WHAT WE WORK ON

Class I,  II, and III Medical Devices & Software

Imaging Systems, Infusion Pumps, Ventilators, Radiological Review Stations, CT and MRI, Smartphone Apps, Insulin Pumps and Glucose Monitors, Patient Monitors, Hospital Beds, Retinal Imaging, Surgical Tools, Would Devices, Pulse Oximeters, Medication Dispensing, EHR systems 

Combination Products

Kits, Prefilled Pens, Syringes, Autoinjectors, On-Body Devices, Patches, Inhalers, Surgical Adhesives

Laboratory Instrumentation and Diagnostics

Assays, Kits, Automation, Pharmacy Compounders

Discovery Research

Field Research, Exploratory Studies, Stakeholder Interviews

Simulated-Use Testing

Formative, HF Validation, Summative Studies

Analytical Methods

Threshold Analyses, Heuristic Analyses, Competitive Benchmarking

Human Factors Risk Management

Use-Related Risk Analyses, Use Specifications, Gap Analyses, Adherence to Annex C

Usability and Ergonomic Studies

Time-Motion, Anthropometric, Positioning, Advanced Techniques

Interface Design and Labeling Development

GUIs, Cartons, PDPs, Instructions for Use, Prescribing Information, Quick Reference Guides

 Healthcare Professionals

Surgeons, Physicians, Nurses, Technologists, Technicians, Therapists, Pharmacists, Medical Assistants

Lay Users

Adult and Pediatric Patients, Caregivers, Healthy Adults, Pediatrics

How We Recruit 

We have our own internal recruiters that understand the medical space so that we get the right participants for the study.    

We recruit for our facility in Charlotte, NC and locations throughout the United States.

MANAGING DIRECTOR 

As our Managing Director, Christina is responsible for the operations of the company and provides technical oversight of all programs. Christina is an expert at translating research findings such as user needs, requirements, product strengths and weaknesses into compelling design directions and solutions. She brings over a decade of experience in human factors having spent more than 5000 hours in surgical suites, medical device usability studies, and outpatient facilities. She has been an invited speaker for multiple conferences and workshops with being invited, most recently, as an expert panelist for a program conducted by the FDA . Christina has a PhD in experimental psychology and ergonomics from North Carolina State University. 

SENIOR TECHNICAL DIRECTOR

Liz has over 20 years of diverse experience in human factors research, design, and testing. She is also experienced in applying the requirements of IEC 62366, HE75, and various FDA Guidance documents to support the development of safe and effective medical products. Liz holds a Masters Degree in Human-Computer Interaction from Carnegie Mellon University. 

 TECHNICAL DIRECTOR  

Eric brings two decades of human factors experience to the company. He has spent a good portion of that time in product development with a focus on warnings and risk communication. Prior to joining Human Factors MD, he was in charge of human factors for a large, multinational medical device company. Eric holds a PhD in Ergonomics Psychology from North Carolina State University.  

TECHNICAL DIRECTOR 

Rachel has been working as a human factors consultant applying HF to medical devices and drug-delivery combination products since 2013. As a board-certified human factors professional, Rachel leads and oversees various research and usability testing activities, advises clients on human factors regulatory expectations, and helps clients apply human factors design principles to maximize a product’s safety and intuitiveness. Rachel is a co-author of Designing for Safe Use – 100 Principles for Making Products Safer. She holds a B.S. in Human Factors Engineering from Tufts University and an M.S. in Interactive Design from Northeastern University.

RESEARCH MANAGER  

 Marissa coordinates study logistics including recruitment, facilities, and data management. She holds a Bachelor’s degree in Health Communication and Public Health through The University of North Carolina at Charlotte. 

RESEARCH ASSOCIATE 

Angie has over 20 years of healthcare experience, most recently as a registered radiologic technologist. She has worked with a broad spectrum of patients, ranging from trauma, pediatric, geriatric, neurosurgical, and oncology. She has logged in numerous clinical hours throughout the course of her career and is highly skilled in operating imaging and medical devices. As a research associate, she brings a clinical mindset to study setup and study moderation. She also contributes to building our database of healthcare professionals in the Greater Charlotte area.

RESEARCH ASSOCIATE  

 Margaret has a Master’s in Health Communication through The University of North Carolina at Charlotte. Margaret assists with project facilitation including data entry, video operations, and quality control. 

OFFICE MANAGER   

Ashley has over 20 years of experience in management and business administration. 

RESEARCH ASSOCIATE   

Kathy brings a diverse background to our company. She has over a decade of experience conducting cognitive psychology research as well as teaching psychology at the college level, including research design courses. Kathy has a PhD in cognitive experimental psychology from Georgia State University.