From clinical idea to
effective
cardiovascular devices

Preclinical CRO & Engineering Support for Every Stage of Cardiovascular Device Development

With over 20 years of experience, our team operates as a specialized preclinical CRO, transforming innovative concepts into life-saving technologies. From design to implementation, we provide comprehensive engineering and contract research services to ensure groundbreaking ideas become reality. Our approach helps innovators de-risk designs, accelerate development timelines, and navigate regulatory requirements with confidence.

Idea to Concept design

We transform medical insights into early-stage design concepts that visually and functionally demonstrate how an innovation could be developed and applied in real-world healthcare settings. This process includes identifying clinical needs, exploring solution pathways, and creating initial visualizations and functional outlines that lay the foundation for detailed engineering and development.

Design & Optimization

We advance early-stage concepts into detailed, optimized designs through 3D CAD modeling, engineering drawings, and computational analysis—verifying performance with patient-specific anatomy and supporting intellectual property development. This phase also includes iterative refinement and validation of transcatheter and surgical heart valve designs to ensure clinical feasibility and manufacturability.

Computational modeling & simulation

We use advanced computational modeling and simulation to evaluate device performance and patient-specific outcomes in a virtual environment. This includes image-based cardiac and device modeling, hemodynamic simulations, intraventricular fluid dynamics and vortex analysis, valve dynamics analysis, pressure-volume loop modeling, and in silico testing tailored to individual patient anatomies.

Device prototyping

We translate digital designs into tangible prototypes using advanced fabrication techniques that support rapid iteration and functional testing. High-resolution 3D printing, silicone molding for soft-tissue analogs, and precision machining for structural components are employed to create realistic, testable models that closely replicate final device behaviour.

Ex vivo & in vitro testing

We evaluate device performance in controlled laboratory environments using ex vivo and in vitro cardiac simulators that replicate physiological conditions. Techniques such as particle image velocimetry, Doppler echocardiography, and cardiac catheterization are used to assess flow dynamics, valve function, and overall device behavior under realistic conditions.

Regulatory support & virtual trials

We support regulatory readiness by documenting device performance and effectiveness through rigorous testing and analysis. This includes conducting virtual clinical trials in simulated patient cohorts and compiling evidence from ex vivo, in vitro, and computational studies to strengthen regulatory submissions.

Benefits of Partnering with DIAGNICS

Gain a Trusted Engineering Partner with 20+ Years of experience

With over 20 years of specialized experience in hardware and software development, cardiovascular engineering, and verification and validation, our team offers comprehensive, end-to-end support. We act as your single point of contact for all your engineering and manufacturing needs, streamlining the development process and eliminating the complexity of managing multiple vendors. Our expertise guides your innovation from a clinical idea to a life-saving solution, ensuring a seamless and efficient journey to commercialization.

Accelerate
Time-to-Market:

Bring your cardiovascular device from concept to clinical reality faster than ever. Our integrated approach combines advanced computational modeling, rapid prototyping, in vitro and ex vivo experimentation, and virtual trials to streamline every stage of development. By simulating performance under diverse physiological conditions and validating designs early, we minimize costly iterations and reduce regulatory hurdles. This means fewer delays, lower development costs, and a clear path to market, without compromising safety or efficacy.

From in silico simulation to ex vivo hemodynamic testing
Validated Virtually, Proven Physically

De-Risk the Development Process:

Our advanced tomographic time-resolved four-camera particle image velocimetry enables unprecedented flow and device investigations. The rigorous combination of this advanced method with our in silico, in vitro and ex vivo testing identifies potential design flaws early, saving you significant time and cost associated with late-stage changes.

Strengthen Regulatory Submissions:

Our advanced patient-specific in vitro cardiac simulator, combined with Doppler echocardiography, enables highly precise assessment of both hemodynamic and hydrodynamic performance of devices. We provide extensive, data-rich reports and virtual trial evidence to build a robust and compelling case for regulatory readiness, increasing the likelihood of first-pass approval.
Engineering Success From the Smallest Details

At Diagnics, we recognize that a device’s long‑term performance is determined by its micro‑scale features. Every material choice, surface characteristic, and structural nuance is examined with scientific rigor to ensure nothing undermines safety or reliability.

Optimize Device Performance:

Accelerate Device Innovation with Virtual Testing

Cut development time and costs by simulating designs before building physical prototypes.

Predict Performance Across Diverse Patient Conditions

Ensure your device works safely and effectively for a wide range of anatomies and physiological scenarios.

Reduce Risk with Advanced Computational Modeling

Validate your design virtually to meet the highest standards of safety and efficacy.

Reduce Costly Prototypes and Animal Testing

Leverage simulation to minimize physical trials and streamline regulatory compliance.

Refine Designs Faster with Patient-Specific Analysis

Personalized modeling helps you optimize performance for real-world applications.

Achieve Confidence Before the First Prototype

Validate and iterate virtually to guarantee reliability and effectiveness from the start.

Connecting Breakthroughs to
Real-World Care

Seamlessly Bridge Research and Clinical Practice:

Our advanced ultrasound and echocardiography capabilities enable us to connect laboratory-measured data directly to real-world clinical scenarios. This is supported by our advanced patient-specific in vitro and ex vivo cardiac simulators, combined with Doppler echocardiography, which enable a highly precise assessment of the hemodynamic and hydrodynamic performance of devices. This ensures your device is optimized for fast-tracking to clinical use and effectiveness.

We believe a life-saving device must be be intuitive and reliable in the hands of the medical professionals who use it. Our design process seamlessly integrates with clinical feedback to optimize for usability, ergonomics, and seamless integration into surgical workflows. We ensure your device is not only technically superior but also practical, reducing surgical complexity and boosting confidence for the clinician. This holistic approach bridges the gap between the lab and the operating room, delivering a solution that is both highly functional and easy to deploy.

Extensive actionable deliverables

DIAGNICS provides its clients with extensive reports that contain data with comprehensive interpretation of findings and recommendations depending on the stage of development or regulatory approval.

Do you have an innovative cardiovascular device idea?

Our engineering team—specialized in the design, research, and development of cardiovascular devices—offers comprehensive, end-to-end support to companies, clinical teams, and individual innovators. From conceptualization to bedside application, we guide you through every stage of development and commercialization, transforming your vision into a tangible, life-saving solution.

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