Typically, wearable injectors are used for high volume medications, pharmaceutical formulae with high viscosities (e.g. monoclonal antibodies), and regimens that require timed injection of a medication over a sustained period. On-body injectors are best leveraged in situations where wearable injectors are used as an alternative to requiring the patient to be admitted to a medical facility for clinical support of an injection.
To achieve wide adoption, technology platforms need to not only achieve efficacy, but also minimize incremental cost increases to pharmaceutical companies, healthcare payers, and the patient. Largely due to the cost of wearable injectors, compared to oral medication or that delivered by an autoinjector, adoption of wearable injector technology has generally lagged behind expected predictions.
With the advent of COVID-19, both the parent strain and recent mutated variants, Healthcare providers are increasingly turning to Telehealth to augment patient care, both for routine medical appointments and for more complex treatment that historically has occurred in clinic. Early in the pandemic, patients deferred medical treatment for chronic illnesses (i.e. cancer, diabetes, cardiovascular disease), for fear of catching COVID-19 while receiving care in a clinic or a hospital. This led to a cascade of “excess deaths” or those deaths due to ordinarily preventable medical conditions that were left untreated.
Patient-deferred medical care for chronic conditions not only resulted in excess deaths, but also more serious illnesses in those patients who eventually did seek care. This led to poorer patient outcomes and increased cost to the Healthcare payer and to the patient. Amplified use of Telehealth and Remote Medicine helped to reverse this trend; by end of 2020, the use of Telehealth and Remote Medicine increased more than 150% over the previous fiscal year. And with this, the use of wearable injectors is expected to grow significantly, by over USD $4.12 billion by 2024.
Wearable injectors will be a meaningful alternative for patients in their home environments, thus preventing unnecessary and potentially risky trips to the clinic or hospital to receive medical support for an injection, while ensuring timely and effective preventive care for chronic conditions. In addition, as wearable injectors are leveraged for the treatment of diabetes, cancer, and cardiovascular disease, they may also be deployed for monoclonal antibody treatment of COVID-19, which is the only treatment known to prevent COVID-related hospitalizations. Due to hospital space constraints, only 20% of the existing monoclonal antibody supply has been used, as this treatment traditionally requires clinical support to administer.
Design for Manufacturing Impacts Wearables
While there is a growing case for the adoption of wearable injector technology, achieving a design that meets both the needs of the pharmaceutical industry and the patient is a challenge.
Typical wearable injectors need to either “push” or “pull” the medication from the device once adhered to the patient’s skin. To accomplish this, the on-body device requires either an expanding battery, peristaltic pump, or other moving part to move the medication through and out of the device. The inclusion of these parts creates several hurdles. First, the presence of these parts increases the size of the wearable device and noisy operation, which may decrease patient acceptance and adherence, particularly if it can be observed through clothing or heard during use. In addition, additional parts inside the device chassis increases manufacturing cost, which is either absorbed by the pharmaceutical company or passed on to the Healthcare payer or patient. Finally, and perhaps most importantly, the use of moving parts in the wearable device complicates the reliability and robustness of the device, both during the manufacturing process and as used by the patient. And there is always a chance the moving parts may damage or compromise the integrity of the active pharmaceutical ingredient as delivered to the patient.
New designs for wearable injectors, notably those developed and patented by Subcuject, lack moving parts that drive up cost, increase overall product risk, and decrease patient acceptance and adherence. The Subcuject Wearable Bolus Injector (WBI) relies on osmosis to deliver 1-10 mL of medication to the patient in a discrete, battery-free device, leading to a small device profile with noiseless operation. Without the need for batteries or electronics, validation and verification processes are simplified, leading also to faster product development execution.
The innovative platform by Subcuject addresses the key concerns of the wearable injector market and is poised to improve patient outcomes in the time of COVID while reducing overall healthcare costs by allowing for at-home treatment.
Subcuject has chosen Phillips-Medisize to collaborate in the next-stage development and manufacturing of the WBI, bringing together the innovation of Subcuject with the proven design, development, and manufacturing experience of Phillips-Medisize.
“The urgent demands for quality and affordable patient care are driving momentum across the entire drug-delivery sector, including the wearable injector segment,” said Paul Jansen, a leading drug-device consultant, and Subcuject board member. “The collaboration between Phillips-Medisize and Subcuject combines technology innovation, proven engineering, and manufacturing expertise to speed and scale the realization of this exciting new product.”
And the leadership team at Phillips-Medisize agrees: “Teaming with Subcuject to develop an affordable, versatile wearable injector leverages our combined strengths and global expertise in proprietary device platforms,” said Paul Chaffin, president of Phillips-Medisize. “We’re excited to develop the technology and pave the way toward commercialization at a time when market dynamics are paving the way for unprecedented levels of adoption.”