• 29 Jun 2025

• By admin

• BLOG

Comparing Global vs. Indian Needs in Cardiac Device Development

Table Of Contents 

1. Burden of Disease: Volume vs. Complexity
2. Affordability vs. Sophistication
3. Infrastructure and Deployment Environment
4. Regulatory Pathways and Speed to Market
5. User-Centric Design: Surgeon Preferences and Training Gaps
6. Final Thoughts

As cardiovascular disease (CVD) continues to be the leading cause of death worldwide, the demand for advanced, effective, and affordable cardiac devices—like stents and catheters—has never been higher. However, while the end goal is universal—saving lives—the needs and priorities for cardiac device development vary significantly between global and Indian markets.

To build devices that truly serve the population, manufacturers must consider these regional differences across clinical, economic, infrastructural, and regulatory dimensions.

Here’s how cardiac device development diverges across global and Indian contexts—and what it means for the future of MedTech innovation.

1. Burden of Disease: Volume vs. Complexity

Globally, cardiac diseases account for nearly 18 million deaths annually. In India alone, CVDs are responsible for 28% of all deaths and are increasingly affecting younger populations—often under the age of 50.

• Global markets (e.g., the US, EU, Japan) tend to focus on complex cardiac conditions like heart failure, congenital defects, or arrhythmias that require advanced interventions like ventricular assist devices or 3D-mapped ablation tools.
• India, however, is dealing with high volume, early-onset, lifestyle-driven CVDs such as coronary artery disease (CAD) in low- and middle-income segments, which demands cost-effective, scalable solutions.

2. Affordability vs. Sophistication

In developed countries, device innovation is heavily driven by sophisticated R&D and advanced hospital infrastructure, where cost is often covered by robust insurance systems or government-funded healthcare.

In India:

• Over 65% of healthcare expenses are out-of-pocket.
• The average coronary stent price in India was capped at around (~$360) by the National Pharmaceutical Pricing Authority (NPPA), compared to $1,000–$3,000 per stent in the U.S.

Thus, cardiac devices in India must balance high performance with strict cost controls—a challenge that necessitates frugal engineering and innovative materials without compromising efficacy.

3. Infrastructure and Deployment Environment

In countries like Germany or the U.S., cardiac devices are deployed in highly equipped, tech-integrated cath labs with real-time imaging, robotic support, and trained specialists.

In India, especially in tier 2/3 cities:

• Basic cardiac infrastructure is often limited.
• Devices must be designed for rugged, variable conditions, with simplified interfaces for easier training and minimal dependency on high-end equipment.

Examples include:

• Pre-loaded balloon catheters with simplified deployment mechanisms
• Color-coded tubing for faster, error-free connections
• Wireless, battery-efficient monitoring tools that can operate in semi-urban or mobile units

4. Regulatory Pathways and Speed to Market

Global manufacturers often face longer, more expensive regulatory approval timelines via agencies like the FDA or European Medicines Agency, but also enjoy large, well-funded markets upon approval.

In India: India has streamlined device classification, introduced Unified Licensing, and is promoting faster domestic approvals, especially under the Make in India and PLI schemes.

This allows Indian manufacturers to innovate, test, and deploy faster, especially for devices catering to regional needs.

5. User-Centric Design: Surgeon Preferences and Training Gaps

Globally, device developers often work closely with interventional cardiologists who are highly trained, sub-specialized, and tech-savvy.

In India:

• There’s a wider variance in experience levels.
• Devices need to have low learning curves, offer ergonomic comfort, and support visual, multilingual cues for better usability and faster adoption.

Human-centered design is not a luxury—it’s a necessity.

Final Thoughts

Global cardiac device markets are driven by advanced technology, high complexity, and insurance-backed affordability. India’s market, in contrast, demands scalable, affordable, easy-to-use innovations tailored for younger patients, infrastructure gaps, and price-sensitive segments.

The opportunity lies not in choosing one path over the other—but in blending both. Cardiac device developers who can merge engineering excellence with contextual empathy—especially in emerging markets like India—are poised to lead the next wave of global MedTech transformation.