Startup (Medical Device)
Calgary, Alberta, Canada
Industrial and Mechanical Design, Electrical Design, Firmware Design, Simulations (CFD), Medical Device Compliance, Prototyping, Testing, Design for Manufacturing, Initial Manufacturing Build, Volume Manufacturing
Supply Chain Establishment
EYE THERAPY DEVICE
Tangent was contracted to provide product design services for a new therapeutic device developed by a local medical devices start-up firm. The therapeutic device was intended to be wearable, and required full regulatory compliance as a class II medical device.
Tangent’s scope of work involved initial ideation and industrial design, as well as an initial concept development and alpha prototype. The alpha prototype was a multidisciplinary effort involving Tangent’s mechanical, electrical, and firmware design teams. All work completed was done as per Tangent’s ISO 13485 qualified quality management system. The performance testing of the
alpha prototype drove change in the product form factor and overall system design. This change was captured in
the production of a beta prototype unit, which became the basis for the initial production run (low volume for in-field testing). Tangent was able to design a very compact, wearable therapeutic device that performed as per the required specifications and had a very appealing form, which was a key end user requirement.
Tangent continues to support the client’s development of future product features and minor modifications based on in-field feedback. Tangent maintains and holds the Design History File for the Client and assisted in creating the Device Master Record and other key documentation required for medical device compliance.