Bringing digital twinning software into your medical device development process can seem complex at first. The technology might feel abstract, and introducing new software into your workflow may put you off.
However, our team of experts makes sure you are guided through the whole process and can start using the software from day 1, without long onboarding and steep learning curves.
So what exactly happens between that initial conversation with our team and holding FDA-ready digital evidence in your hands?
We’ve guided dozens of medical device companies through this journey, from innovative startups to established industry leaders. Here’s what you can expect when you partner with Virtonomy.
Stage 1: Initial Consultation & Project Scoping
Purpose:
Understand your goals, device, and clinical context.
In our first conversation, we dive into your current development stage, target population, and regulatory plans. This ensures we tailor the project to your specific needs—from simulation strategy to final deliverables.
Whether you’re just starting in the early design phase or preparing for pre-clinical testing, we work closely with you to align your project with regulatory expectations from the very beginning. One of our first steps is helping you define the ‘Question of Interest’—the specific question the model is meant to answer. This clarity not only sharpens the approach but also ensures your project is built on a solid regulatory foundation.
We’ll discuss:
- Device type and design stage
- Target patient anatomy and pathology
- Regulatory goals (FDA, EMA, etc.)
- Existing challenges in testing or validation
You’ll receive:
- A detailed project proposal
- Scope of work with timeline and deliverables
- Transparent pricing (no hidden fees)
📅 Typical timeline: 3–5 business days
Stage 2: Patient Selection & Data Strategy
Purpose:
Choose the right digital patient cohort for testing.
We work closely with you to define the most clinically relevant digital patient twins for your device testing (optimal fitting patient group, pathology, sex, and other parameters). We agree on specific patient measurements you need based on your device type, and highlight challenging anatomical variants that could impact device performance. You can choose to incorporate edge cases, or define an average cohort representative of your target patient group.
You’ll receive:
- A curated dataset of patient anatomies
- Detailed anatomical measurements
- A patient selection rationale document (valuable for submissions)
📅 Timeline: 1–2 weeks, depending on complexity
Stage 3: 3D Model Development & Onboarding
Purpose:
Bring your patient data to life as 3D patient models.
We convert imaging data into high-resolution 3D anatomical models. During onboarding, we walk you through the patient cohort and introduce your team to the v-Patients platform—so you can begin testing device designs right away.
What we’ll cover:
- Overview of patient models and key measurements
- Step-by-step walkthrough of the digital twinning software
- Support on device placement and design validation
You’ll receive:
- Patient 3D models
- Access to our interactive visualization platform
Stage 4 (Optional): Advanced Simulation & Analysis
Purpose:
Test your device performance—virtually.
If you choose our simulation add-on, our team runs advanced simulations to help you assess flow dynamics, device/organ interaction, or anatomical constraints—before you build a single prototype. Test your device in a virtual benchtop test or over your patient population. Use the the digital evidence for design optimization or regulatory submission.
You’ll receive:
- Simulation reports with key performance metrics and according to the reporting guidelines of the regulatory bodies
- Visuals to help interpret and present results
📅 Timeline: 4 weeks+ depending on complexity
Stage 5: Ongoing Support
Purpose:
Keep moving forward with expert guidance.
We stay involved beyond delivery. As your project evolves, we’re here to provide technical support, help with new simulations, or assist your internal teams in interpreting results.
You’ll receive:
- On-demand technical support
- Access to new patient datasets (if needed)
- Guidance for iteration or market adaptation
📅 Flexible timing — based on your development cycle
Stage 6: Regulatory Documentation & Submission Support
Purpose:
Turn your results into submission-ready evidence.
Our team helps you compile simulation data into well-documented, regulator-aligned formats—so you can confidently include in silico results in your FDA, EMA, or notified body submissions.
You’ll receive:
- Methodology reports and simulation protocols
- Evidence summaries aligned with current regulatory guidance
- Support on how to position simulation data in submissions
What Makes the Virtonomy Process Different?
- Collaborative: We support and assist you along the way.
- Regulatory-aligned: Everything we do considers current and evolving guidelines.
- Accessible: No steep learning curves—your team can start working with the platform from Day 1.
- Transparent: From pricing to timelines, you’re always in the loop.
Ready to Start?
Whether you’ve just started working your device design, or preparing for clinical trials, this process ensures you’ll have clear expectations, validated outputs, and a dedicated team from concept to submission.
Schedule your initial consultation today and see how our digital twinning software can accelerate your medical device development.
