The cardiology sector is evolving rapidly in response to behavioral, metabolic, environmental, and genetic factors. The global cardiovascular device market, valued at US $53.67 billion in 2024, is expected to grow at a compound annual growth rate of 8.4% through 2030. This expansion offers significant opportunities for medical device original equipment manufacturers (OEMs), alongside an array of technical and operational challenges that must be addressed to deliver new advancements in cardiovascular treatment.

Success depends on integrated strategies that bring together robust design, advanced engineering, and effective manufacturing while keeping compliance top of mind. This article reviews the primary challenges faced by cardiology device manufacturers and outlines practical solutions for delivering innovative therapies safely and efficiently.

The Race to Miniaturization in Catheter-Based Therapies

A prominent trend in cardiovascular care is the advancement of smaller, less invasive transcatheter-based interventions that reach previously inaccessible areas of the body. These innovations integrate multiple functionalities into a single system—combining diverse energy sources with advanced sensing and mapping capabilities. This has opened new treatment options for patients who may not be candidates for traditional surgery and has spurred developments in several areas.

• Electrophysiology (EP) Ablation: The introduction of pulsed field ablation (PFA) and improved mapping systems enhances precision and safety in managing arrhythmias.
• Transcatheter Valve Replacement/Repair (TAVR/TMVR): Continued refinement of valves and delivery systems is expanding access for a wider range of patients.
• Vascular Grafts: Innovations in stent grafts have improved flexibility and conformability for tailored aneurysm treatment.

These therapies impose specific technical demands on device development. Catheters must effectively navigate the vascular system, requiring a balance of flexibility and pushability. Important functional specifications include low crossing force, reliable hemostasis to limit bleeding, and compatibility with a variety of device sizes. In particular, hemostasis relies on advanced valve and seal designs—such as multi-layer membranes and precisely engineered geometries—that maintain performance and safety.

The Decisive Role of Material Selection

Device performance and longevity are closely linked to material selection and processing. For catheter-based and implantable devices, certain material attributes are essential. Elastomers used must be biocompatible, resistant to wear and fatigue, and able to maintain function through repeated use. Low-friction surfaces allow for smooth articulation, and reliable sterilization properties preserve essential components subjected to ethylene oxide or gamma radiation.

Another key consideration is the tendency of elastomers to reseal after being slit for valve use. This property requires careful attention to formulation and processing to avoid compromising reliability or functionality. Understanding material behavior early in the design process helps minimize redesign effort and supports manufacturing consistency.

Achieving Manufacturing Excellence at Scale

The transition from design to reliable large-scale production demands attention to detail at every step. Accurate tooling alignment prevents unwanted parting line shifts, preserving component tolerances and device integrity. Controlled molding processes promote repeatability and high quality throughout the product lifecycle.

For components with intricate requirements, such as hemostasis valves, precise control over features like slit location and depth is essential. Automated inspection systems enable thorough evaluation of these characteristics, supporting consistent quality.

Supply chain management presents operational challenges, particularly in securing specialized components and materials. Developing a resilient and well-structured supply chain is important for maintaining manufacturing flow and ensuring access to high-quality inputs.

Advanced Extrusion Drives Development

The creation of some cardiovascular devices depends on advanced extrusion techniques. Modern extrusion enables the formation of complex, multifunctional components, supporting ongoing trends in device miniaturization and increased functionality.

Contract design manufacturers (CDMs) can extrude multi-lumen tubing with high precision, allowing for the inclusion of multiple wires or channels. Technologies such as variable cross-section extrusion eliminate the need for additional bonding steps, resulting in stronger and more hygienic products. Additional extrusion capabilities include:

• Thin-walled balloon tubing produced from flexible silicones
• Kink-resistant tubing, which utilizes embedded filaments for improved flexibility
• Wire and cable jacketing using single or multiple silicone layers
• Dip coating for seamless sensor encapsulation or uniform device surfaces
• Formed extrusions for specialized shapes suited to anatomical requirements

Further enhancements (e.g., colored striping, reinforcement braiding, and co-extrusions) create additional opportunities for device development. These techniques enable engineers to respond to evolving medical needs and regulatory expectations.

Partnership as a Strategy: The Power of Early Collaboration

Successfully addressing the complexities of cardiology device development typically involves early engagement with a CDM partner that can provide expertise in material selection, design for manufacturability (DfM), and process validation.

For example, an OEM was developing a left ventricular assist device (LVAD)—an FDA Class III implant designed for patients awaiting heart transplants. When scaling production for complex subassemblies became a challenge, Trelleborg Medical Solutions offered specialized knowledge in materials, insert molding of metals with silicone, and extrusion for critical driveline components. Through open communication and a systematic quality management approach, the client received efficient design refinement, process scalability, and a scheduled product launch. Trelleborg also ensured that the device followed regulatory standards for safety and effectiveness, adhering to requirements from organizations such as the FDA and EU MDR from early development through post-market surveillance.

The Future of Cardiovascular Innovation

Cardiology is likely to continue advancing toward smaller, more integrated device designs with bioresorbable materials, offering benefits in risk reduction and long-term safety. AI is expected to drive further improvements in diagnostics, patient monitoring, and manufacturing efficiency. Medical device companies are positioned to deliver meaningful improvements in cardiovascular care by combining regulatory awareness with technical innovation and reliable manufacturing. Early and ongoing collaboration with specialized component partners enhances the ability to address complexity and bring new therapies to market quickly and efficiently.

Don Bonitati spearheads the growth and expansion of Trelleborg’s medical device capabilities in the U.S., E.U., and APAC. He also oversees the business area’s capabilities for the advancement of active pharmaceutical ingredients within combination products. Bonitati is responsible for evaluating financial performance, monitoring trends, and analyzing market share, including target markets and product positioning. With over 20 years of experience in the healthcare and medical industry, Bonitati has led technical and operations teams in new product development and commercial execution. He has successfully launched multiple Class II and III products in the cardiac rhythm management, neuroscience, and electrophysiology sectors.