Medical Device Courses | seg28 | Activity

seg28 replied to the topic "Are you an X or Y?" -

Sun, 03 May 2026 23:21:27 -0400

As a manager, I would prefer a Y employee who is motivated but lacks some required knowledge rather than an X employee in this scenario. Motivation is harder to teach than technical skills. Someone who is motivated from the start… Read more»

seg28 replied to the topic "Understanding Project Management as a Non-Project Manager" -

Sun, 03 May 2026 22:53:58 -0400

Understanding project management is useful even if you’re not the one leading the project. Engineers are still involved with working with timelines, budgets, and project goals. Having this knowledge allows you to see how your role as a team member… Read more»

seg28 replied to the topic "Overworked Americans vs. Motivation" -

Sun, 03 May 2026 22:26:47 -0400

I think it’s less about people being more motivated, and more about feeling pressured to keep up. From what I’ve seen and heard from my peers, many employees are expected to take on workloads that aren’t realistic to complete within… Read more»

seg28 replied to the topic "Employee Engagement" -

Mon, 27 Apr 2026 01:34:09 -0400

The only industry experience I have so far is through my internship at a biotechnology company, however, this company made a strong effort to keep interns engaged. One of the things the company did was host weekly presentations on different… Read more»

seg28 replied to the topic "Why Do People Leave?" -

Mon, 27 Apr 2026 01:10:11 -0400

I don’t think job satisfaction is the most important factor for employee retention and engagement. People also stay for growth opportunities, team relationships, compensation, and benefits. I think what’s most important is to avoid demotivating employees. For example, there is… Read more»

seg28 replied to the topic "Let's Be Motivated!!!" -

Mon, 27 Apr 2026 00:09:53 -0400

If I were a project manager in the medical device industry, I would focus not only on motivating my team, but also on avoiding things that would demotivate team members. I would recognize individual contributions, support their growth, and create… Read more»

seg28 replied to the topic "Changining staff" -

Mon, 20 Apr 2026 00:12:30 -0400

My first thought after reading this post is that a project manager could look to hire someone new to replace that person. However, hiring someone new can take longer than expected, especially with onboarding and training. Because of this, a… Read more»

seg28 replied to the topic "Navigating unknown project budgets" -

Sun, 19 Apr 2026 23:47:56 -0400

One way a project manager can handle an unknown budget is by setting aside a contingency reserve for risks and potential design changes. Even if the budget is unknown to the project manager, the PM would usually have rough estimates… Read more»

seg28 replied to the topic "Nine Knowledge Areas" -

Sun, 19 Apr 2026 22:21:10 -0400

I think the most important knowledge areas are scope, time, and cost management. Scope management is important because it defines the goals of the project and the work that must be done. If scope isn’t clearly defined, it can lead… Read more»

seg28 replied to the topic "Validation and Verification" -

Mon, 13 Apr 2026 00:10:13 -0400

Design verification focuses on testing if the device is built correctly according to design specifications and validation ensures that the “correct device” is built and meets the user needs or intended use. Most of the verification and validation activities take… Read more»

seg28 replied to the topic "Factors affect schedule variance (SV)" -

Sun, 12 Apr 2026 23:45:52 -0400

There are many different factors that can impact schedule variance for a medical device project. For example, delays in regulatory approvals can add weeks or months to a schedule and lower earned value. Failing during verification or validation can cause… Read more»

seg28 replied to the topic "Medical Device Companies" -

Sun, 12 Apr 2026 23:10:52 -0400

Since a lot of people have already shared many great companies on the East Coast, I wanted to share a few that I was particularly interested in when I was living in California. In Southern California there are a lot… Read more»

seg28 replied to the topic "Overlapping activities" -

Sun, 15 Mar 2026 22:44:40 -0400

I agree that returning to an earlier phase of a project does not necessarily mean the project is failing, however, in the case of medical device projects, this can be very costly and potentially derail a project. Because of this,… Read more»

seg28 replied to the topic "Most Important Phase" -

Sun, 15 Mar 2026 22:23:36 -0400

I think the most important phase in the project process is the planning phase because it establishes the foundation for the entire project. During planning, the project scope, timeline, and project team are clearly defined. For a medical device project,… Read more»

seg28 replied to the topic "PM Personnel Management" -

Sun, 15 Mar 2026 21:56:55 -0400

I think that a project manager can be accommodating to their team members while also successfully managing a project through good communication and setting clear expectations. If team members understand project goals, the project timeline, and their responsibilities from the… Read more»

seg28 replied to the topic "Importance of Stakeholders" -

Mon, 09 Mar 2026 03:11:32 -0400

I think that managers and stakeholders are both important to a project, however when it comes to completing a project promptly, managers play the more critical role. Investors provide the funding and resources needed to begin a project, while managers… Read more»

seg28 replied to the topic "Making Design Reviews Work in Medical Devices" -

Mon, 09 Mar 2026 02:50:36 -0400

Being prepared before a design review meeting is important to ensure the meeting runs smoothly and a decision about moving forward to the next phase of the design control process can be made. Before the meeting, I think it would… Read more»

seg28 replied to the topic "Risk Management in Project Planning" -

Mon, 09 Mar 2026 02:34:20 -0400

Balancing risk and reward is one of the biggest challenges in risk management. While minimizing risk is necessary, trying to eliminate every possible risk can slow down development and increase costs. It is best practice to focus on reducing risks… Read more»

seg28 replied to the topic "Project Slack Time" -

Mon, 02 Mar 2026 03:03:51 -0500

Slack is the amount of time a task can be delayed without delaying the project completion date. As others have stated, project slack is important because it gives a project manager flexibility. A project schedule without any slack would mean… Read more»

seg28 replied to the topic "Cost and Resource Allocation in Project Planning" -

Mon, 02 Mar 2026 02:43:38 -0500

Estimation failures in the planning phase of a medical device project can severely threaten the success of a project because cost, project timeline, and regulatory compliance are connected. If tasks in the work breakdown structure like verification testing or biocompatibility… Read more»

seg28 replied to the topic "Avoidance in each Project Area" -

Mon, 02 Mar 2026 02:17:38 -0500

Avoidance is most easily incorporated during the product design phase. During the design phase the device is still conceptual, and hazards can be eliminated before they are built into the product. In addition, design changes at this stage are less… Read more»

seg28 replied to the topic "Team members personal issues with eachother" -

Sun, 22 Feb 2026 23:36:52 -0500

I agree that it is important to remain impartial when dealing with conflicts between team members. However, this becomes much more challenging when the project manager and a team member are the ones experiencing issues. I have experienced this while… Read more»

seg28 replied to the topic "Planning Techniques" -

Sun, 22 Feb 2026 22:36:56 -0500

Detailed planning should definitely take place before the planning phase of the project management process concludes. However, I think it’s important that the project management plan should not be viewed as a document that is finalized and instead be treated… Read more»

seg28 replied to the topic "Making connections between people and schools" -

Sun, 22 Feb 2026 00:49:29 -0500

Hi everyone!
My name is Sarah Gildea, and I am pursuing a graduate certificate in Biomedical Device Development at NJIT. I look forward to connecting with all of you!
Here is my LinkedIn: https://www.linkedin.com/in/sarah-gildea1/

seg28 replied to the topic "The effect that organizational structures have on project management" -

Mon, 16 Feb 2026 00:07:32 -0500

While I do not have direct experience in the medical device industry, I have experience working at a local retail store whose structure closely resembled a matrix organization. As a supervisor and department head of the toy department, I reported… Read more»

seg28 replied to the topic "A Hypothetical Perspective about the First Simulation" -

Sun, 15 Feb 2026 23:45:57 -0500

After completing the simulation, I do not believe changing the Design Specification Document (DSD) is necessary to resolve the failed verification test. When I asked if there is a minimum or maximum temperature the product must remain at, Dr. Simon… Read more»

seg28 replied to the topic "Failed Verification Testing" -

Sun, 15 Feb 2026 23:20:09 -0500

While I don’t have any formal industry experience, I do have experience following the design control process for my undergraduate capstone process. Over the course of one year, my team was developing a prototype of the arm that could train… Read more»

seg28 replied to the topic "Design Input Document (DID) and Design Specification Document (DSD)" -

Sun, 08 Feb 2026 20:04:35 -0500

I also have wondered why the design inputs and specifications are split into two documents. The Design Input Document falls under the planning phase of the PDCA cycle and focuses on user needs and intended use while the Design Specification… Read more»

seg28 replied to the topic "The Nine Points of Design Control and How to Effictively Use and Understand Them." -

Sun, 08 Feb 2026 19:32:45 -0500

I agree that it is crucial to treat a DHF as a living document that is built throughout the project rather than assembled at the end. Waiting until the design is completed significantly increases the risk of missing documentation or… Read more»

seg28 replied to the topic "Determining Spec" -

Sun, 08 Feb 2026 18:38:59 -0500

It is extremely important to have justified specifications for each design input when following design controls for medical devices. To determine specification, you would look at each design input individually and define a measurable value or range that meets that… Read more»

seg28 replied to the topic "Sizes of Project Teams" -

Mon, 02 Feb 2026 01:52:22 -0500

When working on a project, and especially when leading a project, I prefer to have a smaller team. Smaller project teams make communication more effective and allow the project manager to more easily monitor progress and ensure that everyone stays… Read more»

seg28 replied to the topic "PM's Role Addressing Challenges in Device Approval Pathways" -

Mon, 02 Feb 2026 01:26:07 -0500

For Class II and Class III medical devices long timelines and high costs are almost always inevitable. Because of this, one of the most important roles of a project manager is to maintain control over the budget and timeline. One… Read more»

seg28 replied to the topic "Misclassification of a Device?" -

Sun, 01 Feb 2026 18:44:09 -0500

In addition to the challenges that would come up for filing the incorrect device classification, this may also signal to the FDA that the company submitting the classification does not completely understand the risk of the device or its intended… Read more»

seg28 replied to the topic "Role of Project Management in Medical Device Development" -

Sun, 25 Jan 2026 20:17:30 -0500

I think the biggest challenge in managing medical device projects is balancing regulatory requirements with innovation. With medical device development, regulatory compliance needs to be implemented into every phase of the project, rather than treated as a final step. This… Read more»

seg28 replied to the topic "How to communicate effectively between team mates in project team ?" -

Sun, 25 Jan 2026 18:48:15 -0500

To communicate effectively with members of a project team, the team leader or project manager should clearly set expectations regarding project goals, major deadlines, and team member roles and responsibilities at the start of the project. Everyone on a team… Read more»

seg28 replied to the topic "Team Conflict with Project Manager" -

Sun, 25 Jan 2026 17:51:14 -0500

I have experienced working in a project team where team members have had interpersonal issues in the past. The first step to solve this is for the Project Manager to address the conflict in a private meeting and focus on… Read more»

seg28 replied to the topic "Poka-Yoke/ Error Proofing" -

Sun, 16 Nov 2025 20:30:50 -0500

Poka-yoke is a Lean manufacturing principle focused on preventing mistakes by making errors either impossible or immediately detectable. Common examples include designing components that can only be assembled in one orientation, using uniquely shaped connectors, or applying clear color coding… Read more»

seg28 replied to the topic "Can Risk Really Be Eliminated — or Only Managed?" -

Sun, 16 Nov 2025 20:13:59 -0500

I do not believe companies should strive for completely risk-free designs but rather work to reduce risk as much as possible without compromising the device’s intended function. Every medical device carries some level of inherent risk, and the goal is… Read more»

seg28 replied to the topic "Risk Acceptance" -

Sat, 15 Nov 2025 19:40:18 -0500

Risk acceptance does not necessarily increase the probability that a risk will occur. Risks are typically accepted rather than mitigated when they cannot be further reduced through design changes, when the overall benefits of the device outweigh the potential harms,… Read more»

seg28 replied to the topic "Capstone Project Proposals (Shortened PDF)" -

Sun, 09 Nov 2025 21:00:58 -0500

My senior project was a model of the upper extremity that trains physical therapy and medical students to perform ligament integrity tests and joint reductions. The prototype incorporated mechanically relevant soft tissue structures and provided real-time force feedback through a… Read more»

seg28 replied to the topic "Bridging the Gap Between Users Needs and Design Inputs" -

Sun, 09 Nov 2025 20:09:20 -0500

The best way to translate a qualitative user need into a quantitative and testable design specification is through thorough research of standards and peer-reviewed literature. You must begin by identifying the functional requirements that directly support the user need, then… Read more»

seg28 replied to the topic "Design Matrix Content" -

Sat, 08 Nov 2025 18:10:26 -0500

I believe that the four columns (design inputs, specifications, verification, and validation) provide enough information for a design matrix. The purpose of the matrix is to serve as a tool for mapping and tracking the entire design control process, and… Read more»

seg28 replied to the topic "How Many Design Reviews Are Enough?" -

Sat, 01 Nov 2025 01:14:06 -0400

I think that the number of design reviews should depend on the complexity of the device. Although the FDA requires only one formal review, a single review is not sufficient for most devices and may raise concerns during regulatory evaluation…. Read more»

seg28 replied to the topic "Do Design Controls Help Innovation or Slow It Down?" -

Fri, 31 Oct 2025 23:44:13 -0400

I believe that design controls actually support innovation rather than hinder it, because they require clearly defined user needs and plan for each stage of the design process. Creating a medical device without a genuine user need or large enough… Read more»

seg28 replied to the topic "The Relationship Between Verification and Validation" -

Fri, 31 Oct 2025 22:22:15 -0400

I believe it is more common for verification and validation activities to remain separate processes. Verification ensures that a device has been designed correctly, while validation confirms that the correct device has been designed to meet user needs. Verification can… Read more»

seg28 replied to the topic "Clinical Trial Roles" -

Mon, 27 Oct 2025 01:46:51 -0400

If I worked in clinical research, I would like to have the role of a monitor. Monitors have the role of ensuring clinical trials are run safely and ethically, that data is accurate and reliable, and that patients’ rights are… Read more»

seg28 replied to the topic "Placebo Effect" -

Mon, 27 Oct 2025 01:13:16 -0400

The placebo effect can make it difficult to tell whether improvements in patients are due to the actual drug or simply their belief that they are receiving treatment. To differentiate, results are compared between the placebo group and the active… Read more»

seg28 replied to the topic "Gold Standard or Paperwork Nightmare?" -

Mon, 27 Oct 2025 00:34:07 -0400

While many GCP guidelines involve extensive documentation, I believe they are absolutely necessary to protect patients participating in clinical trials. These standards are the foundation for building trust between patients, physicians, and researchers as new medical innovations emerge. They protect… Read more»

seg28 replied to the topic "Discussion Topic: The Fifth "P" of Marketing" -

Sun, 19 Oct 2025 16:57:58 -0400

A clever example of participation that I have personally witnessed is how brands interact with people’s videos on TikTok. Many companies now reply to user generated social media content in the comment section or even create their own “stitches” with… Read more»

seg28 replied to the topic "Market growth rate" -

Sat, 18 Oct 2025 00:18:07 -0400

Novo Nordisk has experienced remarkable growth in recent years, due to the success of its drugs Ozempic and Wegovy. The company’s market value and revenue increased significantly in both 2023 and 2024, with annual revenue reaching $33.72 billion in 2023… Read more»