Biologics are a class of medicine developed from living organisms. Biologics can be highly effective treatments for conditions like cancer, autoimmune disorders, and rare diseases. Despite these advantages, issues such as cost, availability, and difficulty of delivery can make biologics hard to access and use for patients and medical providers alike. Scientists are hoping to solve these issues with increasing research into drug delivery mechanisms for biologics. A medicine’s delivery mechanism, such as intravenous injection or oral ingestion, can have significant effects on patient satisfaction and treatment plan retention. Researchers and device developers are looking to new materials, new forms of delivery, and new integrations with technology for their devices to maximize patient comfort, minimize cost and risk of complication, all while producing increasingly reliable treatment outcomes.
Traditional Biologic Delivery and Challenges for New Devices
Biologics are commonly administered via intravenous injection at a healthcare facility, or via self-injection at home. Intravenous injection allows patients interaction with their healthcare providers, often requires less frequent dosing, and may be more comfortable than self-injection. However, intravenous injection can be inconvenient for patients and disruptive to their daily lives. Self-injection offers greater convenience, but some patients find it painful, difficult, or simply untenable. Device designers must take all of these issues into account, as patients are more likely to adhere to their treatment plan if it is convenient, comfortable, and easily managed. New biologic delivery devices must be able to deliver an increased volume of high-viscosity drugs at the proper force for treatment to be effective. They must meet specific FDA and other governmental regulations, be financially accessible to providers and patients, and strive towards a greater level of convenience and comfort for users.
Biologic Delivery Trends: From IV to Wearable Injectors
Designers of new biologic delivery medical devices are shifting away from the traditional IV route in favor of wearable pre-filled injection devices. Wearables promise comfortable, reliable treatment within one’s own home. They are capable of delivering the higher volumes of medication that new biologic treatments require, offering greater flexibility in the kinds of treatments supported, and providing patients greater ease of use. This move towards prefilled devices lowers costs, increases reliability and accuracy of dosing, and reduces waste. Wearables can also include new safety features, such as a function allowing users to pause injections. New delivery systems require new materials, however, which is why many biologic containment and delivery systems are eschewing glass-based vials and syringes in exchange for plastics and polymers that ensure greater safety and quality for their medicinal contents.
Oral Delivery and Nanomedicines
Oral medication has long been favored by patients for its ease of consumption. Unfortunately, medical providers have not found success in administering biologics in this manner. A major challenge to oral delivery of biologics has been the human body’s natural barriers in the GI tract, which limit the absorption of these medicines. New pills and capsules being proposed and prototyped by researchers, developed with special coatings to resist stomach acid, would make their way to the patient’s intestine to deposit microneedles and microinjectors that are able to safely deliver medicine to the intestinal or stomach walls. This new method could prove to be a revolutionary development in biologic drug delivery.
Biologic Delivery Via Injectable Nanomachines
Another exciting innovation within biologic delivery systems is increasing research around injectable nanomedicines. This technology has the potential to solve many issues with more traditional methods of drug delivery, offering patients a lower risk of side effects, lower costs, and greater comfort. As an example, researchers are working on a biologic implantable that could help patients with age-related macular degeneration. This method could allow patients who receive the implant to go months without having to see their provider for treatment, while lessening the risk of the side effects associated with regular injections. In “The Impact of Nano-Technology on Biologic Drug Development,” author Jin Seon Park discusses biologic implantables in the form of injectable nanomachines which could lessen patient pain and adverse reactions to the medicine. Polymer-based particles act as carriers for the medicine allowing for the accommodation of more kinds of medicine, as well as greater stability, specificity, bioavailability, and improved dosing capabilities. Further, with more and more clinical trials featuring these polymer-based particles, and ever more research being conducted to better optimize the monoclonal antibodies that are the main class of biologic medications, the future of biologic nanomedicines looks promising.
The Push Toward Digitalization in Drug Delivery
Digitalization is another innovation in drug delivery, with both biologic and non-biologic medications represented in new designs. Many new drug delivery devices are being designed with built-in sensors that integrate with digital applications on users’ phones and other devices. Applications integrated with devices could monitor and track relevant patient health data so that medical providers can better understand and optimize patients’ treatment plans. “Smart” devices, aided with digital tech, can also be designed to reduce or eliminate patient errors in usage, aid compliance to a health plan over time, and ensure proper dosing of medication. For instance, biologics could be administered via a needle-free injector connected to relevant tracking and dosing data to aid patients in administration and give care providers valuable data to adjust and optimize treatment.
Drug and Biologic Drug Delivery Device Design and Development at Proven Process
Proven Process has extensive experience in the design, engineering, testing, manufacturing, and validation of cutting-edge Class II and III medical devices including those used for drug and biologic delivery. At every stage of production, we ensure that our medical devices and software meet the highest standards of usability, safety, comfort, and reliability. Every device we design is engineered according to our own rigorous Quality System in every step of design, iteration, and production. From engineering to software development, to medical device validation and verification, and on through manufacturing, Proven Process offers an industry-leading team of experts that can help bring your concept for a medical device onto the market while ensuring it provides users the quality and reliability they demand.