The implantable medical device market is projected to nearly double from $91.87 billion in 2020 to $179 billion by 2030, driven by an ageing population and the increasing prevalence of chronic diseases and therefore–through the growing demand for advanced healthcare solutions. This prediction highlights the urgent need for innovative therapeutic strategies and technologies that offer more effective and personalised treatments (1). Soft robotic drug delivery devices (SRDDDs) are an innovative approach towards advancing biomedical and pharmaceutical technology. Their potential to enhance patient outcomes and address challenges like the foreign body response (FBR) is certainly a key factor driving market interest and investment in this field (2). However, the FBR remains a major obstacle for implanted medical devices (3), despite numerous mitigation strategies. Mechanostimulation and mechanotherapy–using controlled vibrations or actuations to disrupt FBR progression and enhance spatial therapeutic distribution through convection-enhanced delivery are among the most promising solutions (2–4). Agarose gel concentrations have previously been used to mimic impedance changes linked to the progressive nature of the FBR to assess device functionality across impedance parameters (2). However, these agarose concentrations do not reflect the actual FBR impedance, potentially limiting SRDDDs in-vivo relevance. Moreover, previous analyses were limited to two-dimensional characterisation, constraining insights into diffusion dynamics. To address this, we aim to develop an agarose-based FBR mimic that replicates the progressive impedance of a developing FBR, as observed in previous rodent studies, and to establish a method for more accurate characterisation and mapping of drug diffusion in 3D.
