01
Cranial PEEK Implant
Cranioplasty plate machined from implant-grade PEEK to the defect margin taken from the patient's own series. Radiolucent, so it does not obscure follow-up imaging.
PEEK · CRANIAL
Patient-Specific Implant Solutions · Malaysia
Patient-Specific Solutions for Cranial and Maxillofacial Reconstruction
As Protomed's authorised distributor in Malaysia, Biocraft Medical provides local case coordination from initial submission through implant delivery.
Loading model
Patient-specific implants · 3D model
CASE SUBMISSION
- Implant, the part we supply
- Patient anatomy
01 · Implants
What We Supply
Six lines, each patient-matched and delivered against the surgeon's own plan. Biocraft handles case intake, design review scheduling, importation and delivery in Malaysia.
02
Cranial Titanium Implant
The same patient-matched geometry in implant-grade titanium, for cases where the surgeon specifies a metallic reconstruction.
TITANIUM · CRANIAL
03
Implant Fixation Systems
Screws and micro-plates sized to each case and supplied with the implant, used to secure it against the surrounding bone at the positions the surgical plan specifies.
TITANIUM · FIXATION
04
OMF Implant
Patient-specific components for oral and maxillofacial procedures such as TMJ replacement, LeFort I osteotomy and genioplasty, plus the cutting guides that carry each plan into theatre.
TITANIUM · OMF
05
Virtual Surgical Planning
Biocraft coordinates a planning session between the surgeon and Protomed's engineering team, working from a 3D model built from the patient's CT and dental scan data.
VSP · SURGICAL PLANNING
06
Anatomical Mould
A 1:1 mould of the patient's own anatomy for rehearsal, plate pre-bending and consent. Ordered on its own or alongside an implant.
MOULD · PLANNING & CONSENT
How the process works
From Case Submission to Implant Delivery
Biocraft Medical coordinates each patient-specific implant case in Malaysia, working with Protomed and the surgical team from initial submission through final delivery.
Submit a Case-
Submit the patient's CT or MRI data, case details, and surgical requirements to Biocraft Medical for initial intake.
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Biocraft reviews the submitted information and coordinates the case with Protomed's technical team.
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Protomed develops the implant design from the patient's imaging data and submitted case requirements.
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The proposed design is shared with the surgical team for review. Production begins only after approval.
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Following approval, Protomed manufactures the implant while Biocraft coordinates delivery and local case support in Malaysia.
03 · Specification
Materials, data and what arrives
Numbers, dimensions, case references, lot codes and material names are the substance of this business. They are set in mono throughout this site so they are never mistaken for marketing copy.
Every part carries its own case reference from the moment the dataset is accepted through to the pouch label, so the part in theatre is traceable to the series it was built from.
Specimen pouch label · illustrative
CASE BC-2604-118
MATERIAL IMPLANT-GRADE PEEK
LOT 4471
STERILE R · SINGLE USE
| Materials | Implant-grade PEEK and implant-grade titanium, both biocompatible |
|---|---|
| Indications | Cranioplasty, craniofacial and maxillofacial reconstruction, TMJ replacement, orthognathic planning |
| Source data | CT OR MRI SERIES, DICOM |
| Lead time | 2–4 WEEKS FROM ACCEPTED DATASET |
| Supplied | Sterile-packaged, patient-matched, single use |
| Identification | Case reference and lot number carried on the pouch label |
| Manufactured by | Protomed, Singapore and Sri Lanka |
| Distributed by | Biocraft Medical Sdn Bhd, Malaysia |
Imagery
Placeholder · replace with real assetsCT slice
CAD mesh
Machined part
5-axis mill
04 · Quality & regulatory
Who holds what
Biocraft Medical Sdn Bhd does not manufacture. All implants are manufactured by Protomed and supplied under Protomed's quality system. Biocraft is responsible for importation, distribution and case coordination in Malaysia.
Protomed · manufacturer
- ISO 13485:2016 Medical device quality management system
- GMP Good Manufacturing Practice certified
- NMRA Registered with the National Medicines Regulatory Authority, Sri Lanka
- HSA Manufacturing licence, Health Sciences Authority, Singapore
Biocraft Medical · distributor
- MDA licence Establishment licence, Medical Device Authority Malaysia Number TBC
- Registration Device registration held for the distributed range Numbers TBC
- SSM Biocraft Medical Sdn Bhd, Companies Commission of Malaysia Number TBC
- Scope Importation, distribution, case coordination and post-market vigilance liaison
05 · Manufacturing partner
Protomed
Protomed is a Singapore–Sri Lanka collaboration established in April 2019, manufacturing patient-specific PEEK and titanium implants and anatomical models for neurosurgery and maxillofacial surgery. It describes itself as Sri Lanka's first and only patient-specific implant manufacturer.
Manufacturing runs from Colombo with a Singapore operation, and the company lists offices in Singapore, New Delhi, Accra and Kuala Lumpur. Biocraft Medical is its authorised distributor for Malaysia.
| Established | APRIL 2019 |
|---|---|
| Manufacturing | Colombo, Sri Lanka |
| Operations | Singapore, New Delhi, Accra, Kuala Lumpur |
| Disciplines | Neurosurgery, maxillofacial, orthognathic, TMJ |
| Output | Patient-specific implants and anatomical models |
06 · Submit a case
Start a case
Send the details below and Biocraft will confirm whether the dataset is suitable, and what the case will take.
Do not attach patient-identifying information to this form. Share the imaging through your hospital's own secure transfer once the case is open.
Or contact directly
DELON HIN · HEAD OF SALES OPERATIONS
+60 17-332 2690
delon@biocraft.my
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