Medical Device Courses | archishak | Activity

archishak replied to the topic "Scope Management Optimization Strategies" -

Thu, 11 Apr 2024 02:08:15 -0400

In addition to the control measures mentioned in the previous replies, there are other ways to control scope creep. One essential way is to maintain open and transparent communication with everyone involved in the project, especially the stakeholders. Doing so… Read more»

archishak replied to the topic "Necessity of Quality Management" -

Thu, 11 Apr 2024 00:43:55 -0400

There are multiple factors as to why smaller companies do not have Quality Management (QM). One of the reasons is because of resource constraints. Smaller companies typically have limited personnel and financial resources and implementing a Quality Management System (QMS)… Read more»

archishak replied to the topic "Bottom-Up vs Analogous Estimations - Project Cost Management" -

Thu, 11 Apr 2024 00:34:15 -0400

Both bottom-up estimations and analogous estimations have their benefits and limitations. For more complex projects, a bottom-up estimation may be more effective where the tasks are well-defined and the project scope is clear. Moreover, projects with higher stakes often have… Read more»

archishak replied to the topic "Verification & Validation NDAs" -

Sun, 07 Apr 2024 18:15:51 -0400

It can be tricky to ascertain when a gag order is needed. For example, a gag order should not be issued when reporting illegal activities or when there is a violation of ethical standards. Therefore, it is important to maintain… Read more»

archishak replied to the topic "Collaborative Research in Academia and Industry" -

Sun, 07 Apr 2024 18:03:22 -0400

Ensuring that academia’s open research culture is aligned with the industry’s need for secured data can be difficult but possible. First, clear communication and expectations should be outlined where data sharing, storage, and protection should be discussed. Data sharing agreements… Read more»

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

Sun, 07 Apr 2024 17:39:41 -0400

Although schedule, budget, resources, performance, and scope are some parameters that should be closely monitored and controlled, there are a few other parameters that should be controlled as well. One of them being quality assurance. It is essential to control… Read more»

archishak replied to the topic "Changes to Products in Production" -

Sat, 23 Mar 2024 01:54:50 -0400

The project manager/team may still be involved with the product even if the project is closed and is being transitioned into production. This is because they may provide valuable expertise or knowledge regarding the product and serve as SMEs. The… Read more»

archishak replied to the topic "Strategies to Counteract Negative Schedule Variance" -

Sat, 23 Mar 2024 01:25:39 -0400

One way to navigate through negative SV is to identify the root cause behind the delay in the project schedule. Reasons could include resource constraints or changes in requirements that delay the schedule. Reallocating resources could also aid in navigating… Read more»

archishak replied to the topic "Leaders of Change Control" -

Fri, 22 Mar 2024 17:56:19 -0400

When working with medical devices, the safety and efficacy of the products must be maintained, especially through change controls. It is typically the change control board/committee that oversees these changes. The board/committee contains individuals who are equipped with the necessary… Read more»

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

Sun, 10 Mar 2024 23:49:09 -0400

Balancing internal and external expectations requires a combination of communication, collaboration, and having a clear framework for decision-making. This can be achieved by ensuring that the changes in the project align with the strategic objectives of both companies and ensuring… Read more»

archishak replied to the topic "Instances of Multiple PMs" -

Sun, 10 Mar 2024 23:11:28 -0400

As mentioned in the responses above, there are multiple ways to navigate dynamics between multiple project managers. Establishing clear goals and responsibilities for each manager would diminish any confusion between them; moreover, tasks can be allocated depending on specific project… Read more»

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

Sun, 10 Mar 2024 05:05:52 -0400

Companies need to manage risks while also balancing innovation and patient safety. Some ways to do that can be through iterative design and verification processes where the project would have incremental improvements while also ensuring that each iteration is up… Read more»

archishak replied to the topic "Initiating Process Group" -

Wed, 28 Feb 2024 23:55:47 -0500

As mentioned in previous replies, organizational process assets (OPAs) are the primary source for procedures and guidelines that exist within a company. OPAs contain documented procedures and guidelines that provide a framework for how the work is performed in the… Read more»

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

Wed, 28 Feb 2024 23:38:18 -0500

The pre-feasibility/feasibility dataset and the BAM dataset are interrelated in many ways. One way is that the data gathered in the pre-feasibility/feasibility dataset provides information regarding the technical and financial aspects of the project which sets up the premise for… Read more»

archishak replied to the topic "Determining relationships between tasks" -

Wed, 28 Feb 2024 19:12:40 -0500

Using and developing a detailed Gantt chart can be time-consuming. Even more so when the dependency is solely on the project manager. To mitigate this issue, the project manager should hold collaborative planning sessions where team members from different areas… Read more»

archishak replied to the topic "Project Charter" -

Thu, 22 Feb 2024 01:10:41 -0500

Mitigating financial challenges requires a multifaceted approach where the focus is not only on the business case presentation but also on developing strategic and innovative financial planning. Some ways to mitigate the obstacles mentioned can be through the use of… Read more»

archishak replied to the topic "Keeping Finances a Secret from the PM" -

Thu, 22 Feb 2024 00:13:36 -0500

Keeping project finances from PMs does seem counterintuitive; however, there are some reasons why it may be beneficial. One of the reasons could be that organizations want to encourage creativity and innovation and limiting knowledge of the budget could force… Read more»

archishak replied to the topic "FS and SF in Gantt Chart Relationships" -

Wed, 21 Feb 2024 23:49:28 -0500

The key distinction between FS and SF is the direction of dependency. FS can be described as having a “forward-looking” dependency where Task B’s start is dependent on Task A’s finish. SF can be described as an almost “backward-looking” dependency… Read more»

archishak replied to the topic "Estimates When Making the Project Plan" -

Thu, 15 Feb 2024 01:05:14 -0500

There are different avenues that new companies could approach to develop these estimates. One of them is to consult experts within the industry, for example, subject matter experts (SMEs), who can provide valuable insight regarding the estimates. Moreover, these new… Read more»

archishak replied to the topic "Initiating Medical Device Projects" -

Thu, 15 Feb 2024 00:55:24 -0500

There are various traps and obstacles that can occur during the project initiation phase. One of them could be the possibility of having unclear project objectives which would result in delays and even project failure. This can be mitigated by… Read more»

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

Wed, 14 Feb 2024 23:58:38 -0500

Avoidance is more easily incorporated and possible in the product design phase of the product, product design, and manufacturing process. This is because the product design phase is in the earlier developmental stage of the product lifecycle. This means changes… Read more»

archishak replied to the topic "Strategies for Conducting Effective Design Review Meetings" -

Thu, 08 Feb 2024 01:45:14 -0500

To ensure appropriate approvals during the design review meetings, project managers need to incorporate careful planning with appropriate preparation and effective communication. Project managers should clearly and precisely define goals and objectives for the team to follow. These expectations should… Read more»

archishak replied to the topic "Effective Resource Negotiation Strateiges" -

Thu, 08 Feb 2024 01:19:40 -0500

In a matrix organization, effective communication and negotiation are essential for proper resource allocation between the project manager and the functional manager. One way to do this is by clearly stating the project’s objectives and deliverables and what the impact… Read more»

archishak replied to the topic "Project Management for Non-PM Positions" -

Wed, 07 Feb 2024 19:58:09 -0500

Having a basic understanding of project management can always come in handy, even if one does not plan on going into that particular field. It can help one understand the various roles seen within a project and by doing so,… Read more»

archishak replied to the topic "Unique Product Lifecycles in Medical Devices" -

Thu, 01 Feb 2024 19:56:14 -0500

As you mentioned, class I devices such as tongue depressors or masks would have an extended maturity phase due to the consistent demand for these products and the limited room for significant improvement. In addition to many class I devices,… Read more»

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

Thu, 01 Feb 2024 19:04:54 -0500

For successful management of a project that the manager has little expertise in, there are multiple steps that the manager can take to ensure the success of the project. The first step could be to assemble a team of experts… Read more»

archishak replied to the topic "Functional Organization vs. Weak Matrix Organization" -

Thu, 01 Feb 2024 00:07:16 -0500

To put it simply, functional organizations have centralized authority, whereas weak matrix organizations have shared authority between functional managers and project managers. Additionally, for functional organizations, projects are managed within functional departments while for weak matrix organizations, projects have dedicated… Read…[Read more]

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

Thu, 25 Jan 2024 01:03:56 -0500

Team members must be appropriately motivated to report their tasks which can become a tedious task at some points. Here are a few ways the team members can be motivated: 1. Recognizing and showcasing the individual contributions of the team… Read more»

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

Thu, 25 Jan 2024 00:02:19 -0500

I agree with the notion that culture plays a crucial role in project management and although I am not personally aware of any company or organization that is in dire need of culture upgrade, I can talk about some points… Read more»

archishak replied to the topic "Difference between drug and medical device?" -

Wed, 24 Jan 2024 23:22:08 -0500

Both medical devices and drugs are essential parts of healthcare and medicine. Although both have quite a few similarities, they also have quite a few differences. They’re similar in that they can be used to diagnose, prevent, and treat diseases… Read more»

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

Mon, 22 Jan 2024 01:06:24 -0500

Emotional intelligence is quite crucial to the path to success. However, schools and training facilities focus more on cognitive abilities and academic access due to the traditional path implemented for the longest time. Emotional intelligence is also quite subjective and… Read more»

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

Mon, 22 Jan 2024 00:47:28 -0500

Employees with different specialties are involved at each stage of the PDCA cycle. The plan and the do stage often consists of engineers, scientists, and regulatory affairs specialists who create and implement the technical aspects of the projects. The check… Read more»

archishak replied to the topic "Project Management in the Biomedical Industry" -

Mon, 22 Jan 2024 00:04:24 -0500

Some topics that are unique to the biomedical industry are risk management in clinical trials and regulatory compliance. Biomedical industries often involve clinical trials that require managing the risks associated with it. Such as integrity issues and handling experiment subjects… Read more»

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

Fri, 01 Dec 2023 21:51:26 -0500

I have not experienced gift-giving in the corporate world; however, there should be some set rules and expectations when it comes to giving gifts. When giving gifts, the company should keep the gifts at a small and nominal level such… Read more»

archishak replied to the topic "International Contract Law" -

Fri, 01 Dec 2023 21:22:53 -0500

International contract law should provide uniformity and consistency across all countries so that there is an even playing field. Moreover, the contract should have a standardized dispute-resolution mechanism so that there is less uncertainty across the multiple legal systems across… Read more»

archishak replied to the topic "Confidential Agreement Secrecy" -

Fri, 01 Dec 2023 17:17:03 -0500

To add to the comments made earlier, a confidential agreement (in addition to the basic components of the contract) should first clearly define what constitutes the document to be confidential and it should also underscore the duration of the confidential… Read more»

archishak replied to the topic "Group Projects: Organizational Types" -

Sun, 26 Nov 2023 19:18:38 -0500

Given that the groups had already been assigned their specialty, such as marketing, pre-clinical research, clinical research, etc., the groups have taken on the structure of a functional organization where there is a clear hierarchy among team members and the… Read more»

archishak replied to the topic "Impact of Covid-19 pandemic on organizational behavior" -

Sun, 26 Nov 2023 18:22:54 -0500

The shift from an in-person environment to a virtual environment definitely had a huge impact on the workforce. For functional organizations, the shift may have impacted maintaining that traditional hierarchy that is often seen in functional organizations. This could have… Read more»

archishak replied to the topic "Matrix Strength" -

Sun, 26 Nov 2023 15:54:46 -0500

The choice of matrix type depends not only on the nature of the medical device being developed but also on various other factors such as organizational structures. A strong matrix type would work well with medical devices that are complex… Read more»

archishak replied to the topic "SWOT analysis for risk management" -

Sat, 18 Nov 2023 21:59:11 -0500

Here is a SWOT analysis for the case mentioned above: Strength: The proposed lithium pump is a novel solution to the problem mentioned and the device could have a significant medical impact and improve the lives of patients with traumatic… Read more»

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

Fri, 17 Nov 2023 22:53:43 -0500

Following the responses made above, ISO 14971 is an internationally recognized standard for risk assessment that both the US and EU use. ISO 13845 is a specific type of risk assessment standard that highlights the requirements for quality management systems… Read more»

archishak replied to the topic "Risk Assessments are necessary or not for medical devices?" -

Fri, 17 Nov 2023 22:11:57 -0500

Based on the question asked in the title, it is absolutely necessary for medical devices to have risk assessments. The risk assessment is conducted in accordance with international standards such as the ISO 14971: Medical devices – application of risk… Read more»

archishak replied to the topic "Design control and risk management" -

Fri, 10 Nov 2023 21:23:39 -0500

The purpose of design control is to create a structured method of managing the design and development process of the product being made. There are several ways design control can be conducted. Design control helps define the requirements of the… Read more»

archishak replied to the topic "Project Proposal" -

Fri, 10 Nov 2023 20:45:51 -0500

A project proposal should include an executive summary, where a brief overview of the project is discussed. It should also include the business needs for the project as well as the objectives of the project. Next, the proposal should include… Read more»

archishak replied to the topic "Document Corrections" -

Fri, 10 Nov 2023 17:07:53 -0500

When it comes to significant errors found in design input documents (DID) or design specification documents (DSD), several steps are often taken to rectify the error. First, the error must be identified. Then a change request (to fix the error)… Read more»

archishak replied to the topic "Design Output" -

Sun, 05 Nov 2023 04:58:53 -0500

You are correct in the sense that every input in the design control process should have an output. However, some companies do not and one of the reasons could be because of the simplistic nature of the medical device at… Read more»

archishak replied to the topic "Initializing Design Controls" -

Sun, 05 Nov 2023 04:06:33 -0500

The first and most important part to implement would be to create a well-structured and communicated process for the change that will be occurring. This can be done through several steps starting with outlining the process that will be implemented… Read more»

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

Sun, 05 Nov 2023 01:20:33 -0400

The medical device that I will be discussing is the digital blood pressure monitor. The functional requirement of this device would be that the device should accurately measure systolic and diastolic blood pressure values and accurately output the heart rate… Read more»

archishak replied to the topic "Clinical Trial Phase 2 Observations" -

Sat, 28 Oct 2023 00:16:09 -0400

Phase 2 of a clinical trial is crucial for testing new medications. It is during this phase that researchers observe the effect of the drugs being tested on a small group of people for an extended period of time. This… Read more»

archishak replied to the topic "Tests and treatments involved in clinical trials" -

Fri, 27 Oct 2023 23:24:04 -0400

A specific testing used in clinical research within the medical device industry is the Premarket Approval (PMA) process. The purpose of this process is to evaluate and ensure that the medical device at hand (a life-sustaining device) is safe and… Read more»