Industry
Client Overview
OrthoVision Devices is a well-established, global leader in orthopedic medical devices, based in Australia. For decades, they have been known for the quality of their physical implants. To maintain their market leadership against more agile competitors, they needed to embrace digital health and create a software-based value proposition. Their strategic goal was to develop a "Software as a Medical Device" (SaMD) that would help surgeons plan complex knee replacement surgeries with greater precision, using AI to analyze patient MRI scans.
Client Testimonial
"Entering the world of SaMD was a new frontier for us, and the regulatory hurdles were daunting. CIS was our guide and our engineering powerhouse. Their team's expertise in both medical-grade software development and the specifics of MDR/FDA compliance was invaluable. They didn't just build software; they delivered a fully compliant technical file. We went into our regulatory audits with a level of confidence we wouldn't have had otherwise." - Lawrence Wright, Senior Product Manager, OrthoVision Devices
Problem
OrthoVision needed to build a sophisticated, AI-powered 3D surgical planning software from scratch. This software had to be incredibly accurate, reliable, and, most importantly, compliant with the stringent regulations for medical devices in their target markets (Australia's TGA, Europe's MDR, and the US's FDA). Their in-house R&D team were experts in materials science and biomechanics, not in building Class II medical software.
Key Challenges
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Regulatory Compliance : The software needed to be developed under a rigorous Quality Management System (QMS) compliant with ISO 13485, with comprehensive documentation for FDA 510(k) and MDR submissions.
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02
Algorithmic Accuracy & Validation : The AI model had to accurately segment bone and cartilage from MRI scans and recommend implant sizing and positioning with sub-millimeter precision. The model's performance had to be clinically validated.
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Complex 3D Visualization : The software required an advanced 3D rendering engine to allow surgeons to view and manipulate the patient's anatomy and the planned implant position in real-time.
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Integration with Hospital IT : The software needed to integrate with hospital Picture Archiving and Communication Systems (PACS) to pull MRI scans, and the final surgical plan needed to be exportable.
Our Solution
CIS was engaged as the end-to-end development partner, providing a "Vertical / App Solution POD" that included experts in AI, medical imaging, 3D graphics, and regulatory compliance.
ISO 13485 Compliant Development Process : We executed the entire project within a pre-established QMS framework compliant with ISO 13485. Every stage, from requirements gathering to testing and release, was meticulously documented to create the technical file required for regulatory submissions.
AI-Powered Segmentation Model : Our AI team developed a deep learning model (a U-Net architecture) trained on thousands of anonymized MRI scans. The model achieved a Dice score of over 0.95 for bone segmentation, outperforming existing solutions. We produced a detailed validation report, including performance on diverse patient demographics.
High-Fidelity 3D Planning Interface : We built the desktop application using C++ and a high-performance 3D graphics library (VTK). The interface provided surgeons with intuitive tools to visualize the AI segmentation, adjust the implant position, measure angles, and simulate the post-operative range of motion.
DICOM/PACS Integration Module : We developed a robust module for handling DICOM, the standard for medical imaging. This allowed the software to query a hospital's PACS server, retrieve patient MRI series securely, and anonymize them for processing.
Implementation & Execution
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Regulatory & Requirements
We worked with OrthoVision's regulatory consultants to define the software's intended use, classification (Class IIa/II), and the full set of requirements traceable to user needs and regulatory standards.
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AI Model Development & Validation
This phase was dedicated to training, testing, and validating the AI segmentation model. We worked with a panel of orthopedic surgeons to review the model's outputs and refine its performance.
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Application Development & 3D Interface
Parallel to AI development, the application team built the core software, the 3D visualization engine, and the DICOM/PACS integration module.
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Verification, Validation & Testing
This was the most critical phase. We conducted exhaustive unit, integration, and system testing. A formal clinical validation study was conducted with surgeons to prove the software's accuracy and usability. All results were documented for the regulatory submission.
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Technical File Compilation
We compiled the complete technical documentation, including the risk management file (ISO 14971), software requirements specification, architectural design, and all V&V reports.
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Submission & Post-Market Surveillance
CIS provided support during the regulatory review process. After clearance, we implemented a post-market surveillance plan to monitor the software's performance in the field.
Positive Outcome
1. Successful Regulatory Clearances
The software successfully received clearance from the TGA, FDA (510(k)), and a CE Mark under MDR, allowing OrthoVision to launch in its three key markets.
2. Enhanced Surgical Precision
Surgeons using the software reported a 20% improvement in the accuracy of implant positioning compared to traditional methods.
3. New Revenue Stream
The SaMD created a new, recurring software revenue stream for OrthoVision, shifting their business model from a one-time hardware sale to a long-term partnership with hospitals.
4. Strengthened Market Position
The launch of the AI-powered software solidified OrthoVision's position as an innovator in the orthopedic space, giving it a powerful competitive differentiator.
Why Choose Us
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Verifiable Process Maturity
Our CMMI Level 5 and ISO 13485-compliant processes were not just a benefit; they were a prerequisite for this project.
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Fortress-Grade Security
Security was built-in, from secure handling of PHI to ensuring the software was hardened against cyber threats.
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Deep Domain Expertise
We possessed the rare combination of expertise in AI, medical imaging (DICOM), 3D graphics, and medical device regulations.
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Measurable ROI Focus
The goal was clear: achieve regulatory clearance and create a product that surgeons would pay for.
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100% In-House Experts
The project's complexity required tight collaboration between multiple specialist teams, all under the CIS umbrella.
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Flexible Engagement PODs
The "Vertical Solution POD" model ensured OrthoVision had all the required skills without needing to hire a large, specialized team.
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Radical Transparency
OrthoVision had full access to our QMS documentation and participated in all major design and risk reviews.
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Future-Proof Technology
The modular architecture allows for future updates, such as adding AI models for different joints or integrating with surgical robots.
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Guaranteed Peace of Mind
We navigated the high-risk, high-reward world of SaMD development and delivered a compliant, market-ready product.
Conclusion
This case study highlights CIS's unique capability to serve as a full-service development partner for complex, regulated medical software. We bridge the gap between traditional manufacturing and the digital future, enabling established device companies like OrthoVision to innovate with confidence and bring life-changing AI-powered tools to the market.