Optical-based medical devices have unique dynamics and requirements that make their path to market exceptional. From translational research through development, verification, scale-up, and full commercial manufacturing, a collaborative partnership is the best path to market.
Developing a medical device may require companies to work with multiple partners through translational research, development & systems integration, and manufacturing scaleup. The medical device development process also carries technological, clinical, and regulatory aspects that can make the project more complex.
As a result, the risks to schedule and cost increase exponentially. As optical medical devices have unique challenges like precision tolerances and fragmented supply chains, managing those risks requires a well-organized multidisciplinary team that can bridge across development hurdles and make optimal decisions for the product’s entire life cycle.
In this reference guide, we present the impacts of the Cost of Change during the product design phase, optical medical device development challenges for technical and business leaders and how a partnered approach with a truly end-to-end offering can streamlines the optical medical device development pathway.