Our medical device projects show our capabilities. We create designs and documentation compliant with each client’s quality system. Projects that follow this process achieve FDA and CE approval.
Surgical Tools: These are typically Class I exempt devices. They are hand-driven, all mechanical devices that contain miniaturized mechanisms, and are disposable or reposable. We optimize ergonomics, engineer the mechanisms, and design for cost-effective quality production. We can provide formative usability studies, industrial design, mechanical engineering and design for manufacturing. (EndoEvolution, Soteira).
Capital Medical Equipment: We provide industrial design and engineering for the enclosure, frame, and component packaging. Our clients develop the medical technology. We optimize ergonomics and human interaction; we create an industrial design that projects quality and reliability. We provide formative usability research; build models to test product size, control location and physical stability. We work in phases, with clearly documented decisions, and address applicable regulations. We design to meet 60601-Edition3 standards. We create documentation for direct transfer to the client’s design history file. (Cynosure, LENSAR)
Clinical Test Platforms: We design prototype devices for clinical trials or other research. These projects are first steps in developing new products for therapies or procedures. The goal is a safe product for use in an IRB approved patient trial. We carefully select components and technology that are directly linked to treatment outcomes for future use in a production design.
Consumer Health Products: Consumer health products may be sold by prescription or over the counter. These products must be simple, intuitive, safe, reliable and cost effective. They are really consumer products that are also medical devices. (See SQUID and KINSA projects)