Customize
Regulatory Status Disclosed
Overview
Customize by 3D-Side SA is a web-based platform designed to optimize and streamline preoperative planning, design, and production of patient-specific medical devices. It connects surgeons, patients, and medical device companies, leveraging artificial intelligence for the segmentation of medical images (DICOM data from CT scans and X-rays) to generate precise 3D CAD files for surgical planning. The platform supports a wide range of anatomies and surgical procedures, including shoulder and ankle arthroplasties, cranioplasty, bone tumor resections, and corrective osteotomies. Customize aims to enhance communication, organization, and compliance throughout the patient journey, from initial image upload to post-market surveillance of custom-made devices.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered 3D preoperative planning
- Patient-specific medical device design and production
- Web-based platform for case management
- DICOM data upload and AI-segmentation
- Interactive 2D & 3D views for planning
- Integrated implant library
- Communication tools (chatbox, notifications, email generation)
- Full history and traceability for cases
- Automatic document generation
- Customizable workflow integration
Use Cases
- Shoulder arthroplasty planning
- Ankle arthroplasty planning
- Cranioplasty solutions and custom cranial implants
- Bone tumor resection planning and cutting guides
- Corrective osteotomy planning and cutting guides
- Patient-specific instrument (PSI) production
What Physicians Need to Know
DICOM Support & Standards
Customize is a web-based platform that serves as a backbone for creating custom-made medical devices, supporting the upload of DICOMs. It handles medical images in the DICOM format, a widely used standard, and can store and display various diagnostic images including X-rays, CT scans, MRIs, and ultrasounds. The platform facilitates DICOM transfer and automatic series detection, analysis, and sorting. For arthroplasty planning, it uses multi-slice DICOM data from CT scanners.
PACS Integration Method
Customize is a connectable, web-based platform. While direct PACS integration methods aren't explicitly detailed, the platform's ability to upload DICOMs suggests compatibility with image transfer from PACS. Modern PACS often integrate with 3D applications through standardized context-sharing protocols like HL7-CCOW, or by allowing 3D tools to receive imaging data directly from modalities or through DICOM transfers from the PACS archive.
Reading Room Workflow Impact
Customize aims to automate case management, image analysis, segmentation, communication, and traceability to reduce workload and allow physicians to focus on the patient. It offers interactive 2D & 3D views, annotations, an integrated chatbox, and automatic notifications and email generation to improve communication and organization. The platform streamlines pre-operative planning and patient-specific case management, connecting surgeons, patients, engineers, and designers. This can lead to more efficient workflows, reducing lead time and improving quality-related tasks.
AI Model Architecture (deep learning approach)
Customize is powered by Artificial Intelligence and utilizes automatic AI-segmentation for several anatomies. This AI segmentation is supervised by an engineer, and manual editing tools are available for full control. The platform incorporates artificial intelligence, including nonadaptive machine learning, followed by human supervision during the segmentation process.
FDA Clearance Pathway (510k/De Novo)
Customize for Arthroplasty has received 510(k) clearance for shoulder and ankle anatomies. The platform itself is a medically cleared platform with 510(k) clearance and CE mark. 3D-Side received 510(k) clearance for its pre-operative planning software, Customize, for shoulder replacement surgery in March 2022. An additional 510(k) clearance for ankle arthroplasty was granted in August 2022.
Supported Modalities (CT/MRI/X-ray/US)
Customize processes multi-slice DICOM data from CT scanners for arthroplasty planning. It can read and visualize medical images compliant with the DICOM standard, and for ankle arthroplasty planning, it uses CT-scan data and can incorporate information from X-ray images. The platform generally handles a wide range of diagnostic images, including X-rays, CT scans, MRIs, and ultrasounds.
RSNA/ACR Validation
While 3D-Side's Customize is a platform for patient-specific medical devices and surgical planning, and the RSNA and ACR have a 3D printing clinical data registry and appropriateness criteria for medical 3D printing, there is no explicit mention of Customize undergoing direct RSNA/ACR validation or being listed in their registries in the provided information.
Physician Tip
Leverage Customize's automated AI-segmentation as a powerful starting point, but always utilize the available manual editing tools to ensure full control and fine-tune results to your specific patient anatomy and surgical plan. The interactive 2D & 3D views, integrated chat, and automatic notifications can significantly enhance communication with engineers and other stakeholders, streamlining the patient-specific device creation process. Remember that Customize is intended for pre-operative planning and patient-specific case management, not for diagnostic purposes.
Customize is designed as a web-based platform that acts as a backbone for personalized medical devices, emphasizing its 'plug & play' and 'connectable' nature. It integrates with your existing workflow for patient-specific cases and can connect to intra-operative guidance systems. The platform's ability to handle DICOM data facilitates integration with imaging modalities and potentially PACS, though specific PACS integration protocols are not detailed.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing | Unknown |
| Deployment | Web Platform |
| Compliance | |
| BAA Available | Unknown |
| HIPAA Compliant | Unknown |
| FDA Status | Cleared AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Orthopedics, Plastic Surgery |
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Press & Coverage
3D-Side
Customize | 3D Medical Software - 3D-Side
CUSTOMIZE is a web-based platform by 3D-Side for pre-surgical planning and patient-specific case management, connecting surgeons, patients, engineers, and designers. It streamlines the creation of custom-made devices from DICOM uploads to post-market surveillance, integrating unique workflows and offering automated features like AI-segmentation.
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Med-Tech Innovation Expo
3D-Side - Med-Tech Innovation Expo 2023
3D-Side showcased its 'Customize' platform at the Med-Tech Innovation Expo 2023, highlighting its role in developing custom cranial implants and patient-specific instruments (PSI) for complex bone surgery. The platform, built over years, is fully customizable to other medical companies' needs.
2023-05
3D-Side
About Us - 3D-Side
3D-Side, a spin-off from UCLouvain University, developed the 'Customize' platform to connect surgeons, patients, and medical device companies for optimizing patient-specific medical device creation and production. Since 2018, this in-house technology has been offered to external medical device companies.
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3D-Side
3D-Side | Personalized 3D Preoperative Planning & Medical Devices
3D-Side supports healthcare professionals with AI-powered 3D preoperative planning and patient-specific medical devices through its 'Customize' web platform. This all-in-one solution streamlines workflows from DICOM uploading to post-market surveillance, with AI automation across case management, quality management, and document generation.
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3D-Side
Knee Arthroplasty Planning & PSI | 3D-Arthro I 3D-Side
3D-Side offers a configurable platform, 3D-Arthro Knee, for knee arthroplasty solutions, which includes digital planning and patient-specific instrumentation. The 'Customize' software, which underpins this, is CE marked for Europe and 510(k)-cleared for specific applications in the USA.
2026-02
3D-Side
Bone Tumor Resection I 3D-Side
3D-Side's '3D-Cut' technology, integrated with the 'Customize' platform, offers personalized pre-operative planning and custom resection guides for complex bone tumor resections. This approach aims to improve accuracy, reduce surgery duration, and preserve essential tissues.
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3D-Side
News | 3D-Side
3D-Side's news section features case studies and articles highlighting the role of 3D planning and patient-specific solutions in modern surgery, including applications for sacroiliac tumor resection and total knee arthroplasty. These articles demonstrate the practical application of their 'Customize' platform and related technologies.
2026-07
ResearchGate
Set-Up of ISO 13485 Standards for 3D-Printing Technologies in ...
A publication on ResearchGate mentions 3D-Side's 'Customize' as a medical device software for 3D visualization and regulatory compliance in the context of ISO 13485 standards for 3D-printing technologies in medical applications.
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Videos
Product demos, reviews, and walkthroughs for Customize.
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Frequently Asked Questions
Customizing AI can streamline specific clinical workflows by tailoring the AI to your practice's unique protocols, EMR system, and patient population. This can lead to more efficient data analysis, personalized treatment recommendations, and improved diagnostic accuracy, ultimately enhancing patient outcomes and reducing physician burnout.
When customizing AI, it's crucial to ensure that all data used for training and deployment adheres strictly to HIPAA and other relevant data privacy regulations. This involves robust data de-identification, secure data handling protocols, and ensuring the customized AI's outputs do not inadvertently expose protected health information (PHI). Regular audits and legal counsel are recommended to maintain compliance.
Yes, many vendors offer highly configurable off-the-shelf AI solutions that allow for significant adaptation without full custom development. These alternatives often provide faster deployment and lower initial costs but may offer less granular control or specific functionality compared to a fully customized system. The trade-off lies between bespoke precision and readily available, cost-effective deployment.
Pricing for AI customization typically involves initial development costs, ongoing maintenance, and potential licensing fees, often based on the complexity of the customization and the scope of integration. Factors influencing cost include the volume and type of data required for training, the complexity of the algorithms, the level of integration with existing systems, and the need for specialized expertise.
Practical limitations include the availability of sufficient, high-quality, and diverse datasets for training, which can impact model generalizability across different patient populations or conditions. Ethical considerations, such as algorithmic bias and ensuring equitable access, also pose significant challenges. Over-customization can also lead to overfitting, where the AI performs well only on specific data but poorly on new, unseen data.
Physician involvement is crucial for defining clinical requirements, validating data, and evaluating the AI's performance in real-world scenarios. While deep technical expertise isn't typically required, physicians need to articulate their workflow challenges and desired outcomes clearly. Collaboration with AI developers ensures the customized solution aligns with clinical needs and integrates seamlessly into practice.
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| Last Verified: 2026-04-20 | First Added: 2026-04-20
Investors who backed Customize
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