Global Human Factors Strategy for MedTech: U.S., EU & UK Requirements Explained скачать в хорошем качестве

Global Human Factors Strategy for MedTech: U.S., EU & UK Requirements Explained

Global human factors requirements are expanding fast—and each region has unique expectations that can create costly delays if you plan too late. In this Friday In-Focus session, Jessica Parry (Senior Human Factors Consultant & Manager, UK Site Lead, ClariMed) and Jenny Collinson (Director of Human Factors Strategy & Advisory, ClariMed) break down what MedTech teams need to know about aligning human factors strategy across the U.S., EU, and UK—plus how global planning affects testing, labeling, documentation, and timelines. You’ll learn: • How global human factors requirements are evolving (EU MDR, UK MHRA, China guidance, Japan) • Validation testing differences: FDA’s U.S.-resident requirement vs EU/UK flexibility (with justification) • Why EU MDR labeling and broader use statements complicate global usability evidence • How to structure a phased testing strategy (formative → summative) across markets • Why early collaboration with risk management improves study design and evidence quality • Common pitfalls: delayed formatives, weak user-group definitions, poor survey design, and translation bias • How to reduce rework, protect timelines, and avoid expensive redesigns late in development Speakers: • Jessica Parry — Senior Human Factors Consultant & Manager, UK Site Lead, ClariMed • Jenny Collinson — Director of Human Factors Strategy & Advisory, ClariMed • Hosted by Sean Smith (MedTech Leading Voice / MLVx) Transcript 00:00 – Welcome + housekeeping (recording, certificates) 03:39 – Global human factors landscape: why requirements are expanding 07:55 – Regional differences in validation testing (FDA vs EU/UK vs China) 09:00 – EU/UK documentation: usability engineering file vs FDA-style report 14:00 – China requirements: Mandarin testing + external evaluators 19:23 – Building a phased global testing strategy (formative → summative) 25:06 – Market research vs usability testing: how they complement early work 26:49 – Global HF strategy kit: what it includes and how to request it 27:30 – EU MDR labeling + intended use differences: why it impacts usability 36:19 – Translation and reporting realities (Mandarin reports, time/cost impacts) 40:47 – Cultural/user-group differences: why UK ≠ US even in English 44:00 – Segmenting user groups by region in use specifications 46:56 – Cost of skipping formative studies: redesigns, delays, brand risk 48:28 – Building a global plan that reduces overall risk despite higher upfront effort 52:48 – Top strategic advice: define launch markets early + integrate HF early 54:17 – Participant numbers and rare user group justification 54:50 – Risk management collaboration: making risk your “best friend” 55:56 – Using risk outputs to focus critical tasks and testing scope 58:00 – How to arrange private team workshops + follow-up support 59:00 – Unanswered questions follow-up + closing notes