Key principles:

• Once you get into product development, having previously used research to understand and identify user needs, you move into a process of verification and validation of your designs
• An important part of this process is identifying potential risks related to the human factors of a product and finding ways to mitigate them. You can do this as part of initial research into known problems, or as part of formative research or summative evaluation.
• Good clinical practice is an international standard of ethics, science and practices to protect the public during clinical research. In the UK it is overseen by the MHRA who monitor and ensure compliance.
• You should have a process in place for monitoring and reporting adverse events and incidents before embarking on patient research or clinical trials. An adverse event is any untoward medical occurrence in a patient or clinical trial subject who has been given a medicinal product.
• You also need to think about whether your product is easy and pleasant to use. To ensure this, build some sort of usability evaluation into your development. There are a variety of techniques you can use for this at either the formative or summative stage.
• Many healthcare products are intended to be used over a period of time, which means that your testing will be more effective if it also looks at use over time, using longitudinal evaluation.
• The most robust form of trial is a clinical evaluation, which often takes the form of a randomised control trial (RCT), the gold standard, which has very strict protocols and inclusion criteria.
• There are some disadvantages to the RCT though, which means that real world evidence (RWE) can be a useful supplementary source of information, bringing in data from patient use after launch to see how a product is actually being used.