Medical therapy helmet SLA biocompatible prototype.

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.

How we approach medical therapy helmet design

A medical therapy helmet has to fit one specific person, which turns conventional product design on its head. We work from 3D scan data of the patient, clean and repair the mesh, and design the helmet geometry with controlled offsets for padding and ventilation. Wall thicknesses are tuned for the printing process so the shell is light but stiff, and every design decision that touches the patient — materials, edge radii, strap anchor loads — is documented. Material selection prioritises skin-safe, cleanable polymers, and we design for the clinician’s fitting workflow with adjustment allowances built in.

Documentation and delivery for medical device projects

Deliverables include the patient-specific CAD model derived from scan data, a drawing package defining critical dimensions and materials, print process documentation for repeatability, and revision-controlled files so any re-print matches the fitted device. We work alongside the treating clinician’s requirements and flag anything that needs formal regulatory consideration early, keeping the engineering record clean enough to support whatever approval pathway applies.

Working with clinical requirements

Patient-specific devices sit at the intersection of engineering and clinical practice, and the workflow has to respect both. We establish the clinical requirements — treatment duration, adjustment needs, hygiene protocols — before geometry work begins, and design review includes the treating clinician, not just engineers. Scan-to-device turnaround matters for paediatric patients especially, because a growing child’s geometry changes; our process keeps the scan-to-fitted-device cycle short and repeatable. Every medical therapy helmet we deliver carries documentation linking the delivered geometry back to the source scan and the approved design revision, which protects the patient, the clinician and the device history.

We handle patient-specific device projects with the discretion and documentation rigour they demand, working directly with clinicians and allied health providers. If you have scan data and a clinical requirement, we can advise on the design and manufacturing pathway — including where formal regulatory processes apply — before any commitment is made.