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Top 10 Medical Device Testing and Certification Companies - 2019

UX Firm: One-Stop Shop for Usability Testing and UX Consulting Services

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Carol Barnum, Director of User Research & Founding Partner

In the medical sector, bringing a new or predicate medical device to market requires usability testing that demonstrates the safe and effective use of the product for all its intended users. Pressure from regulatory bodies such as FDA requires applying a rigorous methodology to evaluate all aspects of the product, including labeling and packaging. With over 35 years of combined experience in user experience research, industry veterans Carol Barnum and Jimmy Ginn formed UX Firm to help companies align product development processes accordingly. As a one-stop shop for usability testing and UX consulting services, UX Firm provides a portfolio of UX research tools to support the needs of their clients. “We focus entirely on research in user experience and human factors engineering and validation. Effective research is our core strength, as it allows us to stay razor focused on what’s happening in the research space, FDA, and medical device companies,” asserts Carol who serves UX Firm as Director of User Research.

The company offers a broad range of tools from its UX toolkit for every phase of design to gain insights into users’ goals and context of use. Research can be conducted in-house, at locations where user populations are available, or remotely; and irrespective of the stage their clients have reached with their product design and development plans.

UX Firm not only ensures compliance in medical device human factors validation testing but also has a proven track record of delivering effective test protocols for FDA review, high quality formative and summative usability evaluations, and detailed, fully documented reports to be used in 510(k) pre-market submissions. In addition to medical device usability testing, UX Firm provides usability lab design services as well as custom usability training.

Effective research is our core strength as it allows us to stay razor focused on what’s happening in the research space, FDA requirements, and the needs of medical device companies

Among the latest developments in the medical device space, the ones gaining the most traction are The Internet of Medical Things (IoMT) and the increasing scrutiny by the FDA on the Information For Use (IFU), including the labeling and packaging, especially with consumer-based products. IoMT is becoming increasingly mainstream, connecting health and wellness devices to an app in the mobile device and to a consumer-facing website. Aligning to this trend, UX Firm builds user experience research into the development timeline through iterative usability testing and other strategies such as diary studies for insights into user experience over time. Small formative studies enable research findings to be built into agile development processes quickly and effectively.

Prior to founding UX Firm, Carol served as Professor and Program Director for a graduate program in Information Design and Communication at Southern Polytechnic State University and founder of the Usability Center, where she worked with clients on projects ranging from documentation to websites to software, hardware, and apps. Partner Jimmy Ginn brings a background in user experience consulting and as Director of Corporate Research Partnerships at Georgia Institute of Technology with a focus on digital health and medical partnerships with Children’s Healthcare of Atlanta, CDC, McKesson, Intel Digital Health, and Emory University School of Medicine.

With expert, consumer-centric leadership and a wide range of niche-specific offerings, UX Firm has earned clients globally. Their unique market offering is that all projects engage the full commitment of both founders, which means that clients are assured the highest level of expertise and quality for every research project. For the future, the company looks forward to working with more startups and to further expansion internationally. Also, 2020 awaits the release of the second edition of Carol’s popular award-winning book— Usability Testing Essentials: Ready, Set...Test!