders - Gain insights from global MedTech innovators and hands-on practitioners.
- Engage in Interactive Roundtables - Solve real-world challenges collaboratively with peers facing similar pressures.
KEY TAKEAWAYS
SCALE HUMAN-CENTERED STRATEGY
Practical frameworks to implement and scale Use-Related Risk Analysis (URRA)
Strategies to prevent and manage validation failures
Techniques to improve findings classification in HF validation studies
Integrating cognitive psychology principles into root cause analysis
Designing inclusive and diverse user-centered solutions early in development
Leveraging simulation, AR/VR, and AI to enhance usability testing realism
Building metrics-driven HF programs that demonstrate measurable ROI
Strengthening cross-functional collaboration between HF, regulatory, clinical, and risk teams
Bridging pre-market usability insights with post-market safety data
Scaling HF processes across complex product portfolios and platforms
Moments Captured
Take a glimpse into the highlights of our conferences, where ideas come to life and connections are made
Our Testimonials
It was a great honour to attend this conference and meet an excellent group of HF/UE professionals!
– Team Manager – Active Medical Devices
An excellent learning journey with insightful contributions from industry leaders.
– Senior Human Factors Lead, Global Healthcare Operations
An event with ignited minds.
– Head Global Human Factors Engineering
I thoroughly enjoyed attending the conference. A lot of effort was made to ensure engaging and educational sessions were offered. The niche conference offers valuable insights from leaders in the field and many meaningful connections were created.
– Human Factors Researcher
Unique in Europe. We need more of these events!
– Founder & CEO
It was amazing to hear about the innovative HF methods being used globally. I have come away from this conference with new inspiration for our HF team!
– Principal HF Design Engineer
Good learning material and an excellent networking opportunity.
– Sr. Human Factor Engineer
It was a great opportunity to meet industry experts and exchange challenges, thoughts and ideas. Looking forward to next year.
– Human Factors & UX Consultant
The exchange with HFE enthusiasts was a kind of well-being.
– Head Global Human Factors Engineering
The Annual European Medical Device Human Factors and Usability Engineering Conference brings people together with the same user-centred mindset, which makes the discussions and networking moments very interesting.
– Product Lead
YOUR ALL-IN-ONE GUIDE TO THE EVENT
Get the full scoop on what’s in store!
Explore the event overview and dive into the agenda for the US MEDICAL DEVICE HUMAN FACTORS AND USABILITY ENGINEERING CONFERENCE—your gateway to 3 days of strategy, science, and innovation.
COLLOCATE WITH US/EUROPE
- 20th - 22nd October 2026
- Boston, MA, US
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