Beyond the needle: engineering and industrial insight on oral delivery devices for biologics.

The development of biologics has transformed disease treatment, yet their clinical use remains constrained by a reliance on parenteral administration. Oral delivery offers a more patient-friendly alternative, but its effectiveness is limited by a range of physiological and biochemical barriers. Recent advances in ingestible robotic devices provide a promising pathway for oral delivery of biologics by enabling controlled release and site-specific targeting. Yet despite this momentum, no device-enabled oral biologic has reached regulatory approval. This review surveys current robotic oral delivery technologies, classifying them according to their power and actuation strategies, mechanisms of mucus interaction or penetration, and target regions of the gastrointestinal system. For each category, we examine underlying design principles, along with key advantages and limitations. We also present an industrial perspective on development status and commercial potential, highlighting translational challenges related to manufacturing, regulatory approval, and clinical integration. This review investigates the underappreciated downstream consequences of early-stage engineering decisions on manufacturing scalability, regulatory classification, chronic biocompatibility, and cost of goods. Here, we evaluate translational viability by defining the engineering, pharmacokinetic, safety, and economic criteria that devices must simultaneously satisfy to advance beyond proof-of-concept.