Welcome to an exploration of digital twin technologies and their transformative impact on the medical device industry. This blog post, which adds to a live session led by Dr. Sven Herrmann from Simq, reveals how advanced simulations can redefine medical devices’ entire product life cycle, from research and design (R&D) to post-market phases.
Figure 1: Summarized illustration of a medical device’s life cycle from discovery to post-market monitoring.
With over 14 years of experience in medical engineering and computational biomechanics, Dr. Herrmann provides invaluable insights into overcoming the industry’s toughest challenges.
How Digital Twin Technologies Enhance the Product Life Cycle
Simq offers comprehensive services leveraging digital twin technologies to optimize medical device development across various stages. In the R&D phase, we utilize numerical simulations to reduce costs and time by up to 50%, enhancing prototype quality and safety.
We streamline verification through virtual testing and patient-specific simulations for the approval process, aiding faster regulatory compliance.
Simq provides real-time performance monitoring and detailed failure analysis in post-market surveillance to ensure ongoing device efficacy and safety. These services collectively accelerate time to market and improve overall product reliability.
Figure 2: Simq’s approach to making participants in the healthcare industry benefit from digital twin technology.
R&D Phase: Optimizing Prototypes
The R&D phase is critical yet fraught with challenges such as high costs, time-consuming iterations, and frequent failures. Traditional methods often fall short, leading to prolonged development cycles and hefty expenses.
This is where digital twin technologies come into place. These simulations replicate physical prototypes virtually, allowing for thorough testing and optimization before physical production begins. By simulating real-world conditions, developers can identify and rectify potential issues early on, significantly reducing R&D costs and time to market. For more information about how digital twin technology can benefit your R&D, visit Simq’s R&D services.
Approval Process: Streamlining Verification
Gaining approval for medical devices is a rigorous process that requires extensive preclinical and clinical testing. Digital twin technologies provide a more efficient alternative by offering virtual benchtop tests and patient-specific simulations. These methods enable comprehensive testing across various scenarios, ensuring robust verification and validation.
For instance, manufacturers can simulate clinical trials with virtual patient cohorts, generating statistically significant data that supports regulatory submissions and expedites approval processes. Learn more about this in Simq’s simulation in the approval process.
Post-Market Surveillance: Ensuring Ongoing Compliance and Improvement
Medical devices’ journey doesn’t end with market approval. Continuous post-market surveillance is essential to maintaining device efficacy and safety. Digital twins facilitate this by enabling detailed failure analysis and real-time performance monitoring.
Manufacturers can simulate potential design changes, assess their impact, and ensure compliance with regulatory standards, such as the European MDR. Additionally, they can reconstruct patient-specific scenarios to investigate and mitigate issues, enhancing overall device reliability. Check out Simq’s post-market surveillance services for more details.
Real-World Applications and Benefits
Simq’s digital twin technology already benefits many individuals and businesses in the healthcare industry. Visit our customer success section to learn about our successful projects and inspiring client collaborations.
Figure 3: Companies that are already benefiting from Simq products and services.
Case Study: R&D Optimization with Spinal Systems
In collaboration with a medical company, Simq utilized digital twin technology to address a critical issue in the spinal system. During surgery, the risk of screw failure was identified.
The company determined the safe force thresholds through virtual simulations, enhancing the product’s safety and quality even before physical testing. For a closer look into virtual implant testing, read about Simq VIT.
Approval Success: FDA Submission with Dental Solutions
Dental Solutions faced an FDA challenge regarding their product’s worst-case scenario verification. Simq’s simulations objectively identified the worst-case scenarios, allowing Dental Solutions to provide accurate data and secure timely approval, avoiding costly delays. Read more about this process in our blog post about FDA approval of dental implants.
Post-Market Surveillance: Mandibular Fracture Devices
In response to the new MDR requirements, Simq assisted Medartis in proving the benefits of their mandibular fracture device through detailed simulations. This provided robust post-market clinical follow-up data, supporting ongoing product improvements and regulatory compliance.
Comparing Conventional Methods and Digital Twin Technologies
Figure 4 compares the life cycle of medical devices when using conventional methods vs. digital twin technologies. The superiority of applying the digital twin technology is clear regarding the Key Performance Indicators (KPI), time-to-market, research and design costs, and failure.
Figure 4: How implementing digital twin technologies improves the whole medical device life cycle from idea to market.
Conclusion
Digital twin technologies are a promising futuristic concept and a practical solution transforming the medical device industry today. Integrating these advanced simulations into your product life cycle can accelerate R&D processes, streamline regulatory approvals, and enhance post-market surveillance. Embrace the power of digital twins to innovate and lead in the medical device market.
Visit Simq’s service page for more detailed insights and examples. Our website contains comprehensive information on how digital twin technologies can improve your approach to developing medical devices.
Adopting digital twin technologies can significantly reduce R&D costs, shorten time to market, and ensure compliance with regulatory standards.
Contact us today to learn how Simq can help optimize your medical device development process!
Next Steps
Stay tuned for our next live session, where Dr. Sven Herrmann will discuss the latest FDA guidance on simulation technologies and how you can leverage them for a smoother approval process.
Sources:
[1] JACC 2016: Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices
[2] Revital Hirsch: The Medical Device Milestone Map
[3] University of Minnesota: Medical Device Innovation Handbook
