Frequently Asked Questions

BlackHägen Design is a multidisciplinary, user research and product development firm. At our core, user-centered processes drive innovation and sustainable product development of usability-critical devices and systems.
We work with a variety of companies from individuals to start-ups and global Fortune 500 corporations. 
BlackHägen Design develops medical devices, industrial/commercial/military products, and consumer products. However, 80% of our business is typically medical device development for Class I, II, and III products leveraging our substantial clinical experience and thorough understanding of risk-based usability expectations and regulatory compliance.
Rely on BlackHägen Design when you need specialized experience, focused design and critical resources. We have a seasoned team of engineers, designers, technical and regulatory experts with precise competency in all areas of the regulated design process. Our Quality Management System is ISO 13485 and 21CFR820-compliant and audited by top medical device firms. We can manage and submit your Design History Files through 510(K) clearance, and we can likely help you bring your project to market more rapidly than via internal resources. Our commitment to our clients and your project goals always comes first. 
At BlackHägen Design, client relationships and our reputation for quality and reliability means everything to us and has been the reason we have survived and flourished over the last 2 decades despite difficult economic times. We always seek to optimize your budget and lead time with our focused Usability Design methodology. Our Principals each bring 30 years of project management experience to help inform those critical decisions you must often make throughout the design process. We will supplement our seasoned staff with strategic partner resources like regulatory, testing and manufacturing as necessary to complete your outsourced needs.
BlackHägen Design begins every RFP by assessing the critical task pathway and determining strategies to reduce or apply concurrent activities without adding risk. Our expertise in assessing Usability Needs up front brings robustness to Design Inputs that enable a direct and rapid Development process. Our fast-thinking problem solvers further shorten the time to advance your vision from definition through development, testing and release. Our experience developing hundreds of designs gets your device to market faster with reduced risk. 
With BlackHägen Design as a part of your creative team, our design process will make sure you don’t overlook the best ideas because you want to run quickly with the first viable idea. This will help you make the most of your investment, maximize market share and profits, while still executing speed to release. 
Normally, a Buyer will want to see a device in limited production with good initial sales penetration. One step back, at far less cost to the inventor, is a functioning prototype with defendable IP and successful clinical trials behind it. Further back are illustrations and mock-ups of the concept, patent pending, KOL endorsement and market research to defend the idea. The earlier the involvement, the less likely a buyer will buy all the rights, and may simply invest in ongoing development to seize a lion’s share of the potential profits. At any stage, BH can assist you in illustrating your ideas into a compelling presentation, design and build proof-of-concept prototypes, and of course help you to realize the final commercial design, rapidly and as cost-effectively as possible.