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.

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.  […]