Medical Device Courses Forum - Recent Topics

Broadening the test groups in clinical trials

mmk68 — Sun, 26 Apr 2026 22:26:11 +0000

As discussed this week, clinical trials are important for class 2 and 3 devices. They also require significant planning, communication, and overview. The CITI training for clinical researchers warns about the dangers of selecting trial participants in regards to protected characteristics, providing informed consent, minimizing harm, etc. However, in many studies I've read, unless the clinical trials call for a specific age group or demographic (such as pregnant women or elderly patients), they often include cis, white, male, college-age participants at a disproportional rate, which can skew trial results by making them only tested/technically valid for a specific people group. Of course, college students can be easily recruited due to their proximity to a large number of labs and willigness to participate for a monetary reward, but college students may be at more of a physical prime than middle-aged adults, or for studies that involve dietary practices, sleep, or other psychological factors, may be under unique stressors. When looking to plan clinical trials, how can you try to ethically involve more people groups (age, gender, physicality, etc)? How can you reach and motivate adults to participate if they are not experiencing the medical issue themselves and would in theory find out about the trial via the hospital/their doctors?

Navigating unknown project budgets

JacobChabuel — Fri, 17 Apr 2026 22:13:38 +0000

This weeks slides showed us that the medical device field hinges on regulatory and legal requirements. This including patient protections and design controls. In terms of integration management, the slides state that the responsibility of a PM is to determine what are necessary changes proactively define and solve problems. However, it can often be difficult to do so as budgets are often unknown to PMs. Therefore, if new requirements or design changes arise during a project lifecycle, how can a PM best navigate the challenge of an unknown budget while still implementing necessary changes for the project?

Project Delays and Returning to Schedule

mmk68 — Sat, 28 Mar 2026 20:12:39 +0000

In any project, delays and setbacks are to be anticipated. However, your team is expected to meet certain hard deadlines, either for the customer or a regulatory agency, for example. In a scenario where everyone on the team is working hard but something out of the team's control goes wrong (say a machine failure or delays in shipping for some part) that delays the entire project timeline, what is a suitable approach for this problem? In this scenario, small parts of the overall project can still be worked on by the team, but major milestone progress hinges on whatever task the unexpected delay impacted. Until that task is completed, other tasks can't be finished. Have you encountered something like that, either for a capstone project or in the workplace? How was that resolved, since it's not the team's fault? What measures should the team take to get back on schedule after the delay is resolved?

Monitoring and Controlling Process

cra24 — Wed, 25 Mar 2026 16:27:12 +0000

This week we covered the monitoring and controlling process and discuss its recursive nature throughout the duration of a projuct. As a PM, what are some tools or practices you can employ to ensure that you are thorougly checking the device throughout its development? Additionally, when the board in charge of the project dictates that there must be a change in the product from your baseline proposal, what steps do you go through to implement that change without creating a significant deficit in the product performance. Finally, are there any other processes that also occur throughout the duration of a products development, either in parallel or in contrast to the monitorin and controlling process?

Tools for Plan Execution

mmk68 — Sun, 15 Mar 2026 18:39:20 +0000

This week we discussed various strategies to help with plan execution. These broadly include general management and product skills, work authorization systems, status review meetings, project management information system, and organizational procedures. While these are all important for a PM to have/do, which would you say is the most important? Have you been a part of a project team where a PM was lacking in one of these areas? How did that impact the project, and if the issue was resolved, how was it resolved?

Validation and Verification

cra24 — Thu, 12 Mar 2026 18:27:54 +0000

This week we go in depth in learning about verification and validation. What are the primary differences between verification and validation and in what phase of the project do they come into play? Additionally how does the validation of a PM differ from that of an engineer or manufacturer? Finally, what tools or processes should be followed to ensure a smooth verification and validation process?

PM Personnel Management

cra24 — Thu, 12 Mar 2026 16:34:25 +0000

As a PM it is fair to say one of your most daunting tasks is managing your team to ensure that all work gets done efficiently and effectively while adhering to the schedule you have set. However, each of your team members have other responsibilities, whether it be to another team, their family, or other personal circumstances. With all that being said, how can you as a PM successfully manage your team to complete your project in time while still being accomadating to them as people? Additionally, how should you handle if a team member is lackluster in their work, or failing to meet expectations?

Managing Resources When Faced with Design Flaws

cra24 — Mon, 02 Mar 2026 15:46:52 +0000

With week 7 we begin our second simulation and the project presented me with a question; how can you as a PM decide what factors to tweak during the test process? With the second simulation we are presented with a bone growth factor device and need to find a way to store it properly. There are no preliminary tests or data for us to work off of this time so how do you know what to change. For this simulation we can choose as many ideas as we may want and Dr. Simon will let us know the outcome, however in reality it is not so simple. Each new test takes more time and more money and with strict deadlines and tight budgets it becomes difficult to decide what to change. My question is thus, how do you decide what your preliminary tests are and how can you complete those verification tests while remaining in your existing resource constraints? Further, what do you do as a PM when your product fails time and time again after changing the simple conditions, what part of the product do you change when all external components are controlled?

Balancing time and money expectations in project planning

mmk68 — Sun, 01 Mar 2026 22:22:57 +0000

When creating a medical device, key expectations are to be met that are held by the FDA, shareholders, and customers. Especially for Class II or Class III devices, the FDA regulatory pathways can take significant time and money, and FDA requirements such as animal/clinical trials cannot be rushed and may have unpredictable results, causing costly delays. As discussed in this week's lecture, PMs may not even know the costs when planning out the WBS for a project. If a project gets to be too expensive, there may be more applied pressure from shareholders. How should a PM balance expectations from the FDA, shareholders, and consumers, especially as it relates to cost and time to complete the device and get it to market? How should a PM plan for unknown costs in a project?

Cost and Resource Allocation in Project Planning

JacobChabuel — Sun, 01 Mar 2026 22:17:21 +0000

Cost and resource estimation can be an challenging aspect of project planning for any industry. As the lecture this week pointed out, the planning phase involves going through individual tasks within the WBS structure to determine where to allocate costs and resources. Common pitfalls include estimating wildly off mark, assuming costs before the tasks are finalized, not accounting for risk and associated contingency plans, and failing to incorporate vacations or typical work week hours. While these oversights are basic in nature, they can have detrimental effects on the project. For example, an initial biocompatibility task that was budgeted out at a particular cost may require additional testing that would now be outside of budget constraints. This could lead the device to be gatekept by regulatory requirements to undergo further testing and ultimately lead to a failed project. How do estimation failures in the planning phase of a medical device project threaten the success of a project/product? Given employee vacations, holidays, and typical work weeks, how should PMs account for theoretical vs realistic employee resource allocation? Lastly, what do you believe is the most effective way to structure contingency plans for costs and resource estimates to protect against potential roadblocks?