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Human Factors Behavioral Research & Design

"Small Team Agility, Large Company Quality"

OUR SERVICES

HFCSI provides a wide range of verification and validation services including (but not limited to):

  • Gap Analysis
  • Expert Heuristic Analysis
  • Formative Testing
  • Summative and Actual Use Testing
  • Prototype Testing and Down-Selection
  • Ethnographic Research
  • Marketing Research and HF Testing Integrated!
  • Post-Market Evaluation
  • IFU Development and Testing
  • Other needs? Contact us!

Gap Analysis

Evaluation of your product’s current design and documentation, and identification of any missing components needed to meet FDA and International standards. HFCSI can then specify a complete road map for providing all HF requirements needed for a successful submission.

Expert Heuristic Analysis

This is a fast, inexpensive way to determine major design issues before performing costly studies. HFCSI uses a mix of standard and proprietary techniques to produce this precision snapshot summarizing issues likely to result in critical use errors or significant usability problems.

Formative Testing

Exploratory and targeted studies to guide development and prepare you for validation. HFCSI’s capabilities include any testing needed, from early market explorations to pre-Summative “dress rehearsals”. We specialize in providing you with design-relevant data presentations.

Summative and Actual Use Testing

Comprehensive validation testing provides evidence for submission to the FDA and EU. HFCSI can handle all aspects of test design, recruitment, data collection, statistical testing and root cause analyses.

Prototype Testing and Down-Selection

Customized testing to evaluate the relative performance and/or preference of alternative designs your team is considering. Provides invaluable insights to guide early development.

Ethnographic Research

We can test completed products or advanced product prototypes in the field where users would use, or are currently using, your product. Both end users and/or HCPs can be studied.

Marketing Research and HF Testing Integrated!

HFCSI can perform early market studies or post-launch evaluations. We also offer unique combinations of marketing-oriented research with usability studies or human factors heuristic or performance studies. A blend of our techniques can provide important cross-functional insights.

Post-Market Evaluation

Gathering intelligence on how your product is performing in the field provides insights to guide future development. Methodologies are customized for each client depending on your specific objectives (e.g., to address known pain points, conduct general assessments of user
groups, gather subjective insights, compare international to domestic markets, etc.)

IFU Development and Testing

IFUs (Instructions for Use) are crucial for successful products & FDA submissions. Are your IFUs designed at the end of development?  Is your IFU production not user-centric (most are not!)? Are you experiencing a delayed approval due to an ineffective IFU?  If any of these questions sound familiar, contact us to discuss our Task-Driven IFU® devlopment and testing service.

Have "Other" HF/UX Needs?

HFCSI can provide other related analyses and customized services. Feel free to contact us to discuss your needs.

OUR EXPERIENCE

Since our inception in 2006, HFCSI has:

  • Worked on a diverse array of medical products for 50+ clients, across a variety of disease states and user populations
  • Conducted over 250 explorative and formative studies and 50 summative validation studies
  • Had no FDA rejections of our HF validation studies since our founding

Recent Projects

Pen injectors, Autoinjectors,
& On-Body Injectors

Multiple device formats for therapies including rare conditions (e.g. hemophilia, HGH, PAH, etc.)

Digital Health Apps
& Mobile Connectivity

Mobile app development integrated with state of the art devices, legacy devices, enterprise systems and cloud-based data analysis

Glucose Sensors
(CGM)

UX requirements, complete UI design, prototype down-selection, life-cycle HF research

Mechanical
Ventilators

Validation for updates to legacy devices and next generation touchscreen ventilators

HCP Informatics
& Dynamic Displays

System design: from concept development through final validation testing

Hospital Monitoring
Devices

System Design: from user requirements through design verification

Smart Infusion Pumps
for Hospital Use

Requirements definition, UI development, controllers and durables, V&V testing

Multi-Format
Viewing Stations

New product development, field evaluation in complex clinical environments

Some Recent Clients

Amgen
Breathe Technologies
Carefusion
DEKA
Dexcom
eVent Medical
Genentech
iCare USA
ICU Medical
IMT Medical
Medtronic Diabetes
Medtronic Cardiac & Vascular
Novo Nordisk
Owlet
Roche
RxSight
SetPoint Medical
Stuart Karten Design
Targus
Timpel
United Therapeutics

Recent User Populations

Anemia
Ankylosing Spondylitis
Cancer and chemo complications
Cardiovascular Diseases
COPD
Crohn’s Disease
Diabetes
Glaucoma
High Cholesterol
ITP
Juvenile Idiopathic Arthritis
Migraine
Neurological conditions
Noonan Syndrome
Plaque Psoriasis
Psoriatic Arthritis
Pulmonary Arterial Hypertension
Respiratory conditions
Rheumatoid Arthritis
SGA
Turner Syndrome
Ulcerative Colitis

Where We've Worked

We go to the user population! Our projects have taken us all over the world; across the United States, throughout Europe, as well as Asia and Australia.

ABOUT US

What you should know about our company:

  • HFCSI was founded in 2006 in Los Angeles, California and operates in the U.S., Europe, Asia, and Australia
  • Our team members have Graduate level training in HF psychology, engineering and advanced research methods
  • To date, we have conducted usability testing with a total of 3,000+ users world-wide…and counting!
  • We cover HF/Usability needs in all phases of medical product development
  • Our specialists can integrate seamlessly with your cross functional teams
  • HFCSI adapts to tightening deadlines or changing requirements
  • Our team maintains high standards of quality, service and on-time delivery
  • We have a proven 15 year track record of successful performance

Our Core Team

  • Mike Kasamanian

    President

    Mike Kasamanian

    President

    Mike Kasamanian is President at HFCSI and provides expertise in the areas of Human Factors and Technology application. He holds a M.A. degree in Human Factors Applied Psychology and is a certified Quality Function Deployment (QFD) Green Belt. He is an active member of the Human Factors and Ergonomics Society (HFES) and the Association for the Advancement of Medical Instrumentation (AAMI). Mike's expertise includes the following domains: Voice-of-Customer research, User Requirements, Wireframing, Hardware User Interface Design, Rapid Prototyping of Electromechanical devices, FDA verification/validation testing, K-12 instruction, Field Robotics, Multimedia Systems, Acoustic Analysis, and project management.
  • Zachary Chesler

    Managing Director

    Zachary Chesler

    Managing Director

    Zachary Chesler is Managing Director at HFCSI and has over fifteen years experience as a user experience designer and usability researcher. As a specialist in this field, he has worked on projects across several industries including medical/healthcare, training/education, automotive, entertainment, energy management, and digital publishing. Since 2010, Zachary's primary focus has been in the healthcare space, with a specialization in the design and evaluation of medical devices, software, and mobile apps. Zachary earned his Bachelor's degree from University of California, Santa Barbara and a Master's Degree in Human Factors Applied Psychology from California State University, Northridge.
  • Wei-Ting Xie

    Sr. Human Factors Manager

    Wei-Ting Xie

    Sr. Human Factors Manager

    Wei-Ting Xie is Senior Human Factors Manager at HFCSI and has over 10 years of experience in medical Human Factors. She has expertise in leading and designing human factors research, conducting human factors analyses, developing user requirements, and wireframing / prototyping. Wei-Ting holds a master’s degree in Human Factors and Applied Psychology from California State University, Northridge. In her spare time, she enjoys hiking and is an avid crafter who loves all projects “DIY."
  • Leah Gudiel

    Principal Human Factors Engineer

    Leah Gudiel

    Principal Human Factors Engineer

    Leah Gudiel is a Principal Human Factors Engineer with experience in software usability evaluations, concept sketches, flow charts, task analysis and usability testing. She holds a Bachelor's Degree in Graphic Design and a Master's Degree in Human Factors & Applied Psychology. Her background in design helps in optimizing prototypes in the creative process to receive the best feedback from potential customers. She enjoys attending music festivals, wine tastings, and exploring faraway countries.
  • Veronica Mendez

    Principal Human Factors Engineer

    Veronica Mendez

    Principal Human Factors Engineer

    Veronica Mendez is a Principal Human Factors Engineer with a demonstrated history in working with the design of university websites, various application software and medical devices.  She is skilled in wireframing, persona development, user needs requirements, protocol development, usability testing (both formative and summative), data analysis and report writing. Veronica graduated cum laude from California State University, Northridge with a Bachelor of Arts Degree in Psychology (minor in Ethnic Studies). Veronica went on to earn a Master of Arts Degree in Human Factors and Applied Psychology from California State University, Northridge.
  • Jet Boden

    Sr. Human Factors Engineer

    Jet Boden

    Sr. Human Factors Engineer

    Jet Boden is a Senior Human Factors Engineer with over five years experience in medical device usability and validation testing, interview facilitation, data analysis and project management. With a strong talent for process development, Jet has accumulated over 15 years of usability and design experience within the medical, enterprise software, e-commerce, entertainment and aeronautic industries. Jet graduated summa cum laude from California State University, Northridge with a Bachelors Degree in Psychology
  • Vanui Barakezyan

    Sr. Human Factors Engineer

    Vanui Barakezyan

    Sr. Human Factors Engineer

    Vanui Barakezyan is a Senior Human Factors Engineer who was trained to the Master's level in Human Factors at California State University, Long Beach. She has a BA in Psychology from California State University, Northridge, and an AA in Aviation Science and Commercial Flight. She loves cognitive psychology, attention, and perception. Vanui is a private pilot.
  • Livia Kommel

    Sr. Human Factors Engineer

    Livia Kommel

    Sr. Human Factors Engineer

    Livia Kommel is a Senior Human Factors Engineer. She joined HFCSI in 2017; since then she has worked closely with the team in formative assessments and summative usability studies. Livia received her Master’s degree in Human Factors & Applied Psychology from California State University, Nothridge in 2013. She was trained in task analysis, needs analysis, facilitation, observation, and data analysis.
  • Kevin Lee

    Sr. Human Factor Engineer

    Kevin Lee

    Sr. Human Factor Engineer

    Kevin is a Senior Human Factors Engineer with experience in web and interface usability. He has worked in government, and academia helping organizations optimize their interface designs as well as educating teams on user experience prior to joining HFCSI. he received his Masters in Human Factors from the University of Idaho and a Bachelors in Psychology and Asian American Studies from California State University Northridge. In his free time he enjoys working on and driving cars, spending time outdoors and drinking boba.
  • Damon Cook

    Sr. Human Factors Consultant

    Damon Cook

    Sr. Human Factors Consultant

    Damon Cook has over 10 years of human factors experience, with a focus on medical devices and combination products. His background includes degrees in computer science and human-computer interaction (with a master's degree from the University of Illinois at Urbana-Champaign), corporate human factors jobs at Medtronic and Amgen, and several years of human factors consulting. His product experience ranges from highly technical surgical equipment to use-at-home injection devices. He has expertise in design, testing, regulatory submissions, and process development.
  • Nicole Clifton

    Sr. Human Factors Consultant

    Nicole Clifton

    Sr. Human Factors Consultant

    Nicole Clifton is a Human Factors Specialist with experience in validation and verification of medical devices in regard to FDA requirements for safety and usability. She specializes in usability testing project management, facilitation, data analysis, design recommendations, and test/report writing. Nicole earned a Bachelor's degree in Psychology and a Master's Degree in Human Factors and Applied Psychology, both from California State University, Northridge.
  • You?

    Human Factors Jedi

    You?

    Human Factors Jedi

    If you are interested in joining our team at HFCSI, please send a message to info@hfcsi.com and tell us a little about yourself!
 

Our Research Facility

Though we have traveled the globe to conduct research with diverse user populations, we also have our own research facility space at our headquarters in Los Angeles.

Professional Affiliations

We are active, contributing members of the following industry organizations, including the authoring of best practice documents and standards.

© 2021 Human Factors Consulting Services, Inc.