The Problem: After FDA clearance, most small medical device companies have challenging options when considering sales in low- and middle-income countries. For each country, they must build up an internal team to apply for regulatory clearance, establish an in-country ‘daughter company’, build an in-country team, import devices, gather new customers, … all while meeting the needs of other (often more profitable) markets like the USA. This is an extremely time-intensive, costly approach – especially for the small companies who drive much of the innovation in the medical device space. The result is that few medical devices reach international countries where they are most needed.
Our Approach: As the world’s first not-for-profit medical device distributor, Worldwide Initiative for Device Equity (WIDE) stands out through its innovative approach to bridging the gap between cutting-edge medical devices and underserved markets in low and middle-income countries. Unlike traditional nonprofits or distributors, WIDE focuses on streamlining the regulatory process for small medical device companies, enabling them to expand into new markets with unique capital efficiently. Our unique “bundled” approach to regulatory clearance across multiple countries reduces costs and complexity for innovators. We go beyond simple distribution by providing comprehensive support, including ongoing training for healthcare providers, maintenance services, and tailored market entry strategies. By combining regulatory expertise, market intelligence, and a commitment to sustainable healthcare solutions, WIDE creates a powerful ecosystem that benefits device manufacturers, healthcare providers, and patients alike. Our model not only facilitates access to life-saving technologies but also ensures their effective implementation and long-term impact in resource-constrained settings.
Join our team of healthcare entrepreneurs, clinicians, patients, and industry veterans.
widehealthaccess.org 