Deciding on what type of study to run is a complex matter with many interlocking factors to be taken into consideration.

1. First and foremost, of course, the therapeutic area and specific indication that the device targets will be vital, top-level considerations. A new hip joint will naturally require a greater burden of evidence supporting safety and efficacy claims than an external knee support designed for intermittent use, for example.
2. Almost as important is the purpose of the study. This will be a major indicator of how much data – and just as importantly, what type of data you will need to collect. For example, if you are designing a clinical trial to support an application for market access for an innovative new product in, say, risk class II, the breadth and depth of data required to adequately support claims of efficacy and safety will be significantly more challenging to acquire than that needed to maintain market access under MDR PMS for an existing product operating in the same risk class with a well understood technology and safety profile.
3. Similarly, the regulatory framework your study will be operating under will be a key issue to factor into decisions made about study design. In the EU, for example, MDR interpretation can vary from country to country so it’s vital that you have a very clear understanding of the expectations of each specific Competent Authority the trial will operate under.
4. Finally, the depth and breadth of current scientific opinion and available data about the class of devices your device falls under will also be an important factor to take into account.