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gy66 replied to the topic Challenges PM face in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
A challenge I often notice PM’s have to face is being able to follow along with the details each team member shares during meetings. Each team member spends a lot of their time and resources to provide their deliverables. During daily meetings, each member needs to explain the status of their duties and address any issue they face. Understandably,…[Read more]
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gy66 replied to the topic PM: Handling Team Issues in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
There are a number of things the PM can and cannot do when it comes to dealing with team members that have diverted their time and efforts away from the project. The obvious first course of action is to have a sit down with the associate and professionally discuss the concern. If this does not resolve the situation, it may be worth bringing it up…[Read more]
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gy66 replied to the topic Customer Inputs in the forum Project Management Process and Medical Device Development 6 years, 4 months ago
Part of a workflow our company supports involves scanning in a jaw model of a patient so that a dental restoration can be designed and milled. One step in the scanning workflow requires the customer to screw in a “locator” post that screws into the implant replica in the model. This locator is required to be scanned in so the screw channel for the…[Read more]
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gy66 replied to the topic Risk Management Selection in the forum Project Management Process and Medical Device Development 6 years, 4 months ago
From what I’ve seen, there are several pros and cons of having the PM team responsible for managing risks of a project. Because the product managers should be familiar with all of the functions and processes of the different teams responsible for developing the project, they should be better suited to foresee risks associated with a project. In…[Read more]
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gy66 replied to the topic Points to look for while out sourcing in the forum Project Management Process and Medical Device Development 6 years, 4 months ago
I would think there are many points to consider when selecting a vendor to outsource a specific aspect of a product. One of the most important factors I believe should be considered is the quality of the product. This includes all of the features that the device or end product will depend on to maintain the design specifications. Some examples of…[Read more]
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gy66 replied to the topic Discussion Topic: State of your Organization in the forum Introduction to Project Management 6 years, 4 months ago
I currently work at Nobel Biocare Procera. We are a project-based organization. Because we primarily focus on developing innovative dental prosthetics and implants, as well as implementing them into various softwares, separating each new product or objective into its own project is both appropriate and effective. All project teams usually consist…[Read more]
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gy66 replied to the topic Difference in the forum Introduction to Project Management 6 years, 4 months ago
Of course this all varies depending on the nature of the company, I believe they’re both more different than you’re describing. Clinical Project Managers indeed are more focused on the clinical trials and the clinical significance and relevance of the development of a project. But I believe that is their main priority and have a lot less to do…[Read more]
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gy66 replied to the topic Determining project priority in the forum Introduction to Project Management 6 years, 4 months ago
This is a very interesting topic. Working at my company, I too have experienced project delays and cancelations due to multiple reasons. I think it is important to consider the finances when it comes to this topic. Every project is allotted a certain budget to be used for the duration of its development. This amount is determined based on the…[Read more]
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gy66 replied to the topic Initiating a Project Idea in the forum Introduction to Project Management 6 years, 4 months ago
Initiating a project idea is certainly a very challenging tasks. One must develop a well-defined scope that clearly defines the objectives of the project. In addition, determining the customer need and coming up with a realistic cost/profit margin to justify the execution of the project is both difficult and necessary when pitching the idea. All,…[Read more]
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gy66 replied to the topic Interpersonal skills vs technical knowledge in the forum Introduction to Project Management 6 years, 4 months ago
I think the “system” is designed to prepare incoming engineers to effectively contribute to the industry early on. By emphasizing on technical skills, young engineers can somewhat integrate in a rather technically-intense environment that will be forgiving to those who have more interpersonal skills than technical. The way I see it, positions in…[Read more]
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gy66 replied to the topic Project Manager Skills in the forum Introduction to Project Management 6 years, 4 months ago
Working on multiple development projects with different project managers, I’ve come to take note of the various skills an effective PM needs to drive a project. One important skill I’ve come to realize ever PM needs is understanding the duties and functions of every department involved, and potentially will be involved, in the project- because in…[Read more]
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gy66 replied to the topic Should Interpersonal skills be more valuable than technical skills? in the forum Introduction to Project Management 6 years, 4 months ago
I believe this “ratio” strongly depends on the nature of the position the individual(s) will be applying to. I’ve met many coworkers of mine that have highly technical roles that have surprisingly weak interpersonal skills. I have noticed that roles, such as product managers and sales engineers, that require very strong interpersonal skills, still…[Read more]
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gy66 replied to the topic Determining Spec in the forum Introduction to Project Management 6 years, 4 months ago
To start off, the specs that should be specified for a medical device should only be directly related to its functionality, as well as interaction with the user. Functions such as image accuracy and scan speed of a dental scanner, for instance, would be appropriate specs to be specified because they directly define the functionality of the…[Read more]
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gy66 replied to the topic Flaw in the design process in the forum Introduction to Project Management 6 years, 4 months ago
I believe, with the way the FDA enforces its regulations, improvements on the design process must improve. The FDA can only do so much to prevent companies from producing medical devices that may harm users down the line. As time progresses, medical devices have grown more and more complex, which undoubtedly calls for stricter and more elaborate…[Read more]
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gy66 replied to the topic Collaboration projects in the forum Organizational Development in Device Companies 6 years, 7 months ago
I agree with those who believe Matrix would be a better choice. Collaboration between multiple companies for a project is very difficult to accomplish and transfer of knowledge and proper utilization of resources is even more critical. In Matrix Organization, engineers are not locked in for a single project and are able to contribute to multiple…[Read more]
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gy66 replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies 6 years, 7 months ago
I work with a team to create theatrical sets for plays and from the experiences I gained from that alone, I personally like to believe I would be better suited for upper management. Mostly because I typically keep my focus on the big picture when collaborating. Being able to always consider the set vision makes it much easier for me to suggest the…[Read more]
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gy66 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 6 years, 7 months ago
Creating a productive dynamic for a project group is definitely a critical and tricky task. I believe having members that are both knowledgeable and easy to communicate with are equally as important; one cannot make up for the other. For instance, projects rarely progress as planned and the ones that meet deadlines and ultimately succeed are the…[Read more]
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gy66 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 7 months ago
I absolutely agree, at first I, I too felt surprised how ineffective labels and warning are the least effective in preventing residual risk in our products. In our case at work, there are currently a couple of “exploits” in our software that allows the customer to either produce a part for much cheaper or request a part that is simply unproducible…[Read more]
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gy66 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 7 months ago
In terms of high risk, I would probably lean towards either mitigation or transference, depending on the situation. If the high severity of risk is able to be sufficiently resolved or at least minimized by me and my team, obviously mitigating it directly would be the best course of action. Otherwise, transferring it on to the appropriate teams…[Read more]
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gy66 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 6 years, 7 months ago
Multiple different teams in R&D, at least at my company, must assess risks when developing a new product or update in software. On my team, we validate products and the software updates and test any bugs or even unexpected behaviors along the way. Anything that we notice, we immediately record and then discuss among each other of how high of a…[Read more]
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