Hey there! Welcome to the next GLOBAL webinar in our series where we have been discussing how to effectively resource and manage a writing team working on device portfolios under EU MDR sustained work. My name is Luke Baker and I’m a Senior Manager here at GLOBAL and today I will be taking you through how effective teamwork can be applied through a single project.
But first, let me encourage you to go back and check out part 1 and 2 of our series. We’ve been discussing lots of teamwork in these series and we hope that this can be beneficial to you and your organization. They can be found on the GLBOAL Regulatory Writing and Consulting website or you can connect to us through our LinkedIn.
Just a bit about GLOBAL before we jump right in: We support Medtech and Biopharma innovators with strong, collaborative partnerships, tailored regulatory consulting and writing services, and deep strategic expertise.
So here at GLOBAL I would like to tell you about how we approach success. So we have 6 core values by which we define ourselves and measure success. Your organization may have different core values and we encourage that you use these or own core values as a lens through which you examine the success of your team.
Today our discussion of a teamwide approach for a single project will really center two of our six core values: Collecitve Intelligence and Inclusiveness. All teams have a collective intelligence that can be relied upon to see your project through to completion. As for inclusiveness, you should look for ways to maximize everyone’s contribution according to their interests and their strengths. We will discuss more in a bit how we can assign people the right roles and make sure that everyone is in the right seat at the right project.
So let me present the scenario that we will be discussing today. In the last few years, GLOBAL was approached by a new client with a few unique characteristics. They were relatively, and still are a relatively new startup that had several devices that had already been CE marked under MDD. And while some of the devices in the portfolio had received approval under MDR, the team was actually working on new products and they were in the midst of preparing for an internal technical review. When they approached us, they really needed their documents to be finalized in about six weeks. Not only was this a tight deadline, they also had a very strict budget that they needed to follow.
Among the identified challenges that this project presented was of course that expedited timeline, but also this project comprised an update and remediation of six documents which included 3 plans and 3 reports. Some of their documents had been completed in the years prior but required significant updating. The information in it was a little unclear and they had new clinical data to incorporate. So they looked to us to make sure that their documents were updated correctly and the story of their devices was told as clearly as possible. Furthermore, what really increased the challenge of hitting their deadline was what I mentioned just a second ago – a lot of new clinical data.
So how did we approach this? From the initial scoping call, we realized that this project scope was beyond the capacity of one writer. There was simply too much to accomplish within the timeframe. We could have demanded that a single writer work overtime and plunge ahead, getting it all done in the six weeks, but that doesn’t really align with the core values we have here at GLOBAL. So we decided that teamwork was really the only viable way forward. So first we appointed a project lead. This person maintained full responsibility of the content of the documents, and this meant that they were in charge of assimilating all available content, reviewing all safety and performance analysis, and providing a final risk benefit analysis. This person also handled all direct client communication and facilitated cross functional communication between all project stakeholders.
The project lead then met with a team of writers assigned to this project. This team collaborated to identify all the critical tasks that needed to be done. There was a lot to do! The project lead then determined how much time could be spent on each task to ensure that the whole project stayed on budget, and that we could hit that six week deadline. At this point, the team took on tasks based on their individual strengths and interests. For example, we had one writer that had a lot of experience with complaint analysis. The complaints we received from this particular client required extensive processing and organization. So the team member with all that complaint experience was a natural fit for this task. Another team member took on collecting the clinical claims from the client’s marketing materials. There was a lot to go through. And then once we executed the literature search, everyone joined in on the screening and extraction – kind of like a literature screening party.
Sot his team based approach enabled us to get through several time intensive tasks in a relatively short amount of time. Within two and a half weeks, we had most of the items checked off and the project lead could start pulling these items together into the safety and performance analysis and overall assessment of the risk benefit ratio. So if this approach is right for your team for some specific projects, it is critical that the writers that join this team based approach can put aside less critical tasks and prioritize the group project. When everyone is asked to join in, other tasks kind of have to fall by the wayside while we move forward on the project that requires the most urgency.
So on the previous slide I mentioned a literature screening party. Everyone on the screen contributed to this particular task. So the team had performed a literature search and that had yielded a lot of articles to screen and then extract. So I wanted to take a second to dig into this a little deeper to analyze and talk about how a team can take on one task like this. In many cases on many projects, the literature search screen and extraction is completed by one writer. They get their literature, they start screening everything, maybe they do it in one sitting or a couple, depending on the amount of literature, and then they start extracting it. There is some definite benefits for this – one writer may lead to greater consistency in the application of the inclusion and exclusion criteria. One writer may be able to identify clinical data gaps as they look through the literature and have a holistic view of everything. And they may be able to start sorting that literature into individual sections as they screen it. However, depending on the amount of literature, this can take a very long time and eat up a significant portion of the project budget and that one writer’s working time. So instead of doing that, we decided to take a team approach.
We initial sat down together, reviewed the screening criteria, to make sure we were applying it equally across all writers. And then we took the literature and divided into sections. One writer took the state of the art literature, one writer took the subject device literature, and one writer took the competitor device literature. We were able to knock out screening in about a day. Similarly, we tackled the extraction as a team. We had a list of all the articles that needed extracting, and we crossed them off the list as we leap frogged each other down the list, making sure that each article was extracted correctly. So this task that would normally take up toa week to complete, we were able to squeeze it into about three days. Saving time on these high pressure projects wherever we can is critical for making sure that we hit those deadlines.
So as the project proceeded and because of this tight deadline, the team decided on a twice weekly meeting. This meeting cadence was a little bit more than what our team was used to, but we wanted to make sure that everyone had the helped they needed and that all the tasks were moving forward appropriately. The project generally had a lot of strategy decisions that required input from each of the team members. These meeting spaces were great for discussing roadblocks, strategy solutions, and some of the critical issues that were facing the project. Our team leveraged our core value of collective intelligence and inclusiveness. Everyone was able to bring their best selves and contribution, and the project’s success was dependent on the collective efforts of the team. Throughout the project, we had peer reviews to ensure that everyone was compete and correct. And the ultimate responsibility was on the project leader to make sure that that was true across all tasks. As individual tasks were completed, as I said the project lead began assembling individual components to make sure the data were correct, that the analysis was appropriate, and that the voice of the document was singular throughout.
It was through this collective effort that we were able to complete the project on time and on budget. The client was thrilled to have this project delivered according to their timeline and their budget, and we were thrilled to deliver a high-quality product on an aggressive deadline without too much disruption to our regular workflows.
Ok so that is a focused look at a recent project we had here at GLOBAL. You might be asking yourself, how does this apply to your organization? So currently your organization may empower each writer to be their own project manager. This affords them a lot of responsibility and project ownership, but there are times when this approach can feel isolating. There may be opportunities on some projects to take a full or small team approach. It is important to give opportunities to all team members for them to help contribute to the overall success. There are times when a project's success may require input from everyone, and sometimes a group approach is the right way to tackle a big urgent project. This allows for the workload to be shared across team members so that no one is forced to do crazy overtime hours or just share the burden of that singular project. Ultimately however, these projects require strong project leadership to ensure everyone is contributing according to their interests and skillsets. Most importantly, this approach creates helps build a united team so you can continue problem solving together into the future.
Thank you so much for joining us for another GLOBAL webinar. We look forward to connecting with you again through our LinkedIn page or through our website. Thank you.
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