Medical Device Courses | vthampi | Activity

vthampi posted a new topic "Enabling Stakeholder Engagement in Clinical Trials" -

Mon, 15 Apr 2024 01:31:01 -0400

Stakeholder engagement is a critical aspect of clinical trial project management, influencing everything in how a project progresses. However, maintaining effective communication and collaboration among stakeholders can be challenging. How can project teams use stakeholder feedback and insights to enhance… Read more»

vthampi posted a new topic "Outsourcing Clinical Trials" -

Mon, 15 Apr 2024 01:05:56 -0400

Clinical trials are projects to provide relevant data to show the safety and efficacy of a Class I or Class III device. They’re necessary for these devices to be on the market. What are the most prevalent reasons that a… Read more»

vthampi replied to the topic "Clinical Trials" -

Mon, 15 Apr 2024 00:40:41 -0400

Clinical trials are a decisive method to evaluate the safety and efficacy of a device before they hit the market. “Substantial data” to me is more than just the quantity of tests run, but the quality of the tests and… Read more»

vthampi posted a new topic "Team Development at a Low Budget" -

Mon, 08 Apr 2024 04:44:16 -0400

Human resource management contains strategies to help develop the project team. This includes team building activities, reward systems, trainings, and more. However, all of these things cost money and may likely not be upper management’s priority during a project. What… Read more»

vthampi posted a new topic "Necessity of Quality Management" -

Mon, 08 Apr 2024 04:26:58 -0400

Quality Management is about ensuring that the project meets its goals and meets standards set by regulatory bodies. It includes three main processes: quality planning, quality assurance, and quality control. Quality planning establishes the standards that need to be met… Read more»

vthampi posted a new topic "Scope Management Optimization Strategies" -

Mon, 08 Apr 2024 03:42:35 -0400

Establishing project scope is one of the most vital steps of project initiation. However, it can be incredibly difficult because projects need to have boundaries as to what it encompasses, but it also needs to be flexible enough to be… Read more»

vthampi replied to the topic "Risk Management in Medical Device Development" -

Tue, 02 Apr 2024 04:48:13 -0400

Balancing product innovation and patient safety is only possible with rigorous quality standards and a strict adherence to them. First, performing comprehensive risk assessments on the device during every phase of the project is essential in creating an updated risk… Read more»

vthampi replied to the topic "Key Questions in Root Cause Analysis" -

Tue, 02 Apr 2024 04:23:06 -0400

All of the questions above are excellent and I would like to add a few other important ones. “How frequently does the problem occur?” and “Are there any variations between instances?” can help gauge the broader impact of the problem…. Read more»

vthampi replied to the topic "Monitoring and Controlling in a Project" -

Tue, 02 Apr 2024 04:11:16 -0400

In a medical device project, a robust monitoring and controlling process is crucial in clinical trials. These trials essentially determine the safety and efficacy of your product, so it is critical that their progress is monitored closely. Unexpected developments during… Read more»

vthampi posted a new topic "Changes to Products in Production" -

Tue, 19 Mar 2024 04:24:46 -0400

Once a project closes and it is ready for production, all documents necessary for making the product are handed over to manufacturing and the product goes into production. However, does this mean that the project manager and project team has… Read more»

vthampi posted a new topic "Strategies to Counteract Negative Schedule Variance" -

Tue, 19 Mar 2024 04:05:27 -0400

Schedule Variance (SV) is the quantification of the monetary difference between where the project is (by percent completed and the total budget, not the actual cost) and where the project originally planned to be at that point in time. A… Read more»

vthampi posted a new topic "Leaders of Change Control" -

Tue, 19 Mar 2024 03:54:53 -0400

Change control is critical in any medical device company, considering the products that are sold are directly affecting the lives of patients. For this reason, any changes made to these products must go through vigorous review and approval processes via… Read more»

vthampi replied to the topic "PM in External Partnerships" -

Tue, 05 Mar 2024 05:39:17 -0500

Managing internal and external expectations can get really complex. In addition to having clear communication with everyone, critical decisions need to be made with key stakeholders from both the internal and external sponsors being in the same meeting so that… Read more»

vthampi posted a new topic "Compromises in Conflict" -

Tue, 05 Mar 2024 05:12:41 -0500

In this week’s mini-sim, the first hurdle to overcome was a management-dictated timeline being ultimately unreasonable without a significant increase in project risk. The preferred outcome to this was to put management and a technical expert in the same room… Read more»

vthampi posted a new topic "Instances of Multiple PMs" -

Tue, 05 Mar 2024 04:51:18 -0500

After this week’s lecture, it’s not hard to imagine that managing a project can get extremely overwhelming for one person. Especially during the execution of the project, the PM has so many responsibilities including, but not limited to: distributing information… Read more»

vthampi replied to the topic "Monitoring and Controlling Planned Value" -

Mon, 26 Feb 2024 01:28:54 -0500

There are a few techniques to regularly maintain the planned value during the monitoring phase: consistently tracking project progress, analyzing the root causes of variances that come up, and keeping up with risk management strategies. Regularly monitoring during the monitoring… Read more»

vthampi replied to the topic "What is the difference between project management process and design control?" -

Mon, 26 Feb 2024 01:11:44 -0500

Design controls are what is required to complete a project. Project Management is what’s required for it to go SMOOTHLY. To be more specific, design controls (if done correctly) are a surefire way to meet regulatory standards and thoroughly document… Read more»

vthampi replied to the topic "Feasibility Research vs Marketing Research" -

Mon, 26 Feb 2024 01:02:04 -0500

The pre-feasibility/feasibility dataset and BAM are both critical in initiating projects. The pre-feasibility/feasibility dataset feeds into the BAM by making an assessment on the economic, operational, and technical viability of the project. Without this data, it would be significantly more… Read more»

vthampi replied to the topic "Project Charter" -

Mon, 19 Feb 2024 20:38:32 -0500

As you said, market and technical research is incredibly important for stakeholders’ consideration. If the idea is really that “grand,” then the market research should reflect that. Business presentation is also a factor, having done extensive research is absolutely necessary… Read more»

vthampi posted a new topic "Keeping Finances a Secret from the PM" -

Mon, 19 Feb 2024 20:23:44 -0500

In the lectures for this week, the professor mentioned that the managers sometimes keep project finances a secret from Project Managers. Can anyone provide insight as to why this may be? What benefits are derived from not disclosing the budget… Read more»

vthampi posted a new topic "FS and SF in Gantt Chart Relationships" -

Mon, 19 Feb 2024 20:13:09 -0500

There are four main relationships among tasks in Gantt charts: start-to-finish (SF), finish-to-start (FS), finish-to-finish (FF), and start-to-start (SS). These are all relationships that two tasks may have with each other. SF refers to when the start of one task… Read more»

vthampi replied to the topic "Difficulty of Changes" -

Mon, 12 Feb 2024 02:06:23 -0500

I agree with @sah67 in that in general, changes made at the beginning of a project are the easiest to implement. As time goes on, documents start to build up and information is based off of previous documents. More and… Read more»

vthampi posted a new topic "Transference of Risk in Medical Device Companies" -

Mon, 12 Feb 2024 01:46:27 -0500

There are four main ways of dealing with risk: avoidance, mitigation, acceptance, and transference. I understand the first three in the context of the medical device industry. For example, three methods of dealing with risk can be seen in a… Read more»

vthampi posted a new topic "Estimates When Making the Project Plan" -

Mon, 12 Feb 2024 01:35:37 -0500

As mentioned in lecture today, the project plan includes a lot of estimates that do not have to be entirely accurate. This includes a vague timeline of the project, budgets for different stages of the project, and a few regulatory… Read more»

vthampi posted a new topic "Project Management Software" -

Tue, 06 Feb 2024 02:26:22 -0500

What constitutes optimal project management software? Are there any recommended ones? I only ever have experience in using Microsoft Project, which I thought was sufficient for what I needed (capstone). However, I am aware that the medical device industry may… Read more»

vthampi posted a new topic "Effective Resource Negotiation Strateiges" -

Tue, 06 Feb 2024 01:44:44 -0500

What are strategies to convey the importance of one’s project to a functional manager (particularly in a matrix organization)? I had limited exposure to resource management in the medical device industry so I do not know how it works. From… Read more»

vthampi posted a new topic "Project Management for Non-PM Positions" -

Tue, 06 Feb 2024 01:31:39 -0500

How important is knowing about project management if someone does not plan on going into it as a career? Is a basic understanding of project management critical even if you are not a PM? I imagine that having at least… Read more»

vthampi replied to the topic "Combination Product Project Management" -

Tue, 30 Jan 2024 04:15:01 -0500

I agree with the above posters in that consultants or SMEs would likely be the most cost-effective and efficient solution. However, if combination products are going to become more staple in the company, they might need to consider investing in… Read more»

vthampi posted a new topic "Functional Organization vs. Weak Matrix Organization" -

Tue, 30 Jan 2024 04:00:18 -0500

Different types of organizations exist in the medical device industry. However, there are two in particular that seem very similar: functional organizations and weak matrix organizations. Functional organizations are organizations that feature departmental silos with the staff working in the… Read more»

vthampi posted a new topic "Unique Product Lifecycles in Medical Devices" -

Tue, 30 Jan 2024 03:42:22 -0500

The product lifecycle has five distinct phases: development, introduction, growth, maturity, and decline. These cycles are generally depicted seeing the sales volume change over time. During development, nothing is being sold. The introduction is the product’s first break into the… Read more»

vthampi replied to the topic "Importance of Culture in Project Management" -

Mon, 22 Jan 2024 22:24:54 -0500

I agree with the previous poster in that project team work culture may differ greatly with the general company work culture. I interned briefly at Stryker and my team was quite supportive and cooperative in terms of collaboration and helping… Read more»

vthampi replied to the topic "PDCA cycle in Biomedical Engineering" -

Mon, 22 Jan 2024 22:10:26 -0500

Each process taken taken in the biomedical industry roughly follows the PDCA cycle, either on a larger project-based scale, or smaller continuous improvements within departments. The planning phase involves identifying problems with the current state, goal setting, and determining what… Read more»

vthampi replied to the topic "Project Management Information Systems" -

Mon, 22 Jan 2024 21:26:50 -0500

Each individual member of a project team reporting progress on their own tasks is an incredibly useful tool for a project manager because they are able to quantify exactly how the project is progressing and have an understanding of what… Read more»

vthampi replied to the topic "project team" -

Wed, 17 Jan 2024 19:38:00 -0500

A role that has been around for a long time but is sometimes severely underutilized in the biomedical industry is usability engineering. Usability engineering is a term for people who help alter designs, packaging, manuals, and other aspects of a… Read more»

vthampi posted a new topic "Project Management in the Biomedical Industry" -

Wed, 17 Jan 2024 19:26:58 -0500

Are there any topics in Project Management that one would find in a Medical Device company that are unique to the biomedical industry? Conversely, are there any topics that appear frequently in Project Management for most industries but are… Read more»

vthampi replied to the topic "How to increase emotional intelligence" -

Wed, 17 Jan 2024 19:13:55 -0500

Increasing one’s emotional intelligence (EI) is a lot harder and more personalized than increasing one’s technical knowledge or critical thinking skills. I think something really important in raising EI is having the ability to recognize one’s lack of it and… Read more»

vthampi replied to the topic "Contract Law components examples" -

Mon, 27 Nov 2023 18:21:12 -0500

An example of contract law can be a joint replacement (JR) company buying their raw materials from a company specializing in metal. The offer and acceptance of the contract would be the terms of the agreement. The metal company will… Read more»

vthampi replied to the topic "Confidential Agreement Secrecy" -

Mon, 27 Nov 2023 17:56:47 -0500

As the other posts have already mentioned, confidentiality agreements contain all of the basic components of a contract. Offer and acceptance indicates that both parties are aware of the agreement and have both accepted it. Consideration is directly stating what… Read more»

vthampi replied to the topic "When is giving gifts like the "old days" too much?" -

Mon, 27 Nov 2023 04:40:21 -0500

I have not experienced gift-giving in the corporate world myself, although we did have training on it. As a commentor above has said, it is pretty similar to academia where an instructor accepting a gift may lead to bias in… Read more»

vthampi replied to the topic "Malsow's law in organization" -

Sat, 18 Nov 2023 19:04:30 -0500

I think something that is heavily under-utilized in corporate settings is “esteem” in Maslow’s hierarchy of needs. Starting from the bottom, I believe that physiological and safety needs are likely being met by necessity in the corporate world. There could… Read more»

vthampi replied to the topic "project management: organization structure" -

Sat, 18 Nov 2023 18:47:56 -0500

Organizational structures will affect project management in the way the project is conducted and how much power the project manager, functional lead, or executive head will have. A functional organization will place a lot of power in the chief executive’s… Read more»

vthampi replied to the topic "Matrix Organization success examples" -

Sat, 18 Nov 2023 17:23:03 -0500

In my personal experience I have only experienced a “Weak Matrix” organization, so I can only speak to that scenario from experience, but I can assume how it might work in a “Strong Matrix” organization.From my own experience, I was… Read more»

vthampi replied to the topic "US FDA vs EU MDR Risk management" -

Wed, 15 Nov 2023 16:07:52 -0500

ISO 13485 is functionally the same as ISO 14971, however there is an additional requirement on following EU MDR (European Union Medical Device Regulations). EU MDR does have some significant differences from the regulations dictated by the FDA. One important… Read more»

vthampi replied to the topic "Risk Analysis Experience" -

Wed, 15 Nov 2023 15:56:30 -0500

I have interned with a risk management team of a medical device whiles they were dealing with a pretty big non-conformance in their processes, so I have had experience in the CAPA process. CAPA stands for corrective and preventative action,… Read more»

vthampi replied to the topic "Risk Management: Risk v.s. Reward" -

Wed, 15 Nov 2023 15:39:36 -0500

Risk management happens throughout the lifecycle of the device, so it is absolutely looked at to determine the rewards and profits that the device could bring. However, it is often not the primary reason the project will continue or cease…. Read more»

vthampi replied to the topic "Project Proposal" -

Wed, 08 Nov 2023 00:28:32 -0500

I think the most important steps about a project proposal is having realistic expectations of the project. Being specific and having clear expectations for the device and the processes going into making it is ideal. Being able to fully and… Read more»

vthampi replied to the topic "Design Input Requirement Categories" -

Wed, 08 Nov 2023 00:12:34 -0500

A heart monitor is a device that adheres to a patient’s chest for a specified amount of time and records their heartbeat in that duration. A functional requirement is that it must be able to accurately obtain data on the… Read more»

vthampi replied to the topic "Document Corrections" -

Tue, 07 Nov 2023 23:50:05 -0500

There will always be some form of change control as long as these documents are not in a “draft” state. If the document has a revision associated with it, any and all changes will go through change control, no matter… Read more»

vthampi replied to the topic "Design Control Job Roles" -

Sat, 28 Oct 2023 21:59:46 -0400

I have worked in a medical device company as a quality engineer and although I did not directly work with design controls on new products, I did get a chance to learn about the processes quite a bit. The first… Read more»

vthampi replied to the topic "Steps of Process Validation" -

Sat, 28 Oct 2023 21:39:37 -0400

Validation during design controls is meant to provide evidence that the device inputs address the customer needs. This is vaguely captured by the following four facets of validation: planning, review, methods, and documentation. Planning essentially details all the features of… Read more»