BlackHägen Design, a user-centric medical device development consultancy, is pleased to announce its founder, Sean Hägen, and design team members Bartosz Korec and James Brown have been named as contributing inventors on a multi-country patent for Bayer U.S. LLC. The designs incorporate innovative features for medical device packaging, storage, and sterile fluid path management.
The inventions provide sterile fluid path solutions for prefilled contrast injection syringes while enabling more efficient packing, positioning, and handling of the syringes during shipment, storage, and deployment. The designs also offer a safe and familiar means of removing the sterile path protective features without the risks of damaging the syringe connector that could contaminate the sterile fluid path.
“This has been a very satisfying assignment for BlackHagen Design as we have a strong focus on Human Factors Engineering during the design process,” said Sean Hägen, BlackHägen Design Principal, Founder, and Director of Research and Synthesis. “Syringes and medical injectors are used to introduce fluids into a patient’s body for a number of different procedures. They need to be designed with the highest integrity to insure sterility and structural integrity for the benefit of both users and patients. This particular packaging solution involved a commitment to exceptional user-centric design and engineering techniques to make sure that is the outcome."
Bayer summited for approval on this patent from several countries (Europe, Switzerland, Japan, China, and patent pending in the US), which supports BlackHägen’s global objective to be an instrumental design research and usability design partner for its customers in the medical device, healthcare, and pharmaceutical industries.
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 www.blackhagen.com.