Hello 9275: Our Medical Device Development class brings to reality things I never knew before, the Matrix Organizational Structure, for instance. It's quite exciting; I hope you'll agree. In my opinion, every Biomedical Engineer should go through this course, because they wouldn't know what they would be missing if they didn't; it's the least a BME engineer should do - no one wants to get lost out there. It's a very practical course. Thanks to Dr. Simon. Just being in the course is very fulfilling.

My project manager seems to have already done this project, else where. So he knew exactly what we were getting into. He started by distributing some project related literature which we were to learn from. We were then to fill out our functionally related templates following what we learnt.

To do this right, I personally did a lot of extra digging intent on educating my project partners - even my already knowledgeable project manager - on aspects relating to our project - especially on marketing related issues related to our project in other parts of our world. This I hoped would make the template filling more exciting to whoever read what I wrote.

We meet every Friday at 7 pm on Google Hangouts (Conference Call) to share our aspects of the project with the rest of the team. Specifically, how far we have come completing our area of the project; and possibly, ask any questions, if any.

I can't help it, but I am very much into this course. I don't know about you. And good luck with your project.

Andrew Disame

My team has had our first in-person meeting this week and we went over the gantt chart and what exactly needs to be done first so the rest of the project can get going. For example the DID which is actually my part because I am the marketing department on my team should be done first so that the regulatory person can get started on their parts. Then after the regulatory parts are done the pre clinical and clinical parts can begin.I also am keeping in touch with another friend who is in the marketing department to make sure we are both getting our work done. A challenge I have noticed is actually keeping up with the gantt chart especially since the team does not meet everyday but only once a week it makes it hard to stay on time.

My team had their first meeting last Saturday. During this meeting we discussed everyones role and what documentation is necessary from each department. We discussed which documents should be completed as soon as possible because it is needed from other departments. We agreed that the DID should be done first. We also agreed that every person should have at least 20% of their document completed. We have a meeting this Saturday (Nov 23) to discuss each others documents and give input/advice.

We are planning on having weekly meetings to make sure everyone is on track. So far, we have completed the DID and DDP. Our project manager created a document where we wrote down the date we expect to finish our own departments' parts and send to him as he is the one responsible for putting it all together and submitting to the professor at the end of the semester. I haven't had the chance to work with anybody else yet but we decided to have our documents open to each other (sharing on google drive) so that if anybody needs assistance with something for their parts or wants to learn more about what other departments are working on, they can easily pull up their documents and look through them. I suggest you do that if you haven't already.

The first thing our team did was go over the timeline of the project. We set up a simple flowchart of what has to happen and what everyone needs to do. Then, we started giving tasks to the people that needed to do their job and give it to other people. We set deadlines for that and at the next meeting we will move onto the next developmental stage. It is a largely hierarchal setup but is so far proving effective. How does your project leader organize the meetings? Is it a concrete outline or loose bullet points?

The first thing our team did with the help of PM coordination, we created a group chat that we can communicate effectively and have every member on the same page. Also, we created a shared folder so all of us can review and see the documents from other departments. the benefit of it is that to make sure the project is going as scheduled for and for our own knowledge too. currently, everyone had assigned a task to finish it and will meet in person in the school to review and discuss our project to finalize it and make sure we meet our deadline. Also, My role is a quality management, So I been in contact with other quality members from the class. We briefly discuss our documentation and what needs to be added to it.

We had our first meeting on Friday after the initial meeting where we formed a team. We meet every Friday at 7 pm on Google Hangouts through a conference call to share our perspective status of the project with every member of the team. The reason being, all of us are able to share our responsibilities, its timeline, and raise any questions if any. The first meeting was simply stating responsibility of each and every person in a team and setting a timeframe based on it. My department is regulatory, so after communicating with marketing dept. I created my document for another department to work on.

For my team, I completed the DID and my partner completed the RA document. We haven't had our first meeting yet due to conflicts but so far the project is going quite smoothly. One of the challenging things about working on my team is coordinating in-person meetings because it's very hard to get people together at the same time because of course conflicts. A challenging part about the project is giving input and helping each other because it's always important to give feedback and help your teammates as much as possible. In my opinion, a team is most likely going to be confident and achieve success if each individual feels like they have support from other members. We are still in the 1st stage but we are progressing. We haven't worked with each other yet but we are planning to meet soon! The hardest challenge in this project for my team is understanding all of the information about the medical device so that each person can do his/her part. It's easy to complete the work if you know what your end goal is and what to do to get there. However, understanding what you have to do is the hard part because the work itself isn't hard but you have to make sure that you don't make careless mistakes or leave important things out.

In my team, we started off by having the PM send out the DDP, a form to help him fill form a gantt chart, as well as all documents related to his project that he already had prepared. We then decided to have weekly meetings every Friday at 7 pm via call-in to discuss the progress on the project. Just recently, I sent out the DID based off some of the documents that the PM had sent out about the project and am currently working on a marketing plan as our regulatory member works on their documents. The biggest challenge I've noticed currently is overall communication, as the only time we're really able to communicate right now is during the weekly meeting, which may make working with other departments tough, but other than that the project seems to be going pretty smoothly for the time being.

We haven't had a in person meeting yet but will are scheduled to meet every Thursday. We have been communicating through groupme, text, and by email. All of are documents are being done through google word. As of today we must have completed DID and RA. This Thursday we will meet and review them. In my group all departments are adding feedback and inputs that are assisting in filling out documents. My job is to complete the RA, which was a challenge because it was something I never done, but I completed it as schedule. Now we just have to review it and go from there with is pre-clinical.

We have a Google drive folder set up that everyone has access to. Our PM uploaded each document and also created a rough draft of the DID which had a column on the side for comments. We had a week to make our suggestions and then we will finalize them in person. The RA draft was also completed and we will add our suggestions to it. We plan to meet in person on Thursday with an option to attend via Hangouts, Skype, etc. So far I believe we are on time with our documents but we should anticipate some setbacks due to upcoming exams and final projects for other classes. However I think our project manager is very flexible and organized our deadlines so that we have enough time to complete our tasks.

It is interesting that you pointed out how we're working in martix type organization. Our team has the first  meeting on last Friday and we have decided to keep Fridays fixed for our weekly meeting. As we all weren't aware of the details of the project, we took some time to understand the project. Me as a pre-clinical person will be sharing my position with one of my friends from the team. Hopefully it will give me an ides how to work with a friend in a workplace. We finished the DID in our first meeting. We all helped to make the DID wholesome. It was quite an interesting experience for me as I have no experience in the industry. Our next step is to make DDP. I am looking forward to see how this projects turns out at the end. 

We had our first in-person meeting the very next week Friday our project team was formed. We have decided to meed every Friday evening to check our progress on the project and help each other by having inputs from everyone at each stage of our project which I believe will give a good understanding of how medical device development takes place within an industry to some extent. It was quite interesting how well our discussion turned out to be as to how everyone had different outlook to a particular issue and how quickly someone else can come up with a solution to it. At the end of our first meeting we had our DID ready. We all have started preparing for our roles simultaneously and currently the DDP is in progress. I am really excited about the project and look forward to have learnt a lot from this and have it completed within time. 

So, we had decided to meet on video call as its difficult to manage to come for an in-person meet every week, we have completed the DDP, DID and have come up with Pre-Clinical, clinical and regulatory first draft.
So we are taking things one at a time assigned by Dr.Simon, the workflow is what he suggested in class and we are following the same.
So at this point, we have to come up with a risk management plan which I have to create a discussion next week and also make little changes to the first draft and update the DHF.
The challenge is to complete the document on time, also a lot of people are doing this for the first time so it is taking a bit longer to complete the files.