Wearable drug delivery systems, also known as on-body systems, are designed to accurately deliver the right dose of a drug to the right place at the right time, via a pump and cannula or needle, or a drug delivery patch. These can be particularly useful for chronic diseases needing regular treatment in the long-term, such as diabetes, ocular disorders, cancer, and cardiovascular disease, or for a condition that needs a longer bolus delivery, such as wound healing. They can deliver a large volume over a long period, and/or specific doses at specific times.
Wearable delivery systems range from smart patches to pumps that are worn on a strap or adhere to the skin, and include microelectromechanical systems (MEMS). These are miniaturised integrated devices that combine electrical and mechanical components, and may be powered or non-powered. Wearable systems can incorporate sensors or link to smartphones. [1-6]
A wearable drug delivery device will include some or all of the following components: [3, 7]
●A method to wear the device or attach it to the body
●A route for the drug (channels or tubes)
●A pump
●A drug reservoir
●A needle insertion system
●A needle or soft cannula
●A power source
●Sensors
●Electronics.
The connected drug delivery devices market size is growing - it is expected to be worth $1.18 billion in 2024, rising to $5.30 billion in 2029 (CAGR of 35.13%). [8]
Benefits and challenges
Some drugs, including biologics, have to be delivered as subcutaneous, intramuscular or intravenous injection. [9] Intravenous drug delivery requires patients to attend a hospital or clinic, which can be inconvenient and raises the costs because of requirements for staff and clinic space. While self-injection devices allow patients to administer their own drugs at home, patients with poor manual dexterity or who have issues with anxiety can struggle with self-injection. Anxiety can also increase the perception of pain. These factors have an impact on adherence, and poor adherence is associated with up to 69% of routine hospitalisations in the US. In addition, the manufacturing, shipping and disposal of single use injection devices has environmental implications. [2, 10]
A wearable drug delivery system makes treatment easier and more convenient for the patient, reduces the need for clinic or hospital visits, takes away the anxiety involved in self-injection, improves adherence and reduces errors and waste. Closed loop drug delivery systems allow doses to be tailored to the patient's needs. As well as supporting the systemic delivery of biologics, wearables can deliver drugs locally, for example to the eye, reducing the concerns associated with systemic toxicity and allowing the drug to be delivered across biological barriers. [6, 7, 11]
Companies need to be aware of certain issues when developing and manufacturing wearable delivery systems. The skin underneath a wearable device, particularly one that sticks to the skin, can become irritated by sweat or ingredients in adhesives, or as a result of contact with the metallic or synthetic materials making up the device. [1] Also, the power sources can generate heat, causing discomfort. [5]
Anything that is worn on or close to the body for an extended period of time must be safe. Manufacturers need to adhere to safety, regulatory and certification guidelines in order to get their products onto the market. Requirements will vary according to location but may include: [6, 7, 12]
●Dosing and dose delivery profiles
●Adhesive properties (for patch-based systems)
●Needle/cannula insertion distance
●Behaviour under environmental conditions
●Electrical safety testing
●Battery safety testing
●Specific absorption rate (SAR) testing
●Biocompatibility
●Data security, both in the device and in the cloud
●Electromagnetic compatibility (EMC)
●Usability
●Wireless device testing.
Closed loop systems
Closed loop drug delivery systems combine diagnostics, real-time mon...
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