“ More capital needs to be invested developing integrated systems within the 3D printer that monitor the source code that designs the device , and the reliability of the output of the printer ”
Dr . Robroy MacIver that even more applications will be developed due to the unique capabilities of AM3DP , and that they want to support the efforts through a regulatory process that supports the next generation of devices .
“ With the publication of the final guidance , the FDA has indicated the technologies can be used safely and they ’ ve provided the framework to do that as AM3DP processes get faster and even more precise including to the micro and nano-scale . This can only help .”
One of the key goals here for the FDA is to establish a standard process for production of these devices which ensures they are safe .
“ More capital needs to be invested developing integrated systems within the 3D printer that monitor the source code that designs the device , and the reliability of the output of the printer ,” Dr . Robroy MacIver , a congenital heart surgeon who has pioneered the use of 3D printed models for surgery preparation , told Medical Design and Outsourcing . “ Safety , therefore , will depend on adherence to a rigid process , rather than simply the end result .”
The requirement to establish a cover-all-bases approach which is safe does not , however , mean that all
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