Accelerating medical device development and clinical trials 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.

The medical device development industry is confronted by rapidly increasing complexity impacting risk, cost, and time-to-market. Digital solutions are the only way to face these challenges.

Reduce risks, time and cost

by performing data-driven device development & virtual clinical trials using statistical analysis, simulations & optimization

Master new regulatory & ethical demands

by performing data-driven device development & virtual clinical trials using statistical analysis, simulations & optimization

Safe animal & clinical trials

by accessing Digital Twins based on clinical data of thousands of humans and animals

Use virtual patients as digital evidence for submission to regulatory bodies

Regulatory viewpoint

The FDA and European Commission show strong support for virtual patients and simulation.

Useful links:

FDA’s view on virtual patients

EU Commission’s proposal

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.

Our end-to-end digital twin solution

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

Virtual Patients

Create and analyze virtual patient cohorts based on the clinical data input representing anatomical variation, demographic diversity, and various pathological conditions.

Statistical Analysis

Fully automatic statistical population analysis based on the virtual cohort to evaluate the proper target sub -population group, outliers, worst-cases, eligibility criteria for a clinical trial and more.

Simulation

Simulation with minimal input from the user based on the input of the implant design and material data; perform virtual implantations, device-tissue-blood evaluation, and design optimization.

Regulatory Reporting

Based on the anatomy, statistical, and simulation results, regulatory compliant digital evidence can be created to replace in vitro and in vivo evidence where possible.

The new revolutionary way of developing your medical device

Validate your device design at every step of the product life cycle with the help of virtual patients. Significantly reduce the risk for design changes in  a late stage where costs are tremendously higher.

Benefits of using v-Patients

  • reduce costs and time by up to 50%
  • reduce animal trials by up to 60%
  • increase evaluation confidence
  • ensure product safety prior to clinical trials
  • close the inequality gap of underrepresented populations

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

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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