KEY CHALLENGES WITH THE TECHNOLOGY , ACCORDING TO MCDANIEL …
• Regulatory environment : “ The FDA ’ s release of the final guidance has made this bit less of a challenge , but some of the underlying needs are still a challenge . When possible , the FDA refers to existing standards . For additive manufacturing ( AM ), this is an area with much work to do and one to which I volunteer my time through the America Makes / ANSI AM Standardization Collaborative , ASTM F42 Committee , and ASTM / ISO joint groups .”
• Technology and materials : “ Faster processes capable of micro and nano-level precision are needed to expand the applications . The number of materials that can be printed needs to expand , whether for strength , biocompatibility , and / or ease of sterilisation . What can be printed today is limited when compared to traditional manufacturing methods .”
• Reimbursement : “ For some areas like anatomic models and surgical guides , reimbursement is very limited . Most have found a way to justify their use through overall savings or value-add , but being able to include proven 3D-printed models , guides , etc . as those covered by payers will greatly increase their impact on patients .”
• Qualified workforce : “ The growth of AM3DP in medicine requires the collaboration of medicine and engineering with AM3DP-trained bioengineers playing a key role .”
FDA reviewed more than 100 devices currently on the market which were manufactured on 3D printers , including a number of patient-matched devices , tailored to fit a patient ’ s anatomy , such as knee replacements and implants designed to fit like a missing puzzle piece into a patient ’ s skull for facial reconstruction .
“ In order to help ensure the safety and effectiveness of these products , we ’ re working to establish a regulatory framework for how we plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalised devices for specific patients they are treating ,” said
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