EU MDR State-of-the-Art: Tips and Tricks

Do you know the crucial part of every medical device clinical evaluation? Yep, you guessed it – the state-of-the-art section!

 
This part might not be the trickiest, but trust me, it comes with its own challenges.
 
How much state-of-the-art background should you write?
 
Do you include all of your device’s indications if it is intended for many different purposes or to treat many ailments?
 
And how far back should you go to describe the history of the medical condition and treatment involved?
 
And how many medical alternatives should you include?
 
So, let’s dive into our top five tips and tricks to write a kick-ass state-of-the-art section!
 
A note before we start: while state-of-the-art in other contexts might mean the most technologically advanced solution, that is different for the state-of-the-art in relation to clinical evaluations. It simply means the standard of care, current technical capability, or generally accepted knowledge in a particular area.
 

What is the clinical evaluation?

Before we start, a quick note on clinical evaluations. Medical device clinical evaluations are where you gather all your clinical data, including risk management data, post-market surveillance data, scientific literature, adverse event data, safety and performance requirements, and clinical outcome parameters to evaluate whether your device remains safe and efficient. Clinical evaluations demonstrate that a medical device, while not the most technically advanced solution, is on par with similar devices on the market and that the benefits of using the device outweigh the risks.
 
For guidelines on clinical evaluations, see the EU Medical Device Regulation (EU MDR, 2017/45, and MEDDEV 2.7/1, Rev.4).
 
Now that that’s in place, let’s get to the tips!
 

Tip 1: Do Some Serious Research

Okay, here’s the deal: you gotta really understand the ins and outs of the medical device you’re dealing with.
 
You can’t just skim the surface; you gotta do a deep dive!
 
Check out the device’s function mechanism, how it interacts with its accessories, what the material is, and how that impacts the device.
 
And don’t stop there – look up all the treatments it’s supposed to handle and any alternative options out there.
 
Sure, most regulatory folks and medical writers have some idea about the functioning of most medical devices, but you will probably not know it like the back of your hand.
 
Even when you’re doing the clinical evaluation for a device within your own company, it is unlikely you know more profoundly than what is written in the instructions for use and marketing materials.
 
I’ve worked in several prominent medical device companies as a regulatory professional, and even though we did market authorizations and technical documentation for many markets, I did not understand the ins and out of every device in the portfolio (we managed more than 200 devices in +10 markets). I had a general sense of our competitors but no more than cursory knowledge.
 
So, buckle up and spend some time googling.
 
Check out your competitors’ websites and get the scoop on how they do things.
 
It’ll save you a ton of time later when you’re doing the literature search, as you will have a more comprehensive image of the devices in play and how they work.
 
Working as an external consultant or medical writer will also allow you to investigate any similar devices and let the manufacturer know if they have missed any.
 
Likewise, if the manufacturer has given you a list of similar medical devices, a little research lets you confirm if they are using the same technology or if any medical devices should be removed from the similar list.
 

Tip 2: Time Travel, Anyone?

Now, every state-of-the-art section needs a bit of history. But hold your horses before you go back to the Bronze Age!
 
What’s the goal here? Typically, a clinical evaluation aims to demonstrate that the benefits of using the device outweigh the risks and establish the medical device as the standard of care/state-of-the-art.
 
So, you need to consider the technological characteristics of your device – is it a technology that has developed vastly in the last decade, such as 3D printed implants, or has it been essentially unchanged for many decades, such as plaster casts?
 
If your device is modern and relatively recent, you don’t need to be nostalgic about the past. Keep it relevant and focus on the last few decades – that’s where the juicy stuff is. For novel devices, you may only need to focus on the previous 3-5 years!
 
Unless you are working with traditional and relatively unchanged tech, a few lines on the distant past should be enough.
 

Tip 3: Cite Everything Like a Pro

It probably doesn’t need to be said, but references really are your best friends!
 
Reference everything you put in your report.
 
Even if you think it’s common knowledge, stick it in there.
 
If it ain’t in the bibliography, it ain’t in the report – simple as that!
 

Tip 4: Format Your Way to Success

Trying to structure a whole chapter from zero can be a real headache. Little by little is a much easier work process.
 
So, here’s a cool trick I use – open up your clinical evaluation report template/document and keep it ready while you’re doing your research.
 
As you read through your included articles, jot down your thoughts and ideas in the report template. Soon, you’ll have a working outline based on the literature you already include in your report.
 
Easy-peasy!
 
For example, during a recent state-of-the-art report on molecular scaffolds when used as dermal fillers, I was still determining the alternative uses of molecular scaffolds when not used as dermal fillers.
 
Even though I had done my initial research, molecular scaffolds are such a novel technology that there is a limited amount of information on the general internet about it.
 
So, I opened up my state-of-the-art report template and kept it open while reading through the literature, so I could note down all the other molecular scaffold uses described there.
 
And what do you know? By the time I had reviewed all my included literature, I had an outline for the many alternative uses of molecular scaffolds and how they interlink with the scaffolds used in dermal fillers, as well as a few different chemical scaffold formulas and how they can be modified.
 
And then all that was left was to fill in the different sections!
 

Tip 5: Don’t Get Lost 

The state-of-the-art is like a treasure trove of dazzling science and history.
 
Most medical writers and regulatory folks come from a scientific background, and we science nerds love diving into the details!
 
For me, personally, the state-of-the-art is the most exciting part of any clinical evaluation, as it gives me a chance to dive into a topic and do some good ol’ academic research.
 
But remember, this section is just the appetizer.
 
The main course is proving your device is safe, efficient, and does what it’s supposed to do without putting people at risk.
 
Keep it organized, keep it snappy, and don’t go overboard.
 
It’s enough to set the stage, but keep sight of the real goal – demonstrating the acceptability of the risk-benefit profile of your medical device!