Medical Device Courses Forum - Recent Topics

The NSF Board and the Future of Research

Dev Doshi — Mon, 04 May 2026 03:47:17 +0000

On April 24, 2026, the Trump administration fired all 22 members of the National Science Board, which is one of the governing bodies of the U.S. National Science Foundation (NSF). The National Science Board helps set the major funding for research in science and engineering. Many students and labs get funded by NSF grants for their research, and I personally have been funded by NSF for one of my summers during my undergrad. However, the Trump administration completely fired this board, and there has not been a replacement yet as of early May. The broader context for this is concerns about NSF funding and cuts that the Trump administration wanted to put on the $9 billion budget for research.

Research is affected by the decisions that the government makes, which can hinder scientific progress significantly. A lot of medical device development starts with basic research, and without this funding, future medical device development has no strong foundation for growth. Science takes years of development and research, but the entire board that oversaw the funding for this was fired on such short notice. How do you think the future of research will be affected by this decision, and how will medical device development be affected in turn? Are there any fail-safes? Do you think this will mainly affect basic science research, or could it eventually affect clinical trials and medical device innovation too?

How much time/money should be invested into trying to make a cheaper vendor's product work?

mmk68 — Sun, 03 May 2026 00:44:21 +0000

As part of the fourth simulation, we are faced with the problem of ordering smelly (and therefore unusable) pouches from a cheaper vendor or switching to a more expensive vendor whose pouches don't have that issue. While this isn't close to a description of the full simulation or the problems it touched upon, it made me wonder at what point is it worth it to a company to switch to a more expensive alternative? In a scenario like this, the company could run a bunch of tests on the CamTech (smelly) pouches to diagnose and potentially fix the smell, but after a point, it would start to get costly. For one, this company is running tests that should probably be the responsibility of the vendor, CamTech, but it's also delaying the launch of their updated product. However, going with the second, more expensive vendor is going to add up as that high price needs to continue to be paid every time more pouches need to be ordered. How much time and money should this company sink into trying to salvage the use of CamTech as a pouch vendor before giving up and switching to the second company? Whose responsibility is it to fix the pouch odor?

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?