BI&T July/August 2017

Although many nuances exist when considering the feedback of patients and clinical end users, medical device makers and federal regulators have long agreed that incorporating their input is vitally important. In recent years, the Food and Drug Administration (FDA) has ramped up its efforts along these lines, with the Center for Devices and Radiological Health launching its Patient Preference Initiative in 2013 and a Patient Engagement Advisory Committee in 2015. Factors such as the type of device, including its complexity and use setting (e.g., hospital vs. home care), are important when considering patient feedback. If a device is intended to be used by clinicians, then patient feedback is less important, and ultimately what matters is that end users are able to safely interact with the device. Given that healthcare technology management professionals are optimally positioned directly between vendors and clinical end users, their feedback can play a vital role in developing safe and effective products. Beyond improving the effectiveness of work by device makers and FDA, listening to patients and end users will ultimately result in enhanced care and better quality of life for patients.

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