EXOGEN® is the only FDA-approved bone healing device that uses ultrasound to stimulate the body’s natural healing process. Therapy is performed at home by the patient in a simple process that takes 20 minutes a day.
Bioventus wanted a next-generation device to stimulate business growth. Design Concepts studied customers, internal stakeholders and related technology to collect actionable insights. Our team included human factors engineers, design researchers, industrial designers and engineers. We interviewed fracture patients, prescribing physicians and the chief medical officers of insurance companies. We visited homes and clinics to observe use and discover unmet needs.
Three themes emerged that led to the following action items:
- Establish expectations and promote patient compliance with daily therapy.
- Collect compliance and outcome data to convince physicians and insurers of efficacy and value.
- Provide an easy-to-hold device with screen visibility when resting on a table or sofa arm.
We rode along with Bioventus sales representatives, job shadowed reimbursement staff and interviewed executives to gather insights into the business model. This helped us identify opportunities for improvement in the device and business model that could increase usability, simplify order processing and improve the conversion rate for reimbursement.
Working from these insights, the team created storyboards and form study models that were shared with customers during concept preference testing.
The end result? An updated EXOGEN with:
- Streamlined profile featuring soft-touch grip areas, non-skid pads and contouring that’s easier to grasp and operated with one hand.
- Recessed viewing screen that’s larger, backlit and full color for easy viewing from multiple angles.
- Built-in treatment tracking calendar that helps patients keep track of their progress while validating compliance for physicians and insurers.
- Treatment delivery with the press of one button.
- Rechargeable battery that meets non-hazardous air shipping standards for overnight delivery.
Because EXOGEN is a Class III medical device, Design Concepts performed a Summative Usability Study and User Error Risk Analysis to help Bioventus meet FDA requirements.
Stakeholder feedback throughout the design and innovation process resulted in a measurable improvement in patient adherence, which may help to optimize clinical outcomes.
After the next-generation EXOGEN was launched, Bioventus conducted research to determine if the built-in treatment tracking calendar improved patient adherence to the prescribed therapy over a six-month period. They analyzed 12,984 data files from patients prescribed either the earlier- or the updated EXOGEN device. Over the six-month period, overall patient compliance was 83.8 percent with the next-generation device, compared with 74.2 percent for the previous version. Compliance never decreased below 76 percent over the analysis period for the updated device, whereas compliance with the earlier-generation product fell to 51 percent.
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