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 (get a reminder). 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 (Get a reminder).

Categories:
Do you like it?0
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 (get a reminder). 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 (Get a reminder).

Categories:
Do you like it?0
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 (get a reminder). 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 (Get a reminder).

Categories:
Do you like it?0
May 3, 2018

Benefits of Outsourced Medical Writing

As business increases, medical device and pharmaceutical companies are finding success turning to outside vendors to meet their technical and regulatory writing needs. In doing so, these organizations gain real and specific benefits that, because of a streamlined approach, can lead to a bigger bottom line. Below are a few examples of the advantages that your company can gain by outsourcing your writing needs.

 

Money

Save Money

Of course money is top of mind when it comes to benefits. No matter how great other benefits might be, if it doesn’t make sense fiscally, why do it? Organizations can save money several ways when outsourcing. The first is by reducing or outright eliminating in-house staff and turning to a team of experienced writers from the outside, an organization saves on costs associated with in-house employees. This includes, standard salaries, paid time off, and insurance costs.

 

The next way that outsourced writing can save money is through bundling services. Like in any line of work, technical writers can offer a package of services for less money. Once again, by saving money in this area, your company will be able to allocate more funds where needed.

 

A focus on writingFocus on Writing

It can often times be difficult for organizations, especially smaller ones, to divert their attention away from research and development to focus on other aspects of the company. Again, this comes down to how resources within a company’s structure are allocated. By outsourcing writing duties to a team of experts, a company knows that all aspects of the technical writing process will be covered.

The medical device and pharmaceutical landscape is constantly evolving. By employing a team of experts to handle the writing needs, you can have the piece of mind, knowing that all rules and regulations will be followed with precision.

 

Flexibility

As stated above, often times keeping a staff of in-house writers can, at times, be a bit of an albatross for a company. Utilizing outsourced writing professionals can free up an organization, as you only employee their services when needed.

As most companies can attest, their writing needs fluctuate throughout the year, depending on where their products stand in the pipeline. By employing outside vendors based on need, an organization frees itself up to use the extra capital as they see fit.

In the end, because of the variables involved, every company’s technical writing needs will be different. However, regardless of the variables, organizations should always be looking for ways to employ the best individuals for their needs, find ways to become more flexible through resource allocation, and finally, save money. Outsourcing writing duties to a team of experts can help accomplish all of this.


Criterion Edge is a regulatory writing company that provides outsourced writing services to the pharmaceutical and medical device industries. The company’s expertise in regulatory writing best practices, honed over decades, produces superior deliverables and provides budget, resource and timeline flexibility for regulatory managers. Criterion Edge empowers companies to deliver superior health care solutions. To learn more about how Criterion Edge can help you achieve your regulatory goals, click here to contact us, call us at 805-202-5520, or use the email: info@criterionedge.com

Categories:
Do you like it?0
January 11, 2018

[Infographic] Medical Writing Budget Control: 5 Key Questions to Help Manage Your Budget

Regulatory writing and publishing is a critical component in regulatory affairs, and manufacturers must comply with varying regional regulations and increasingly rigorous disclosure and evaluation standards. Companies therefore need good strategies to keep the budget for medical writing in check, while meeting escalating demands, evolving regulations, and unrelenting timelines.

Are you are asking yourself, “How can I get the most out of my project budget?” We can help you answer this.

We have developed a guide with 5 Key Questions that you should ask yourself before fully allocating your budget. Manage your project, team, and resources in the best possible way to stay within budget. Get the complete infographic and make sure you’re asking yourself the right questions.

5_Questions_To_Manage_Budget

 

You might also be interested in: How Outsourced Regulatory Writing Can Benefit Your Organization 

Categories:
Do you like it?0

Laurie Mitchell

CE President, Laurie Mitchell, discusses safety reviews

Sign up for this free webinar today!

Title: Intro to Adverse Event Review
Date: Wednesday, July 18, 2018
Time: 11 am PST | 2 PM EST
Details: 30 minute presentation | 30 minute Q&A