Our History Tour New Facility

BlackHägen Design is a multidisciplinary, user-research and product design firm, supporting start-ups through Fortune 50 companies. Our pragmatic approach to product design is well suited to safety-critical and environmentally challenging industries and have a long-standing history serving those clients. At our core, user-centered 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 more than 100 patents and trade secrets over the last two 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 both 21CFR 820 (FDA) and ISO 13485, while easily adaptable to our clients' in-house QMS for seamless documentation transfer.

 

Principals

Sean earned a Bachelor of Science in Product Design from The Ohio State University’s Industrial Design program, minoring in human factors engineering. Sean has over 30 years of research and product development experience in a variety of industries ranging from marine transportation and mission critical, ruggedized electronics to medical devices.

Since founding BlackHägen Design in 1995, Sean has been the principal investigator for design research and usability design, within both institutional and home environments, across eighteen countries. His current focus is in the management of the user research and insight translation phases of product development. That focus includes usability testing, user-centric innovation and establishing user requirements as they apply to product definition. Sean has published numerous articles on usability research and design as well as contributing to domestic and international standards for usability development processes as a member of the AAMI HE committee. In this role, he was a contributing author for AAMI TIR 50and 59 as well as ANSI/AAMI HE75. He was the IDSA Medical Section Chair from 2010 to 2017 and sits on the Board of Directors. He implemented, as chair, the first IDSA Medical Design conference (2014).
In 2002, Philip Remedios joined BlackHägen Design as a partner. His executive and medical device design development expertise hails from a leading full-service product development firm in California.
  • Our Vision

    To achieve sustainable growth, we have established a vision with clear goals:

    People: Create a rewarding work environment where our driven staff are inspired to be the best they can be.

    Partners: Cultivate and support a winning network of industry resources and client partners building on mutual respect, trust and loyalty.

    Profit: Ensuring profitability for corporate security while setting the standard for quality and recognizing our simultaneous responsibilities to our staff and clients.

    Portfolio: Build a pragmatic and feature-rich portfolio of efficient, cost-effective, relevant products and experiences that anticipate and satisfy market needs and desires.

    Environment: Be responsible global citizens that make a difference in designing sustainable, environmentally friendly products and experiences.

  • Our Mission

    To address the increasing need to imagine and design easy to use, safe, cost-effective, and innovative products in competitive global markets

    To support our clients in robust project management, product definition, design, product development and dependable design-transfer

    To develop long-term partnerships with start-up entities and market leaders alike by supporting them to achieve profitability and market-share growth through intelligent, highly-effective R&D collaboration and consistent communication.

    To optimize our robust and seasoned contextual inquiry research methodology based on defining actionable user-need requirements and use-error mitigation strategies.

    To continue to yield significant product and process innovations for our clients through deployment of highly effective user-centered methodologies.