One of the biggest challenges in project management is balancing the triple constraint—time, cost, and scope. In medical device development, each of these factors is crucial. For example, if a company rushes a project to meet an aggressive deadline, they might sacrifice quality, leading to potential FDA compliance issues. On the other hand, extending timelines to perfect a product can increase costs and delay market entry, allowing competitors to gain an advantage.
A real-world example is the development of ultrasound devices for bone regeneration. These projects require coordination across multiple teams—engineers, regulatory specialists, and marketing strategists—all while ensuring the device meets strict safety and performance standards. Project managers must continuously assess risks, adjust schedules, and reallocate resources to stay on track.
So, how do we effectively manage the triple constraint? One strategy is adopting Agile methodologies, which allow for flexibility and iterative improvements. However, in the regulated medical field, Agile must be balanced with compliance requirements.
In your experience, which of the three constraints—time, cost, or scope is the hardest to control in a medical device project? Why?
I think the biggest challenge out of the triple constraint is scope. Scope has to be almost perfectly planned out before the medical device development, especially before FDA approval. The scope needs to be definitive. If it turns out the scope needed to change during the medical device development process, this results in set backs in the other constraints of time and cost. The time lost to redefine the scope through replacing the updated details in the medical device documents such as a 510(k). Then, the cost of correcting this issue of updating the new scope. This may sound cheesy, but time is money too. The more time you are using your team for the medical device development costs money, especially during a setback which could have been avoided if the scope was accurate. Overall, time and cost are more predictable than scope, with scope requiring a lot of overhaul to the medical device development process.
Focusing on time, cost, and scope during the design and development life cycles of a medical device is one of the challenges of project management commonly known as the ‘Project Management Triangle.’ The focus on these aspects is very crucial and it is important to choose which to focus on first, the project objectives, regulations, or the market. This is due to the fact that changes on one of these factors impact the other two.
In the development of medical devices, these factors have an even great impact because of the regulations in place and the safety concerns for patients. An instance is for a company that is developing a diagnostic device and attempt to shorten the time to market the product in order to meet competition, it might spend more as a result of costly testing or other activities to make sure that all quality and compliance standards set by the FDA or ISO are achieved. Similarly, increasing the scope of the project to incorporate new and creative ideas could increase expenditures and prolong the time needed to get approvals which could be a risk.
Another very practical tool is earned value management (EVM), which enables tracking the progress status of the project concerning schedule, budget, and completion percentage. Issues can be flagged earlier by EVM which will allow the team to change drugs, reassign tasks, and lower the priorities of what needs to be done first so that major issues do not happen.
What do you believe makes it difficult most in working with time, cost, and the project scope of medical devices? And what do you do when you feel that there has to be a trade-off?
Although I don’t have direct experience managing medical device projects, my background in chemical engineering and biomedical engineering studies have given me insight into the challenges of balancing time, cost, and scope. From what I’ve learned, scope is often the hardest to control, as ensuring compliance with regulatory and safety standards can lead to unexpected design changes and testing, affecting both time and cost. Clear project requirements, strong communication, and flexibility are essential for managing these challenges effectively. I’d love to hear how experienced professionals handle this in practice.
In medical device project management, balancing time, cost, and scope is a constant challenge. While all three are interconnected, I believe time is the hardest to control. Delays can happen due to regulatory hurdles, unexpected design issues, or supply chain problems, and these delays often increase costs and force changes in scope.
For example, imagine a company developing a new wearable glucose monitor. If unexpected testing failures occur, the team must go back and refine the design, which adds time to the project. This extra time increases costs due to extended labor and testing expenses. Additionally, to meet a deadline, the team might have to scale back certain features (scope) to get the product approved on time.
One way to manage these challenges is by setting realistic timelines and having contingency plans in place. Regular risk assessments and early regulatory planning can help prevent surprises that cause major delays. By keeping time under control, companies can better manage costs and deliver a high-quality product without cutting essential features.
In my experience, time is the most difficult aspect of a project to control. I had a personal experience with this when I was working on designing a medical catheter, which was designed to burst at a certain pressure to clear blockages. The final product had taken months to develop (lets say 6 months), and after we had thought the design/product was finalized, we realized one of the testing machines had not been functioning properly. Further, the product wasn't actually going to perform in the way we thought it would, and we were going to have to restart the design process. What I learned from this experience is that there are a lot of considerations a company must take in order to smoothly design a product. For example, in order to redesign our product, we would need to use testing and manufacturing equipment again. However, the schedules for assembly lines and testing rooms are laid out months in advance. Even though we knew designing the product could be done in 6 months, it was now going to take much longer because of scheduling complications. In medical devices, what may seem like a small time delay can quickly turn into a large one and it may be due to circumstances beyond your control. This can become very problematic if you have clients who are in need of life changing/ saving technologies.
Scope is the one factor that can severely affect the other factors in consideration if done poorly. It needs to be carefully planned or else issues may arise later on. If the scope is not carefully planned then that can lead to the misclassification of a medical device. It can lead into the entirety of a project needing to be conducted again as changes may introduce new factors and data that must be recorded. Even if the project is minimized, then that means resources were wasted trying to incorporate it into the original project. This may also mean that there is a miscommunication between what the project is accomplishing versus what a client may have wanted. Consulting with the client and documenting these changes can cause additional delays in the timeline of the project or even the cancellation of it.
