title: Design evolution enhances patient compliance for low-intensity pulsed ultrasound device usage.
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.
authors.affiliation: Bioventus LLC, Durham, NC, USA.
authors.forename: Neill M
authors.initials: NM
authors.lastname: Pounder
authors.affiliation: Bioventus LLC, Durham, NC, USA.
authors.forename: John T
authors.initials: JT
authors.lastname: Jones
authors.affiliation: Bioventus LLC, Durham, NC, USA.
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Tanis
keywords: LIPUS; compliance; medical device design; patient adherence; ultrasound