Iowa Adaptive Technologies, Inc. — Department of Health and Human Services SBIR Phase II: 600

Description

AbstractA significant number of conscious hospitalized patients are unable to independently activate standard nurse call systemsand overof mechanically ventilated ICU patients need assistance to communicate with their caregiversBased on those estimates and the annual U Shospital discharge rateone can extrapolate that at leastmillion American patients may have required some form of assistive technologyoften unavailableto be able to summon help and communicate with their healthcare providersIt is clearly essential that solutions be found that allow intubated and physically weak patients to summon help and to effectively communicateTo address that needIowa Adaptive TechnologiesVoxellois developing next generation solutions to improve patient provider communication and to allow patients to better manage their symptoms and effectively participate in their care as well as in medical decision making and end of life conversationsPatients who cannot communicate with doctorsnursesother health professionals and caregivers are at a threefold risk of experiencing adverse medical outcomesReducing communication barriers has the potential to annually reduce nearlypreventable adverse events and to save nearly $billion in healthcare costs each yearIn its successful Phase I SBIR projectthe Voxello team demonstrated the feasibility of using the noddleTM which allows patients to activate the nurse call and to simultaneously control a communication app with a small intentional gestureThe noddleTM uses a patented signal processing algorithm to detect small intentional gestures such as tongue clicksan eye blinkor any other small motor movementVoxello has also developed the noddle chatTM communication app to allow patients who are unable to speak to effectively communicate with their healthcare providersthereby reducing the risk of adverse medical outcomes and increasing patient satisfactionVoxello used an iterative design approach that was informed by feedback from patientsnurses and family membersPreliminary clinical data indicated that patients who use the Voxello technology report greater ease in summoning nurses and being able to effectively communicateVoxello is proposing a Phase II SBIR project focused on broad based validation and testing designed to produce the type and volume of data required to engage Phase III commercialization partners investorsPhase II work will increase the number of intentional gestures that the noddleTM can detect and will expand the communication templates in noddle chatTM to support medical decision making as well as the needs of non English speaking patientsVoxello will conduct clinical trials during Phase II to determine how easily the noddleTM and noddlechatTM can be implemented across clinical settings to enable patients to summon their nurses and effectively communicateVoxello has applied to the FDA to obtain clearance for the noddleTM as a Class II medical deviceand we intend to manufacture the noddleTM at our manufacturing partnerandapos s US based certified medical device facility and develop distribution channels to serve the hospitallong term care and home care markets Project Narrative Poor patient provider communication is a key factor associated with adverse medical outcomes especially in seriously ill patientsPatients who cannot effectively summon a nurse and communicate about pain and other symptomsare at greater risk of health risks such as pressure ulcersaspiration pneumoniaadverse drug reactions and fallsThis Phase II SBIR project is designed to fully validate that Iowa Adaptive TechnologiesandaposnoddleTM technology will reduce communication barriers and thereby lead to an annual reduction ofpreventable adverse events and save $billion in U Shealthcare costs while also improving patientsandapossatisfaction with their care