FROM SWALLOWABLE DEVICES TO SMART THERAPEUTICS: ADVANCES IN ORALLY INGESTIBLE MEDICAL DEVICES AND SOMA-BASED BIOLOGIC DELIVERY

Orally ingestible medical devices represent an emerging approach in modern healthcare, offering minimally invasive methods for drug delivery, sensing, sampling, imaging, diagnosis, and targeted therapy within the gastrointestinal (GI) tract. Unlike conventional oral dosage forms, these devices can perform specific functions after ingestion and may improve the localized delivery and monitoring of therapeutic agents. Recent advances in microengineering, robotics, biomaterials, and programmable systems have enabled the development of ingestible devices with applications ranging from gastrointestinal imaging and microbiome sampling to biological drug delivery. One notable example is the self-orienting millimeter-scale applicator (SOMA), an experimental ingestible device developed for the oral delivery of biologic therapeutics such as insulin. SOMA is designed to autonomously orient itself within the stomach and deploy a drug-loaded microneedle into the gastric tissue, thereby enabling drug delivery while avoiding conventional injections. Preclinical studies have demonstrated the feasibility of this approach, although SOMA is not currently an FDA-approved or marketed therapeutic device. Beyond insulin delivery, the underlying technology may have potential for delivering other biological medicines that are difficult to administer orally because of degradation and poor gastrointestinal permeability. This review discusses the classification and applications of orally ingestible medical devices, their mechanisms of action, major challenges in oral delivery of biologics, and the design and working principle of SOMA. It also highlights the potential advantages, limitations, and future prospects of ingestible devices in improving patient-friendly and minimally invasive delivery of therapeutic agents.