Avoiding Cost of Change with Minnetronix and INO
Avoiding Cost of Change with Minnetronix and INO
From concept to design to prototyping to production, bringing an optical medical device to market can be a long and challenging undertaking. Assuring safety, capability, and effectiveness of an optical med device is a costly undertaking. Adding to the challenges is the dreaded Cost of Change, widely documented as having exponential impact with time.
Any design changes after validation could invalidate clinical trials results and require re-filing for FDA approval. Typically, this puts immense pressure on teams to ‘do it right the first time.’ At each phase, teams make long-term decisions about costs and manufacturability of their device designs. It’s unreasonable to think each of these decisions will be exactly right each time, yet the potential cost of changes is high.
In particular, the optics marketplace is demanding with exceptional requirements on precision and tolerance. It’s a broad and fragmented marketplace which serves many other industries in addition to optical medical devices. A partnered approach helps mitigate the risks and avoid the Cost of Change.
However, a partnered approach may require multiple partners from translational research to development. Every interface and transition can increase, not decrease, the Cost of Change. To truly avoid as many change costs as possible and gain the most reliable timeline to market, a single end-to-end partnership is ideal. Historically, this has not been available in the highly specialized optics marketplace.
Fortunately, Minnetronix and INO have partnered to create a truly end-to-end offering to pipeline your optical medical device from translational research, through development, verification, scale-up, and full commercial manufacturing.
Read more details on our partner website, INO.ca.