The key product requirements include:

1. Biocompatibility: The valve must be made of materials that are compatible with the human body to prevent adverse reactions, such as inflammation, rejection, or infection.
2. Durability: The valve should be highly durable and able to withstand the constant mechanical stress of opening and closing hundreds of thousands of times per day without degrading. Mechanical valves should ideally last a lifetime, while bioprosthetic valves should have a lifespan of at least 10-15 years.
3. Hemodynamics: The valve must ensure smooth blood flow with minimal resistance or turbulence, mimicking the natural function of heart valves. It should prevent blood leakage (regurgitation) and minimize pressure gradients across the valve.
4. Thrombogenicity: The design should minimize the risk of blood clot formation (thrombosis), particularly in mechanical valves, to reduce the need for lifelong anticoagulation therapy.
5. Size Variety: The valve should come in multiple sizes to accommodate different patient anatomies, as heart valves need to be precisely matched to ensure optimal function and minimize complications.
6. Ease of Implantation: The valve must be designed to allow for straightforward implantation, whether through open-heart surgery or minimally invasive techniques such as transcatheter aortic valve replacement (TAVR).
7. Long-Term Reliability: The valve should demonstrate consistent long-term performance without deterioration, calcification, or structural failure. Both mechanical and bioprosthetic valves should be tested rigorously for reliability over time.
8. Cost-Effectiveness: The valve must be affordable for a broad range of healthcare systems, particularly in low-resource settings. This includes not only the cost of the valve itself but also the cost of associated surgeries and follow-up care.
9. Regulatory Compliance: The valve must meet all relevant regulatory standards, such as ISO 5840 (Cardiovascular implants – Cardiac valve prostheses) and other region-specific requirements, ensuring patient safety and device efficiency.
10. Patient Comfort and Adaptability: The design should prioritize the comfort of the patient during and after surgery, ensuring a smooth recovery process.