Introduction to Project Management - Medical Device Courses Forum

Verification and PM's

mmk68 — Mon, 16 Feb 2026 01:12:06 +0000

In the first simulation that we were given this week, we met with an issue where a part of a product failed verification testing, and we had to propose ideas to rectify that. In a real-world situation, what would the overlap between the Project Manager and the verification team be? How would the R&D teams fit in? I would assume the project manager and verification team should be independent to prevent any biases during the testing, however, verification is an important part of a product's development. Have you encountered any situations similar to the project simulation in a corporate environment? How were they resolved?

PM Problem Involving Pre-clinical Trial Results and Market Entry Deadlines

JacobChabuel — Fri, 13 Feb 2026 16:18:47 +0000

Suppose you are the project manager for a class III device, a bio-absorbable vascular stent. The current strategy is to introduce this device to market that dissolves quicker than the industry standard. During pre-clinical trials, the results demonstrate that the stent is safe, but dissolves too quickly failing to meet long term clinical needs for vessel support. This then raises the question of how should a PM deal with a situation animal study data conflicts with the original project plan/ business strategy? What affect does this have on the time, cost, and scope of the project and how can PM's manage this? Lastly, in animal studies we are told there is an ethical obligation to reduce total animal use, but at what point does that outweigh the need to continue testing until results fit the desired outcomes for the device?

Product Life Cycle - Impacts & Management

at644 — Sat, 07 Feb 2026 23:14:42 +0000

The phases of the product life cycle can change in response to internal and external factors. Products such as smartphones become obsolete quickly, and newer models are released. Medical devices may also have short product lifecycles due to competition and advances in technology & software. However, companies that pursue extensive verification and validation are designing products with longer, more stable life cycles. Verification and validation depend on the device; for example, IEC 60601 testing is for software. Regardless, it is important that the initiating and planning phases are executed effectively to ensure the company meets the design control requirements. One example is the marketing plan, which includes an initial market and competitive analysis. Additionally, the environments are analyzed to identify the product's strengths and weaknesses, as well as the opportunities and threats associated with it. What are other tools or factors that apply to the product life cycle? What are your further thoughts on the topic? Is there a particular device that comes to mind?

The Nine Points of Design Control and How to Effictively Use and Understand Them.

cra24 — Sat, 07 Feb 2026 19:21:22 +0000

Throughout work on a given project, there are 9 points of design control that ultimately culminate into the Design History Form (DHF). The DHF is the end result of any project detailing the steps and processes and the ultimate decisions that were made. What steps and procedures could a PM follow to ensure that the DHF they make at the end of their project is comprehensive and all inclusive, such that any can read it and understand the design process used, and that it covers all legal bases ensuring the product and the companies safety upon release of the device? Further, how should the DHF be constructed, should the PM take the responsibility for its writing or should they delegate it at points; should the PM wait for the resolution of the design or work on it continuously throughout the project?

Project Management and Design Controls

JacobChabuel — Tue, 03 Feb 2026 15:43:50 +0000

In the lecture this week we discussed both aspects of design controls and project management in the life cycle of a project. It is emphasized that the design controls of the project and project management should overlap with shared documents, meetings, and decision points throughout the project life cycle. In practice however, these systems are often treated as separate processes or design controls are mistaken for project management processes altogether. How might this separation affect a project in terms of verification, validation, or design reviews? What affect would this likely have on maintenance of the Design History File (DHF) of a project? Lastly, how should a project manager ensure that regulatory compliance and project completion remain aligned through the life cycle of a project?

Project Managers utilization of PDCA and other structured processes

JacobChabuel — Tue, 03 Feb 2026 02:40:44 +0000

Medical device development is reliant on organization and structure in order to produce a successful product. These structured processes can include design reviews, design changes, and the PDCA cycle. In addition to this, project managers throughout the course of a project must make decisions when to conduct reviews or approve changes that can have an impact on project performance. At what point in the PDCA cycle do you believe design reviews and design change requests are most important? In addition, how should project managers decide to prioritize certain aspects of the project, such as resource pressures, using these tools?

PM's Role Addressing Challenges in Device Approval Pathways

mmk68 — Sun, 01 Feb 2026 08:59:54 +0000

Especially for Class II and III devices, the pathway to FDA approval can take many years and a sizeable budget. As a PM, what are ways that you can ensure the project is following the intended timeline and budget? From experience, when animal or clinical trials are required, there is a significant amount of unpredictability that can occur, which can cause lengthy delays or extra expenses. In the case of delays or extra expenses, what sort of "give and take" might a PM expect when looking to compensate/catch up as best they can, especially balancing project expectations, requirements, and timelines between the FDA and the medical device company?

Project Manager role in Post Market Surveillance

JacobChabuel — Wed, 28 Jan 2026 22:10:53 +0000

In this weeks lecture, we discuss in depth the role of the regulatory department after a project has been completed and is now an available medical device on the market. The regulatory department is responsible for maintaining documentation, maintaining readiness for inspections, maintaining change controls, and more during the post market surveillance phase. That being said, when a project shifts from the development phase to market release, what is the role/responsibilities of the project manager during the post market management phase of a project? What methods or tools should be implemented by a project manager to ensure that they are meeting the requirements of their role during this phase? Lastly, what should a PM do in the event that a device is recalled by the FDA? Let me know your thoughts!

Relationship between the FDA and Project Managers

cra24 — Tue, 27 Jan 2026 19:39:52 +0000

The relationship between the FDA and Project Managers is collaborative but stringent on regulations and constraints. PMs ensure that all aspects of a projects development phases align with the constraints established by the FDA. his means integrating regulatory strategy into project timelines, managing risk through proper validation and verification processes, and maintaining clear documentation such as Design History Files and Device Master Records. What do you think is the most effective method for PMs to maneuver the sometimes highly constrained regulations of the FDA to ensure that a device meets all guidelines required? Additionally, what kind of skills or tools should a PM employ to bring a design to fruition?

Team Conflict with Project Manager

mmk68 — Sun, 25 Jan 2026 00:25:55 +0000

As discussed in other posts, a project manager's interpersonal skills are quite important for the role, and project managers may not possess all of the technical expertise of their team members. In a scenario where one skilled team member and the project manager keep butting heads or seemingly can't resolve their differences, what would the ideal solution be? Interpersonal issues have the chance of impacting the project timeline, and it would be potentially detrimental to remove either of these employees. This is, of course, a dramatic scenario where there may be some level of emotional immaturity, but in a highly collaborative project, I'm sure there are many cases of interpersonal friction. Have you ever encountered this, and what was the solution?