BlackHägen Design, a multidisciplinary, user-research and product design firm, is expanding its staff expertise in the medical device arena in the areas of Industrial and User Experience (UX) Design, Human Factors, Mechanical and Software Engineering. The expansion is in response to new requirements for the development of advanced products and procedures in the fast-growing MedTech industry.

“BlackHӓgen Design, with our expanded expertise in critical user-centered design, is poised to be an integral part of this growth,” said Philip Remedios, principal and director of design and development, BlackHägen. “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.”

In its announcement, the company noted that 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 a wider range of MedTech customers.

Headquartered in Dunedin, Florida, BlackHägen Design specializes in user-centered processes that drive innovation and sustainable product development. The company uses a systematic methodology to translate research insights into design requirements. Its Quality Management System is structured to be compatible with both 21CFR 820 (FDA) and ISO 13485.