There is no doubt that establishing state of the art is a challenge. It ranges from key information on the medical condition to a neutral, comprehensive analysis of treatment options, and culminates in a succinct yet comprehensive presentation that defines the currently accepted safety and performance standards against which the device is measured. Not surprisingly, common pitfalls include a perspective that is too broad and inclusion of too much detail, or a perspective that is too narrow, omitting relevant indications and alternative therapeutic options. An important critical aspect of the clinical evaluation that relies on state of the art data is also to appropriately define the position of the device within the currently available treatment portfolio.
To avoid such pitfalls, it can be helpful to develop a conceptual outline or “anatomy” of the state of the art section early during the review (see the figure below).
If you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4, you can download our full whitepaper.
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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