![\"User](\"https:\/\/www.voluntis.com\/wp-content\/uploads\/2022\/08\/Severine-1-1024x635.png\")
<\/figure><\/div>\n\n\n\r\n\t\t\t\t\t\t\t\t\tCan you tell us about your job? \t\t\t\t\t\t\t\t<\/h4>\r\n\r\n\t\t\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\tMy job brings together the skills of a human factors specialist and a user experience (UX) designer. It consists of making sure the digital therapeutics we develop meet users\u2019 needs while being safe and easy to use; we also make sure users are satisfied with the solution. <\/span><\/span>To do this, we need to know our users well and understand the context of where they use the solution, whether it\u2019s at home, in a clinic, or both. We also need to involve our users in the design of the solution, allowing them to test it and provide feedback. <\/span><\/span><\/p>\n\t\t\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\tWhat makes designing digital therapeutics different to designing other general-purpose apps?\t\t\t\t\t\t\t\t<\/h4>\r\n\r\n\t\t\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\tThe method is quite similar, but what makes it different are the users themselves. Our users are patients. Some might have dexterity issues that make it difficult to hold and manipulate a smartphone. Others might have treatment-related side effects such as fatigue, memory or concentration issues, pain or nausea. Because a patient\u2019s condition will impact their use of the solution, we have to use these \u201ccharacteristics\u201d as an input for the design of the solution. <\/span><\/span><\/p>\n\u00a0<\/span><\/span><\/p>\nAnother difference relates to the formalization of the activities we conduct with the end users to address regulatory requirements. In fact, the human factors activities conducted all along the design and development of the solution must be tracked and presented to health authorities before the device is commercialized. <\/span><\/span><\/p>\n\t\t\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\tHow do you identify user\u2019s needs through product design and development? \t\t\t\t\t\t\t\t<\/h4>\r\n\r\n\t\t\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\tThere are three main ways to collect information on users\u2019 needs:<\/p>\n
\n- Conducting interviews or focus groups with the intended users will give you a deep understanding of how a disease impact their life, as well as the difficulties they might experience or have experienced. You begin to understand what really matters for them \u2013 and what solutions they might have found themselves in the face of these difficulties.<\/li>\n
- Patient experts and Key Opinion Leaders<\/a> also bring valuable feedback. Both are interested in sharing their experience to help research, science and any other initiative that aims to improve the patient\u2019s quality of life.<\/li>\n
- Finally, a literature analysis can help identify unmet needs and learn about challenges encountered by other researchers or patients who have designed or used similar solutions.<\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t
\r\n\t\t\t\t\t\t\t\t\tHow do you make sure users will be satisfied with the solution that you develop, and that it will meet their needs? \t\t\t\t\t\t\t\t<\/h4>\r\n\r\n\t\t\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\tThe IEC 62366 medical devices standard describes two main evaluation activities: formative studies and summative studies (also called Human Factors Validation Testing). Both play an important role in ensuring that a DTx product is both useful and usable.<\/span><\/span><\/p>\n\u00a0<\/span><\/span><\/p>\nA formative study happens at key milestones throughout the software development lifecycle. The solution doesn\u2019t need to be finalized for a study to take place; it can be conducted on wireframes, screen mock-ups or prototypes. It enables the manufacturer to identify the strengths and weaknesses of the current solution and to identify design changes that would enhance its overall usability. <\/span><\/span><\/p>\n\u00a0<\/span><\/span><\/p>\nFormative studies can rely on the expertise of human factors specialists who conduct expert reviews of the device\u2019s user interface, based on ergonomics criteria. The manufacturer may also decide to conduct a user test where a small panel of intended users are invited to use the device during individual test sessions and provide their feedback. In particular, the manufacturer will want to know any difficulties they experience when using the device.<\/span><\/span><\/p>\n\u00a0<\/span><\/span><\/p>\nThe summative study is a key validation step in the development of a digital therapeutic. It aims to provide clear evidence of the effectiveness and safe use of the solution. It takes place once the product is finalized and before a file is submitted for regulatory clearance<\/a>. <\/span><\/span><\/p>\n\u00a0<\/span><\/span><\/p>\nThe summative study is conducted like a user test. There should be at least 15 participants per intended user group, such as 15 patients or 15 healthcare professionals in our case. While the formative studies can be conducted on any features of the device, the summative study must focus on critical tasks that could lead to a serious harm for the user. These tasks are defined according to the results of the risk analysis. The manufacturer delegates the organization of the summative study to a human factors company specializing in the evaluation of medical devices. Depending on the finding, the manufacturer might need to make design changes and then conduct a supplemental validation testing to assess the efficiency of these design changes. <\/span><\/span><\/p>\n\t\t\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\tWhat makes someone want to use a DTx product? \t\t\t\t\t\t\t\t<\/h4>\r\n\r\n\t\t\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t\t\t\t\tIf you want your device to be used, you must ensure two things: <\/span><\/span>First, it must be useful, meaning that it answers users\u2019 needs. <\/span><\/span>Secondly, you have to make sure that it is usable, meaning that it is easy to use. <\/span><\/span>If you create a device that is useful but that nobody knows how to use, well, nobody will use it. If you create a device that is super easy to use but does not meet users\u2019 needs, again, nobody will use it. User satisfaction is key, and you really have to pay attention to the user experience!<\/span><\/span><\/p>\n\t\t\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t<\/div>\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/section>\r\n<\/div><\/div>\n\n\n\n\nIf you wish to know more about how we design our solutions, please click here.<\/a><\/p>\n<\/div><\/div>\n\n\n\n
My job brings together the skills of a human factors specialist and a user experience (UX) designer. It consists of making sure the digital therapeutics we develop meet users\u2019 needs while being safe and easy to use; we also make sure users are satisfied with the solution. <\/span><\/span>To do this, we need to know our users well and understand the context of where they use the solution, whether it\u2019s at home, in a clinic, or both. We also need to involve our users in the design of the solution, allowing them to test it and provide feedback. <\/span><\/span><\/p>\n\t\t\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t\t\t\t\t The method is quite similar, but what makes it different are the users themselves. Our users are patients. Some might have dexterity issues that make it difficult to hold and manipulate a smartphone. Others might have treatment-related side effects such as fatigue, memory or concentration issues, pain or nausea. Because a patient\u2019s condition will impact their use of the solution, we have to use these \u201ccharacteristics\u201d as an input for the design of the solution. <\/span><\/span><\/p>\n \u00a0<\/span><\/span><\/p>\n Another difference relates to the formalization of the activities we conduct with the end users to address regulatory requirements. In fact, the human factors activities conducted all along the design and development of the solution must be tracked and presented to health authorities before the device is commercialized. <\/span><\/span><\/p>\n\t\t\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t\t\t\t\t There are three main ways to collect information on users\u2019 needs:<\/p>\n The IEC 62366 medical devices standard describes two main evaluation activities: formative studies and summative studies (also called Human Factors Validation Testing). Both play an important role in ensuring that a DTx product is both useful and usable.<\/span><\/span><\/p>\n \u00a0<\/span><\/span><\/p>\n A formative study happens at key milestones throughout the software development lifecycle. The solution doesn\u2019t need to be finalized for a study to take place; it can be conducted on wireframes, screen mock-ups or prototypes. It enables the manufacturer to identify the strengths and weaknesses of the current solution and to identify design changes that would enhance its overall usability. <\/span><\/span><\/p>\n \u00a0<\/span><\/span><\/p>\n Formative studies can rely on the expertise of human factors specialists who conduct expert reviews of the device\u2019s user interface, based on ergonomics criteria. The manufacturer may also decide to conduct a user test where a small panel of intended users are invited to use the device during individual test sessions and provide their feedback. In particular, the manufacturer will want to know any difficulties they experience when using the device.<\/span><\/span><\/p>\n \u00a0<\/span><\/span><\/p>\n The summative study is a key validation step in the development of a digital therapeutic. It aims to provide clear evidence of the effectiveness and safe use of the solution. It takes place once the product is finalized and before a file is submitted for regulatory clearance<\/a>. <\/span><\/span><\/p>\n \u00a0<\/span><\/span><\/p>\n The summative study is conducted like a user test. There should be at least 15 participants per intended user group, such as 15 patients or 15 healthcare professionals in our case. While the formative studies can be conducted on any features of the device, the summative study must focus on critical tasks that could lead to a serious harm for the user. These tasks are defined according to the results of the risk analysis. The manufacturer delegates the organization of the summative study to a human factors company specializing in the evaluation of medical devices. Depending on the finding, the manufacturer might need to make design changes and then conduct a supplemental validation testing to assess the efficiency of these design changes. <\/span><\/span><\/p>\n\t\t\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t\t\t\t\t If you want your device to be used, you must ensure two things: <\/span><\/span>First, it must be useful, meaning that it answers users\u2019 needs. <\/span><\/span>Secondly, you have to make sure that it is usable, meaning that it is easy to use. <\/span><\/span>If you create a device that is useful but that nobody knows how to use, well, nobody will use it. If you create a device that is super easy to use but does not meet users\u2019 needs, again, nobody will use it. User satisfaction is key, and you really have to pay attention to the user experience!<\/span><\/span><\/p>\n\t\t\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t<\/div>\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/section>\r\n<\/div><\/div>\n\n\n\n If you wish to know more about how we design our solutions, please click here.<\/a><\/p>\n<\/div><\/div>\n\n\n\n\r\n\t\t\t\t\t\t\t\t\tWhat makes designing digital therapeutics different to designing other general-purpose apps?\t\t\t\t\t\t\t\t<\/h4>\r\n\r\n\t\t\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t
\r\n\t\t\t\t\t\t\t\t\tHow do you identify user\u2019s needs through product design and development? \t\t\t\t\t\t\t\t<\/h4>\r\n\r\n\t\t\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t
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\r\n\t\t\t\t\t\t\t\t\tHow do you make sure users will be satisfied with the solution that you develop, and that it will meet their needs? \t\t\t\t\t\t\t\t<\/h4>\r\n\r\n\t\t\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t
\r\n\t\t\t\t\t\t\t\t\tWhat makes someone want to use a DTx product? \t\t\t\t\t\t\t\t<\/h4>\r\n\r\n\t\t\t\t\t\t\t\t<\/span>\r\n\t\t\t\t\t\t\t<\/div>\r\n\r\n\t\t\t\t\t\t\t