Our History Tour Facility

BlackHägen Design is a multidisciplinary, usability engineering and product design firm supporting start-ups through Fortune 100 companies. Our pragmatic approach to product design is well suited to safety-critical and environmentally challenging industries, and we have produced award-winning designs for many of those clients. At our core, user-centered design processes drive innovation and sustainable product development. This systematic methodology for translating research insights into design requirements and creating valuable intellectual property has contributed to over 100 patents and trade secrets for nearly three decades.

We continuously optimize the quality of our methodologies and services through rigorous deployment of our Quality Management System, which is structured to be compatible with 21CFR 820 (FDA) and ISO 13485 and is easily adaptable to our clients’ in-house QMS for seamless documentation transfer.

Leadership

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Philip has over 35 years of international experience in executive and technical management, product and automotive design, systems engineering and commercialization. With a focus on medical devices, he has led development projects and vertically integrated teams for clients that include corporations such as Philips Healthcare, J&J, Baxter, Medtronic, Bayer, and Olympus, is a regular speaker and subject matter expert at national conventions focused on design and innovation.
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Jeff has more than 20 years of Human Factors Engineering experience in design research, usability design/testing and risk management practices, predominantly in the healthcare space. He has contributed to the design of surgical robots, point-of-care and combination devices, is an active member of HFES and has worked with AAMI to develop Human Factors Engineering Guidance ANSI/AAMI HE75 and the book “Applied Human Factors in Medical Device Design”.

Management

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