A proper validation process should revolve around the patient by ensuring that the medical device under development meets the user’s needs. An important aspect of design validation, as mentioned in lecture, is the application of clinical human studies in order to analyze how a demographic of patients respond to the applied medical device. An important point mentioned in the MDDI Campbell article posted this week is that a validation process must include the manufacturing controls and conditions (which explains why validation is often confused with verification). Injection molding a medical device for example requires distinct parameters such as temperature and pressure which can only be applied across a specific range throughout processing. It is overall necessary to include these factors in validation simply because they determine the outcome/performance of the product, which in turn is decided by the patient.

If the patient is not satisfied with the performance of a clinical device, then validation will have to re-examine the specifications of the device, which can include going back to the input-output relationship (the verification). This explains why the validation process can take several years to fulfill and even result in preventing a product from being launched to market. Are there any scenarios in which design validation can be avoided, such as in the case of a low-medium risk device? The Campbell article also specifies the importance of including the equipment and the facility at which manufacturing takes place, known as installation qualification (IQ). What type of controls or environmental maintenance needs to be accounted for to satisfy the IQ requirements?

Reference:
Campbell, Bryan “Validation Can Make a Product Launch a Sure Thing” (2011) Product Development Insight