22 Jan 2024

Modular Medical submits next-gen insulin pump for FDA clearance

Modular Medical has submitted its latest insulin pump, the MODD1, for FDA 510(k) clearance, signalling a move to advance glycemic control through innovative technology. Developed by the San Diego-based company, led by founder Paul DiPerna, who previously founded Tandem Diabetes Care, the MODD1 incorporates new microfluidics technology to facilitate cost-effective insulin pumping. The pump boasts an intuitive design, a 300 units/3mL reservoir, and the convenience of monitoring via a cell phone without the need for an external controller. Modular Medical is optimistic that the simplified design will attract individuals who have been hesitant to adopt insulin pumps due to perceived complexity and high costs.


In a strategic move, Modular Medical plans to address both FDA inquiries and prepare for marketing approval in the UK during the quarter ending June 30, 2024. Simultaneously, the company aims to transition its pilot production line to a manufacturing partner in preparation for the commercial launch of the MODD1. CEO Jeb Besser emphasises the potential impact of pump adoption on reducing healthcare costs and improving long-term patient outcomes. Besser identifies common barriers to pump adoption as the "three-Cs": complexity, cumbersomeness, and cost, and underscores the MODD1's differentiation through a user-friendly design, easy-to-learn interface, and scalable manufacturing.


The MODD1's two-part patch pump design and affordability focus are positioned to address challenges faced by those requiring daily insulin, offering a simpler and more cost-effective alternative to current solutions. Modular Medical's approach aims to overcome the perceived hurdles of insulin pump adoption, potentially expanding the accessibility of this technology for diabetes management.


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