How important is the FDA Pre-sub meeting? If saving time and money is important, then taking advantage of the FDA Pre-submission meeting program is key.
The FDA issued its final guidance for medical device interoperability on Sept. 6, 2017. The guidance offers insight into what the agency is looking for in terms of safety and effectiveness for medical devices that are connected to each other and to other technology.
November proved to be a busy month in the MedTech Industry. From a custom 3D printed shoulder implant helping a patient overcome the wounds of a shooting tragedy to the world’s first jaw reconstruction surgery using 3D printing. Here’s what you missed last month:
The dream of using 3D printing technology to regenerate damaged or diseased tissues faces a number of technological and biological challenges, not the least of which is providing the new tissues with just the right amount of a complex mix of proteins referred to as growth factors needed for development of stem cells after implantation.
It is probably safe to say that the advancements in additive manufacturing of medical devices have come at a pace that has outstripped the visions of even the most ardent supporters. 3D printed devices have already been implanted into people’s backs, skulls and jaws.
Kapstone Medical is a single-source service provider to medical device companies lacking the appropriate human capital to bring to market new and safe products. We provide customized solutions that are flexible and cost effective in an ever changing regulatory environment.
