May 30, 2018

Developing the state of the art section of the CER: challenges and pitfalls

At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will be giving a presentation with Evidence Partners entitled: State of the Art: Best Practices and Literature Review Using DistillerSR. In this blog post, we will give you insight into some of that content, but to see the whole topic, we recommend you register for the conference, or check back on our blog in late June to download our full whitepaper. Below is a sneak peak at this topic.

 

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 come see our presentation at the 2018 MedTech Summit June 11 – 15 in Brussels, Belgium (register here), or check back on our blog after this date to download our full whitepaper.

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May 22, 2018

Why is it important to establish state of the art during the clinical evaluation?

At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will be giving a presentation with Evidence Partners entitled: State of the Art: Best Practices and Literature Review Using DistillerSR. In this blog post, we will give you insight into some of that content, but to see the whole topic, we recommend you register for the conference, or check back on our blog in late June to download our full whitepaper. Below is a sneak peak at this topic.

The large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance, purpose, and role of establishing the state of the art, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis.

 

Establishing and describing state of the art is not an isolated task, but is central to the entire clinical evaluation. Defining the current, accepted best treatment options, and describing the risks and benefits of these options, provides essential information for multiple aspects of the clinical evaluation. Thus, establishing state of the art yields information that is essential for determining if the safety and performance of a device is compatible with current standards (in comparison to available treatment options). In other words, state of the art establishes a reference standard that is used throughout the clinical evaluation.


If you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4, you can come see our presentation at the 2018 MedTech Summit June 11 – 15 in Brussels, Belgium (register here), or check back on our blog after this date to download our full whitepaper.

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May 9, 2018

How has MEDDEV 2.7/1 rev 4 changed the requirements around State of the Art?

At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will be giving a presentation with Evidence Partners entitled: State of the Art: Best Practices and Literature Review Using DistillerSR. In this blog post, we will give you insight into some of that content, but to see the whole topic, we recommend you register for the conference, or check back on our blog in late June to download our full whitepaper. Below is a sneak peak at this topic.

 

Prior to MEDDEV 2.7/1 rev 4, guidance referred to state of the art only vaguely. MEDDEV 2.7/1 rev 3 requested the discussion of clinical data “in comparison with” and “taking account of” state of the art, and that the clinical literature data cited “reflect current medical practice and the generally acknowledged state of the art technologies”. From a methodological standpoint, this is not much guidance. Thus, methodology, depth, and presentation of the medical background for a device was largely left to one’s interpretation, and thus conducted inconsistently, or, at least, heterogeneously.SoA Fig 1

MEDDEV 2.7/1 rev 4 not only clarifies the definition and purpose of establishing state of the art, but also includes guidance on methodology and required content. The revision expands substantially on the four very brief mentions of “state of the art” in the previous guidance (see the figure below). A total of 39 mentions on 26 pages of the MEDDEV 2.7/1 rev 4 document not only provides a comprehensive understanding of the meaning and significance of state of the art, but also details requirements of how to establish and document this information.

According to MEDDEV 2.7/1 rev 4, state of the art describes what is currently and generally considered standard of care, or best practice, for the medical condition or treatment for which the device is used. Analysis and description of the state of the art provides the context in which the manufacturer (and Notified Body) can assess the safety and performance of the device, and determine the acceptability of its benefits and risks, in comparison to other available therapeutic options. In the presentation and whitepaper, we look into the importance of state of the art, and present practical approaches to developing the state of the art in more detail.


If you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4, you can come see our presentation at the 2018 MedTech Summit June 11 – 15 in Brussels, Belgium (register here), or check back on our blog after this date to download our full whitepaper.

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