Do it yourself — vital design considerations for self-administrative delivery devices

The trend of self-administered therapies is expected to grow, according to research, due to, in part, the increased incidences of chronic conditions and the development of biologics to treat these indications. However, self-administrative devices need to be safe, intuitive and reliable with a design that supports patient adherence being vital. Here, SHL detail some important design considerations.

The growing emphasis on self-administered therapies has given rise to injectable drug delivery devices such as auto injectors and pen injectors. According to research, this trend is expected to grow at an annual rate of 7.6% until 2026.¹

Important factors contributing to this growth are the increased incidence of a number of chronic conditions as well as the rapid development of biologic drugs to treat these indications, such as diabetes, autoimmune diseases and cancer. With self-administered auto injectors, patients can avoid expensive and time consuming visits to clinics and hospitals, and deliver the treatment themselves in the comfort of their own homes.

Nevertheless, as injections are administered without the supervision of healthcare professionals, designing a safe, intuitive and reliable drug delivery device that supports patient adherence is at the forefront of the development of any self-administered system.

Putting usability first

The purpose of any medical device is to support treatment outcome. Research has shown that reducing fear and anxiety can help improve patient adherence,² as such, comfort and usability are fundamental to self-administered drug delivery. To meet this end, self-injection devices must be intuitive, safe and reliable so as to meet the unique challenges of every single disease. For example, patients with rheumatoid arthritis suffer from dexterity issues and often have difficulty gripping and holding onto objects. SHL’s auto injectors are designed taking this into consideration, improving usability with features such as enhancing the device’s grip, including a cap that is easier to remove, as well as incorporating simple and intuitive two-step or three-step operations.

A well-designed device, however, is not just about how one grips and holds a device; it is also about how the device is understood and accepted by the patient. Auto injectors should also include proper visual, audio and tactile feedbacks to help users gain a better understanding of what is going on both outside and inside the injector. These feedback mechanisms help ensure the successful delivery of treatment, and also give the patients more confidence when self-administering the injection.

Prescribing less frequent injections

Today, with the development of the new generation of biologic drugs, there is a growing trend in the pharmaceutical industry to further optimise patient comfort with formulations that require less frequent dosing. Nevertheless, when formulating a biologic drug for this purpose, developers often face challenges with high viscosity, which may also lead to higher volumes.

The question, therefore, is what position will self-treatment and auto injectors have on the development of these new drugs, and how will the method of delivery further benefit the patient?

The answer to the latter is clear. Using an auto injector, patients no longer need to be confined to hospital treatments; with less frequent injections, they will have even more freedom to lead normal lives while living with a chronic disease. However, as first generation auto injectors were developed for smaller volumes and lower viscosities, an auto injector capable of delivering high viscous/high volume formulations requires a more advanced technology. With this new technology in place, pharmaceutical companies can save time and costs reformulating their biologics and bring their products to market in a timely manner.

Building upon more than 10 years of experience with auto injectors for highly viscous drugs, SHL has developed the Rotaject, a constant force technology that makes the delivery of formulations with viscosities of up to several hundred centipoise possible within seconds. To meet the request for a wider range of volumes, the technology is also compatible with disposable auto injectors using either a 1.0 mL or a larger 2.25 mL syringe.

Adherence and beyond

The challenge that comes with self-administering less frequently leads us back to adherence - helping patients administer their injections in a timely manner, and also ensuring that the injections are conducted correctly.

A study by Minnock shows that a simple add-on device with reminders about the time since last injection can significantly improve health outcomes for patients with diabetes.³ In drug delivery, connected devices can support adherence through communication with a smartphone or a cloud-based system. At a basic level, connected systems can track injection records, send reminders for the next injection and provide additional services, such as in-app training, for patient support. Moreover, with the collected data, larger opportunities are opened-up for not only the patients, but also for healthcare professionals, payers, pharmaceutical companies and other stakeholders.

With an increasing number of biologic drugs being developed and the popularity of auto injectors continuing to grow, pharmaceutical companies have begun seeking differentiation for their drug delivery devices. While connected solutions can serve as a means to this end, to provide a truly valuable experience for patient and other stakeholders, drug delivery systems need to be developed with a weighted approach that is aimed at improving patient adherence and safeguarding treatment outcome. With near three decades of experience developing advanced drug delivery injection devices, SHL uses multilateral approaches to develop solutions that bring value for both patients and stakeholders alike.

References:

1. Global Autoinjectors Market 2016–2026. Roots Analysis, 2016.
2. Miller, T.A., Patient Educ. Couns., 2016;99:1079–1086.
3. Examining the Effects of an Insulin pen compliance device on HbA1C and lifestyle on Individuals living with Type 1 Diabetes Mellitus, Minnock, D., O’Donnell, S., Doyle, G., Canavan, R., O’Shea, D., Conference Paper https://www.researchgate.net/publication/313800507_Examining_the_Effects_of_an_Insulin_pen_compliance_device_on_HbA1C_and_lifestyle_in_Individuals_living_with_Type_1_Diabetes_Mellitus