How to Maintain Momentum After a Regulatory Submission
We’ve skipped the whole of January.
I know, I am sorry.
However, I am sure you weren’t that fussed about hearing about my Christmas and New Year, and how this year is going to be bigger and better than ever. So I thought I’d just skip it.
I’ve wanted to write about this topic for a while, but it is something that can be a bit hard to fit into a topic that is really more about technicality for me a lot of the time.
I wanted to discuss today is inertia, momentum and ultimately energy. Specifically, the momentum required to develop and place a medical device on the market.
The sequentiality, parallelity and coordination of activities that must be completed is really remarkable. If only the everyday person knew all of the work it takes to get that device in front of them.
Devices often can end up with regulatory hurdles, from very early uninformed decisions that result in the business being in a bit of a difficult situation. The details of the situation are irrelevant. However, the circumstance and nature of maintaining momentum as a profession within a regulatory project while being constantly met with hurdle by hurdle is a real skill.
The real nuance with getting a device on the market, is that when the approval authorities have the files to review, they very much have a short period of time to understand things (unless competent authorities).
Therefore, it is always the case that there will be things they need clarity on.
Now, when we think about a regulatory authority raising deficiencies or queries on a device. The situation in a large medical device manufacturer can be drastically different to that of a small business. However, one thing remains a constant in both of these situations. Energy.
Anyone that has worked on a technical file submission knows that once it is submitted, the entire project team has a bit of time to back off from the pressure and intensity, and this naturally results in a bit of a quiet following week.
However, it is now the case, in both small and large medical device manufacturers that once one task is completed, it’s on to the next one.
Now, when we have a team of humans, how can we keep them motivated? How do we maintain energy?
Overcoming Inertia
When beginning any project, there is likely to be a burn in period. Where the team gels, plans are written and resources are allocated. This can really take a bit of energy to get things going at first in a device development project.
Leaders need to be engaged and driven to be able to influence the team in a positive project direction.
Pre-empt the “Post-Submission Slump”
The mistake most leaders make is treating the submission as the end of the marathon. In reality, it’s just the end of the first lap.
The Strategy: Schedule a mandatory “reset week” immediately after filing. Not for more work, but for low-intensity administrative cleanup or professional development. By planning for the lull, you prevent the crash.
Accept and prepare for hurdles
When a regulator asks for more data, teams can often feel demotivated. As a result, it is important for these teams to understand that leadership is realistic with the time it takes to complete certain activities and key dependencies.
The Strategy: Reframe queries not as “failures” of the initial file, but as part of the process. . It is key that leaders ensure that their teams know that the business understands that this is a part of the path to market.
The Power of Parallel Momentum
Momentum is lost if a team is purely waiting for feedback and it can often be hard to pick that back up:
The Strategy: Maintain a “shadow backlog” of continuous improvement tasks—UX enhancements, post-market surveillance prep, or process optimizations—that keep the gears turning without the high-stakes pressure of the initial submission.
Device change: Although the Pre-Determined Change Control Plan (PCCP) was initially discussed in the context of software devices, it is useful to think of this when designing your device from a general product development perspective and how it will evolve. This can form part of a good narrative and dialogue to ensure minimisation of the risk of fundamental device change hurdles.
Minimise switching priorities
One of the fastest ways to drain a team’s energy is the “whiplash” effect. Regulatory work requires immense cognitive load; jumping between a response to a deficiency notice and a new product development meeting doesn’t just take time, it is also the amount of knowledge that is required to cover the full lifecycle either in one person or across a team—it is a huge task.
People will argue that changing tasks is a part of the modern world, and I would agree. But it doesn’t mean it’s not helpful to be mindful that it takes a toll on the team.
The Strategy: Create Regulatory “Sprints.” Instead of having the team juggle five different tasks poorly, give them the air cover to focus on one. If a deficiency notice comes in, that becomes the only priority for a dedicated “strike team” until it’s cleared. Establish periods where the team is shielded from non-urgent internal requests. Leaders have to be the filter here. When the business asks for a “quick pivot,” leaders must be the one to calculate the “switching cost.” and not just panic, and switch priority.
I am thinking to write a small series on Regulatory Leadership, so maybe this can be a part of the beginning. Or not.