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Q: How are supply partners to medical device OEMs aiding in ensuring patient safety with home healthcare devices?

Human factors design and testing, combined with improved instructions for use, can greatly enhance patient compliance and health outcomes. Many well-intentioned devices are underutilized because the patient cannot understand the proper way to use the product and gets frustrated.

The United States Food and Drug Administration requires human factors testing for all drug-device combination products. Since many pharmaceutical and biotech companies lack in-house device expertise, they rely on device developers for guidance and support. Device manufacturers routinely perform this evaluation as required in their design verification and validation, and can optimize repeat testing efficiently for a pharmaceutical company’s drug-device combination product.

The goal of device design is to make the product intuitive and reduce reliance on detailed instructions for use. Although this can be addressed with human factors design and testing, instructions for use is an area where communication and comprehension can be improved. Improved graphic design, reduction of text, and limiting the number of steps required for successful drug delivery can be employed to improve communication.

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