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Mass Customization of Respiratory Protective Equipment
           mesh, forming the contact region between the mask and   assembly and manufacturing instructions so that he/she
           the user’s face, greater details can be found in Li et al. .   can  manufacture the  mask at  home  (if a  3D printer  is
                                                        [65]
           These points together with the set of landmarks act as the   available) or through commercial 3D printing services.
           reference geometry in the CAD model generation step.  This also served as a supply chain response to the global
               In the previous study ,  Autodesk Fusion 360    mask shortage at that time, as the 3D printed mask could
                                   [65]
           API was employed. However, as it cannot be readily   be used as a face covering or face shield.
           integrated with the rest of the pipeline which was      As facial  scans  are  sensitive  biometric  data,
           written in MATLAB, a Python based Blender script is   Data Protection  Impact Assessment has been carefully
           now utilized to seamlessly interface the CAD API into   conducted and approved by Imperial College London to
           the pipeline such that the whole pipeline can run in a   ensure all data-associated activities, including online data
           headless mode. Blender builds polygonal 3D models   collection, transfer, storage, and analyses, are secure and
           from successive addition of vertices, edges, and faces   compliant with relevant data protection regulations. The
           through functions with defined rules and constraints. This   study protocol (19IC5167) was approved by the Science
           polygon-based generative geometric modeling approach   Engineering  Technology  Research  Ethics  Committee,
           can robustly handle the complexity and high variation   Imperial College London.
           of  facial  topographies,  particularly  around  the  nasal   Eligible  participants  were  adults  (≥18  years)
           regions, making it well suited to the requirements of a   regardless of gender, ethnicity, or BMI. Before scanning,
           MC pipeline for RPE. The design of the respirator mask   participants  were asked to read through a Participant
           (Figure  2) remained the same  with three standard   Information  Sheet to understand the project,  how
                                      [65]
           components (grey) and a modifiable component (blue)   their data will be utilized and to clarify any questions.
           that will be updated geometrically in blender to achieve   Written instructions  were also provided on the online
                                                                               [68]
           custom-fit.                                         portal  to instruct participants  to prepare for scanning
                                                               by doing the followings: clean shave their face, remove
           2.2. Participants                                   any  glasses, and pin/tie  all  hair  if  it  is  obstructing  the
                                                                                   [68]
           Participants were recruited from mid-July 2020 to mid-  face. Video instructions  were provided to ensure that
           October 2020. Due to travel restrictions  during the   facial  data were acquired under the same conditions.
           COVID-19 pandemic,  a dedicated  online  portal  was   Participants were recommended to use an iPhone X or
                                                    [66]
           created  to  collect  3D facial  scans remotely.  This  way   newer versions (Apple Inc., Cupertino, California, USA)
           of data collection transcends geographical  boundaries,   with  a TrueDepth  camera  to  acquire  their  facial  scans.
           thereby  enabling  us to  reach a  wider  demographics.   However, facial  scans obtained from other  acquisition
           Recruitment  was advertised  on mainstream  media   devices  were also accepted.  If an iPhone was used,
           platforms such as the BBC , as well as on various   software applications recommended for creating  and
                                   [67]
           social  media  platforms.  As a token of appreciation  to   exporting  3D facial  scans were ScandyPro (Scandy,
           each participant, a custom-fitted mask model generated   New Orleans, USA) and Bellus3D (Bellus3D, Campbell,
           from  the  pipeline  was emailed  to  the  participant  with   California, USA).  Participants were also instructed to
                                                               remain in a neutral expression during the data acquisition
                                                               process. Once a scan had been acquired, participants
                                                               were instructed to upload their scans through the online
                                                               portal. Demographic information including age, gender,
                                                               ethnicity, weight, and height  were collected  through a
                                                               short survey in the submission process. Before the final
                                                               submission, permission was sought from each participant
                                                               to use their data anonymously through an Adult Consent
                                                               Form. Details  of the survey and consent  form can be
                                                               found in the online portal .
                                                                                    [69]
                                                               2.3. Scan exclusion
                                                               Facial data acquisition is not a trivial task and will
                                                               require the user to have a good level of understanding
                                                               of the  acquisition  device  and software to  obtain  3D
                                                               facial  data  with minimal  noise and obstruction.  While
                                                               written and video instructions were provided to guide the
           Figure 2. Custom-fitted mask body generated using Blender with   participants on data acquisition, it cannot be assumed that
           standard FFP3 filter components.                    all participants have followed the instructions diligently

           126                         International Journal of Bioprinting (2021)–Volume 7, Issue 4
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