In today’s rapidly evolving minimally invasive interventional medical device industry, where innovative products are emerging one after another, safety and efficacy testing are critical for ensuring product quality and accelerating time-to-market. Traditional testing methods, which rely on animal studies and simple in vitro models, suffer from long timelines, high costs, and limited clinical relevance, making it difficult to meet the precise validation requirements of high-end interventional devices. Fortunately, breakthroughs in medical simulation technologies—centered on AI, digital twins, 3D simulation, and organoids—are now driving a transformation in testing paradigms, shifting from experience-based approaches to digitally precise ones and serving as a core enabler of industry-wide upgrades. Notably, Xi’an Dewei Medical leverages its technical expertise and product advantages to deliver precise and efficient simulation testing solutions for medical device engineers, thereby serving as a critical pillar of the industry.

I. International Leadership: AI Digital Twins Reshape the Testing Paradigm

Across the globe, simulation testing technologies continue to innovate. In early March of this year, The U.S. FDA has approved DASI Simulations’ AI-powered 3D planning platform, which accurately simulates the mechanical interaction between the valve stent and the patient’s anatomical structures during TAVR procedures and dynamically reproduces the postoperative tissue repair process. This helps R&D personnel quickly identify design defects and shorten the development cycle. Companies such as Dassault Systèmes are also accelerating their strategic deployment; their 3DEXPERIENCE platform integrates generative AI with digital twin technology to provide intelligent support across the entire medical-device design and testing process, thereby enhancing testing efficiency and reliability.

II. Breaking Through Domestically: Indigenous Simulation Technology Shatters Overseas Monopoly

Multiple breakthroughs have been achieved in the domestic simulation model testing field, accelerating the localization process. Xi’an Dewei Medical has demonstrated outstanding performance as a provider specializing in high-end medical testing equipment and specialized services. With extensive experience in medical simulation and test-system development, the company offers turnkey testing solutions for minimally invasive interventional-device manufacturers and research laboratories, precisely meeting engineers’ R&D needs.

Develop a biomimetic platform for multi-parameter regulation and intelligent feedback to empower critical care education and the R&D of advanced medical devices.

(Source: Website of Southern Medical University)

By the end of 2025, Southern Medical University, in collaboration with relevant institutions, secured approval for a National Key R&D Program, focusing on core technologies such as intelligent cardiopulmonary coupling simulation. The models developed under this program can accurately replicate human cardiopulmonary physiological and pathological states, providing clinical-relevant test data. The Second Affiliated Hospital of Zhejiang University School of Medicine has established a “Whole-Vascular Digital Human” system that precisely replicates vascular anatomy and hemodynamic characteristics at a 1:1 scale, significantly enhancing testing efficiency. The addition of Dewei Medical has further expanded the portfolio of domestically developed simulation products, injecting new vitality into the industry.

Schematic Diagram of the All-Vascular Digital Human Technology Platform (Source: The Second Affiliated Hospital of Zhejiang University)

III. Empowering with 3D Printing: Real-World Applications of Personalized Simulation

3D printing has been deeply integrated with medical simulation. Domestic companies employ stereolithography to rapidly fabricate 1:1 patient-specific lesion models based on CT data, achieving high precision and using materials that meet medical-grade standards, thereby providing reliable support for the development of customized medical devices.

DeWei Medical’s simulation models boast outstanding competitiveness: they can replicate human anatomical structures on a 1:1 scale, with vascular models crafted from a proprietary, highly transparent soft silicone material that accurately reproduces hemodynamic behavior and vascular physiological characteristics. Paired with a comprehensive suite of testing equipment—including sensors and flow monitors—these models enable all-round, high-precision evaluation of device performance during operation, helping engineers validate functionality and optimize design. Notably, its neurointerventional vascular model has supported Zhongtian Medical in completing R&D testing for its related products, thereby accelerating product launch.

DeWei Medical Product Showcase

IV. Policy Support: New Technologies Receive Regulatory Backing

Regulatory authorities in China, the United States, and Europe continue to refine relevant policies, with a clear stipulation from 2025 that organoid-based experimental data may be used to support new drug applications. The FDA has lifted the mandatory requirement for animal studies in the approval process for certain drugs, a policy direction that also applies to the field of minimally invasive interventional devices.

Organoid-based simulation models can accurately mimic human organ function, yielding more reliable test results while reducing costs, shortening development timelines, and mitigating ethical concerns. DeWei Medical’s solutions are rigorously aligned with both domestic and international standards, providing access to specialized literature and data reports, supporting compliance with the FDA’s new QMSR regulations, helping companies overcome challenges in regulatory testing, and ensuring smooth product export and market launch.

V. Full-Chain Integration: Spanning the Entire R&D-to-Marketing Process

The simulation model has established a comprehensive, end-to-end system encompassing “virtual testing—clinical pre-implementation—product optimization,” deeply integrated with the entire lifecycle of medical device R&D, testing, and market launch, thereby providing tailored solutions for a wide range of interventional devices.

DeWei Medical’s solutions provide end-to-end coverage across all clinical scenarios. Its simulated vascular models are compatible with interventional procedures for neurovascular, coronary, and peripheral vascular applications, capable of replicating a wide range of lesion types. Moreover, the company offers custom model development tailored to specific customer requirements, ensuring precise alignment with engineers’ individual testing needs.

DeWei Medical Products Receive Positive Market Feedback

VI. Summary and Outlook

With the iterative integration of related technologies, Simulation models are progressively replacing traditional testing approaches, serving as a critical enabler for high-quality industrial development. Moving forward, Dewei Medical will continue to deepen its expertise in the field of medical simulation, iteratively refining and optimizing its solutions to provide engineers with more professional and efficient testing support, thereby helping China’s minimally invasive interventional device industry advance toward higher-end, precision-driven, and domestically produced capabilities.

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