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Study Design Services

Case Studies

Non-Contact Continuous Monitoring System

There is a growing need to enhance the quality of care of hospitalized patients and reduce adverse events that lead to extended stay, added costs and at times, in-hospital morbidity and mortality. The need is especially noted in general floors in acute-care and long-term care facilities, where patients are susceptible to falls, pressure ulcer, respiratory arrest, heart rate irregularities, infections, etc.

A company had developed a highly innovative, contact-less monitoring system that can track changes in patients’ physical and physiological status, without requiring direct placement of electrodes on the patient. The system alerts clinical staff of changes requiring attention, and provides information supporting clinical decisions once the staff arrives at the patient’s bed.

Being involved with the company since its early stages, Boston MedTech Advisors has developed a plan for clinical assessment of the system, intended to demonstrate the system’s natural fit with staff workflow, acceptance by the clinical staff and overall utility.

Boston MedTech CRO identified the proper clinical setting for the study and interfaced with the hospital’s administration, clinical and research staff to ensure IRB approval, and embedding of the system into a regular clinical floor. The program was designed to support continuing R&D, as well as provide initial visibility for future potential partners of the company. 

Additional services provided by Boston MedTech CRO included development of CRFs, supporting training of clinical staff, managing all aspects of equipment logistics and overall management of the study.

Experience gained from the successful completion of the study led to further refinements of the system, and subsequent product launch, with the study site eventually becoming one of the first entities to purchase the systems for routine clinical use.