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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 is a multidisciplinary, user research and product design firm, supporting start-ups through Fortune 500 companies. At BlackHägen Design’s core, user-centric processes drive innovation and sustainable product development of safety-critical devices and systems. The Company’s systematic methodology for translating research insights and creating innovation has contributed to over 100 patents and trade secrets for clients in the last two decades. Additional information about BlackHägen Design can be found on at


Design Partners

Design Partners are a strategic product design and development consultancy, with a dedicated ISO13485 certified Healthcare division. Our integrated process of design, human factors engineering, mechanical engineering, prototyping and usability testing allows for the creation of truly innovative healthcare solutions. At Design Partners, we believe in listening to patients, carers, nurses and doctors, while observing the contextual practices and habits in the clinical environment. By cutting through complexity we identify clear opportunities to enable superior treatment success and improved outcomes for patients. This specialist approach creates strategic solutions and competitive advantage for our clients.



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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