When choosing a manufacturer to launch your medical device, there are a lot of things to consider and options to compare. Cost, quality and lead time usually lead the list. Which ones are most important for your device? In this blog I’m going to focus on an often overlooked attribute that should be a high […]
Posts by Jason Dolynny
Most boutique medical device design and development companies do not have an FDA registered, ISO 13485 compliant medical device manufacturing facility co-located with designers and engineers. StarFish Medical Founder and President, Scott Phillips, believes this investment helps StarFish Medical uniquely tackle challenges and deliver innovation while providing fixed prices to clients.
As your medical device design approaches the manufacturing phase, it can be challenging to decide the best path for production. Should you engage a contract manufacturer or figure out how to set up and start producing your medical device in-house? Many wonder if they need enough product to meet a contract manufacturer minimum volume.
Manufacturing can be treated as an afterthought for medical device design and development companies that do not manufacture in-house. Our vision is a single point of accountability for development clients to ensure a smooth transition from design to manufacturing. No finger pointing.
Once in a while cutting corners can add huge costs. In one memorable case, an electro-mechanical device was transferred to us for manufacture with a number of design for manufacturing elements unverified. Not surprisingly, there were field issues. For example, the coatings hadn’t been tested in the use environment sufficiently and did not hold up. […]