As healthcare trends continue to move towards in-home treatments, the need for self-administration and patient-centric delivery devices becomes crucial for patient health management and safety. These trends drive focus in two areas. The industry is working towards developing parenteral drugs including bio-therapeutics therapies and long acting injectables that drive patient compliance. The role of human factor studies in identifying specific patient needs for devices in terms of intuitiveness and ease of use to minimize user errors has changed the landscape for newer delivery technologies and sophisticated delivery devices.
Pharmaceutical companies are developing therapies moving from intravenous to subcutaneous delivery for ease of administration at home. The growth of biologics for various therapeutic treatments continue to rise and drugs are focused more for smaller patient populations and less block-buster drugs. With biologics, the doses are more concentrated, higher dose and require large volume delivery. Long acting injectables and controlled release drugs are being developed with high molecular weight carriers like oil solutions or polymer matrices where solubility of API can be adjusted to control release of therapy. High viscosity and two-phase system drugs like suspensions, gels, and emulsions pose challenging delivery requirements. Delivery devices are needed that enable a range of presentations to be administered for a range of formulation viscosities and delivered volumes, for both subcutaneous and intramuscular administration.
Along with the challenging needs of the formulation, the device design needs to incorporate patient requirements. From the technical challenging needs of the formulations, to the patient interface side of things when considering self-administration and self-service, a “patient-centric” approach is necessary for device development. A “patient-centric” integrated approach takes into account ease of use, promotes adherence, is non-intimidating, affordable and fits in with the lifestyle of the patient. It is evident that one size does not fit all, whether it be the personalized and targeted dose regimen, control of needle depth due to physiological differences, emotional status of patients, population diversity and cost of the therapy. This brings us to the unmet need of an enabling design that can be customized internally to the challenging technical needs of the application and external customization to patient touch points towards eliminating user errors and successful self-administration.
Delivering value with devices continues to evolve trends towards personalized medicine. It is important to consider many factors like population age, disparity and affordability considerations for adoption. It may not be sustainable to rely on devices that are too complex for certain patient groups. Training of devices is another aspect to consider for self-administration, human factors and usability studies help identify areas for errors and help evolving designs for best use by the intended population. Simple and intuitive designs further help promote patient adherence and compliance.
The focus on intuitive correct use requires more attention to self-administered drug-device combination for marketed products as a part of the product life cycle management. Early characterization work of the formulation can help with a thorough understanding of the formulation being delivered in the context of the delivery mechanism and sensitivity of the drug to environmental influences. Coupled with early user research and formative studies, the path to device design is based on a thorough understanding of the technical and patient needs. Running a range of early-stage user research including surveys, interviews, focus groups helps collect data to identify user needs and scope scale of HF activities required for an application. Early formative studies can include comparative interface and preference studies focused on defining patient user interface functionality.
Patient-Centric Autoinjectors – Photo Credit Oval Medical Technologies, an SMC Ltd. Company
To accommodate flexibility of incorporating technical and patient inputs, a modular design is required for the delivery device where the power pack, primary drug container, and patient interface of the autoinjector can be easily substituted. The modular approach helps optimize each of the requirements separately; customized internally to the challenging technical needs of the application and external customization to patient touchpoints towards eliminating user errors and successful self-administration; thus providing an enabling technology for challenging formulations and better solutions to patients that did not exist before.
Oval Medical Technologies, an SMC Ltd. company, specializes in the development of patient-centric autoinjectors that meet the most challenging requirements arising from diverse patient groups and novel drug formulations. Oval’s approach is built around two key areas; establishing a deep understanding of the cognitive, physical and emotional needs of each patient group; and the comprehensive characterization of formulation behaviors under a range of conditions.
