Welcome to our first in a series of webinars presented by GLOBAL Regulatory Writing and Consulting. Over the course of the series, we will discuss strategies you and your team can use to assess a workload associated with sustained work under EU MDR.
Here at GLOBAL, we support Medtech and Biopharma innovators with strong, collaborative partnerships, tailored regulatory consulting and writing services, and deep strategic expertise. Please visit our LinkedIn page or globalrwc.com to learn more and book a consultation.
First, a little bit about me – my name is Luke Baker, I have been with GLOBAL for six and a half years, and I currently work with a team of six writers for one of our larger clients.
So how many times in our industry have we heard of the EU MDR wave? There was a sense that after the introduction of the EU MDR that there would be this bolus of work related to initial CE marking under the new regulations. And after that, we were promised smooth sailing. Unfortunately, that has not been the reality of many of the manufacturers that we work with. The reality is that device portfolios require significant sustained work under the EU MDR, especially following certification and implementation. Clinical Evaluation Reports, Post Market Surveillance Reports, and Periodic Safety Update Reports have to be updated on a regular cadence. This work can be complicated by diverse device portfolio. Your team projects may comprise initial submissions under MDR, products that are nearing MDR implementation, and innovation with new product development. With all of this in mind, does it sometimes feel like you and your team are on a treadmill and you just can’t keep up with the work? Is your team prepared to carry the workload required by the device portfolio? Well, you are certainly not alone.
I’d like to share the results of a recent survey from MedTech Europe. This survey was completed in the spring of 2024 and found that among device manufacturers, notified body findings were really no longer a major concern. Instead, teams are now feeling burdened by timelines, costs, and predictability related to sustaining devices under EU MDR.
So today we will discuss some strategies your team may use to better handle a project workload under EU MDR. First, we will define success for you and your team. Then I’ll talk to you a little bit about how to know your portfolio better. Then we will discuss managing expectations for you and your team. And then finally we will put it all together into some conclusions.
Alright, let’s define success. Here at GLOBAL, we have six core values by which we define ourselves and measure our success. These may look very different for you and your organization, but we highly suggest using your organization’s core values to help guide your own definition of success. When our team approaches a problem like managing a workload, we look to these values to help us understand how we may find successful solutions. First is agility. This work requires agility. The example we will talk through today will reduce surprises, but the reality of this work is that there are often surprises and adjustments will be needed. Is your team agile enough to take on the work as it comes? We strongly believe in the collective intelligence of you and your team. A successful team will provide the appropriate framework to best support each other. Curiosity invites new strategies and approaches to the work. Are you setting your team up to fully explore the work in front of them? Inclusiveness – does your team’s approach maximize everyone’s contribution? And is your team completing the work with integrity? Finally, one of my favorite core values is sanctuary. Your approach to the work should invite the best from the team and allow them to be their full selves while maintaining an appropriate work-life balance. As I said, the core values we have selected here at GLOBAL are a lens through which we approach our work. Your organizations core values may be different, but we encourage you to examine them and maybe pick some for you and your team for which you define your own success as we approach this work.
Alright, let’s talk about knowing your portfolio. So it’s important for you to know your portfolio. Some of this might seem like low hanging fruit to you – for example, how many devices are in your portfolio? Some of you may be able to recall that number to mind immediately, others may not. However, knowing your portfolio in depth is really crucial to being able to apply the strategies that we will be talking about today in terms of outlining the work and assigning it appropriately to your team over the course of a year. It’s also important to know what the scope of work is. Knowing the EU MDR implementation projects from the initial submissions from the mundane sustained projects – knowing that scope and having it outlined in some type of project management tool is essential to the success of outlining the work in front of you. We recommend that your portfolio be managed in some type of project management tool. For example, here at GLOBAL we use Excel and Microsoft Project, but there are other paid for online applications such as Rike, Smartsheets, and Monday.com that might be good for you to use and check out. Ultimately, all the known projects and deadlines should be identified and outlined in a GANT pool. This allows you and your team to know when the deadlines are approaching, when the projects need to get kicked off, and ultimately allows you to have a full scope and idea of what the workload is in front of you. We also recommend that each individual project should be estimated by effort level. Here at GLOBAL, we use a three-tiered effort level system – low, medium, and high - pretty straightforward. Low effort projects are going to be projects like your end of life projects. So these are devices that are either still sold on the market but you know the end of life is coming, or maybe the end of life has passed and they are no longer on the market, but these are projects that have very little new clinical data and they are going to take an average writer less than 200 hours to complete. Then you will have your medium level projects – these are projects that are mundane, sustained work. They have a known quantity of clinical data that will be added, maybe you have a post market survey out that you have some data to include, but for most writers these are projects that are going to take between 200-300 hours. And then finally you have high effort level projects. These are projects that might require a new template transfer for your organization, they may be new EU MDR submissions, or they just might be projects that have a very high quantity of new clinical data that you know will be added. And so for these projects we estimate that writers will take over 300 hours.
Estimating the number of hours that a project is going to take is a little bit of a feeling and this should be guided by educated guesses. For example, you can ask yourself has this already been submitted under MDR? If it has, that might reduce the overall workload. If it hasn’t yet, that might increase the overall workload. What is the volume of the new clinical data for your product? When were these documents last updated? These are questions that can help guide you towards a better understanding of your portfolio and for the number of hours that are going to be required for a given project.
So we talked about the number of hours that a given project might require. Now that we’ve talked about that, let’s now move on to how we manage expectations for each individual writer so that we can combine this knowledge into an overall workload assessment. So for most writers working as a full time employee, we expect that they will be working for 40 hours a week. However, 40 solid working hours completely dedicated towards writing is often unrealistic due to other duties that a writer might have. These other duties include administrative tasks, general communication through teams and email, meetings that they might be required to attend. So in a given 40 hour work week, most writers will probably be dedicated to the writing at 32 hours or what we consider 80% capacity. Other members of your team that might have more managerial duties or other administrative tasks beyond the writing and regular meeting attendance, might even have a more reduced capacity at 60% or what would equal 24 hours of dedicated time to writing. It is important to adjust your expectations so that when you outline the work over the course of a year or a given period of time, that you are not overestimating what a writer can do for your portfolio.
So with that knowledge, we can start to now estimate that time out over the course of a year. So in a working year, there are 52 weeks. We estimate that most folks will take about 4 weeks of PTO and our company also recognizes 8 holidays. So with those times combined, that leads to about 47 weeks of working time in a given year. At 40 hours, 47 weeks yields 1,880 working hours for a full-time employee. At 80% capacity, that yields about 1,504 writing hours and at 60% it is less at about 1100 hours. So the reason I am presenting this math for you is so that you know how many hours a given writer has in a year and how that can then be overlayed with the projects that have been estimated into a high, medium, or low effort level. You can start to understand how we are going to combine this and overlay this information.
Alright, now that we have discussed managing expectations for your team of writers and we have talked about estimating the number of hours required for a given project, we can start to put this information together into a project schedule. Here I have provided an example schedule of the first four months of 2025, broken into two-week increments. In this example portfolio, we have four devices. Three of these projects are extremely high effort level projects, each requiring more than 300 hours' worth of dedicated writing time. In this example, let’s pretend that Coll D is an end-of-life project, and that project is only going to require about 200 hours' worth of dedicated writing time. In total, we know that in the first four months of 2025, our team will need to dedicate 1,420 hours exclusively to writing. So how many writers might be needed to handle that amount of work? Let’s first look at the last 2 weeks of February. So in this example we can pretend that over the course of these 4 projects, this is going to be a very high – this period of time is going to require a lot of work. There is going to be 240 hours worth of work spread out over 2 weeks. So that equals about 120 hours of dedicated writing time needed for each one week period. From that, we can determine that if we have writers working at 40 hours per week, and they are dedicated to writing at 40 hours a week, that we will need three full time writers for that period of time. But we already talked about managing expectations for your team of writers. Really, each writer is probably only going to work or write at that level for 32 hours per week, and so we will need about 3.75 writers working- writing – at 32 hours per week to make sure this project workload is moving forward. For the period of time between February and March, we see that about 3 writers are going to be needed. However, that is not necessarily true for January when the projects are getting kicked off and started, or in April when the projects are winding down. So knowing the number of writers that you will be needing throughout the course of your portfolio and those projects needed, will help you better understand your own staffing needs and how to best set your team up for success.
And finally, we have talked a lot about math and pretend project schedules – ultimately you also need to know your writers. One writer’s 32 hours is not another writer’s 32 hours, and so understanding their actual capacity can make sure that each writer is in the right seat with the right project to ensure success for your overall portfolio.
Aright, we have talked a lot today about how to manage expectations, and then how to estimate the number of hours needed for a given project. Let’s put this together into some conclusions. So once you’ve done this example or you’ve taken what you have learned today and project it to your own device portfolio, does your calculation of staffing needs match your current staff levels? That’s the first question you have to ask yourself. Do you have enough writers dedicated to the work at hand to make sure that you are moving the work forward and that you are hitting all the necessary deadlines for you and your organization? Secondly, does your current culture support the elevated times of stress, or the capacity that will be stretched if you don’t have enough staffing to meet your current needs? And finally, if the answer to those questions is no and you need additional help, how does your current organization feel about the need for additional hires or temporary contract support? There is help out there and there are ways to provide flexibility to your own organization to make sure that you have the staffing needs to make sure that your deadlines are met.
So a few things that we recommend. First, you need a dedicated project manager. A dedicated project manager is going to identify and schedule all projects for the year – basically take the example that I showed you today and apply it for your organization and to your device portfolio. These project managers can communicate when the project starts, major milestones, and the target deadlines, and make sure that the projects are moving forward at the right speed. We also recommend conducting kickoffs. We have found that a lot of times that the stress related to the project moving forward can be connected to stakeholder feedback, stakeholder agreement, and so having a kickoff at the top end of the project really helps make sure everyone is on the same page and the project can move forward. And then we get to the large part of what we talked about today – resourcing and team support. When you are analyzing the workload over the course of the year, it is really important to assign projects according to writers ability, capacity, and availability. Knowing the number of writers that you are going to need to make sure your work is done. And finally, all of this can help build a team of support. Building a team dedicated to success can be supplemented by ad hoc vendors or contracted support to ensure your team remains agile an flexible.
This work is a challenge and really understanding the overall workload for a given year is an ever-evolving puzzle. If you feel like you could benefit from what we talked about today, or from a specific resourcing analysis and plan for your work, please contact us at info@globalrwc.com. My name is Luke Baker and I appreciate your attendance today.
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