The Million Dollar Question – When is a Clinical Study Needed?

Clinical studies are the lengthiest and costliest activities in product development of medical devices. The question – when a clinical study is actually needed – is fundamental to small and medium sized companies. The economic allocation of their financial resources is vital. Thus many believe that they should avoid clinical studies, if not required.

In order to assess whether a clinical study is required, we have to carefully look at the new EU Medical Device Regulation and the existing regulatory frameworks such as the conformity assessment procedures and post-market surveillance. But regulatory requirements should not be the only factor determining the answer to this question. We also have to look at other potential benefits of clinical studies such as the value of the clinical evidence.

Clinical studies are expensive. We would also like to offer few strategies on how to succeed in clinical studies.

In this presentation, we will try to tackle this million-dollar question by looking at:
  • Pre-market vs. post-market studies
  • Strategies for success in clinical studies

  • Presented by:
    Celina Wang, NAMSA