Medical Device Courses | nm523@njit.edu | Activity

nm523@njit.edu replied to the topic "Bottom-Up vs Analogous Estimations - Project Cost Management" -

Mon, 15 Apr 2024 03:20:58 -0400

@archishak brings up very good points, but I would also add that which option is chosen for cost estimation should also depend on the state of your organization at the time of pitching the project. Companies go through fluctuations in… Read more»

nm523@njit.edu replied to the topic "Which factors should be followed while deciding number of alternative vendors ?" -

Mon, 15 Apr 2024 03:09:57 -0400

There is also the matter of long term effect of choosing one vs multiple vendors. If there is a need to change the DSD anyways and alter the project timeline, then the drawbacks (design changes, time) of adding another vendor… Read more»

nm523@njit.edu replied to the topic "Time Management in Medical Devices" -

Mon, 15 Apr 2024 03:06:19 -0400

Another strategy can be in holding stand-up meetings to keep track of every team member’s task. This will ensure that critical tasks are being completed in a timely manner and that nothing is off-track. This will also help keep team… Read more»

nm523@njit.edu replied to the topic "Project Management Knowledge Areas" -

Mon, 08 Apr 2024 03:36:42 -0400

A good tool for ensuring that all knowledge areas are synced and properly coordinated is the Work Breakdown Structure (WBS). This tool allows the project manager to keep track of all the workstreams, from an integration management perspective, scope management,… Read more»

nm523@njit.edu replied to the topic "Integration of KA in Project Scope Management" -

Mon, 08 Apr 2024 03:18:47 -0400

The scope is largely defined by the budget and target product release timeline. For example, the original scope for the project in the initial planning phases may require a 6 year launch timeline, however through discussion with stakeholders, you find… Read more»

nm523@njit.edu replied to the topic "Benefits associated with Work Breakdown Structure" -

Mon, 08 Apr 2024 03:11:41 -0400

Most significantly, a WBS shows 100% of the project, as in it shows every aspect, from the overall project top-level objectives, to the breakdown of tasks, to the team member responsible, to the budget allocated for each task. This allows… Read more»

nm523@njit.edu replied to the topic "Leaders of Change Control" -

Mon, 25 Mar 2024 02:51:47 -0400

Most larger medical device companies have developed an ‘Approval Matrix’ that details out every potential type of change and document category (ex. change to material spec, process spec, risk document, etc) and based on this matrix you can see which… Read more»

nm523@njit.edu replied to the topic "Monitoring and Controlling in a Project" -

Mon, 25 Mar 2024 02:43:35 -0400

An important aspect of a project to monitor is project risk. At the start of the project a risk register is created with the potential risks, severity levels, and mitigation plans. Throughout the project, these risks may come to be… Read more»

nm523@njit.edu replied to the topic "Compromises in Conflict" -

Mon, 11 Mar 2024 03:21:03 -0400

There are many strategies to try to resolve the conflict and discrepancies in understanding between the project lead and upper management, as described in the replies above. One important thing to consider is how to mitigate conflicts like this from… Read more»

nm523@njit.edu replied to the topic "Examples of when Design Validation is Not Required" -

Mon, 11 Mar 2024 03:08:34 -0400

Validation is not required when the customer need is self evident. For example, if the customer need is for a sterile device, no validation test is required since the sterilization is documented as part of the manufacturing process and verified… Read more»

nm523@njit.edu replied to the topic "Email Communication" -

Mon, 11 Mar 2024 03:05:04 -0400

As @shahil mentioned, setting up rules in your email to sort is a great tool for keeping your email organized. There are a few ways to do this:creating a folder for every team member so that you can reference emails… Read more»

nm523@njit.edu replied to the topic "Planning and Executing in Project Management" -

Mon, 04 Mar 2024 04:07:04 -0500

@torikul Agree with all the above but especially wanted to highlight your point about running pilot studies. As a working engineer, I have seen projects dismiss holding a pilot for the sake of ‘saving time’ only to discover several issues… Read more»

nm523@njit.edu posted a new topic "PM in External Partnerships" -

Mon, 04 Mar 2024 04:02:11 -0500

In this week’s simulation, an orthopedic company with a small Biologics division partnered with an external expert on growth factors to develop a product that would boost the Biologics division revenue. This is a strategy I often see employed by… Read more»

nm523@njit.edu posted a new topic "Key Questions in Root Cause Analysis" -

Mon, 04 Mar 2024 03:53:38 -0500

In this week’s simulation, one of the most critical aspects to successfully determining which experiments to run and how to design the experiments involved asking the right questions. A basic skill taught in DOE (design of experiments), Six Sigma, and… Read more»

nm523@njit.edu replied to the topic "Making connections between people and schools" -

Mon, 26 Feb 2024 03:42:08 -0500

Hi everyone!
My name is Nora Moustafa and I am an R&D Engineer at Ethicon, Johnson & Johnson.
Looking forward to connecting: https://www.linkedin.com/in/nora-moustafa?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app

nm523@njit.edu posted a new topic "Determining relationships between tasks" -

Mon, 26 Feb 2024 03:39:13 -0500

As part of the planning phase, all the tasks for the project are determined and placed in a hierarchical work breakdown structure. The next step is to determine the relationship between the tasks and assign timelines. However, determining dependencies and… Read more»

nm523@njit.edu replied to the topic "Who is a Stakeholder?" -

Mon, 26 Feb 2024 03:23:31 -0500

A major stakeholder in medical devices is the healthcare professional who will be using the device. That’s why as part of design controls, a key initial step is gathering customer needs since they are a main stakeholder in the device.

nm523@njit.edu posted a new topic "Project Charter" -

Mon, 19 Feb 2024 04:50:54 -0500

A challenge faced when working in front end research & development is getting a project to charter, particularly, producing a financial model that sponsors can support. Many times the project idea and feasibility have been proven to fit a market… Read more»

nm523@njit.edu replied to the topic "What is the difference between project management process and design control?" -

Mon, 19 Feb 2024 04:41:00 -0500

Think of it this way – design controls are what you have to do to develop a medical device, project management is how you get it done. Design controls involve key milestones and documentation that needs to be done and… Read more»

nm523@njit.edu replied to the topic "Feasibility Research vs Marketing Research" -

Mon, 19 Feb 2024 04:37:43 -0500

The two go hand in hand to form the final business case that allows the project to be chartered. Marketing will do market research to see what the gaps are in the market, gather data on the target customer and… Read more»

nm523@njit.edu posted a new topic "Project Success and Scope Creep" -

Mon, 12 Feb 2024 04:30:56 -0500

A project manager’s role is challenging because at the end of the project, the PM has to demonstrate how the project succeeded or failed. To determine the project success, the PM has to have set clear objectives at the start… Read more»

nm523@njit.edu replied to the topic "How to communicate effectively between team mates in project team ?" -

Mon, 12 Feb 2024 04:19:06 -0500

There are a few communication strategies that can be employed. If sending an email doesn’t work, I usually direct message them. If that doesn’t work, I put a meeting on that person’s calendar. At that point, if there is extreme… Read more»

nm523@njit.edu posted a new topic "Design Verification Failures" -

Mon, 12 Feb 2024 04:13:05 -0500

In this week’s simulation, we were given a failed design verification test and tasked with redesigning the test to find out why it failed and how to fix the test. In the scenario given, there was a single factor that… Read more»

nm523@njit.edu replied to the topic "Test Method Validation" -

Mon, 05 Feb 2024 03:48:46 -0500

The previous replies explain the definition of test method validation quite well, but to answer your question simply on the role of TMV in design controls: test methods are developed for two main reasons in the product development world, 1…. Read more»

nm523@njit.edu replied to the topic "Design Verification vs Design Validation" -

Mon, 05 Feb 2024 03:38:55 -0500

Even though the overall structure is similar, in practice, they are executed differently because the actual tests in design verification are completely different that the tests executed for design validation. As the previous two replies explain, the goals for these… Read more»

nm523@njit.edu replied to the topic "Strategies for Conducting Effective Design Review Meetings" -

Mon, 05 Feb 2024 03:23:01 -0500

Design reviews are formal, structured meetings that occur at the end of important design controls milestones (at the end of design input, output, verification, validation, and transfer). To effectively run these meetings, an agenda must be sent out ahead of… Read more»

nm523@njit.edu replied to the topic "V&V activities and the FDA approach" -

Mon, 29 Jan 2024 03:51:48 -0500

Its true that sometimes it feels like upper management and their timelines are the biggest challenges in a project (and many times that is the actual case), but that is the reality for most large corporations and project managers and… Read more»

nm523@njit.edu posted a new topic "Regulation Number & Product Code for 510k" -

Mon, 29 Jan 2024 03:39:29 -0500

As discussed in the lecture, a 510k submission for a device can be used if the device is substantially equivalent to a legally marketed device. Once the project team determines to go down this regulatory pathway, the regulatory lead on… Read more»

nm523@njit.edu replied to the topic "Regulatory Project Management" -

Mon, 29 Jan 2024 03:19:00 -0500

First, its important to consider the organizational structure when discussing what skills a certain role needs. In regulatory, there will be a department director that oversees multiple regulatory project leads (these are the RA point of contact for every project),… Read more»

nm523@njit.edu posted a new topic "Project Management Information Systems" -

Mon, 22 Jan 2024 04:33:09 -0500

The PMBOK Guide introductory chapter stresses the importance of collecting data and information about the project as it progresses such as work performance data, information, and reports. Companies and project managers will handle this in different ways and employ different… Read more»

nm523@njit.edu replied to the topic "Importance of Culture in Project Management" -

Mon, 22 Jan 2024 04:22:36 -0500

I think there are multiple levels to the culture that an employee will experience in a company. On the smallest level there is the peer-peer relationship. Then there is the manager-direct report relationship. Then there is the project manager-team relationship…. Read more»

nm523@njit.edu replied to the topic "Challenges in Managing Medical Device Projects" -

Mon, 22 Jan 2024 04:10:54 -0500

Medical device development is indeed a unique industry that requires very unique project management and creative decision making in order to comply with regulations, create a functional and effective technological solution, and manage a diverse team. In my experience in… Read more»

nm523@njit.edu replied to the topic "Non-compete agreements" -

Tue, 30 Nov 2021 01:17:40 -0500

I have never encountered a non-compete agreement but I have been asked to sign non-disclosure agreements. Does anyone know the difference between the two? From what I understand, NCA is just a one-way contract to prevent employees from disclosing information… Read more»

nm523@njit.edu replied to the topic "What are the limitations and protections of trade secrets?" -

Tue, 30 Nov 2021 01:06:59 -0500

Additionally, a trade secret only works if no one else comes up with the same idea, recipe, design, etc. on their own. If another company is able to replicate your product without any of their employees having violated any confidentiality… Read more»

nm523@njit.edu replied to the topic "Controversy regarding Advamed Guidlines" -

Tue, 30 Nov 2021 01:01:42 -0500

It is customary in medical device companies to allow for meals with health care professionals (HCP) where the company representative will pay for the meal. There is typically a limit to how much the meal can cost and regulations around… Read more»

nm523@njit.edu replied to the topic "Different Organizations for Different Industries" -

Tue, 23 Nov 2021 05:11:25 -0500

In the last two years, I have noticed a shift in medical device companies organizational structure and a push from my company’s management to transition to a matrix organization with a project management office (PMO). This is because a PMO… Read more»

nm523@njit.edu replied to the topic "For those that work in a matrix based organization:" -

Tue, 23 Nov 2021 04:56:16 -0500

Juggling multiple projects is definitely challenging, but it can be really beneficial to have your hands in several initiative in the company as you can take lessons learned from one project and apply it to another. To avoid getting overwhelmed,… Read more»

nm523@njit.edu replied to the topic "Seniority and Old Habits Vs. Newbies and New Techniques" -

Tue, 23 Nov 2021 04:49:05 -0500

I have noticed that in recent times most companies are trying to be more inclusive of diverse perspectives, including younger professionals, although there are definitely still those who feel entitled due to their seniority within the company. A new manager… Read more»

nm523@njit.edu replied to the topic "Two Types of Risk" -

Mon, 15 Nov 2021 04:10:29 -0500

Internal risks are easier to identify and manage than external risks. An example of internal risk can be in the QA inspection method implemented. If the inspection test method has inherent risks (operator error, variability in equipment, etc) then defective… Read more»

nm523@njit.edu replied to the topic "Risk Management" -

Mon, 15 Nov 2021 03:59:40 -0500

As mentioned above, there are clear advantages to risk management that makes it absolutely necessary for product development and launch. However, there are some things to watch out for. One issue is if the team goes ‘down the rabbit hole’… Read more»

nm523@njit.edu replied to the topic "What is risk control? What are some examples of risk control measures taken?" -

Mon, 15 Nov 2021 03:08:55 -0500

Another form of risk control may be in restructuring manufacturing processes. Therefore the risk management is not necessarily redesigning the product, but how it is made, to reduce risk of failure. In this case, the manufacturing process may be adjusted… Read more»

nm523@njit.edu replied to the topic "Design "Overvalidation"?" -

Tue, 09 Nov 2021 02:42:53 -0500

Typically, several inputs are determined based on the customer needs provided by marketing and the VOC evaluation done by R&D. These inputs are then consolidated to a list that is both extensive enough that it covers all needs but also… Read more»

nm523@njit.edu replied to the topic "Designing Verification Tests" -

Tue, 09 Nov 2021 02:28:30 -0500

Another factor to consider in verification activities is testing conditions that the actual product will undergo. This is not to be confused with validation however, which actually evaluates how the product is physically used. For the verification, you are testing… Read more»

nm523@njit.edu replied to the topic "Validation vs Verification" -

Tue, 09 Nov 2021 02:12:34 -0500

My experience with design verification and validation is that both activities must have strategies developed in the planning phase of the project. For verification, the strategy varies depending on the type of design project. If it is a new product… Read more»

nm523@njit.edu replied to the topic "Validation Types" -

Sun, 31 Oct 2021 20:11:27 -0400

@mmd55 As you mentioned, TMV are important for proving that the way we are testing the medical device is accurate and consistent, ensuring the decisions made about the product from the result of that test are valid. In the medical… Read more»

nm523@njit.edu replied to the topic "Design Control Experience" -

Sun, 31 Oct 2021 20:01:51 -0400

I work in R&D Lifecycle Management so our design change projects are an update or change to an existing product, not the development of a new product. However, we still use design controls to run these projects. 1.Planning – In… Read more»

nm523@njit.edu replied to the topic "Design Verification Ethics" -

Sun, 31 Oct 2021 19:49:35 -0400

I am not personally aware of any companies that openly promote this, but there are definitely cases of negligence that, when caught in an audit, result in a CAPA (corrective action preventative action) that requires a lot more resources, time,… Read more»

nm523@njit.edu replied to the topic "Adverse events (AEs)" -

Mon, 25 Oct 2021 03:38:30 -0400

While I think that wearable device tracking may capture some adverse events that would have otherwise gone unnoticed, I think the issue of patient privacy would be a barrier to the implementation of such a monitoring tool. An advantage that… Read more»

nm523@njit.edu replied to the topic "Clinical Trials for Today's Vaccine" -

Mon, 25 Oct 2021 03:13:34 -0400

Its definitely an interesting observation that now, more than any other time in history, there is a large population of mixed race individuals that combine the biological profiles of multiple races. This is not a unique issue for the covid… Read more»

nm523@njit.edu replied to the topic "Incentives for Clinical Trial Participants" -

Mon, 25 Oct 2021 02:53:10 -0400

@cb447 Selection bias is certainly a pitfall that clinical researchers may fall into if the only incentive for their study is monetary. However, as mentioned above, there are many other possible incentives to join a study and researchers need to… Read more»