For over two decades BlackHägen Design has provided an integrated approach to research and development resource to industry, with a focus on mission and safety critical devices, including Class I, II, and III medical devices. We provide R&D support to entrepreneurs and start-up entities, through to Fortune 50, multi-national and government-sponsored corporations.

Services may be limited to assistance on a specific task such as Conceptual Design or Usability Testing, or turn-key from design inputs generation through pilot-production of finished product. Our internal Quality System is designed to support regulated industries such as medical device development; conforming to FDA’s Quality System Regulation (QSR) and ISO 13485.  We are periodically audited by Fortune 50 medical device manufacturers to ensure adequate compliance to the client's QMS and are on the Approved Supplier List for many of the top 20 corporations.

 

Process


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Discovery

Problem definition is the key to problem solving. Our Discovery phase utilizes expertise in contextual inquiry, visually communicating insights and translating analysis into actionable requirements.

More about the Discovery Phase
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Conceptualization

Achieving an appropriate aesthetic harmonized with brand language requires rigorous design research, creative problem solving and inspired form development tempered by a pragmatic process and informed through collaborative human factors engineering.

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Design Development

The Design Development phase initially converges alternative concepts into a singular design direction based on an appropriate balance of usability, systems engineering and DFx – Design for X (Manufacture, Assembly, Service, etc.). The 3D design is developed at the assembly level and interprets the conceptual intent while establishing the Bill of Materials, internal component layout and specifications. User interface features are confirmed through prototyping and formative usability studies.

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Implementation

In the Implementation phase the design assembly is detailed in CAD at the sub-assembly, part and feature level. Methods of assembly, test and servicing are determined at this time and materials and processes confirmed. The design intent and specification is finalized by iterating prototypes and usability testing, per our client's Design Controls process.