| Summary: | Neill M Pounder, John T Jones, Kevin J Tanis Bioventus LLC, Durham, NC, USA Abstract: Poor patient compliance or nonadherence with prescribed treatments can have a significant unfavorable impact on medical costs and clinical outcomes. In the current study, voice-of-the-customer research was conducted to aid in the development of a next-generation low-intensity pulsed ultrasound (LIPUS) bone healing product. An opportunity to improve patient compliance reporting was identified, resulting in the incorporation into the next-generation device of a visual calendar that provides direct feedback to the patient, indicating days for which they successfully completed treatment. Further ­investigation was done on whether inclusion of the visual calendar improved patient adherence to the prescribed therapy (20 minutes of daily treatment) over a 6-month period. Thus, 12,984 data files were analyzed from patients prescribed either the earlier- or the next-generation LIPUS device. Over the 6-month period, overall patient compliance was 83.8% with the next-generation LIPUS device, compared with 74.2% for the previous version (p<0.0001). Incorporation of the calendar feature resulted in compliance never decreasing below 76% over the analysis period, whereas compliance with the earlier-generation product fell to 51%. A literature review on the LIPUS device shows a correlation between clinical effectiveness and compliance rates more than 70%. Incorporation of stakeholder feedback throughout the design and innovation process of a next-generation LIPUS device resulted in a measurable improvement in patient adherence, which may help to optimize clinical outcomes. Keywords: LIPUS, ultrasound, compliance, patient adherence, medical device design
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