Accelerating and de-risking medical device development with digital patient twins

Virtonomy introduces v-Patients, enabling medical device developers to perform development and testing in a virtual environment, thereby accelerating development, reducing risks, expenses, and regulatory burden. Our end-to-end digital twin and simulation solution is based on an ever-expanding database of real clinical data to reflect anatomical variability, demographic diversity and pathological conditions.

Streamline development

Optimize your device using advanced anatomical studies and simulations and shorten the iteration loop from years to weeks

Significantly reduce costs and the risk to fail

Test early for a comparably low price in (virtual) humans and ensure product safety & performance prior to and after clinical trials

Ensure clinical trial success

Perform anatomical analysis and simulations for many patients to ensure the optimal design and maximize population coverage

Read more in a blog post

Use virtual patients as digital evidence for submission to regulatory bodies

FDA’s Office of Science and Engineering Laboratories (OSEL) has committed significant resources for transforming computational modeling from a valuable scientific tool to a valuable regulatory tool because of its potential for significant cost-savings in evaluating medical devices, simulating performance under scenarios that may not be possible with human use or that could more effectively be evaluated with simulation.

FDA (source)

Want us to help you draft a virtual testing plan?

Ask our regulatory experts to establish your virtual testing plan connected to your physical testing. We provide this service for free during a special workshop tailored to you. Learn about the new FDA guidance documents and ASME standards for Computational Modeling and Simulation. Our experts will highlight how you can apply them and streamline your regulatory process.

Understanding patient anatomies and optimizing anatomical fit directly impacts the fate of development projects. Virtonomy’s combined expertise in specific pathologies, device/patient interactions and state of the art therapy options is tremendously valuable for anyone looking to create or optimize cardiovascular technologies.

Dr. Maximilian Kütting, Director R&D New Valve Technology
virtonomy v-patients logo

Our end-to-end digital twin solution

Virtonomy’s virtual trial platform supports the full product life cycle of medical device development, from concept phase to regulatory reporting and clinical practice

Thousands of Virtual Patients

  • Virtual patient cohort tailored for you
  • Advanced 3D visualization and interactive implantation
  • Accurate 3D measurements and extensive statistics

Advanced Statistical Shape Models

  • Worst and edge-case anatomies
  • Average patient anatomy
  • Available for any customer-chosen patient group

Advanced Anatomical Simulations

  • Validated ISO benchtop test simulations
  • Validated in-human implant simulations
  • You control the simulations, we take care of all difficulties

Regulatory Services & Consultation

  • Regulatory path with a virtual testing plan
  • Compliance with all regulatory bodies
  • Validated virtual evidence report

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How can you shorten your time-to market?

Talk to our experts to find out how you can utilize digital twins for your specific medical device.

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