00:00:02 Speaker 1
Welcome to Chasing Compliance, the Global Regulatory Writing and Consulting podcast where we discuss all aspects of medical device and pharmaceutical regulatory and clinical strategy from bench to bedside. We are so excited to relaunch our podcast. All of our previous episodes are up and available to check out on our podcast page. We want to take a moment to acknowledge and thank Jamie Hijmans for all the work he put into the podcast from 2020 to 2022. Sadly, Jamie passed away in October of 2024 and his legacy lives on here at global in so many ways and we miss him and honor him. There is a wealth of knowledge in our previous episodes full of incredible work and insights from Jamie, so please check them out.
Today we are chatting with Beth Meier and Luke Baker about how to prepare airtight CER. Luke Baker, based in Louisville, KY, is a senior manager on our medical device team. Luke came to Global in 2018, after receiving his PhD in developmental biology from Indiana University. He currently leads a team of writers focusing on CER writing for one of Global's long standing clients.
Beth Meier is also a senior manager on the medical device team. After completing her PhD in tissue engineering and regenerative medicine at Wayne State University, Beth joined Global in 2018. She currently leads a diverse team of writers supporting EU MDR clinical and risk documentation for Global's clients.
Thank you both for being here. I am sure our audience is looking forward to your insights around CER's. So let's dive in.
So first off, you both have many years of experience writing CER's and loads of insights from that experience when talking to a new medical writer. What would you say are the top two to three things to keep in mind when approaching this document?
00:02:00 Speaker 2
Yeah. Thanks, Rachael. One thing I would say is even though it's a regulatory document, it's really important to use your CER to tell a story. Your CER should cover everything that the reviewer needs to know about your devices history, what your strategy is in terms of collecting and presenting and analyzing data, and what the outcomes were from that analysis. So anyone reviewing this particularly Notified Body should be able to take a look at your CER and really understand from start to finish what the process is, what the main conclusions were, and how you went about your analysis for your medical device kind of along those lines. So I guess the second thing I would say is that when you're putting these documents together, it's really important to remember your audience. You are writing for somebody who is definitely familiar with the field. They should have a good understanding of kind of the basic medical conditions and where this device might be used. But they are not the expert in your device, nor are they the expert in your actual documentation, strategy and approach. So make it easy for them, you know, put your information in tables, add hyperlinks if you're referencing another document, make sure you include the title of that document, what the document number is, and again hyperlinks are going to be your best friend. Make it really easy for your Notified Body reviewer to go through your documents and find the information they need to find. A happy Notified Body reviewer goes a long way for everybody.
00:03:28 Speaker 3
Yeah, those are great points, Beth. And thanks Rachael for having us today, really impressed with your pronunciation of Louisville too. Got pretty close there on the 1st pass. So just echoing best second point there that CER's are enormous documents and it's really important that a writer take their time to present the data clearly. So this ties into that, telling the story and remembering your audience. It's just about presentation is just as important as your analysis or the actual writing that you might be doing in the document. For example, when presenting your data clearly or trying to find the right format for your data. For example, consider the wall of text could be replaced with a table, whatever it is that is going to help you clearly articulate the data associated with their device or help you better tell the story. Consider including that in your CER. I recently heard from a Notified Body reviewer at (redacted) that within a few minutes of an initial review, they can tell if it's going to be a good review or a bad review based on whether or not the hyperlinks and the table of contents work. So remember that you're formatting in the presentation of all your data and all of your writing and story goes a long way toward making that review much easier. And the other thing that I would say that's kind of not technical is when writing a CER, a writer really needs to stay curious. Some of our most successful writers that I work with really ask the right questions, both in their approach to the CER, the strategy for the regulation that they're using, but even just down to the data that we're looking at. When you're doing data extractions from a liter, like from an article, if something doesn't make sense or look right, you need to chase that down and your curiosity as to why that data point doesn't look right is going to make for a more robust and more complete story for your for your device. And yeah, just remember to ask those questions and chase down those loose ends when looking at when you're compiling your story for your device.
00:05:39 Speaker 1
That's awesome. Thank you both. I think those tips are really insightful and helpful, and I love like what you said about the little things really tell you know whether or not the document is ready to go. If your hyperlinks are not sorted, then likely some other things aren't as well. So that makes a lot of sense. We know that manufacturers are often frustrated by Notified Body questions and feedback and you all have a lot of experience in working with this and seeing that feedback come back. So what are some trends that you've seen in Notified Body reviews and what advice would you give our listeners?
00:06:12 Speaker 3
Yeah, this is a question that all manufacturers want to chase down. So earlier I kind of gave a shout out to a Notified Body reviewer that was from (redacted). So I recently attended a conference called Evidence Matters that was hosted in Minneapolis by distiller and it was a great conference that highlighted several Notified Body reviewers from several different notified bodies, and there was a lot of eagerness from the manufacturers to kind of hear from them about what they're looking for. One of the most common findings is, frankly, that these tech files that manufacturers are submitting are not complete, so they might be just missing documentation. A source document hasn't been numbered correctly. It might be outright just missing from the file, and this also goes as far as just missing signatures. Remember that your CR needs to be signed by your authors and by the people approving that CER. Some of these small mistakes can really slow down the review process and really slow down your relationship with the notified body. Other Notified Body findings that I've had experience with in the team that I work with currently, it's just related to clarity. Sometimes when we're in the depths of our CER, we're making logical jumps that make perfect sense to us in terms of how we're presenting the data, how we're handling that data, and how that contributes to the story of our device. But that doesn't mean you're notified by your reviewer is going to be able to follow that logic. So make sure that when you're writing that you are clearly explaining the decisions that you're making. If, for example, like why was this harm captured in the extraction table but not, but was omitted from further analysis? If you, as the writer, made a decision about why that harm might be omitted from analysis? You need to clearly explain that because a good notified by your reviewer is gonna catch that and it's gonna track it down. And as a writer, just explain the decision and sometimes the decision might not be the correct one, but oftentimes a clearly laid out decision is easier to follow than no logic at all.
00:08:24 Speaker 2
Yeah, 100% agree with all that. Luke, thanks so much for sharing, sharing all that kind of echoing some of the key takeaways that Luke mentioned. One thing I would really highlight is don't treat the Notified Body as your enemy. I know sometimes it can feel a little bit combative like there this barrier that's standing in your way to you accomplishing what you want to accomplish. But really at the end of the day, like they're trying to do their job, you're trying to do your job, and we all want the same thing. So engaging with your Notified Body with respect and curiosity is a great way to make sure that you have a productive and helpful relationship, and it will really help you engage with Notified Body in a productive way that you can get the information you need to make sure that you're providing them what they need in order to it in order to improve your CER. So making sure you're approaching the Notified Bodies with curiosity, maybe rather than some of the frustration that you might feel inside on can certainly help the overall success of your submission. Getting into some more specifics, just some things that we've seen on our team from Notified Bodies recently, really simple, but on talking about your device history in the context of the medical field, so typically this will be in your state-of-the-art section. Give that background for kind of how your device came to be now. Sometimes we see people go too far with this. If you're talking about the Roman Empire, you might have gone a little too far, but definitely make sure you're talking about in recent medical history. How have similar devices been used? What's the history in terms of device development? What kind of new and fun features are introduced to your device design? And make sure you go from there. That's also a great way to kind of set up your state-of-the-art in a really nice, organized way. If you're talking about these different these different new technologies, these different features, it can be a really great way to kind of structure your to structure your save your outline and make sure you kind of know what you want to highlight when you're talking about target therapies and alternative therapies so. A little bit of a segue there, but I wanted to make sure call that out because that's something that's really easy for folks to include in their CERs. If you know that, that's something that they're looking for. And then I guess one other thing that we've been seeing quite a bit on is not only our Notified Bodies, expecting clearly defined safety and performance measures or metrics that you're going to use to evaluate the safety and performance of your device, but really really explain the rationale behind how you determine those measures, particularly when it comes to safety. For a while, we had a period where some more kind of generic or consistent safety measures, you know, rate of device related adverse event. For example, for a while that would work just fine, but we're seeing more pointed questions now about what specific adverse events are you expecting? Can you reference your list documentation as well as the state-of-the-art? So making sure that especially when you're assessing safety, you're looking at information that's really, really specific to your particular device’s safety profile, so making sure that you have that clear rationale you're referencing your risk management documents, you're referencing the state-of-the-art and you have a really robust rationale for your approach for assessing your devices safety. So those would be the two things I would add as well as treat Notified Bodies as your friends because they really are at the end of the day.
00:11:41 Speaker 3
Beth, I really like that last point that you highlighted there of connecting your state-of-the-art to the safety performance objectives and how those can be identified very clearly in our see are some of the best writers I think are not just checking the box of the CER, but they are diving into the overall clinical field that their device is part of and helping to identify exactly what types of measures are appropriate for the device you're working on. So great point.
00:12:07 Speaker 2
Yeah, thanks. Yeah. At the end of the day, it all kind of comes back to telling that story right where, you know, we want to make sure that what we're presenting is, is clear. It's tied to tied to the point we're trying to make. So yeah, sounds like you have some great writers.
00:12:22 Speaker 1
I love it. And yeah, I think that, I love your points around clarity and telling the story and really explaining the logic so that it's very clear to those reviewing it. Communication is so critical when writing CER's. So what would be your top tips for writers on how best to approach communication with the interdisciplinary team?
00:12:42 Speaker 3
So this is a pretty tough question. I'm a soft skills leader, I lead with a lot of empathy, for better or for worse. And I think it's really important to leverage some of this in my opinion, soft skills, leadership style into the discussion with cross functional stakeholders, when you're working on a CER, it's really important to unify around the goal of a completed CER, because at times it can feel like all of these different stakeholder groups - regulatory, design assurance met like, medical - that we are at odds or we have different priorities when it comes to the ER, so might say first remember that you're on the same team and that you're all working toward the same goal of a completed and accurate, robust CER for your device. So there are two types of primary communication that I think about when executing a project of this size. It's the pre project alignment, making sure that your team and stakeholders are all on the same page about the direction and strategy of completing the CER. And that might look like a kick off meeting. So in our team, we found that live kickoff meetings are an essential tool for that pre project alignment, whether that be in person, which is awesome, or if your company is still using like a Microsoft Teams or Zoom, it's really important to pull everyone together that has a hand in the completing of that CER that you kind of get them in the same room and then hash out the details of how you're going to approach the execution of that project. The second type of primary communication is the review cycle, and this is where I think a lot of teams can start to break down. As a writer, and I'm speaking to maybe new writers and even writers who've been in the game for a long time, it's really important that you develop some thick skin. You cannot take the edits and reviews of your document personally, and that is a lesson that I have learned in grad school when I was writing manuscripts for publication, and I had to learn it all over again when I came to global and started writing CER's. And just like I said in the beginning of this, it's really important that you remember that the goal is a complete CER and the best CER writers that I know know that you're never going to achieve perfection. These are living documents that are designed to be updated cyclically. They're always going to be tweaked and so it's just you gotta remain flexible. You gotta remain curious and be open to compromise with your team when you're approaching these documents.
00:15:23 Speaker 2
Luke I love that so much, especially like what you said earlier about kind of leaning into the soft skills that because at the end of the day, like if you're going to work together as a team, like you all have to have some sort of shared understanding. So I love that. What I would also add, especially as you're kind of getting into maybe that review phase is, you know, keep in mind what other folks goals are. Oftentimes, if you can kind of tailor your approach to align with other people's goals, folks are going to be far more likely to see your involvement as a win, win scenario. And so you know, sometimes for, for me and for my team what that can mean is being aware of how what these other stakeholders have on their plates. Oftentimes if you're if you're writing a CER for one device, you know the the regulatory affairs folks or the the quality engineering folks they're working on that device, but they're also be working on some other things too. So understanding that you're #1 priority might not be their number one priority. And so if you need their input, what can we do to help, you know, to help them help them make it help make it easier for them. So one thing I always like to do is make sure that when I'm sending a request to any sort of stakeholder in advance, maybe I need an input. Maybe I need them to review something. Maybe I need to make sure that this language I wrote isn't going to offend marketing or something. What I'll do is make sure that, like the communication is really clear, the ask is really straightforward. As many times as possible, if I can structure my question in terms of a yes or no for folks definitely like to do that. Folks are really quick to give a yes or no. They're a little bit slower to be - can you open this 500 page document and scroll to some big reference that I mentioned in the meeting 3 weeks ago? In that latter scenario, you're probably not going to get a good response, so make it easy for folks to be really clear about what you're asking for, and as much as possible, set up, set up the their response so that it can be a short answer on their part. Folks like to engage with things that are easy and fast for them, so making sure you're doing that as well and would definitely echo Luke Luke's recommendation to develop the thick skin. You know, feedback and comments are not criticisms. Again, it is it is a shared goal that we all have and just like whether we're working with the Notified Body or working with our own internal stakeholders, we do want to make sure that you know we're working together with the goal in mind and understanding that, you know folks all just want this to be the best document it can be. So we're all working towards that goal and you know, after the after the CEO's done, it's probably a good idea to celebrate a little bit with your stakeholders. You all have you all put in a lot of effort. So you know sharing a, sharing a cake or something at the end of the project I think is always a good idea if you're able to swing that in person.
00:18:00 Speaker 1
Love it. I think that's great advice, not just for CER's, but just for life, right to build a thick skin, don't take it personal, and have some cake anytime you can.
00:18:09 Speaker 3
Always cake. Yeah. Yeah, that is a great philosophy for approaching life in general. I think one last thing I'll add to this question and this might be low hanging fruit for everyone out there. But if you're going to be working with an interdisciplinary team or cross functional stakeholders, make sure you know their names. It’s so important that when you're hosting that kickoff meeting, that all the right people are in the right seats are actually attending that meeting because nothing's worse. You finally find that open slot on everyone's schedule and you get that meeting on and everyone's chimes in, and suddenly you realize that the wrong regulatory person is in the meeting or the wrong design insurance person is in the meeting. Like, check those stakeholders. And hopefully you get it right on the first time.
00:18:58 Speaker 1
Love it. Ah, this has been great y'all. Thank you so much for your time and the insights you share. I think I wanna shout you both out - the wealth of knowledge you bring both to our team at GLOBAL and the clients that we serve I think cannot be overstated. So it's been really great to have you on the podcast and to pick your brains a little bit. As we wrap up here, are there, any other tips or tricks that you wanna highlight that we didn't cover for teams or writers that you want to throw out there?
00:19:26 Speaker 3
Yeah, I can jump in here quickly, so this might not be available to everyone, but it is a tactic that we use for GLOBAL and that is turtle eye on your team. So we talked a lot about how CER's are a team based document and oftentimes we're referring to that interdisciplinary team of stakeholders. You all want to see the CER across the finish line but what I mean here specifically is if you're a writer and you have other writers around you working on other CERs or other documents and you have the capacity and availability to help each other lean into that, so GLOBAL in particular, if we're working on a CER and it suddenly our literature search returns 800 articles for us to start screening, no one person is going to be looking at that screening document that is going to be a team based approach and we're going to have several writers helping each other to make sure that those 800 articles get screened in half the time that one person could do it. So in the approach to these documents, if it's available to you, lean on your team global does it and it's been really effective for us.
00:20:35 Speaker 2
Yeah. And Luke, you almost stole my idea. You took a slightly different spin on those, so that's perfect. Yeah, definitely. I'm going to echo leaks that about the team and what I would also say too, especially if for you know, for folks who are listening to this, you know, maybe you're not working in a big internal team, maybe you don't kind of have that already developed network. One thing I would say is don't hesitate. Start building it. Umm, one thing that I really enjoyed about this industry in general and it's it's not just specific to EU MDR or CERs, although that that that community is pretty, pretty active is this is a scenario in which a lot of folks are learning together and folks are really, really excited to share knowledge. So even if you're someone, maybe you're working as an independent contractor, or maybe you're working for a small manufacturer and you are in army of one. If you're one of those folks, you have my respect forever because you have a very hard job. You you do, you do it all and it's really impressive. But if you're in those scenarios, it's worth taking the time to build a network, so getting on LinkedIn, you know, searching for EU MDR or CERs, or heck, you know, shameless plug here like need, you know, find me and Luke and LinkedIn. We'll be your friends. You know, we're always happy to share our tips and tricks and recommendations. But having that network to kind of discuss some of those more some of those more tricky situations. Luke and I have the privilege of kind of being able to see a lot of different manufacturers, a lot of different Notified Bodies, a lot of different types of devices and strategies. And not everyone has that. So if you can build out a network, it's a really great way to avoid some of the stumbling points early on. So I would say if you know, if you're not part of a of a large internal team already or even if you are so, so working on building out that network, there's a lot of great information out there and folks are always more than happy to share what they know or what they think they know of what they learned the hard way. So definitely, definitely reach out to folks in the network. But yeah, that's that would be kind of my very big tip and trick for folks.
00:22:38 Speaker 3
Yeah, I love that Beth. Like one of the best things about this work environment in this community, a privilege that we have at GLOBAL is definitely that knowledge sharing. And you know, the camaraderie is to approach these documents. So I wanted to jump in here with one last tip and or tip or trick that a new writer or any writer could use really, and that's to remember that these documents benefit patients. It's very easy to approach these documents, especially the CER from a place of analysis. And it is quite distant, but from you as a writer of a clinical evaluation to the end goal, which is a device helping a patient in a hospital somewhere. But remember that your efforts on this CER is keeping that device that might be life saving for someone on the market and available to be used for that patient, and reminding yourself from time to time of that proximity to the patient and what we're aiming to do in this industry is really critical to success and really helps to make those long days feel worth it.
00:23:46 Speaker 1
I think that's - both incredible points to end on teamwork makes the dream work and remember the impact you're having on other people. That's wonderful. Thank you both for your time. It's been a great conversation. I think we're gonna have a lot of good feedback from our listeners. So yeah, thank you so much for being here. Appreciate you both.
00:24:04 Speaker 3
Thanks, Rachael. Thanks, Beth. This job is made better to work like work with people like you each and every day.
00:24:10 Speaker 2
Right back at ya. Thank you both. Always a privilege. So thanks so much.
00:24:16 Speaker 1
Thank you for listening to this episode of Chasing Compliance. And thank you again to Luke and Beth for joining us. If you are interested in learning more about how GLOBAL can support your regulatory writing and consulting needs, please visit us at www.globalrwc.com or e-mail us at
[email protected]. If you like today's episode, please share it and leave a review. And until next time we wish you continued compliance.
