Project Description:

Diabetes management becomes challenging with age, especially for the more than 5 million U.S. adults over 65 who rely on insulin pens for daily care. Current insulin pens require precise twisting, visual clarity, technical understanding, and grip strength. These abilities are often diminished by arthritis, tremors, vision loss, and neuropathy. As a result, users encounter dosing errors, accidental needlesticks, and an increased risk of hypoglycemia, which creates a significant safety concern for aging patients. The All-Smart Pen addresses these challenges by combining ergonomic design with automated guidance to support safer, more intuitive insulin delivery. The device includes a magnified OLED dose window, audible step-by-step prompts (75–90 dBA), and bright hold-indicator LEDs to help users confidently complete every injection. A redesigned silicone-based ergonomic grip increases torque capacity by 120%, reducing the force required during dose dialing. The automated needle attach-and-release mechanism also simplifies needle replacement, a task that often leads to frustration or injury, and has achieved a verified 93% successful application rate in prototype testing. Engineering validation demonstrates that the All-Smart Pen reduces the time from preparation to injection to under 20 seconds while maintaining high clarity, reliability, and repeatability across use scenarios. These improvements directly target the needs of older adults, enabling greater independence, comfort, and safety during insulin therapy. From a commercialization standpoint, the device serves a 7.8-billion-dollar insulin-delivery market that includes a 620-million-dollar segment dedicated to elderly and dexterity-limited users. With an estimated manufacturing cost of 50 dollars per unit and a projected MSRP of approximately 219 dollars, the All-Smart Pen is positioned as an affordable, high-impact solution that fills the gap between traditional insulin pens and costly smart-injection systems. Future development will focus on diabetic user trials, custom PCB and power optimization, and preparation for regulatory assessment through the FDA 510(k) pathway.