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Medical therapy helmet SLA biocompatible prototype.

Case study: SLA 3D printing of a medical therapy helmet prototype in biocompatible photopolymer for a Melbourne medical device startup — patient-specific geometry from CT data, with internal sensor mounts and ergonomic surface finish.

Medical therapy helmet 3D printing SLA biocompatible Melbourne by ASTCAD
Patient-specific therapy helmet prototype — SLA in biocompatible photopolymer for medical device startup.
Industry
Medical Devices
Location
Melbourne, VIC
Year
2023
Standards
ISO 10993 + ISO 13485
Software
SolidWorks3-maticPreFormMimics

Project overview

ASTCAD partnered with a Melbourne medical device startup to produce a patient-specific therapy helmet prototype. The geometry was derived from CT scan data, processed through 3-matic for surface treatment, and printed via SLA in biocompatible photopolymer with internal mounts for monitoring sensors.

The challenge

The helmet had to fit a specific patient’s head geometry with millimetre accuracy, integrate non-contact sensors, and maintain biocompatibility per ISO 10993 for skin contact. The prototype needed to be production-representative for the customer’s regulatory submission preparation.

Our approach

  • CT data segmentation and surface meshing in Mimics + 3-matic
  • Internal cavity design for monitoring sensors and wiring channels
  • Material selection — biocompatible photopolymer per ISO 10993-1
  • SLA print orientation for surface finish on skin-contact surfaces
  • Post-cure protocol per medical-device prototype standards

Deliverables

  • Patient-fitted prototype helmet (post-cured, finished)
  • Manufacturing dossier suitable for regulatory submission
  • Material biocompatibility documentation
  • Design files in STEP and STL formats
  • Recommendation for production manufacturing path

Outcome

The prototype was used in patient fitting trials and supported the customer’s TGA submission preparation. The customer has since commissioned a second iteration with updated electronics integration and is progressing through the regulatory pathway.

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