Digital Patient Twins & In Silico Testing For Medical Devices

Introducing Dr. Simon Sonntag, a remarkable leader in the field of medical technology and life science, who is revolutionizing the future of healthcare with his innovative and entrepreneurial approach. He brings over a decade of experience in the life science and medical engineering sector and an impressive global network that includes clinicians, key opinion leaders, corporates, and universities.

Currently, Dr. Sonntag is leading the charge at Virtonomy, a company that is accelerating the development of medical products by conducting data-driven studies on virtual patients. Based out of Munich, Germany, Virtonomy is helping medical device developers at various stages of the product lifecycle to perform development and testing in a virtual environment, thereby accelerating development, reducing risks, expenses, and regulatory burden.

In addition to this, he is leading the Task Force for systematic engagement with Notified Bodies within the Avicenna Alliance since June 2020, with the aim to advance in silico trials in Europe and beyond.

An academic at heart, he shares his knowledge as a lecturer at among others Technische Universität München, where he inspires students with topics such as “Digitization of clinical studies with virtual patients” and “Computational Modeling and Simulation in the Development and Regulatory Approval Process of Medical Devices”.

He is also the Governor/Co-Chair of the Working Group Heart Support at the European Society for Artificial Organs. Here, he has been instrumental in establishing relationships with other societies like the European Extracorporeal Life Support Organization.

Furthermore, Dr. Sonntag has been recognized for his work by several prestigious awards, including being named as one of the Top 3 winners in the “Digital Health and Medical Devices” category by Hello Tomorrow Global Summit. His venture Virtonomy was deemed Health-Tech Start-up of the year by Med-Tech World and listed among the Top 5 digital twin solutions impacting healthcare by StartUs Insights.

Having a broad spectrum of expertise from entrepreneurship to academia, Dr. Sonntag stands at the forefront of medical technology innovation and is making an undeniable impact on healthcare’s future. Let’s delve into his journey, insights, and vision for a healthier tomorrow.

  1. Thank you for taking time to share your knowledge and experience about Digital Twins and In silico testing with our audience. Can you start by telling the audience about yourself? 

With a background spanning over a decade in the medical device industry, I’ve been on a dynamic journey throughout this area. My academic path started with a keen interest in mathematics, which led me to the Technical University of Munich and the National University of Singapore. Although I initially struggled with the theoretical aspects, my true passion for creating tangible things emerged. This inclination led me to medical engineering and image processing, where I found my true calling.

My fascination with building and my desire to delve deeper into medical topics eventually led me to pursue a doctorate in medical engineering at RWTH Aachen. Unexpectedly, my journey took me from academia to entrepreneurship when I joined a university spinoff in the medical device consulting domain as Chief Operating Officer. During this pivotal period, I gained insights into the potential of digitalization in medical-device development and clinical trials, and my entrepreneurial spirit was ignited.

In 2019, I co-founded Virtonomy as CEO, a venture aimed at revolutionizing healthcare through digital patient twins and simulation technology. Our mission is to accelerate medical innovation with advanced digital solutions, transforming the way medical products are developed and tested. What keeps me motivated is the opportunity to make a lasting impact on healthcare, streamlining processes and improving patient outcomes. I’m also actively involved in various societies and regulatory  associations, contributing to the adoption of in silico medicine and fostering collaboration across the industry globally.

  1. Can you tell our audience about Virtonomy? What problem is it solving & how?

Virtonomy stands as a pioneer in the realm of digital patient twins, introducing an end-to-end platform that seamlessly merges real world patient data, artificial intelligence, multiphysics simulations, and predictive analytics to support the medical industry. We address a significant problem: mitigating the elevated risks, complexities, and time constraints entailed in medical device development, ultimately streamlining the journey to market introduction.

Utilizing our advanced technology, we enable medical device developers to conduct product development and testing in the computer, reducing traditional in vivo (animal/human) and in vitro (laboratory) tests with so-called  in silico experiments (computer). This makes it possible to explore the interaction of the medical device with physically accurate modeling of the in vitro setup or anatomy of the target population based on real patient data as input. An example is the testing of  artificial heart valves in an in silico benchtop test. This approach is bolstered by our comprehensive database of thousands of real clinical data points, representing anatomical diversity, demographic variations, and different pathological conditions.

Our digital driven process empowers the medical industry to optimize product development by virtually assessing device performance and safety, conducting simulations for device-tissue-blood interaction, evaluating worst case scenarios and design optimization throughout the product development cycle. This transformative shift not only expedites the development process but also significantly curtails costs. It achieves this by mitigating the risk associated with altering the device design in the latter stages of verification or even during the critical validation process.

Beyond time savings and risk reduction, Virtonomy is aligned with modern ethical considerations and the drive toward inclusivity. Our virtual patient twin technology offers a more equitable research and development environment  by ensuring representation of underrepresented groups like children, women, and minorities.

  1. Could you briefly explain what digital patient twins and in silico testing are in the context of medical devices?

A digital patient twin refers to a detailed, computer-based replica of a real patient’s anatomy and physiological characteristics based on real world or synthetic data. It’s a virtual representation that accurately simulates how a specific patient would respond to different medical interventions, treatments, or devices.

In silico testing, on the other hand, involves using computer simulations and modeling techniques to replicate real-world scenarios in a virtual environment. This allows medical device developers to test their products, treatments, or interventions digitally, instead of using traditional in vivo  or in vitro methods.

Bringing these concepts together, digital patient twins and in silico testing enable medical device developers to perform comprehensive simulations of how their devices interact under a wide range of clinical scenarios and patient anatomies.This enables them to gather comprehensive data about the device’s behavior without the ethical considerations or physical risks often associated with traditional methods.

Overall, these technologies revolutionize the medical device development process by providing a safe, efficient, and accurate way to evaluate product efficacy, safety, and performance before moving to clinical trials or market launch.

  1. How does the incorporation of digital patient twins and in silico testing enhance the development process of medical devices?

These technologies allow for extensive simulation and evaluation during the design phase, helping developers identify potential design flaws or performance issues early on. By identifying these issues at an early stage, developers can make necessary adjustments, significantly reducing the time and cost associated with physical prototyping and testing.

Furthermore, these technologies enable developers to simulate patient-specific scenarios, which is crucial for personalized healthcare solutions. By providing an interactive environment to visualize how medical devices will perform inside a human body, developers can make more informed decisions about device modifications or improvements. This ultimately leads to devices that are safer, more effective, and better suited to individual patient needs.

  1. How can in silico testing impact patient safety and performance?

First and foremost, in the design phase, in silico simulations enable designers to meticulously optimize the performance of medical devices even before physical prototypes are manufactured. This advanced approach helps identify and rectify design flaws, potential weaknesses, and inefficiencies that could otherwise jeopardize patient safety or impede the device’s effectiveness. Virtual prototyping emerges as another critical advantage. Creating virtual prototypes of medical devices allows for swift and efficient testing of diverse design iterations, bypassing the need for time-consuming physical manufacturing. This expedites the design process and ensures that only the most promising designs advance for physical production and subsequent testing.

One of the most impactful aspects is the capability to simulate the interaction between the medical device and the human body. Through in silico testing, manufacturers and researchers can simulate and evaluate how the medical device interacts with various tissues, organs, and physiological systems. This process aids already in the early detection of potential issues or risks, such as tissue damage, design-anatomy misalignment, rupture, or adverse events like bleeding or hemolysis, which could otherwise compromise patient safety. Moreover, in silico testing empowers predictive assessments of a medical device’s performance and reliability over time and under diverse conditions. These simulations provide valuable insights into the device’s durability, predict potential wear and tear, and consequently prevent failures that might pose risks to patients.

Risk assessment and mitigation receive a substantial boost through in silico testing. By simulating a wide array of scenarios, manufacturers can identify potential risks associated with the device’s use and develop strategies to mitigate those risks effectively, thereby enhancing patient safety. The application of in silico testing also extends to regulatory compliance. While physical testing remains necessary in many cases, the inclusion of simulation data can provide evidence of a medical device’s safety and performance. This can potentially expedite the regulatory approval process, ensuring quicker access to patients who need the device. Ethical considerations are addressed as well, as in silico testing contributes to reducing the reliance on animal testing during medical device development. This not only aligns with evolving ethical standards but also accelerates the device development timeline

In the context of customization and personalization, in silico testing emerges as well. By simulating the behavior of a medical device within an individual patient’s unique anatomy and health condition, manufacturers can tailor the device’s specifications for optimal performance and enhanced patient safety. For surgical procedures involving medical devices, such as implants, the utility of in silico simulations is particularly relevant. Surgeons can visualize and practice the entire procedure virtually, gaining insights into how the device interacts with the individual patient’s anatomy. This hands-on practice and patient specific planning ensures more precise surgeries and, consequently, safer patient outcomes.

  1. Are there any regulatory challenges associated with digital twins and in silico testing? How are they being addressed?

In recent years, significant advancements have been made by regulatory bodies such as the US Food and Drug Administration (FDA), the American Society of Mechanical Engineers (ASME), and the European Commission (EC) to address the regulatory challenges associated with digital twins and in silico testing for medical devices.

The FDA, in particular, has been proactive in recognizing the potential of digital twins and in silico testing for medical device approval. The agency predicts that a substantial portion of the approval process, approximately 40 percent, could be covered by virtual patients and simulations within the next few years. This recognition reflects the growing acceptance of these technologies in the regulatory landscape.

However, regulatory uncertainty remains a concern for the medical device industry, particularly in the context of computer-driven clinical trials and digital evidence. To address this concern, considerable progress has been achieved. Both the FDA and ASME have played pivotal roles in advancing these developments. They have collaborated to publish documents outlining reporting and validation activities related to digital evidence, like the V&V 40 (“Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices”). By providing clarity on reporting and validation requirements, these organizations contribute to building a structured framework for incorporating digital evidence in the regulatory process.

A significant stride forward is the ongoing development of the Good Simulation Practice, a collaborative effort involving a dedicated community, including the FDA. This initiative aims to establish a standardized process for the submission and approval of digital evidence. Such a standardized approach will enhance consistency and predictability in regulatory assessments of digital twins and in silico testing.

The involvement of the European Commission is also notable. The EC has been working on frameworks and guidelines to facilitate the integration of  in silico testing in the medical device sector within the European Union. This demonstrates a commitment to fostering innovation while ensuring patient safety and regulatory compliance.

Noteworthy, the Avicenna Alliance plays a crucial role in addressing these challenges. It acts as a bridge between industry, academia, and regulatory bodies. By fostering dialogue and collaboration, the Avicenna Alliance helps regulators understand how to adapt existing regulatory frameworks and develop new guidelines that accommodate digital twins and in silico testing. Through initiatives such as workshops, seminars, and the sharing of best practices, the Avicenna Alliance facilitates the development of consensus on validation standards, data privacy protocols, and clinical relevance criteria. This collaborative approach aids in building trust in the technology among both regulators and industry stakeholders. As Virtonomy we are an active member of the Avicenna Alliance and collaborate with many regulators.

  1. Can you discuss some real-world applications of digital twins and in silico testing in the medical device field?

Digital patient twins and in silico testing are being increasingly adopted across various medical fields. For example, in the development of cardiovascular devices like stents,  artificial heart valves, assist devices, pacemakers, in silico testing allows researchers to evaluate the device’s performance and safety under various conditions. Digital patient twins can be created based on patient-specific imaging data, such as CT scans or MRIs. These twins or virtual patients accurately replicate the patient’s cardiovascular anatomy. Our advanced simulation technology can simulate blood flow dynamics, structural mechanics and electrophysiology of the patient’s heart and vessels including the interaction with the device. This enables the assessment of factors like pressure gradients, stress and strain, blood flow velocities, risks like clot formation, hemolysis or wear on the implants. These simulations help  for example identify regions of potential stenosis, evaluate the effectiveness of stent placements, and aid in designing implants that are both effective and durable.

In the case of heart valve replacements, digital twins can simulate the deployment and function of prosthetic valves. In silico testing can assess how different valve sizes and designs interact with the patient’s anatomy, ensuring proper valve function and reducing the risk of leaks or blockages. Additionally, the performance under various conditions and anatomical constraints can be evaluated. For example, simulations can assess how the valve prosthesis responds to changes in heart rate, pressure gradients, positioning and worst-case scenarios.

Additionally, digital patient twins can be created to replicate the anatomical and physiological characteristics of individual patients. This enables personalized simulations for surgical planning, where doctors can virtually practice complex procedures before performing them on the actual patient. For instance, simulations of heart surgeries allow surgeons to optimize their approach and anticipate potential complications. Additionally, medical professionals can use digital twins to train and educate themselves. Simulations provide a risk-free environment to practice procedures, test different approaches, and improve skills without putting patients at risk.

  1. What are the limitations or challenges of using digital twins and in silico testing in healthcare?

While digital twins and in silico testing have immense potential, they also present certain challenges. One key challenge is obtaining extensive data needed to develop accurate digital patient twin populations. The accuracy of digital patient twins heavily depends on the quality and accuracy of the input data, such as medical imaging. If the data is incomplete or inaccurate, it can lead to unreliable simulations and outcomes.

With regard to in silico testing, although it can simulate a wide range of scenarios, it relies on mathematical models which may not fully capture the complexity and variability of human physiology. The simulations are based on defined parameters which may not encompass all possible biological effects seen in real-world scenarios and require simplification. These simplifications can lead to deviations from real-world behavior, affecting the reliability of simulation results, which makes validation very important.

  1. How do you envision the future of medical devices with the continued advancement and adoption of digital twins and in silico testing?

With continued advancements and wider adoption, I envision a future where digital twins and in silico testing become integral components of medical device development processes. They will not only help expedite the design and testing phases but also facilitate personalized healthcare solutions through patient-specific device optimization.

These technologies have the potential to transform post-market surveillance of devices by providing real-time monitoring capabilities and predictive maintenance. This would further enhance device safety and efficacy, leading to improved patient outcomes. As more data becomes available and computational power increases, we can expect even more accurate and complex simulations, further enhancing the benefits of these technologies.

  1. How can these technologies impact healthcare costs?

By enabling early detection of design flaws, they can save time and resources spent on physical prototyping and testing, leading to shorter time-to-market and reduced development costs.

Moreover, by improving device safety and performance through comprehensive testing, they can minimize device failures or malfunctions that could lead to expensive recall events or patient complications. Thus, the cost savings from these technologies can be substantial, making healthcare more affordable and accessible to many more people.

  1. What advice would you give to medical device manufacturers looking to integrate digital patient twins and in silico testing into their development process?

The integration of digital patient twins and in silico testing offers promising avenues for advancing medical device development. To effectively incorporate these technologies, manufacturers should consider several key factors.

First, a robust understanding of the underlying physiological and anatomical aspects of the targeted patient population is essential. This foundational knowledge forms the basis for creating accurate digital patient twins that faithfully replicate real-world complexities.

Second, data quality and accuracy are paramount. Integrating high-fidelity patient data, acquired through advanced imaging techniques and real-world measurements, ensures the authenticity of the digital twin representation.

Third, simulation fidelity plays a crucial role. Precise modeling of device interactions within the virtual environment requires sophisticated multiphysics simulations that account for fluid dynamics, biomechanics, and tissue-device interactions.

With our solution at Virtonomy, we can provide all this and more. Our advanced platform seamlessly integrates real patient data, artificial intelligence, and multiphysics simulations to create highly accurate and dynamic digital patient twins and simulations. We understand the significance of data quality, ethical considerations, regulatory conditions and rigorous verification and validation standards to ensure fidelity.

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