HEALTHCARE 4.0
the construction of devices to an individual patient is one of the leading benefits . For some devices , additive manufacturing and 3D printing offers a method to more effectively create complex structures , more closely matching a person ’ s anatomy – “ such as the porous structures need for osseointegration of orthopedic implants ,” suggests McDaniel .
The ability to cost-effectively manufacture on a smaller , more precise scale has potential for development of devices for rare conditions . One of the greatest benefits of the technology for any industry is the complexity it enables , which is such that traditional design and engineering approaches often have to be put to the side . With 3D printing in particular , surfaces and structures can be optimised for strength , weight and material use . With this in mind , the FDA has characterised the guidelines not just as a “ comprehensive framework ” but also as what they are calling “ leapfrog guidance ” offering the Agency ’ s “ initial thoughts ” on medical devices created by additive manufacturing .
For McDaniel , this is an important distinction .
“ Essentially , this a manufacturing method ,” she says . “ It ’ s not often that a regulatory body would provide guidance on a manufacturing method .
“ That the FDA has done this indicates an understanding of the possibilities and a willingness to help the industry understand that it can use AM3DP for medical devices with some considerations . They have also dedicated resources to help better understand the technology , conducting research on material properties and other key factors in additive manufacturing .
“ The key takeaways from the report are that the FDA is anticipating
20 February 2018