Medical Device Human Factors Consulting and Testing Services
Applying real-world insights across diverse user groups and conditions for superior designs and submission ready documentation.
Global Medical Device Human Factors Testing That Informs Safe and Superior Design
Our dedicated professionals are actively involved in fieldwork, undertaking numerous projects that provide unparalleled insights into user behaviors and needs. We collaborate with diverse user populations across a wide range of medical conditions and clinical environments, to fully understand the varied contexts of device use. Our expertise lies in effectively navigating the medical device human factors process per ISO / IEC 62366, ensuring exceptional user-focused outcomes and a successful regulatory submission.
The Impact of Our Human Factors Team’s Expertise and Experience
In 1 year, our team has completed

Human factors programs completed

Formative evolutions

Validations executed

Field days

Total study participants
What Clients Say
"There was an urgent need to meet expedited regulatory submission and approval timelines to stay competitive in the biosimilar market. Thanks to the support from Veranex, I’m pleased to share that our regulatory submission was completed on schedule, paving the way for our commercial success."
Vice President of Devices & Packaging at a large biotech company
What Clients Say
"Our team engaged with Veranex, and it was truly a positive experience. I want to commend Veranex on their professionalism, organization, and attention to detail that helped make this activity a success. This encounter stands as a best practice in what to expect from a Human Factors Vendor."
Senior Director at a Large MedTech Company
Achieve Device Success with Veranex’s ISO / IEC 62366 Human Factors Expert Services
Trust our team to deliver the evidence and insights required for a successful submission and a product that truly meets the needs of those who use it.
Our comprehensive suite of services, from formative evaluations that inform design refinement to meticulous documentation and end-to-end validation support, is built on a foundation of deep experience across various medical specialties and user populations.
Human Factors Documentation
Build a strong foundation for your device with comprehensive and compliant human factors documentation. We translate complex user interactions and risk analysis into clear, compliant reports, essential for regulatory approval and a successful product launch.
Deliverables and Activities
- Develop comprehensive HFE Reports for FDA and EU MDR submissions.
- Conduct thorough use-related risk analyses (uFMEA, Task Analysis).
- Define and document user needs and detailed usability specifications.
- Create plans aligning with IEC 62366, ISO 14971, and FDA guidance.
- Prepare clear documentation tailored to your device’s regulatory needs
Breadth of Application Across Disease States
Regardless of the therapeutic area your medical device addresses, our human factors team has the deep experience and understanding to navigate the unique user needs, environments, and clinical workflows involved.
We apply our human factors expertise to ensure your device is designed with the specific context of use and patient population in mind, leading to better usability and ultimately improved patient outcomes.
Experience Engaging All Potential User Groups
Your medical device may be used by a diverse group of individuals, each with unique needs and characteristics. We have extensive experience and established relationships for recruiting and engaging with all potential user groups, including patients of varying ages and conditions, caregivers, and healthcare professionals across different specialties and settings.
Understanding the needs of all your intended users is critical for developing a safe, effective, and widely adopted product, and our ability to engage these groups sets us apart
Human Factors Usability Testing
Optimize user experience and validate your device with our expert usability testing.
We uncover critical insights at every stage, from early iterative refinements that catch design flaws to robust summative validation to confirm your device meets all requirements for regulatory approval and market success. Our goal is to provide submission ready documentation and ensure your device is intuitive, effective, and performs flawlessly in its intended environments.
Formative Methodologies
Formative Methodologies
- Conduct early-stage concept evaluations with prototypes and wireframes.
- Perform simulated-use formative usability studies with representative users.
- Execute heuristic analyses, expert reviews, and cognitive walkthroughs.
- Evaluate instructions for use (IFU), quick reference guides (QRGs), and labeling.
- Facilitate comparative use studies for design iteration and benchmarking.
- Provide rapid feedback loops for agile design refinement.

End-to-end Validation Testing Support
End-to-end Validation Testing Support
- Develop comprehensive validation test protocols.
- Recruit and manage participants representing all intended user groups globally.
- Moderate realistic simulated-use testing in appropriate environments.
- Perform thorough data collection, analysis, and interpretation.
- Prepare detailed Human Factors Validation Reports for submission.
- Ensure studies meet FDA, EU MDR, and other relevant regulatory body expectations.

Related Articles
Latest Blog Entries
Meet the Team
Navigate ISO / IEC 62366 for Device Success with Our Human Factors Experts
Let our team guide your device from design to market success, ensuring usability, safety, and a confident regulatory submission.
Nick Choofon
Director, Human Factors Engineering
Nick leads Veranex’s London human factors team and has over 10 years of experience designing, moderating, and reporting on usability evaluations for healthcare technologies. Having worked at Smiths Medical, Olympus Medical, and an HF Consultancy he has a strong medical device development background and has always employed Human Centered Design principles in his work. Following training at Olympus he gravitated to subject matter expert in Human Factors and was responsible for creating and updating an Internal Human Factors Usability procedure. Nick has managed a range of formative and summative usability projects on devices as diverse as injectable devices, mobile applications, suction pumps and consumables. Nick has conducted a range of international usability and research studies in China, US and throughout Europe. He has a BEng from Loughborough University in Product Design Engineering.
Nick Benedetto
Director, Human Factors Engineering
Nick is responsible for leading the Minneapolis-based human factors team, including project management, resource allocation, and talent development, and has over 10 years of experience in Human Factors Engineering of Medical Devices & Combination products. He is skilled in designing usability studies, pre-validation and post-validation residual risk analysis and preparation of documentation for FDA submission. Prior to joining Veranex he worked as a Human Factors Engineer at Baxter International, specializing in renal/dialysis systems and drug delivery devices. He holds a Bachelor of Science in Biomedical Engineering, with a concentration in Cell and Tissue Engineering, and a Minor in Chemical Engineering from The University of Rochester. Additionally, he holds a Master of Science in Technology/Engineering Management with a concentration in Regulatory Affairs at the University of St. Thomas.
Kim Waller
Director, Human Factors Engineering
As Director of Human Factors Engineering, Kimberly has 10+ years of experience contributing to projects in all phases of product development. She has held positions in pre-clinical research, program management, and regulatory/clinical affairs. She leads the team responsible for usability validation (summative), pre-summative, and design validation activities and provides oversight for human research at Veranex, including preparation and facilitation of regulatory submissions. She attains and maintains a level of product and application expertise to communicate effectively with development members, supervisory staff, content experts, regulators, and clients; she works closely with the human-centered industrial design and design assurance teams for usability and regulatory oversight.
Case Studies
Medical Device Human Factors Expertise in Action: Case Studies
See how our expertise guided diverse studies on various prototype fidelities to inform designs, ensure safety, and achieve market and submission success.
Early Design Evaluation of Female Catheter
Situation
A client needed informed design inputs for the next generation of an external female catheter device for critical care and home users.
Successes
- Interviewed RNs nationwide, with extensive experience placing these devices to understand points of pain in workflow.
- Invited 6 RNs to simulate placement of the device on a gynecological training assistant that represented the BMI of interest.
- Collected RN feedback through resonance testing on 4 different prototypes to assess fit and function.
- Concept Evaluation - Evaluated the fit, placement, security and removal, of two novel external female catheter in-hospital designs on 8 “patient” participants that represented the BMI of interest.
- In-Home Longitudinal Study - Iteratively evaluated the fit, placement, security and removal, of multiple novel external female catheter in-home designs on 10 “patient” participants.
Services by Veranex
- Human Factors
- Research & Strategy
- Design and Engineering
3-Phase Formative for an At Home Wearable Device
Situation
The Veranex’s human factors team supported a project to re-imagine a left ventricular assist device (LVAD) for late-stage heart failure patients.
Successes
- The project team executed field research with LVAD patients, co-creation sessions for design concepts, and refined user needs for a wearable innovative LVAD design.
- Human factors team executed a formative study with the refined wearable design in 3 sessions:
- Initial interview for education of participant, overview of research and explanation of home tasks.
- At home exploration of participant with at home tasks over 48 hours with written feedback and video diaries.
- Closing interview 48 hours after initial interview around device size, fit, ranking the tasks and UI interactions on the simulated display.
Services by Veranex
- Research & Strategy
- Human - Centered Design
- Human Factors
Refinement of user needs for drug delivery device
Situation
A pharmaceutical client needed Veranex to conduct research for a drug delivery device platform to identify business needs, improve patient engagement, assess value, and ensure safety and usability without adding burden.
Successes
- Conducted multiple interviews with 11 healthcare professionals, 31 patients, and 10 business stakeholders across the US and Europe to gather insights on existing platforms.
- Identified key pain points and validated features for a connected autoinjectors through workshops and visual stimuli, fostering internal support for development.
- Demonstrated strong evidence of unmet user needs, leading to funded design and development, followed by three usability studies to optimize UI/UX and reduce risks.
Services by Veranex
- Research & strategy
- Human Factors
- UX /UI
Discover More
Related Services at Veranex
Research and Strategy
Our teams specializes in uncovering crucial user needs & defining market opportunities early in the development lifecycle. With a robust strategic plan informed by real-world insights, your product is ensured to be purpose-built and address unmet needs.

Product Design
Our project design teams are constructed for your success. Our Industrial Design and Engineering teams collaborate directly with Human Factors experts, ensuring that ease of use and safety are prioritized from the earliest design inputs.

Regulatory Services
Ensure successful regulatory submission by integrating Human Factors and Regulatory expertise early in your strategic planning. Our collaborative teams work in lockstep to efficiently meet all necessary requirements, preparing a robust submission designed for confident approval.

Engineering and Development
Our specialized engineering services, integrated with rigorous quality assurance, are designed to finalize every design detail. Through iterative prototyping and comprehensive usability testing, we ensure that user needs are fully met, and that ease of use and safety are paramount in the final design.

Unlock your Devices Potential: Connect with our ISO / IEC 62366 Human Factors Experts
No matter where you are in the medical device development lifecycle, our Human Factors expertise, grounded in applying ISO / IEC 62366 and best practices, is ready to support you. We customize our services to meet your specific project needs, providing the guidance and rigor required to ensure your device's safety, usability, and overall success.



