The CustoMED Platform is a cloud-based medical software solution designed to support the creation, review, and delivery of patient-specific instruments (PSI) and anatomical models for orthopedic procedures.
The platform is built to support multiple workflow types, ranging from fully automated AI-driven cases to fully manual expert-designed cases, while maintaining a consistent user experience, safety controls, and regulatory alignment.
Regardless of the workflow type, CustoMED’s goal is to provide the best possible clinical outcome and user experience, adapting the level of automation and human supervision to the specific case, indication, and region of operation.
Platform Building Blocks
The CustoMED platform is composed of several core capabilities:
Case Management & Indication Apps – Select procedure type and manage cases
Secure DICOM Upload & Client-Side Anonymization
Segmentation Viewer – Review and approve anatomy
Viewer & Editor – Visualization, measurement, annotation, and planning (based on permissions)
PSI & Model Generation – Automated, semi-automated, or manual
Role-Based Access Control (RBAC) – Separation of clinical and back-office responsibilities
Audit Trails & Approvals – Full traceability
Workflow & Supervision Types
CustoMED supports four main workflow types. A single case may transition between workflows depending on complexity, anatomy, data quality, or regulatory constraints.
1. Viewer-Only (Visualization & Communication)
Purpose
Used for visualization, review, and communication only.
Key Characteristics
View CT data, 3D models, and case outputs
Measurements and annotations for discussion
No device design or automated clinical decision-making
Ideal for collaboration, review, and education
Typical Users
Surgeons
Clinical reviewers
External collaborators (view-only access)
Regulatory Position
Designed to align with FDA-cleared viewer-type software
No diagnostic claims
No autonomous clinical output
2. Fully Automated Cases (AI-Driven)
Purpose
Fast turnaround cases where AI algorithms can reliably handle the full workflow.
Key Characteristics
Automated segmentation and landmarking
Automated baseline planning and PSI generation
Human review and approval required before export
Best suited for validated, high-volume, standardized indications
Benefits
Shortest turnaround time
Minimal manual intervention
High consistency
Important Note
Even in fully automated cases:
Human validation is always required
The software does not replace clinical judgment
3. Semi-Automated Cases (Hybrid AI + Human)
Key Characteristics
AI provides initial segmentation, landmarks, or draft designs
Manual review, refinement, or correction by CustoMED experts
Final approval by authorized users
Common Scenarios
Anatomical variation
Suboptimal imaging quality
Early-stage or newly supported indications
This is the most common workflow and allows cases to start automatically and continue through manual validation or refinement.
4. Manual Cases (Expert-Led)
Key Characteristics
Manual segmentation and planning by trained experts
External STL-based inputs supported
Suitable for rare anatomies, oncology, deformities, or pilots
Benefits
Highest flexibility
Supports indications not yet fully automated
Workflow Transitions (Important)
A case is not locked to a single workflow type.
Examples:
An automated case may require manual validation
A semi-automated case may revert to full manual design
A manual case may later benefit from partial automation
This adaptive approach ensures safety, quality, and reliability.
Service Levels & Turnaround Time
Standard target:
⏱️ Within 24 hours for segmentation, review, or planningUrgent / critical cases:
📞 If more immediate support is required, please contact the CustoMED team directly so priority handling can be arranged.
Turnaround time may vary depending on:
Workflow type
Indication complexity
Data quality
Regulatory constraints
Regions of Operation
CustoMED supports users across multiple regions, with workflows adapted to local requirements:
United States
European Union
Other regions (subject to local regulatory alignment)
Availability of features, automation level, and indication support may vary by region.
Indication Support
Indications are delivered via Indication Apps
Each indication may support:
Viewer-only
Manual
Semi-automated
Fully automated workflows
Automation level may evolve over time as validation progresses
If an indication is not yet fully supported, CustoMED can often still assist through manual or hybrid workflows.