Minnetronix’ engineering, design, and manufacturing capabilities allowed the client to partner with them through all stages of development, taking intellectual property (IP) from prototype through full manufacturing.
PlaCor™ was looking for a partner to help develop initial prototypes for their blood analyzer. The device was intended to help physicians evaluate the effectiveness of aspirin for inhibiting clot formation. Since PlaCor was a small company without development or manufacturing capabilities, they also realized that if the initial prototypes provided proof-of-concept, they would need a partner capable of working with them through all stages of development and manufacturing.
Based on Minnetronix’ experience with pumps, optical systems, and software development, PlaCor chose Minnetronix for the initial development of a bench-top prototype for use in laboratory testing of their proprietary technology. The goal of the initial project was to provide concept development work and assist with feasibility testing. Minnetronix was responsible for documenting prototype requirements, completing the design and build of the prototype control electronics, developing a PC-based control application, and testing the prototype system.
Following successful proof-of-concept with the bench-top prototype, Minnetronix was charged with completing requirements specifications, design, and design documentation of the PlaCor PRT 7000 Blood Analyzer (PRT) prototype. Responsible for technical project management and completing all design and development tasks, Minnetronix quickly got to work. The engineering team conducted final assembly of the fully-functional prototype and pre-production devices. Throughout this stage of development, Minnetronix maintained internal records compliant with FDA and ISO design control requirements for all technical aspects of the PRT. The records allowed for documenting design control compliance as well as configuration control for the pre-production and clinical unit builds. During this phase, Minnetronix also partnered with an industrial design firm to assist with the industrial design of the prototypes.
With the prototypes successfully developed, Minnetronix began building pre-production product and subsequently production units. During this time, Minnetronix was responsible for technical project management, completing all design and development tasks associated with the builds.The Result
The partnership between the two companies allowed PlaCor to prepare their PRT device for commercialization. Minnetronix was integral to every phase of development through full verification, to design transfer and manufacturing. The services provided by Minnetronix helped the small start-up demonstrate the system and collect data to support their regulatory filings.