Traditional medical devices often fail to account for the dynamic environment within the human body, but by utilizing physiology-guided design principles, we can develop devices that are more effective and less invasive.
Recent example project: We previously employed a physiology-guided design approach to create "sPILL," a simple and scalable oral delivery device that harnesses the dynamic mechanics of the gastrointestinal tract to reliably actuate and systemically deliver biologic drugs. We recognized that gut contractions, variable pH, and degradative enzymes significantly challenge the development of oral delivery systems for biologic drugs by compromising their reliable delivery and therapeutic efficacy. However, by synchronizing device actuation with gut contractions, sPILL and tissue work in tandem to ensure the complete transfer of a loaded therapeutic from sPILL to the tissue, bypassing physical and biochemical barriers and maximizing absorption. Through ex vivo and in silico experiments, we engineered the geometry of sPILL to achieve safe and targeted actuation in the gut, and extensive in vivo experiments involving minipigs demonstrated comparable biologic drug delivery efficacy to subcutaneous injection. This work highlights the importance of understanding and incorporating physiological considerations into the design of a device to optimize its functionality.
Imaging technologies and computational techniques can significantly enhance the precision and personalization of medical devices by providing real-time feedback and enabling predictive responses.
Recent example project: We previously analyzed ophthalmic retinal optical coherence tomography (OCT) images from patients with Alzheimer's disease (AD) to identify retinal layer thickness and ratio changes that may serve as image-based biomarkers for the disease. Through a comparison with age-matched healthy subjects, the changes were attributed to AD only, age only, neither AD nor age, or both AD and age. The demonstrated image segmentation, measurement, and ratiometric analysis of retinal layers in AD patients may yield a noninvasive OCT image-based retinal biomarker that can be used to detect retinal changes associated with this disease.
To ensure that their benefits are widely accessible, it is crucial to design medical devices that are cost-effective, easily scalable, readily distributable, and environmentally sustainable.
Recent example project: In response to the COVID-19 pandemic and the widespread need for respiratory medical devices, we developed "Paperometer," a low-cost incentive spirometer manufactured entirely from recyclable materials. This device aimed to address the multifaceted problem of medical device inaccessibility: high cost, lack of user- or environmental-friendliness, and unavailability to those who need them the most. Using a physiology-guided design approach, Paperometer was prototyped to improve lung function and rehabilitate patients by facilitating slow, deep breaths of air through repeated use. While awaiting clinical validation, the Paperometer concept exemplifies an innovative solution that reduces the cost and environmental burden of meeting the demand for medical devices, emphasizing the importance of accessibility and sustainability in their design.