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4th Human Factors Engineering & Usability Studies Summit -

4th Human Factors Engineering & Usability Studies Summit
February 4–5, 2019
San Francisco, CA

Designing Medical Devices, Combination Products, and IFUs that Satisfy Regulators, Eliminate Errors, and Improve the User Experience

Sponsors – 4th Human Factors Engineering & Usability Studies Summit

The 4th Human Factors Engineering & Usability Studies Summit provides an unequaled forum for networking with decision-makers in the medical device and combination product sector. If you are interested in highlighting your skill at human factors engineering, device design, validation, user group studies, clinical trials, protocol management, or other related areas, please contact Chris Summa at 917-932-0432 or

BlackHägen Design

BlackHägen Design isan interdisciplinary, R&Dconsultancy. At our core, user-centered methodologies drive innovation and sustainable product development of safety-critical devices and systems. This foundation of rigorous processes enables BH to be usability design experts. Our strategic relationships strive to discover, design and develop products and procedures which enhance technical, clinical and lifestyle conditions. We have cultivated long-term partnerships with start-up entities and market-leaders alike, enablingprofitability and market-share growth through highly collaboration.



At Innovenn, we believe input from users (patients, health care providers, industry and advocacy) is critical to understanding unmet needs to inform the design of successful products; products that help people lead healthier lives. Offering HF/UE/UX support, we design, recruit, and implement human factors studies in our facility. We can help you differentiate your product from the competition while following US and International regulatory human factors testing requirements and standards.



Worrell is a global design firm that specializes in healthcare innovation and strategy. Since 1976, Worrell has served medical device and pharmaceutical companies with expertise in ethnographic research, human factors engineering, and design and development programs. Working on the front lines with patients and healthcare professionals, Worrell uncovers unmet needs to bring new drug delivery, medical device, and digital health solutions to the market.



Ximedica is a full-service ISO 13485-certified and FDA-registered medical device and diagnostics product development firm. For 30 years Ximedica has provided a unique growth platform enabling organizations to successfully deploy medical technology products into the market. Its headquarters are in Providence, R.I., with offices in Hong Kong, Minneapolis, San Francisco and Silicon Valley. In November of 2014, SV LifeSciences, a Boston-based private equity firm, acquired a majority stake in Ximedica, enabling the company to execute its growth strategy. For more about Ximedica, visit


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