Project

Research Area | Point-of-Care Medical Technologies for Real World Data and Evidence Generation

Pratik Shah

Real World Data (RWD) and Real World Evidence (RWE) are playing an increasing role in healthcare decisions. FDA and medical product developers are using RWD and RWE to support clinical trial designs and observational studies using mobile phones to generate innovative, new treatment approaches. In a study published in the British Medical Journal, we evaluated the significance and efficacy of RWD generated from advanced technology-enabled, non-invasive diagnostic screening (TES) using smartphones and other point-of-care medical imaging devices vs conventional vital signs examinations [1]. This study led to significant insights regarding strategies for developing technologies at MIT that are ready for deployment and designed for effective and scalable primary care and RWE generation. For example: a) Construction and validation of low-cost, point-of-care, near-infrared imaging devices to diagnose dental caries, cracks, and demineralization without the use of ionizing X-rays have been published [2, 3, 4]. b) We have open-sourced the construction and the algorithm of porphyrin imaging devices and also created a cell pho… View full description

Real World Data (RWD) and Real World Evidence (RWE) are playing an increasing role in healthcare decisions. FDA and medical product developers are using RWD and RWE to support clinical trial designs and observational studies using mobile phones to generate innovative, new treatment approaches. In a study published in the British Medical Journal, we evaluated the significance and efficacy of RWD generated from advanced technology-enabled, non-invasive diagnostic screening (TES) using smartphones and other point-of-care medical imaging devices vs conventional vital signs examinations [1]. This study led to significant insights regarding strategies for developing technologies at MIT that are ready for deployment and designed for effective and scalable primary care and RWE generation. For example: a) Construction and validation of low-cost, point-of-care, near-infrared imaging devices to diagnose dental caries, cracks, and demineralization without the use of ionizing X-rays have been published [2, 3, 4]. b) We have open-sourced the construction and the algorithm of porphyrin imaging devices and also created a cell phone clip that can be used on a mobile phone camera [5]. c) For biomarkers (such as matrix metalloproteinases-8 and -9 linked to oral diseases that cannot be imaged), in collaboration with MIT Chemical Engineering, we have developed and published protocols for a POC lateral flow diagnostic strip to detect the biomarkers in human saliva samples [6]. d) A study of a low-cost mask to screen for sleep apnea through physiological monitoring: respiratory activity (airflow and nasal air pressure) and sleep behavior (motion and noise) has been published [7].