TESTING ON BODY DELIVERY SYSTEMS
Trends in wearable technology follow those of the broader biomedical and electronics industries — devices are getting smaller, smarter, and easier to use. These wearable devices range from on-body drug delivery systems for diabetes and cancer treatment to electrical nerve stimulation patches or sensors t monitor vitals. All treatments increase patient autonomy and are rapidly increasing in popularity in light of higher incidence rates of chronic disease and an aging population. As this trend continues, manufacturers are working to develop robust testing methods to mechanically evaluate all aspects of these devices and ensure that they are performing as expected. For more information on other biomedical applications, visit our Biomedical Industry page.
CHALLENGES OF TESTING WEARABLES
On Body Delivery Systems (OBDS) represent a quickly growing segment of the injectable drug delivery device market. These devices offer unique advantages over more traditional delivery methods. One of their most differentiating features is their ability to support significantly larger volumes of medication than devices like prefilled syringes and autoinjectors, with some OBDS reaching as much as 10 mL of deliverable volume. This is a direct result of the explosion of large molecule biologics, whose efficacy requires higher concentrations and subsequently higher volume in solution. OBDS also simplify patient adherence, as the entire delivery process occurs automatically once the device is placed and activated. In addition, their form factor allows for easier integration of IOT functionality, helping create companion applications to track and monitor patient progress.
Though these devices are just recently starting to be commercialized on drug platforms, the testing requirements are becoming more standardized. ISO 11608-6 was released in 2022, which is the first official standard that provides guidance around evaluating the functionality of OBDS. At this point, the testing specifications are still purposefully broad to apply to a range of devices with different form factors. The dose accuracy, injection time, delivery profile, and needle extension are relatively agnostic of the device, requiring additional testing system capabilities such as an integrated scale and camera. Testing around the properties of the medical grade adhesives is subject to the most uncertainty, with references to a wide range of existing adhesive test standards.
Challenge #2 - Capturing Extended Dose Profiles
Autoinjectors typically dispense their entire volume of fluid at a consistent rate in the range of 1 to 10 seconds. OBDS will work on a longer time scale to address patient comfort associated with large volume injections. In some cases, the delivery profile will vary throughout the duration of the injection to optimize drug absorption. The use of an integrated scale measurement in Bluehill Universal allows for proper visualization representation of the dose profile , aligning with the guidance of the ISO 11608-6 standard [Annex B].