Once a case is approved in CustoMED, the finalized outputs required for manufacturing patient-specific instruments (PSIs) are generated and made available for download. These outputs reflect the exact approved plan and cannot be modified unless the case is reopened.
All PSIs and anatomical models are provided non-sterile. Production, validation, sterilization, and final use must be planned carefully to align with the scheduled surgery.
What Happens After Case Approval
After approval:
The case status is updated to Approved
Finalized output files become available in the case file list
Planning and alignment parameters are locked
Any further changes require reopening the case
All generated files represent the final approved configuration.
Expected Timelines
CustoMED aims to support cases as efficiently as possible while maintaining quality and safety.
Review & Processing
We do our best to review and respond within 24 hours
In some cases, processing may take up to 72 hours, depending on:
Case complexity
Surgeon availability
Time of submission during the week (e.g., weekends or holidays)
Production & Delivery
Production time depends on the selected manufacturing option:
Centralized or third-party facilities may require an additional 1–2 days
Point-of-care (POC) or in-house printing can often be completed the same day
Sterilization (Required)
CustoMED does not perform sterilization and does not deliver sterile devices
All PSIs and anatomical models are delivered non-sterile
Sterilization must be performed by the hospital or designated production facility
Required sterilization time varies by institution and must be included in surgical planning
General recommendation:
To allow sufficient time for review, production, delivery, and sterilization, cases should be submitted so that the final PSI is available at least 72 hours before surgery, whenever possible.
For urgent cases, please contact CustoMED support as early as possible.
What You Receive
Depending on the procedure and configuration, downloadable outputs may include:
PSI STL files
Ready-to-print files defining the patient-specific instrument geometry.Anatomical models (STL)
Pre- or post-operative bone models, when applicable.Planning / Summary PDFs
Documentation summarizing the approved plan, key parameters, and visual references.
These documents support traceability and review but are not instructions for use.
All downloads are logged for audit purposes.
Production Options
You may choose the production method that best fits your workflow:
Hospital In-House / Point-of-Care Printing
Print PSIs and models using approved in-house equipment
Same-day production is possible in many cases
Follow internal quality and validation procedures
CustoMED-Managed Production
CustoMED coordinates production according to predefined specifications
Finished parts are delivered to the hospital or designated facility
Devices are delivered non-sterile
Third-Party Manufacturing
Export files to an external manufacturing partner
Ensure the partner follows appropriate material, quality, and handling requirements
Validation of Printed PSIs
Before sterilization and surgical use, users must validate the printed PSI:
Confirm the printed geometry matches the approved digital model
Verify anatomical fit using a printed bone model, if available
Inspect for print defects, deformation, or surface issues
Validation is the responsibility of the user or institution performing the print.
Sterilization & Surgical Use
Sterilization must be performed according to CustoMED & hospital protocols
CustoMED does not control sterilization methods or timelines
The surgeon must confirm sterilization prior to use
The final decision to use the PSI is made intraoperatively by the surgeon.
PSIs are optional tools that support but do not replace clinical judgment.