{"id":5933,"date":"2022-09-26T10:51:52","date_gmt":"2022-09-26T09:51:52","guid":{"rendered":"https:\/\/www.springboard.pro\/?p=3273"},"modified":"2026-09-15T11:42:51","modified_gmt":"2026-09-15T11:42:51","slug":"wearable-injectors-news-and-trends","status":"publish","type":"blog","link":"https:\/\/www.sanner-group.com\/insights\/blog\/wearable-injectors-news-and-trends\/","title":{"rendered":"Wearable Injectors News and Trends"},"content":{"rendered":"\n
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The on-body delivery system (OBDS)<\/a> market is changing rapidly, and it has become clear that OBDS devices are critical to the delivery of some new drugs in development. The OBDS market is relatively young, which lends itself to exciting innovations and high potential growth rate.\u00a0 This article reviews recent milestones, summarizes the current state of play, and proposes directions for the future.<\/p>\n

Before launching into the details, we need to clarify which OBDSs we are discussing. By far the largest market for wearable injectors is diabetes. However, ambulatory insulin infusion pumps will be considered out of scope of this article because they deserve an article all to themselves. They are focused on one therapy where the flowrate is clinically relevant, and their requirements are covered by IEC-60601-2-24 (if electronic) or ISO 28620 (if non-electronic).<\/p>\n

For this article we shall focus on OBDSs where the flowrate is not clinically relevant (other than avoiding the flowrate being too high which could cause discomfort or leaks), and their requirements are covered by ISO 11608-6:2022. Such OBDSs can be used for a wide and ever-increasing range of indications and drugs, particularly where the relatively high volume, viscosity, or dose timing makes autoinjectors inappropriate.\u00a0 Examples are pegfilgrastim to reduce infections after chemotherapy, evolocumab for reducing cholesterol, drugs for Parkinson\u2019s Disease, and more.<\/p>\n

Recent milestones<\/h2>\n

The first launch of the modern generation of non-insulin OBDSs was Insulet\u2019s Onpro\u00ae for Amgen\u2019s Neulasta\u00ae drug in 2015.[1]\u00a0 This is a modified version of the Omnipod insulin pump and delivers the injection in one bolus approximately 27 hours after the device is filled from a prefilled syringe by a healthcare professional and attached to the patient\u2019s body. Since its launch, over 1 million patients have used the Onpro OBDS to deliver Neulasta.[2]\u00a0 The drive mechanism uses shape memory alloy (\u201cmuscle wire\u201d) to reciprocate a lever arm which rotates a ratchet wheel and leadscrew to push the plunger. The drug container is a custom oval plastic cartridge.<\/p>\n

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West\u2019s SmartDose 3.5 mL was launched in 2016 for Amgen\u2019s Repatha\u00ae and branded \u201cPushtronex\u00ae\u201d.[3] In 2019, scPharmaceuticals (MA, US) announced its intent to go to market with West\u2019s SmartDose\u00ae 10 injector for FUROSCIX\u00ae, a proprietary, subcutaneously delivered furosemide solution for the treatment of worsening heart failure due to congestion[4]. The platform uses an innovative telescopic plunger rod to minimize device size. The primary drug container is a custom cartridge made of cycloolefin polymer.<\/p>\n

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Enable has supported 3 clinical studies using its enFuse\u00ae pump, one of which is published.[5]\u00a0 The enFuse uses a unique approach to drug delivery. The elastomeric technology offers a low, responsive pressure injection that responds to the pressure in the sc tissue and adjusts flow via pressure. Pharmaceutical partners can use their original drug container as the user fills the device just before use, thus inflating an elongated elastomeric drug container. Once on the body and activated, the elastic energy of the drug container expels the drug formulation in \u201cbands\u201d to smooth out the pressure over time. Enable has announced relationships with Lilly, Sanofi, Apellis, Genentech, UCB and CSL Behring[6], and has received USD 215m financing in January 2022.[7]<\/p>\n

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enFuse\u00ae pump<\/em> vial transfer is 1-click by the patient. <\/em><\/p>\n

Ypsomed\u2019s YpsoDose single-use injector is an electromechanical pre-filled and pre-assembled patch device for 10 mL glass cartridges. Needle insertion, injection, end of injection feedback and needle safety steps are all performed automatically. The needle remains hidden at all times and made safe after injection and device removal. Ypsomed is scaling up its manufacturing capability for YpsoDose in Switzerland with first clinical studies starting in 2023.<\/p>\n

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Nemera has completed a formative study on its Symbioze wearable pump and expects to have new prototypes from rapid tooling by the end of 2022. The design has a reusable subassembly containing the motor and electronics, and a disposable subassembly containing the drug container and path. The reusable subassembly checks the identification of the disposable subassembly using NFC before injection. The reusable electronics allows for additional features with minimal impact on cost or the environment, such as Bluetooth connectivity.<\/p>\n

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BD has announced 2 OBDS platforms that are in development:<\/p>\n