Medical Device Courses | f-dot | Activity

f-dot replied to the topic "Overworked Americans vs. Motivation" -

Wed, 15 May 2019 19:15:45 -0400

f-dot replied to the topic "Engineer vs. Manager" -

Wed, 15 May 2019 19:15:44 -0400

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

Wed, 15 May 2019 19:15:43 -0400

I think it’s a little hard to determine what type of employee I am. When it is something I am interested in, then yes I am a Y. I am motivated to learn and get better because I do not… Read more»

f-dot replied to the topic "Different PM techniques based on size" -

Wed, 15 May 2019 19:15:27 -0400

Going through this course I think I have always pictured a big/established company; never really considering the workings of a smaller, start up one. I think it is definitely true that certain projects may be straight forward and predictable while… Read more»

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

Wed, 15 May 2019 19:15:25 -0400

f-dot replied to the topic "Why do people work?" -

Wed, 15 May 2019 19:15:24 -0400

f-dot replied to the topic "Specifications: A double edged sword?" -

Wed, 15 May 2019 19:14:04 -0400

I agree with andria93 and cs22 that specifications should be as accurate as you can to make sure all aspects are documented and followed correctly. The limits are an interesting aspect because there are times when there should be upper… Read more»

f-dot replied to the topic "Deadlines and SOP's" -

Wed, 15 May 2019 19:14:02 -0400

f-dot replied to the topic "Six Sigma and Project Management" -

Wed, 15 May 2019 19:13:58 -0400

f-dot replied to the topic "Importance of Metrics" -

Wed, 15 May 2019 19:07:56 -0400

f-dot replied to the topic "planned value vs actual costs" -

Wed, 15 May 2019 19:07:55 -0400

f-dot replied to the topic "Medical Devices" -

Wed, 15 May 2019 19:07:54 -0400

I think that when it comes to failing with the vendor its important to ask why. Was the product not what they expected, and subsequently lost of interest? Or was the vendor disappointed entirely and pulled its funds. Losing a… Read more»

f-dot replied to the topic "In the Shoes of a Project Manager" -

Wed, 15 May 2019 19:06:47 -0400

As most of the posts above this are comparing the charts, I will chose to answer the second question to change it up. I think the bone drug delivery from the 2nd simulation would be classified as a Class II… Read more»

f-dot replied to the topic "Design Review Meeting Culture" -

Wed, 15 May 2019 19:06:46 -0400

I don’t have any experience working in the industry, so when I imagine the meeting I picture something like kindergarten and theres a talking stick. I think it should go around, but before its passed to the next group, the… Read more»

f-dot replied to the topic "Verification Testing Deviations and Failures" -

Wed, 15 May 2019 19:06:45 -0400

My colleagues above me make some great points. I agree that noticing any deviation earlier is better than after the validation. It would seem we also agree that verification should have as little deviations as possible. But I think srg36… Read more»

f-dot replied to the topic "Risk Management" -

Wed, 15 May 2019 19:06:44 -0400

A medical device I would consider to have significant risk, are contact lenses. Everyday millions of people (guessing, don’t quote me), put contacts into their eyes instead of wearing glasses, but have you considered the risk they are taking? If… Read more»

f-dot replied to the topic "Factors to look for while evaluating change request" -

Wed, 15 May 2019 19:06:43 -0400

Merzkrashed makes a lot of good points. I think something else we would need to consider is the stockholders/team and customers/venders. Will your team agree with the decisions? Do they agree on the change but not the plan of action?… Read more»

f-dot replied to the topic "Which of the following project would you say is better and why" -

Wed, 15 May 2019 19:06:41 -0400

I think cdj24 makes a really good point to think about the company. When thinking of how to answer, I was leaning more towards the idea of having a negative CV and a positive SV, as I think it would… Read more»

f-dot replied to the topic "Change in PM" -

Wed, 15 May 2019 19:04:41 -0400

Hopefully the project does not have to start over (maybe the reason why the PM had to leave), in which case the new PM would start from the beginning like every other time – as long as they know the… Read more»

f-dot replied to the topic "Planning Phase" -

Wed, 15 May 2019 19:04:40 -0400

Where as it is obviously important for everyone involved to know the users needs, I also think it is important to consider what the user does not want. If we are given a list of things to include and given… Read more»

f-dot replied to the topic "task Scheduling :factors" -

Wed, 15 May 2019 19:04:38 -0400

Going off of what srg36 said in response to moniquet07, I think the project scheduling would need a “Clarification” or a “Agreement” step. This way all parties know what they are up against, and if something is not correct (either… Read more»

f-dot replied to the topic "Project Scope: When the timeline you have doesn't work" -

Wed, 15 May 2019 19:04:15 -0400

This is a very interesting case to me. I honestly wouldn’t know what to do. In my life though I have always found that honesty is a better policy. Releasing a product and banking on a placebo test is probably… Read more»

f-dot replied to the topic "Overlapping activities" -

Wed, 15 May 2019 19:04:08 -0400

The planning phase sets the foundation of how to complete the project. When this phase is not executed properly, then project could be terminated or not worth the money for funding. It’s a pain to go back and re evaluate… Read more»

f-dot replied to the topic "Discussion Topic: The critical path" -

Wed, 15 May 2019 19:04:04 -0400

I volunteered in a tissue engineering lab and we were working on trying to make a bio-ink with a decellularized pig heart. We had researched previous inks and composition models and did what we had to do. At the end… Read more»

f-dot replied to the topic "Inputs for Design Input Document" -

Wed, 15 May 2019 19:03:12 -0400

I think it depends on the device in question. While I think engineers are a key aspect of the building part and setting limitations on what can and cannot be done, when it comes to designing something like a prosthetic… Read more»

f-dot replied to the topic "Project Scope Management" -

Wed, 15 May 2019 19:03:10 -0400

Scope management is an important part of the company to inform the public and potential investors the projects description and heading. Its helpful for the company to have this timeline because they can use it to meet deadlines and allow… Read more»

f-dot replied to the topic "Definition of Risk/Benefit Ratio ?" -

Wed, 15 May 2019 19:02:28 -0400

This topic brings to mind the end of any commercial and how there is a long list of things that may happen based on their statistical analysis. For devices, their risks seem to incorporate an entire warning’s page (or something… Read more»

f-dot replied to the topic "Categorization of Medical Devices" -

Wed, 15 May 2019 19:01:57 -0400

I think we can all agree that the classification comes from the risk and novelty of the device. However when preparing my response for another forum post, I learned that this classification system was made back in 1976. And according… Read more»

f-dot replied to the topic "Inadequate Testing" -

Wed, 15 May 2019 19:01:56 -0400

I think she is making a great point. Though I haven’t read the book, from the sound of it I can see it has value. While funding and business needs the “easy” class system to report new devices, I think… Read more»

f-dot replied to the topic "Funding in Medical Devices Industry" -

Wed, 15 May 2019 19:01:54 -0400

I think this is interesting because I want to say that companies should go for it. For established companies, they would have ann easier time looking to the future and establishing new ideas than a company more involved with competition… Read more»

f-dot replied to the topic "Experience with Project Organizations" -

Wed, 15 May 2019 19:00:32 -0400

As a scout we had a very functional organization. We worked in patrols, we had an assistant Patrol leader and a patrol leader. They got together with other leaders and executed decisions made be the senior patrol leader. I did… Read more»

f-dot replied to the topic "Pros and Cons of the 3 Organizational Structures" -

Wed, 15 May 2019 19:00:32 -0400

As a kid I was in the Boy Scouts. We had 4 different patrols, each with a Patrol Leader and his assistant, and then there was the Senior Patrol leader with his two assistances. Even though there was no “skill”… Read more»

f-dot replied to the topic "Your Ideas about How to prepare/write a Successful Project Proposal" -

Wed, 15 May 2019 19:00:26 -0400

I think there are pieces from every post before mine that are critical in what should be included. I agree, to an extent, with what all of you have had to say. I think it needs to be improved by… Read more»

f-dot replied to the topic "Fitbit Medical Device?" -

Wed, 15 May 2019 18:58:51 -0400

I would still say no, the fitbit does not need to be regulated. The CDRH defines a general wellness product as “Products that are intended for only general wellness use and present a low risk to the safety of the… Read more»

f-dot replied to the topic "Product PMOA Classification with FDA Branches" -

Wed, 15 May 2019 18:58:51 -0400

Going in line with the example in the question, there are different coating on implants used to stimulate specific responses. For example the Hydroxyapatite coating on a titanium implant to convert fibrous tissue to bone around loaded implant. The implant… Read more»

f-dot replied to the topic "LifeVest Wearable Cardioverter Defibrillator" -

Wed, 15 May 2019 18:58:51 -0400

The Lifevest would have to be a Class III because it has the potential to save a life, though is a great risk to the wearer. Because the response of the mechanism is based off the persons heartrate, there is… Read more»

f-dot replied to the topic "Difference" -

Wed, 15 May 2019 18:57:35 -0400

I am a little torn on this. On one hand, I believe they are different and yet on the other I say not. Project managers are in charge of obtaining the end, desired result. This is alike for both professions… Read more»

f-dot replied to the topic "General Wellness Product" -

Wed, 15 May 2019 18:57:32 -0400

I may be going out on a limb here, but I think board games could be considered something of a general wellness product. It would be of the first category because games don’t reference diseases or conditions (other than operation?… Read more»

f-dot replied to the topic "Fitbit: A Medical-Grade Device?" -

Wed, 15 May 2019 18:57:32 -0400

I agree with what has been stated before me. I do not think the Fitbit should be considered for FDA approval; as it does not make any medical claim. This function of the watch is merely there for convenience and… Read more»

f-dot replied to the topic Overworked Americans vs. Motivation in the forum Project Management Application: Clinical Trial

Thu, 26 Apr 2018 20:12:39 -0400

There are many considerations to take into account when answering the question. I think it depends on what job or industry we are talking about. Everyone is different so it depends on if that person is staying late because they have to make up for lost time, because they are motivated to do better, or because they are expected to. As many of us…[Read more]

f-dot replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial

Thu, 26 Apr 2018 18:52:22 -0400

I would love to be a research/scientist for some time and work on projects. I have some leadership skills and wouldn’t mind going back to something like that. I agree with most of you in that I would stay where I was to get experience and then move into a manager position so that way I have that experience to help lead others. I wouldn’t want to…[Read more]

f-dot replied to the topic Are you an X or Y? in the forum Project Management Application: Clinical Trial

Thu, 26 Apr 2018 18:37:12 -0400

I think it’s a little hard to determine what type of employee I am. When it is something I am interested in, then yes I am a Y. I am motivated to learn and get better because I do not always feel like I have the necessary skill. If there is something that I’m not interested in, and using the job as say a stepping stone, or thinking it as an…[Read more]

f-dot replied to the topic Different PM techniques based on size in the forum Project Management Application: Clinical Trial

Mon, 23 Apr 2018 03:45:13 -0400

f-dot replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial

Mon, 23 Apr 2018 03:27:48 -0400

Hate to beat a dead horse, but I also agree a project manager’s motivation is helpful and needed in any project. I also think it’s beneficial to have a good understand of why were doing what were doing. I said in the other post that I’ve always believed I would be doing important and impactful work. Having someone believe in you and counting on…[Read more]

f-dot replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial

Mon, 23 Apr 2018 03:10:42 -0400

I can’t say I’m surprised, because I never really considered those aspects before, but I think it makes a lot of sense. When looking for a job, or any work, I’ve always looked most for exciting and challenging work. I love the expression “love what you do and you’ll never work a day in your life”.
The work that I want to be apart of is meaningful…[Read more]

f-dot replied to the topic Specifications: A double edged sword? in the forum Project Management Knowledge Areas

Mon, 16 Apr 2018 03:30:21 -0400

f-dot replied to the topic Deadlines and SOP's in the forum Project Management Knowledge Areas

Mon, 16 Apr 2018 03:18:21 -0400

Reactive management is not terrible if it can be used correctly. If the manager still applies himself and is able to keep the long term goals on track, and able to accomplish their own tasks at the same time (without being swamped in emails) then it is great. But this often doesn’t happen. The problem becomes when they put off the long term work…[Read more]

f-dot replied to the topic Six Sigma and Project Management in the forum Project Management Knowledge Areas

Mon, 16 Apr 2018 02:58:04 -0400

The Six Sigma seems to be a very efficient way for business’s to secure a projects scope. The DMADV also seems like a great way to handle any major decision. Take away the product part and apply to problem solving and it works quite well. It’s no surprise that PMs use the tool to help increase organization and scheduling. I think for them to…[Read more]

f-dot replied to the topic Importance of Metrics in the forum Project Management Process and Medical Device Development

Thu, 29 Mar 2018 19:38:18 -0400

I think we all agree there are different evaluations of the numbers and they all come in handy when determining the future of the company and product. As we know, Metrics are needed in order to show variances and thus help us compare to where we need to be. I agree with what ak977 said and what the professor, every metric that we utilised must be…[Read more]

f-dot replied to the topic planned value vs actual costs in the forum Project Management Process and Medical Device Development

Thu, 29 Mar 2018 19:25:56 -0400

I think it’s little difficult to add a new statement to this conversation, as everyone here has made very good points, but here is my 2 cents.
The monitoring and controlling phase are seen throughout the project to evaluate risk, and lower cost. We know that the PV and AV along with the EV dictate either a positive or negative SV and CV. I t…[Read more]