Building a program to add long lifecycle features to an existing device design, is a little like bolting wings on a pig and hoping it will fly. It’s not very effective, and it irritates the heck out of the pig. Far better to design in long life requirements from the start, before mechanical designs constrain system size and fit, and before significant investment is made in qualification and certification.
Many device development projects focus on creating unique intellectual property – sensors, software, algorithms, and applications. The physical device itself that will take these innovations to market takes a backseat in the design and development phase. We often meet with customers in this early stage to discuss their hardware and system component plans only to discover that they have not fully considered their detailed hardware and system requirements, or more importantly the program requirements that will be needed to extend the selling and support life-cycle of the final delivered device product.
To learn more, download the free white paper – Stability: Designed In or Bolted On?
The integration of commercial off the shelf (COTS) computers, components, and software in today’s medical devices ensures access to the latest technology, improves patient outcomes, speeds new products to market, and helps control costs. However, COTS systems experience supply-chain disruption, as well as rapid unplanned changes in technology, functionality, and quality. This instability creates real risks to the business, user, and patient.
To learn more, download the Free White Paper: Five Risks Every Medical Device Manufacturer Must Overcome