Device Development for Complex Surgeries

An Integrated Ecosystem for Surgical Innovation, Navigation, Engineering, and Traceability

ISP-XR is a cutting-edge platform for 3D surgical planning, enabling surgeons and medical teams to create highly precise, patient-specific models. Through real-time collaboration with biomedical engineers, integration with extended reality (XR) tools, and full regulatory compliance (ISO 13485, MDR), ISP-XR enhances decision-making, reduces surgical risks, and streamlines workflows. Whether you're an experienced user or new to digital surgical planning, our solution provides seamless access to customized, efficient, and traceable surgical procedures.

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What is
b-onic Platform?

ISP-XR is a cloud-based platform managing the entire lifecycle of patient-specific medical device development. From the initial request to final approval, it ensures full traceability and ISO 13485 compliance. Advanced visualization and real-time collaboration improve workflow efficiency and surgical precision.

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Optimized Surgical Planning

By leveraging 3D models and extended reality, ISP-XR enhances precision, reduces operating time, and minimizes complications. Surgeons and engineers can anticipate challenges, improve coordination, and ensure personalized procedures for better patient outcomes and cost efficiency.

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Personalized Medical Devices
  • ISP-XR specializes in individual patient medical devices and advanced navigation systems, optimizing outcomes by adapting to each case. With a controlled development process and personalized navigation scenes, it ensures faster, safer, and more precise surgical solutions, providing insurance to the  surgery.

"The benefits are significant"

Healthcare professionals trust ISP-XR to streamline medical device development and enhance patient care. Its precision in custom device creation, real-time collaboration, and navigation technology drives better clinical results.

Clinicians' Perspective

ISP-XR improves surgical precision and safety, accelerates patient recovery, and delivers personalized solutions tailored to individual needs. By optimizing hospital resources and reducing surgical time, it enhances efficiency, effectiveness, and overall patient satisfaction.

88%
Surgeons consider planning indispensable.
91%
Of professionals value case specific planning.
92%
Medical staff reduces implementation time.
93%
Highlight improved collaboration and communication.

Trusted by Our Clients

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Surgical Planning

Precision, Innovation, and Customization

Surgical planning is a critical step in modern healthcare, enabling greater accuracy, efficiency, and patient-specific solutions. By integrating advanced imaging, engineering expertise, and real-time collaboration, surgical teams can anticipate challenges, optimize workflows, and enhance surgical precision. This approach not only improves patient outcomes but also reduces risks and enhances operational efficiency. Through customized medical devices and innovative planning technologies, surgical procedures become more predictable, safer, and better tailored to each patient’s unique anatomy.

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Data Precision

Surgical planning is the foundation of precision medicine, leveraging patient-specific imaging, 3D modeling, and navigation systems to enhance surgical outcomes. By integrating these technologies, procedures become safer, more predictable, and highly efficient.

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Custom Devices

Through an engineering-driven approach, surgical planning enables the creation of customized medical devices, including guides, implants, and anatomical models.
This ensures a better fit, improved function, and long-term surgical success.

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Live Collaboration
  • Our platform enables real-time collaboration between surgeons and biomedical engineers, ensuring design validation, regulatory compliance, and intraoperative navigation support. It allows key data review during procedures, optimizing precision and safety.
Start your surgical planning today

Engineering in Surgical Innovation

Optimizing Precision, Safety, and Workflow Efficiency
Having a dedicated engineering team in surgical planning ensures control, precision, and safety at every stage of the process. Engineers play a vital role in developing patient-specific medical devices, optimizing navigation systems, and maintaining full traceability to meet regulatory standards.
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Safe Efficiency

A structured engineering process enhances safety and cost efficiency in surgical planning by reducing errors, optimizing workflows, and ensuring traceability. Standardized procedures and advanced navigation systems improve precision while minimizing readmissions and unnecessary interventions, leading to better outcomes and lower costs.

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System Refinement

Engineering notebooks are essential tools for documenting, analyzing, and optimizing surgical planning workflows. They serve as structured repositories where every phase of development is recorded, ensuring repeatability, control, and precision in medical device production and navigation system integration.

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Extended Reality
  • ISP-xr offers a collaborative extended reality environment, allowing medical and engineering teams to review, adjust, and validate surgical plans in real time, regardless of their location. This platform enhances precision and coordination between teams, optimizing surgical decisions and minimizing risks throughout the process.

b-onic® Traceability platform

Complete control over the development of personalized medical devices.
b-onic is the platform that guarantees full traceability in the development of personalized medical devices. Since the implementation of the MDR regulation in May 2021, traceability has become mandatory to ensure safety and regulatory compliance. b-onic manages every stage of the process, from design to final validation, ensuring each step is documented and controlled in line with CE and FDA standards.
  • Phases of the planning process:

  • Medical Image Segmentation
    CT and MRI scans generate precise 3D models.

  • Navigable 3D Models
    Interactive visualization in 3D and extended reality.

  • Personalized Medical Devices
    3D-printed guides and navigation tools.

  • Production and Validation
    Expert collaboration for adjustments and sterilization.

  • Release and Evaluation
    Quality compliance and final assessment.

  • Custody of Certificates and Traceability
    Document management per ISO 13485.

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