The global cardiovascular devices market is on the rise. Analysts estimate it will grow from about USD 84.8 billion in 2023 to USD 140 billion by 2033, driven by innovation across diagnostics, therapies, and advanced implantable systems. Demand for devices that extend and improve life has never been stronger, and that growth brings both opportunity and pressure.
LUDO hardware running CHEF embedded software, shown interfacing with a CHAP-based test application on a laptop
As investment in cardiovascular innovation increases, so do expectations for speed, reliability, and regulatory confidence. But while funding and competition are accelerating, the journey from idea to first-in-human remains slow, expensive, and carries considerable risk.
For most teams, the development challenge starts early. They seek to minimise budget expenditure early by building from scratch or relying on generic off-the-shelf tools. Both options appear logical, but neither is fully capable of meeting the unique demands of cardiac systems or suited to the long-term development program needs. The way forward lies in proven, reusable MCS/Critical Systems-specific frameworks designed for safety-critical medical innovation.
The development challenge
Creating a Class III cardiac device is one of the most challenging technical and regulatory tasks in engineering. Each component, and each line of code, must perform perfectly every second of every day, driving development teams to meet demanding standards for design rigor, verification, traceability and cybersecurity.
Developing from scratch means repeating years of work that others may have already solved. Off-the-shelf tools can speed early prototyping but rarely meet Class III safety or documentation requirements. These approaches can ultimately waste time and budget, add risk, and too often leave promising devices stranded between concept and clinic.
To move faster without compromising safety, developers need a foundation that is already tested, already compliant, fully featured for the MCS domain, and ready to adapt.
In cardiac device development, every second counts, both in the lab and in the body. Our frameworks are designed to give teams a head start, with safety-critical foundations that are proven, compliant, and ready to evolve. It’s about enabling innovation without compromising reliability.
Dean Troake, Hydrix Principal Software Engineer
A better foundation for innovation
At Hydrix, we have spent more than a decade developing and refining a suite of frameworks that address this exact challenge. These platforms give engineering teams a trusted foundation on which to build complex systems while allowing flexibility for new designs and ideas.
They are not constrained toolkits or closed products. They are field-proven environments that evolve with every project, built on the lessons of real programs and refined through collaboration with some of the world’s leading cardiac innovators.
CHEF – Common Hydrix Embedded Framework
A modern embedded software foundation written in C++17. It includes verified libraries, communication layers, and hardware drivers for a wide range of microcontrollers. When a new project begins, requirements are mapped against CHEF’s existing capabilities. Reusable components are incorporated directly, and any new development is folded back into the core framework, strengthening it for future use.
CHAP – Common Hydrix Application Platform
A Windows-based environment that connects to CHEF-driven devices. It supports rapid data streaming, control, and testing. CHAP simplifies integration, allowing teams to build both engineering and user-facing applications quickly and consistently.
LUDO
LUDO brings CHEF and CHAP together on a physical testbed for mechanical circulatory support systems. It allows teams to validate hardware, firmware, and control strategies early, reducing integration risk and saving months of development effort.
Together, these frameworks create a flexible, modular platform that accelerates progress while maintaining the highest standards of safety and reliability.
The system modelling and simulation schematics below demonstrate how Ludo replicates system and motor dynamics in a virtual environment. This model-based design approach allows engineers to develop and validate control algorithms independently of physical hardware, which is particularly valuable when hardware is unavailable, incomplete, or presents excessive risk during early development stages.
Once the algorithms are validated, MATLAB automatically generates C++ code from the simulation models. This code is then integrated into LUDO’s firmware.
Simulation continues to be valuable throughout development. It allows innovators to safely test failure scenarios, ensuring the system responds correctly without risking hardware, animals, or patients.
Inverter and Motor Subsystem
This subsystem models the electrical and mechanical interaction between the inverter control signals and the motor, forming the foundation for analysing performance and efficiency in the simulated environment.
Top-Level LUDO Simulation Model
The complete system simulation harness integrates all control, inverter, and motor subsystems, allowing engineers to develop, validate, and refine algorithms before hardware integration.
Physical System Model
This layer represents the detailed dynamics of the motor and inverter components, enabling high-fidelity simulation of the physical system’s response within the LUDO platform.
Results in practice
These frameworks are proven in the field. They have helped global cardiac programs reach human trials faster and with fewer technical hurdles.
In one recent example, a development team using CHEF and CHAP reduced software timelines by nearly half compared with a full greenfield build. The frameworks also simplified documentation for IEC 62304 compliance, helping the program stay audit-ready from day one. The result was less time spent on administration and more time focused on innovation.
Compliance and security built in
Cybersecurity and regulatory alignment can no longer be treated as late-stage steps. In connected medical systems, they must be designed in from the start.
Hydrix frameworks embed security protocols and regulatory structure at the architectural level, reducing the documentation burden and supporting regulatory submissions. This gives device developers assurance that their systems are built on a secure and compliant foundation from the start.
Why this matters
The next decade of cardiac innovation will reward teams that can move quickly, adapt easily, and maintain the highest levels of quality. Proven frameworks give developers that ability. They reduce risk, preserve flexibility, and bring clinical reality closer, and faster.
For medical innovators, this means less time reinventing the foundations and more time solving the challenges that truly define the future of heart technology.
The road ahead
The growth in the cardiovascular devices market tells a clear story: demand is growing, and expectations are rising with it. Meeting those expectations requires smarter products, and smarter ways to develop them.
Hydrix platforms are helping set that standard, proving that speed and safety can work hand in hand. In a field where precision and trust can mean the difference between life and loss, that confidence defines true innovation.
To discuss how Hydrix platforms can accelerate your cardiac innovation program, contact us to schedule a time with our team.
