Human Factors Research Check Mark

Get through usability testing successfully for your FDA submission (No rejections ever of my submitted usability tests)

Human Factors Research Check Mark

Save development dollars by getting it right early on

Human Factors Research Check Mark

Develop products customers actually want to buy and use

Client Testimonials

Alexey Salamini
Chief Executive Officer
Claria Medical, Inc

I was referred to Dr. Joely Gardner by ourClaria Medical Director of Regulatory Affairs for her expertise in navigating human factors research requirements of the FDA. We needed help crafting a human factors protocol and supporting user surveys/scripts for an important request for authorization from the Agency. Human factors protocols are notoriously sticking points with the FDA. I was extremely impressed with Dr. Gardner's deep understanding of what is required by the FDA as well as her global knowledge of research methodology which is applicable to many fields. Dr. Gardner provided fantastic direction for our research methodology and was extremely efficient in her review and communications.

In my past work at IDEO, I have worked with a number of human factors design researchers who are skilled at extracting unbiased feedback from users to inform design direction and strategy. Not only is Dr. Gardner at the level of these world-class researchers, but her specific expertise with regulatory agencies makes her uniquely positioned to synthesize feedback from users AND accomplish critical regulatory objectives. Dr. Gardner is exactly the type of expert that we needed to help out; I highly recommend her services.

Scott Rickes, PhD
Sr Manager, User Experience
Experience Design Center (XDC)
Thermo Fisher Scientific

I have been collaborating with Dr. Joely Gardner as an external usability consultant for a number of years. She is the person I think of first when we need a research expert. She
consistently leverages her expertise and knowledge of best practices when supporting the usability testing of our projects. Dr. Gardner works extremely well with interdisciplinary teams. I have received compliments on the way the research sessions were structured and the value of Dr. Gardner’s questioning method from several senior staff who observed the research sessions. Her final presentations always provide insights that help drive the direction of our products. I recommend Joely without reservation.

Hal Walbrink
Xinetix Medical Product Development

It has been my pleasure to work with Dr. Joely Gardner on multiple projects. I find she brings deep expertise in all aspects of human factors and usability research, and product testing. I’ve worked with Dr. Gardner through all phases of human factors research, from expert reviews of early-stage prototypes through iterative formative testing and the final summative testing.

Joely has an outstanding ability to bring actionable feedback to the development team, and her participation has always resulted in improved products. I find that she easily integrates into our teams and is highly appreciated and respected by our clients. As a mentor, her ability to communicate complex regulations and concepts has helped management and development teams understand regulatory requirements for usability testing.

I highly recommend Dr. Gardner for any project requiring guidance through the human factors and usability process.

Tony Santicerma

Former Global Director, Strategic Alliance & Marketing at Quest Diagnostics (currently retired)

Research project: Voice of Customer Research to Determine the Market Viability and Customer Needs of a Total Data Integration Offering

Joely is a highly experienced expert in evaluating customer satisfaction and overall industry trends. She provided valuable input that facilitated our strategic decision-making process. I highly recommend her and look forward to working with her again in the future.