Key Tech is an ISO 13485-certified product development firm capable of translating your product requirements set to a finished design ready for manufacturing transfer. We’ve developed a variety of products under FDA design control development, ranging from nutritional compounders, clinical analyzers and pharmaceutical drug preparation and delivery system.
The products we develop typically require multiple disciplines, recruited from top schools that have graduated in the top 1% of their class. They work together to solve intertwined user and technical design challenges throughout the development cycle. Below is our general approach to New Product Development, starting with Project Planning & Prototyping, before locking in design inputs. We then develop alpha and beta prototypes, maturing the design to point where manufacturing transfer is initiated, and verification and validation activities commence.
See examples of our full-scope projects: