BlackHägen Design Expands Expertise in Medical Device Research and Design

BlackHägen Design, a multidisciplinary, user-research, and product design firm, announces a significant expansion of its staff expertise in the areas of Industrial and User Experience (UX) Design, Human Factors, Mechanical, and Software Engineering. BlackHӓgen’s Electronic, Systems, and Compliance Engineering expertise will continue to support these expanded disciplines. Well-known for its user-centered methodologies in developing innovative medical device designs, the expansion of its staff is in direct response to new requirements for the development of advanced products and procedures in this fast-growing industry segment.

According to Fortune Business Insights, the global medical devices market is projected to grow from about $495 billion in 2022 to nearly $719 billion by 2029, a CAGR of 5.5% in the forecast period, 2022 to 2029. These devices range from wearables to in-home vital signs monitoring and drug delivery, to robotics, as well as more complex devices for clinical and hospital environments.

“BlackHӓgen Design, with our expanded expertise in critical user-centered design, is poised to be an integral part of this growth,” said Philip Remedios, BlackHägen’s Principal and Director of Design and Development. “Technological advancements and procedural improvements are impacting the way medical device manufacturers approach design and development. These user-focused methodologies can minimize time-to-market and streamline regulatory approvals, helping to reduce costs and optimize revenue.”


As new technologies drive the pace of MedTech device development, high levels of collaboration are necessary to reduce time-to-market schedules, strategies on product specifications, and iterations to reduce scope, risk, and ultimately time. Considering user needs early on in design development is essential, particularly as the devices must compensate for users of varying experiences. To meet these goals, the usability engineering process involves iterative steps in research, confirmation, and validation through user studies. The expansion of BlackHӓgen’s HFE team and other critical usability-focused design groups such as the rapidly expanding UX team is supporting the company’s ability to deliver its expertise to an even wider range of MedTech customers.

About BlackHägen Design

Headquartered in Dunedin, Florida, BlackHägen Design is a multidisciplinary, user-research and product design firm supporting start-ups through Fortune 50 companies. Its pragmatic approach to product design is well-suited to safety-critical and environmentally challenging industries and has a long-standing history of serving those clients. At BlackHägen Design’s 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.

BlackHägen Design continuously optimizes the quality of its methodologies and services through rigorous deployment of its Quality Management System, which is structured to be compatible with both 21CFR 820 (FDA) and ISO 13485, while easily adaptable to clients’ in-house QMS for seamless documentation transfer. For more information visit:

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