From concept to creation – it’s what we do.

We offer a robust, fast, and cost-effective human factors (HF) process that complies with FDA 21 CFR 820, ISO 13485, and human factors standards from the FDA and EU (such as FDA HE 75, ISO 62366-1, and MDR 2017/745). Our methodology strikes a balance between regulatory rigor and operational efficiency.

The synergistic alignment between user needs, product requirements and system responses through an intuitive and predictable interface that fosters user acceptance.

User Centered Industrial Design is essential for creating a successful product that communicates its function to the user. Our multidisciplined team of designers, user experience, and human factors utilize a variety of methods to create, prototype, and test designs with users.

A beautiful design needs good engineering to really come to life, and it's something we love to do. With more than 25 years as a product development firm we have deep experience executing on engineering solutions that compliments our industrial design.

A robust user research process for new product development begins with clearly defining the target users and business goals, followed by a mix of qualitative and quantitative methods such as interviews, surveys, and usability testing. Researchers gather insights to understand user needs, pain points, and behaviors, then synthesize findings into personas and journey maps. These insights guide ideation and prototyping, which are iteratively tested and refined based on user feedback. Continuous validation ensures the product aligns with real-world user expectations and delivers meaningful value.

Our product development process fully complies with the design assurance guidelines outlined in FDA 21 CFR 820, ISO 13485, and adheres to the FDA and European human factors guidelines including HE 75 and ISO 62366 and incorporates risk management per ISO 14971.

"Build - Test - Refine" is one of our core principles, but how do we acheive it?

Transitioning a product from the prototype stage to manufacturing involves several important steps to ensure a smooth and successful production process.