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Author Finola Austin & Miranda Newbery |
| Abstract Medical device manufacturers may enjoy some freedom to operate during platform device development. However, the absence of a specified drug means that there is a lack of predetermined limits and guidance with regards to various human factors that pertain to intended use, including user characteristics. This paper presents a best practice approach adopted by one manufacturer that aligns with the regulatory process and helps to anticipate the needs of a diverse group of potential end users. An inclusive approach to sampling both intended users and device variants is described alongside the resulting design decisions. |
