My team is flying through the project. We started the first week by working on the DID and DDP so that the Gantt chart could be worked on in the second week, as well as the pre-clinical protocols, clinical protocol, and regulatory documents. I would say our team is almost half way to completing the project and I'm confident with the quality of work we will be submitting. We have been using google hangouts to video call on Wednesdays and each team member usually has work to be put into a shared google drive folder either by the weekend or by the following meeting. So far everyone has been timely about submitting their work to the team for review. This project is teaching me a lot about the structure of a company as they develop a medical device and I can't imagine getting this sort of knowledge anywhere else except for in the medical device industry itself!
At this point we are at the stage where our roles are set. We're researching our roles more closely and outlining the best way to present the most quality information. We submit in each of our corresponding forms the information most necessary to maximize the opportunity for advancement. At the heart of a thriving business is a proper and orderly bureaucracy.
We had our first in person meeting two fridays ago. We spent most of the meeting defining relevant requirement for the DID. It was a fun collaborative experience. I have worked in the industry for some time but it was my first opportunity to participate in a meeting discussing specification of a product at its inception. One of the challenges was the challenge of keeping the requirements at high level and resist the to to be too prematurely add requirements that were too detailed.
Organizationally we started a google hangout group and google docs group to share documents.
So far we have worked on the DID and DDP.
Currently, my team is in the middle stages of our product development project. We have all submitted first drafts of our documents to each other for review, so that we can make required editations before we advance. I am in pre-clinical research, and so far I have noticed the hardest thing about the project is the communication aspect. As expected, because we learned about it, the communication between departments is incredibly important, and actually somewhat difficult to accomplish. In our case specifically, everyone works, and isn't always available, so to read emails, make comments, edit documents, and have group meetings isn't always the easiest thing to do, but our group is making it work and excelling with the project.
In our team, we met the very next Friday and discussed everything in detail and started discussing the DID plans. We have planned to meet every Friday and have also created a "Hangouts" group and have started posting updates and other discussions. It has been going good and I am learning quite a lot as to how a first version is created, drafted and then modified again. It is interesting to learn from another person's perspective. We have finished our DID and DDP and now we are coming up with our assigned document by next week which then will be reviewed by each team member after which we will do risk analysis and then the final submission will take place.
Even though we know our roles it is still confusing and a lot figure out ,but working in a team is fun and a good experience as it gives us the ideal how a real project works. In our project my experience so far has been a learning process as I am in regulatory there a lot I don't know and our PM has been very helpful so far and also been considerate . Now we have plan and also a timeline in place ,we are working on our deliverables accordingly.
I am the PM on my class project and I would reference the Tuckman team forming model. In our first week we went through the forming and storming phases. The group was trying to get to know each other and was concerned with how we would get the project done. There were also specific individuals who expressed their opinions more than others and in some cases played others' roles rather than the one assigned. The second week we are in currently, we are entering the Norming phase. Folks are getting comfortable with their roles, establishing relationships with others and getting into a more stable approach. I think implementing standardized meetings and other communication approaches, deliverables, and a project schedule helped everyone to this stage.
Look forward to the performing stage. They are a good group of people and need me to listen to them, understand their views and help coordinate the activities.
After the team has meet, we did brainstorming for getting all DID inputs and even Risks, Our PM did the planing and the timeline and we are working to get everything done according to the Gantt chart. I am happy that i am working with this team as they all are very helpful and i am learning a lot on how real life projects goes. For the Marketing department we did a small talk for start up but nothing else yet.
For my project, the team members had kick off meeting through Google Meet, which we got know each other and the project manager shared the project's tasks. For my role, I'm the marketing guy that means I started collecting input data from the group members after the first meeting to make Design Input Document (DID). Then, we had discussion during our second meeting about the suggested DID and the next move of every member.
My team has set up meetings every week to discuss the progress of the individual tasks and the project as a whole. In the meetings, we go through the work every team member has done in the entire week and help each other with any queries. We also looked at the drafts made by the Pre-clinical researcher, Clinical researcher, and regulatory person. The meeting minutes are uploaded by the project manager after the meetings to keep the track of work and update the timelines accordingly. I have been as the Clinical Researcher in my project and I am assigned to make a clinical protocol. The challenge would be the deadlines to submit the project report.
I am working on the Quality department of my project so I will be looking at the risk analysis and risk management. I and my team members have set up meetings on Friday evenings to update each other on the progress of the project. Also, we discuss the individual tasks of the project. It is a good experience as this project enables us to understand the typical project environment in the industry. The meeting minutes are tracked by the manager and the agenda of each and every meeting is also discussed prior to the meeting which makes the meeting more efficient and productive.
As we begin our final project, it gradually refines you and shows you how the real industry is. This is more like a preparation of what to expect out there. And the organization type Dr. Simon went with seems more like the project-base organizational type. We were grouped into project teams, with each project team working on different projects and the project manager being the head of the project team.
Working together has been interesting for the most part, we had our first meeting last week, which is scheduled to be once every week. Despite our busy schedule, everyone still finds time to contribute as best as they could and I would say, every little input counts. My project manager works well with the marketing personnel and helps out a lot in trying to put things together making sure the other teams have what they can work with.
This has been the most interesting part of the course, making research, working in teams on a project and knowing what to expect out there in the world. From the experience Dr. Simon gave; when he had to work in a company as a fresh graduate and knew nothing, gave a better insight on how best to project the course, more toward the practical sense of how to work in an industry with the knowledge you receive.
In sum, it goes to show that it is not all about having the intellectual knowledge only, it is also more about hands on, knowing how a company functions and what to expect as well which will help to fit right into a Medical Device company. My take from this project will be:
"there will always be a number of ways to structure a company, however, the best organizational structure is one that fits your management style, company size and overall marketing strategy". - By Rick Suttle.
we are at almost the end of the finishline, we get through the DID, DDP and the risk management plan, only thing left is to come up with a clinical protocol for the clinical study. The challenge that we face is finding time for meetings that suits and works with all our different school and work schedules. It was interesting to see how people within one group with similar backgrounds could have very different opinions when we are brainstorming
Hello. I am writing this discussion late so I have the benefit of having completed the Medical Device Development Project. I had the role of regulatory and was in charge of completing the regulatory rationale. I think one of the biggest challenges our group face was the reliance on certain documents to be completed before moving further. Specifically, the DDP, DID, and regulatory rationale had to be completed for the rest of the documents to be completed correctly. Our solution to this problem was having the rest of the documents started at the beginning and completed to the best of their ability. As the preliminary documents were being completed, the later documents could be continuously updated with the new information.
So far, the project seems to be going well. We have had several meetings which were productive. Up until this point, we are at a comfortable place with the DDP, DID, and Gantt Chart. They certainly can use final touches, but I believe we are on the right track to allow others to begin their responsibilities. As for reaching out to other departments, it has been difficult. I feel it’s still a bit awkward because we do not know what their pace is or where they currently are in their project. Overall, there have not been many challenges so far. Finding a time to meet over video chat was a task in and of itself since we have vastly different schedules. As of right now, we meet once a week for about an hour. I hope that each of the team members are working offline so each meeting can continue to be productive.
