Lancet with dissolvable blade and biodegradable base

Single-use disposable lancets are indispensable components of a self-monitoring of blood glucose (SMBG) system. However, tens of billions of lancets are disposed of unsafely every year, contributing to sharps injuries among caregivers, household members, sanitation workers, and community members. Despite educational and safety awareness campaigns, the inconvenience and expense make improper disposal an ongoing problem around the world. Used lancets also contribute some 12,000 metric tons of single-use plastic to the environment annually. Hemingway Designs is developing an innovative “green lancet” that incorporates novel use of materials to solve both the sharps problem and the plastic waste problem. The green lancet incorporates a needle made of magnesium alloy (MgA). The base and cap is made of polyhydroxyalkanoate (PHA). MgAs are lightweight, strong, biocompatible metals dissolvable in household white vinegar. After using the green lancet, it is placed in a small amount of vinegar which dissolves the needle in minutes. The PHA base is retrieved and along with cap is home composted or placed in the trash where it will readily biodegrade in a landfill. The green lancet meets the inclusion criteria for the NIDDK’s SBIR Research Topic 1.E. “Technologies that may promote and facilitate adherence/compliance by users of diabetes monitoring and control devices.” The green lancet was accepted into the FDA’s Safer Technology Program (STeP) on August 23, 2023. The specific aims of the Phase 1 SBIR are: SA1: Establish the feasibility of fabricating lancet needles from MgA. Candidate MgAs will be evaluated for dimensionality, mechanical properties, machinability, corrosion, and biocompatibility. Nanostructuring techniques to improve mechanical properties and machinability will be evaluated. The required polishing and tip grinding processes will be characterized. SA2: Establish the feasibility of constructing lancet bases and caps from PHA or other biodegradable bioplastic. Candidate PHA formulations will be evaluated for moldability. Strength and flexibility will be evaluated following gamma sterilization and preconditioning. SA3: Verify the performance of the materials in a prototype lancet. The prototype lancet performance will be verified in nonclinical simulated use testing, dissolution testing, and compostability testing. A successful outcome of the proposal will be a product design specification that will initiate a medical device product development effort following ISO 13485 in preparation for a 510(k) submission to the FDA. The product development effort, including nonclinical and clinical testing will be the subject of a future Phase II submission.