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.
September 21-24, 2019 in Philadelphia, PA
Interested in discussing regulatory or medical writing projects? President Laurie Mitchell and CEO Lalitha Jonnavithula will be taking meetings at booth #439 at RAPS 2019.
Book a consultation with us for exclusive tips, assets and more. Stop by the booth and sign up for the chance to win a FREE Amazon Echo!