Beyond wearables and implantables: a scoping review of insertable medical devices

Objective: We aim to propose a definition for a new class of in-body medical devices located in the superficial skin layers, called insertables; to provide an overview of their technological capabilities and challenges, and to summarize current applications and potential future use cases. Methods: A scoping, unsystematic review was conducted to gain an understanding of insertables and identify their clinical applications. Several information sources were used including: (i) peer-reviewed scientific literature; (ii) market research reports and (iii) the Derwent Innovation intellectual property database. An analysis of commercially available insertables and those under development was performed. Results: Desirable characteristics of insertables are: (i) noninvasiveness; (ii) ease of application, positioning and removal; (iii) multi-functionality; (iv) flexible in-body life-span and (v) patient-friendliness. Nineteen insertables were identified, spanning application areas from cardiac monitoring and continuous glucose monitoring to drug delivery. In the near future, a dozen insertables are expected to be brought to market in application areas ranging from analyte detection to electroencephalogram monitoring and measurement of intraocular pressure. Conclusion: Insertables combine useful features of implantables and wearable medical devices in a single offering. Insertables have the potential to deliver clinically useful, reliable physiological data and therapy with negligible patient discomfort and risk.