Future of point of care manufacturing in craniomaxillofacial disease

Abstract

Background: Point of care manufacturing (POCM) is a non-traditional form of manufacturing referring to the just-in-time creation of anatomical models, surgical instruments, prosthetics, and other 3D printing applications at the place of patient care using their personal medical imaging data and digital technology. The POCM has a potential to revolutionalise the healthcare offering equitable and precise personalised treatment and medical devices to improve patient outcomes.

Aims: The primary objective of the study is to identify and examine the barries and enablers of POCM and explore the feasibility of implementing POCM in wider healthcare settings.

Methods: Jaw reconstruction through virtual surgical planning will be utilised as an example of POCM. The prospective jaw reconstruction database will be used to assess the impact on time to treatment, patient quality of life and experience, treatment costs, and effect of the newly introduced medical device regulatory compliance. 

Results: Preliminary results indicate that there is no difference in the time to treatment and adverse event in the POCM cohort of 15 jaw reconstructions compared to the non POCM cohort of 47 cases. Health related quality of life outcome will be finalised. The cost of regulatory compliance is yet to be determined, however, it is estimated to be $1.266 million annually per business. 

Conclusions: POCM offers timely and safe treatment with excellent outcomes. The cost of regulatory compliance is a major barrier to make this technology widely accessible in healthcare settings.