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We understand your challenges and ensure your success.
Our data-powered approach to human factors engineering cuts through complexity and delivers safe and validation-ready solutions - faster and more effective than any other human factors approach on the market today.
Don’t let Human Factors slow you down.
Human Factors is one of the biggest challenges in medical device development.
Without real-world data and pre-validated solutions, development teams are forced into guesswork - leading to inefficiencies and late-stage setbacks.
How it works.
The Human Factors Platform™ combines pre-validated solutions and benchmark data in a powerful, end-to-end system that drives every solution we offer.
Integrated Delivery System
Cover all your human factors-related needs.
Pre-Validated Solutions
Save up to 70% in time and 40% in cost.
Benchmark
Data
Get total clarity and ensure your success.
Your Human Factors Platform™
Built to eliminate guesswork and accelerate approval.
Meet our two most impactful solutions.
Powered by real-world data and proven solutions.
Our Clients Speak for Us. Literally.
I was very impressed with Ergonomics Factory's understanding of their client's needs.
Barbara, Head of Drug Product Development,
Leading Pharmaceutical Company.
I highly recommend Ergonomics Factory for any project requiring outstanding human factors and design expertise.
Matt, Engineering Manager,
Neuroscience Research Organization.
Ergonomics Factory guided our HFE strategy and delivered expert reviews and a complex validation across three countries - outstanding work throughout.
Samuel, Project Manager,
Multinational OEM Device Company.
Ergonomics Factory’s proactive, professional, and collaborative approach made for a very positive experience.
Daniela, Design Control Specialist,
Multinational Pharmaceutical Company.
Their expertise in developing instructions for use, quick reference guides, package labeling, illustrations, and translation services exceeded our expectations.
Francesca, Senior Marketing Manager,
Multinational Medical Technology Company.
The results were extremely valuable and Ergonomics Factory ensured that the study was completed within time and budget.
Alberto, Head of R&D,
Italian Pharmaceutical Company.
Thanks to Ergonomics Factory, we’ve quickly and effectively completed the design & development of our device.
Christoph, Senior Design Manager,
Leading OEM Device Company.
Ergonomics Factory helped us with both the physical ergonomics and the psychological drivers to make our product more user-friendly.
Chris, Director,
Swiss Medical Research Company.
We chose Ergonomics Factory because of their technical and regulatory expertise.
Yu-Ting, Senior Human Factors Engineer,
Multinational Pharmaceutical Company.
Ergonomics Factory made sure that all usability and safety-related aspects were systematically assessed and analyzed.
Thomas, Managing Director,
German Research Organization.
01
SEND US A MESSAGE
Get in touch to discuss your project with our technical experts.
02
GET A TAILORED OFFER
Receive a customised proposal tailored to your needs.
03
STREAMLINE YOUR PROJECT
Eliminate guesswork and accerlerate approval with our data-driven approach.
Facing uncertainty with Human Factors?
Our team understands the complexities you encounter.
Slow timelines, rising costs, and uncertainty about what works and what doesn’t can create major hurdles.
We simplify your process and help you navigate human factors challenges and gain approval - fast.
Step onto a clear path to success, without guesswork.
Q&A
Answers to your most important questions, all in one place.
All our solutions incorporate pre-validated solutions and benchmark data from dozens of approved devices - built into a flexible system with end-to-end delivery capabilities. The result? Faster, more cost-effective outcomes - with even better quality. Instead of slow, costly processes, we provide immediate clarity and a faster path to approval.
It’s a powerful tool that determines your product’s validation readiness by comparing critical design features and risk controls to dozens of approved solutions targeting similar user groups and use contexts. Whether you're early or late in development, it gives you a clear validation readiness level and actionable guidance to move from where you are to successful approval. And the best part? You get results in under a week - insights that would normally take months, sometimes even years.
It gives you instant clarity on how your product compares to market leaders - revealing strengths, risks, design gaps, and next steps toward validation readiness. Whether integrated into our user studies via the Benchmark Navigator™ or delivered as a standalone through the Pre-Validation Factory™, both turn real-world data into actionable insights that boost performance and accelerate approval - saving you months, sometimes even years, of development.
We offer pre-validated strategy roadmaps, design patterns, risk controls, and study setups - built on insights from hundreds of successful projects. It’s your fast track to approval, powered by real-world data, proven best practices, and an integrated end-to-end delivery system.
Absolutely. We offer flexible options so you can start small, see the value, and scale when you’re ready.
No, but they give you a serious head start. Nothing replaces full human factors validation (unless your case qualifies for exemption), but our pre-validated solutions fast-track your way toward approval. Backed by real-world benchmarks, they cut risk, eliminate guesswork, and get you validation-ready faster than traditional approaches.
Absolutely. We seamlessly integrate with internal teams and external partners - because all our engineers have years of in-house experience at pharmaceutical companies, driving cross-functional alignment and managing vendors firsthand. We speak your language, adapt to your workflows, and deliver results that meet your QMS requirements and regulatory expectations.
Yes. Our solutions support every stage - from early research to post-validation - and can be tailored in scope to fit any project landscape. Wherever you are, we deliver strategic and operational support, along with data-driven insights to move you forward with confidence.
We build compliance in from day one. Our solutions align with regulatory requirements worldwide and meet all Human Factors–related expectations. We stay ahead of evolving standards to ensure your product is ready for approval - anywhere.
We work across all types of medical devices and have vast experience with injectables, inhalables, transdermals, implantables, surgical devices, neurostimulators, diagnostic devices, as well as accessories like vial adapters, catheters, and digital applications. Whether you're developing a full device or a supporting component, we help you design, optimize, and launch with confidence.
Our team includes human factors experts with decades of experience in drug delivery; UX and industrial designers specialized in hardware and software solutions - including packaging and labeling for medical devices; and study experts with global access to sites and participants, including rare disease patients, highly specialized healthcare professionals, and other hard-to-reach groups. Backed by experience from over 250 successful projects, we deliver the insight and guidance you need to move forward with confidence.
We’re a multinational group with our head office in Switzerland and a subsidiary in Germany. However, our work is global, and we support clients worldwide through remote consultations and flexible engagement models - wherever you are, we’re ready to collaborate.
That’s a great starting point. We regularly collaborate with internal teams, complementing their work with pre-validated solutions, fresh insights, real-world benchmarks, as well as study and user interface design solutions. It’s a model we know well - helping teams reduce risk, accelerate progress, and increase ROI, while delivering stronger outcomes together.
Yes. Whether you're submitting a new drug–device combination, biosimilar, generic, medical device, IVD, or bringing a legacy product into compliance - we can help. Our support includes validation study protocol submissions, briefing book preparation, and materials for regulatory interactions. We ensure your product meets all human factors–related regulatory expectations and is positioned for approval. With deep expertise in global drug delivery pathways, we bring clarity, confidence, and proven support to your submission process.
Yes. We offer tailored training and workshops grounded in the core components of our platform. From sensitizing drug formulation teams to their impact on device development, to aligning cross-functional teams on human factors, user testing, and regulatory strategy - we customize every session to your needs. It’s a fast, effective way to build internal capabilities and accelerate development with clarity and confidence.
We offer five powerful solutions designed to accelerate medical device development while reducing risk, cost, and timelines:
01. Launch Accelerator™ – The fastest, most cost-effective way to launch, combining pre-validated solutions and benchmark data in one end-to-end system.
02. Milestone Sprint Lab™ – Laser-focused support to fast-track key milestones with speed, compliance, and impact.
03. User Insights Lab™ – Deep user research and competitive benchmarking to ensure usability, safety, and market fit.
04. Innovation Lab™ – A structured approach to turn bold ideas into breakthrough solutions, grounded in real-world success.
05. Pre-Validation Factory™ – Rapid, data-driven readiness assessments to eliminate surprises before validation.
These solutions form a scalable system that meets your needs at any stage - from early concept to regulatory approval.