Many entrepreneurs underestimate the importance of ramping up medical device manufacturing in a small and controlled way – sort of a slow ramp. They often overestimate how quickly they’re going to require high volume and underestimate the value of post-release design changes and the effort that will be required in early launch.
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We asked our new product introduction (NPI) team to reflect on their collective experiences transferring medical devices from design to production. Their top tips for production readiness are listed below.
In a previous medical device company, I worked on a project where First-to-Market (FTM) was a deemed a priority for the company’s survival. To meet that highly compressed timeline, we decided to skip the phase-gate process and replace it with a FTM production release strategy. FTM product commercialization carries a much higher overall project risk […]
Often when a product design is completed and the design transfer to volume production begins, medical device developers run into a tsunami of issues that prevent them from meeting their planned build schedule and impact their capacity to meet forecasted sales.