Design teams might confuse Design Controls and Project Management because they both involve overhead control. Where Design Controls focus on the design of the project and the processes within it, Project Management involves acting as keeper of the design controls, as well as the planning behind it (i.e., Gantt Charts, budgets, relevance to company mission, etc.). You mentioned a good portion of the PM’s roles with these examples.

Now the integration can be tricky since there is a gray area between Design Controls & Project Management. For instance, the DDP is not only influenced by PMs, but all stakeholders of the project. That means that the perspectives and needs of each department will conflict with each other, making the planning of the project more difficult on the side of the PM. The same can be said about the Project Management Plan, as that also includes inputs from all involved departments for creation.

To fix this is a matter of communication. The company culture could begin by prioritizing the need for integration and shared ownership to prevent the gaps in understanding between teams and departments. This is especially important when considering silos, where putting a foot in the door of certain departments can prove difficult due to politics or cultural differences, as stated by Dr. Simon. This would be an issue primarily within Functional or Matrix organizations, not project-based ones (since staff members are each functioning under different PMs). 

Another solution is should implement sub-plans within the PMP that include the DDP itself. That way, all DDP documents will be front and center and up to date rather than having them as separate afterthoughts (as Dr. Simon put it). We could even implement a written agreement and training to ensure that all documents are living and not sporadically updated. This will minimize discrepancies between team members regarding the DDP, the documentation within it, and the PMP’s connection to how the project is supposed to be managed/guided.

I think project teams struggle to integrate Design Controls with Project Management because the two systems are usually treated separately and handled by different groups.
Design Controls get more attention because they are required by the FDA, so teams naturally focus on them more than on planning tools or scheduling.
A lot of engineers also confuse Design Control activities with actual project management, which leads to missing elements like Gantt charts, WBS, and communication plans.
This creates a gap where the technical documents look complete, but the project timeline, responsibilities, and resources are not aligned.
To fix this, organizations need better coordination between project managers and design engineers starting from the early planning stages.
The Design Development Plan should clearly include project management elements so both sides stay connected. giving teams training on how Design Controls and Project Management complement each other can reduce confusion and help projects run more smoothly.

In medical device development, Design Controls and Project Management are often mixed up because both guide the product lifecycle, but they serve fundamentally different purposes. Design Controls focus on ensuring product safety, effectiveness, and regulatory compliance by defining requirements, verification, validation, and design reviews. Project Management, however, centers on planning, scheduling, resource allocation, and risk management to keep development activities on track. Confusion arises because the two processes overlap in timing and involve shared documentation and cross-functional teams. While Design Controls answer “Are we building the right device, and does it work safely?”, Project Management answers “Are we delivering it on time and within budget?”. Mixing them up can lead to gaps in compliance or delays in execution if responsibilities are misunderstood. Recognizing their distinct roles helps teams coordinate more effectively and ensures smoother, compliant, and efficient device development.

Design controls are process-driven, while project management is behavior-driven. Design controls rely heavily on regulatory, while project management is primarily more business oriented. Dealing with both of these seamlessly can be difficult in a project team. Many of the design controls are treated as "regulatory paperwork" as talked about in the past forum posts, so the mindset is often to treat them as checkmarks. However, design controls are very dynamic because any changes directly influence the project plan, but failing to realize this can create an even bigger disconnect between project management and design controls in organizations. Design controls and project management needs to be done on parallel tracks, where both work in a single system. In order to have a successful project, a team needs successful compliance and execution. Without both, a device cannot be sent to market safely. To solve this issue within organizations, cross-functional planning at the start of projects needs to be more heavily emphasized, and making sure that design controls are "living documents" is important to make sure the document guides development throughout the different phases of a project.

I think a key issue in integrating Design Controls and Project Management is the lack of continuous feedback loops between the two. The distinction between the two is blurred, and sometimes they are treated as two separate processes. However, without regular and proper feedback from both sides, there will be critical gaps that become worse as the project advances and evolves. This is common in medical devices. 

Design controls ensure safety and compliance, and Project Management is about efficient delivery. The key to solving the issue of letting one dominate over the other is having cyclical feedback mechanisms that cover all bases. This should happen throughout the entire project lifecycle as opposed to just the start and end of phases. Any task completion or any work done should be accompanied by how it can affect the design controls and project management in two separate forms, and these forms would all be consolidated for an individual working in the department to see and analyse. 

The Design Development Plan, for example, should be treated as a living document, as Dr. Simon has mentioned, and this would be continuously updated by both the management and engineering teams. Each project checkpoint could have a mandatory meeting between the two teams for analysis of the new additions. This would ensure that the project does not get thrown off due to miscommunication. Additionally, a project dashboard that combines the design controls documentation and project management documentation, such as risk assessments, reviews, Gantt charts, and budgets, could show a real-time view of how everything is developing for the team members to prevent conflicts. Training on how to use this software and how everything is integrated would be essential to make this happen. Ensuring they understand the “why” is also important, so the team members do the documentation from their hearts and not just as a measly task. 

How can companies better integrate the methods that I described above? Would this actually help or create more documentation that the staff has to fill out? How can AI be incorporated to better understand design controls and project management?

I think a big reason teams struggle to connect Design Controls with Project Management is simply that most engineers were never really trained in PM tools to begin with. Design Controls feel familiar and safe, so teams naturally default to them, while things like schedules, budgets, or resourcing feel more abstract. On the other side, PMs don’t always see how their timeline decisions affect requirements, verification plans, or risk files.

To me, the fix isn’t more documents; it’s a shared understanding. Even small things like joint onboarding, quick cross-training sessions, or templates that show how a Design Control update impacts the Gantt chart would make a huge difference. When everyone actually understands how the two sides depend on each other, it becomes much easier to keep them integrated instead of treating them like separate worlds.

I think the main gap between design controls and project management is the amount of paperwork involved. In my experience, teams found any work that took them from working on the device to be unwanted and frustrating despite being a necessity for the success of the project. This in turn causes the team to try to blend the design controls with project management with the label of administrative topics. This category primarily focused on one of these topics and little emphasis on the other (ie focusing on design controls and not giving management much attention). While this did increase the time efficiency of the team, it lacked the overall structure that may have benefited from a more thought out project management section. I believe this approach could be useful if each topics were equally tended to.