what we KNOW
As human factors experts, and former aviation and emergency medical professionals, our motivation has always been to optimize human-product performance in complex use environments through the application of human factors science, to enable safe, effective, and enjoyable user experiences.
OUR AREAS OF EXPERTISE INCLUDE:
observational field research, ethnography, and contextual inquiry
task, workflow, and use error analyses
user experience and (graphic) user interface design
(rapid) prototyping, wireframes, and mock-ups
usability testing, (FDA) formative and summative
human factors & usability eng. in agile development, i.e. SCRUM
human factors & usability eng. for medical devices and combination products
design controls and ( risk management, i.e. ISO 14971
FDA, MDD/MDR, IEC 62366, and international usability standards for medical devices
With our dual-market – US and EU, multi-disciplinary background, and our bilingual capabilities – English and German, we can provide insight into tackling the complexities of applying human factors within the medical device research and development process whilst providing a clear regulatory path for FDA submission and CE mark approval.
types of devices we've SUPPORTED
computer-aided aortic occlusion catheters | electrophysiology 3D mapping systems | fluid-management systems | cardiac programmers and monitors | integrated OR imaging and surgical navigation solutions | pre-filled syringes | pressure and volume control ventilators | drug reconstitution self-administration kits | surgical fluid irrigation pumps | infusion pumps | insufflators | surgical generators | surgical robots and tools | diagnostic catheters | implantable devices | acoustic coupling fluid | radiological equipment | AF ablation catheters | autoinjectors | endoscopes | cardio ultrasound | surgical software for minimal invasive surgery
we know MEDICAL DEVICES
& COMBINATION PRODUCTS
For the past two decades we have supported development teams around the globe; researching, designing, engineering, and testing devices, empowering them to develop the safest and most effective human-focused products possible, whilst enriching usability, use experience, user safety, and patient quality of life through the application of human factors science and usability standards and practices.
we know REQUIREMENTS
REGULATIONS & STANDARDS
We are competent in both – US and EU, human factors and usability regulatory requirements and can aid in ensuring alignment between FDA guidances, IEC 62366 standards, MDD/MDR regulations, and international human factors and usability standards.
Human Factors and Usability Expert for Medical Device Research and Development
A Human Factors Consultant with 20 years experience in the application of human factors science and usability practices in the product research and development industry. She founded HFUX Research in 2017, with the vision to empower organizations around the globe, at every budget, knowledge level, and development stage, to realize their human factors vision and usability goals, by employing customized human factors and usability strategies and solutions, tailor fit to each organizations' R & D needs.
With her diverse professional experience as a trained pilot, emergency medical technician, software analyst, and human factors and usability expert within the medical device and combination product development industry, her motivation has been directed towards enhancing human-product performance by optimizing user interface design, information architecture, and user and product workflow, through the application of human factors science and usability guidelines and practices.
She holds patents in GUI design for medical imaging and surgical navigation software systems. She grew up in Germany and has had previous Human Factors and Research roles in the U.S., Luxembourg, and Switzerland. She is bilingual in German and English and holds a BS in Aeronautics and a MS in Human Factors and Systems, both from Embry-Riddle Aeronautical University, as well as technical degrees in Information Technology Management and Emergency Medical Services, from Sacred Heart University and Daytona State College.