From my experience working in the medical device field I have had to sit on design review meetings that dealt with going over the validation process of multiple documents. The meetings are run by the project leader who will open up the discussion, review what had to get done for the week, what needs to be done by the next meeting, and will check in on each team to make sure they got their work done correct and on time. After the project leader speaks, the leader of each team will present what they did and will give a time table showing their progress and what their anticipated end dates are for each of their steps. That way everything is mapped out and updated to the correct time schedule, and if something needs to get pushed back then there will be a discussion on if we need help from another department or if we have to push back the time line. Design Review meetings are important because it makes sure that the design team is all on the same page, that everyone has an understanding of everything going on in the project so there are no surprises and that any problems and changes that need to be made are voiced early on and are dealt with right away. The Design Review meeting needs to be well prepared as everyone is asking very detailed questions so they have a well understanding of the project and their specific roles. The meeting also helps make sure that everything in the project is on track to finish on time and that every member is doing what they have to do for the timeline.
Design reviews are technical meetings held by a group of people who are working on the same project where the design for that particular project or product is evaluated against all of its requirements. These meetings help to identify and address any design issues early on before it gets to the point where it's unavoidable to make changes without risking some sort of loss (time or money). I don't have much experience with design review meetings in the industry but just like most people here, I did have some experience with it in my capstone class. We had weekly meetings with our teams and technical advisors where we discussed the design of our product and whether it met the requirements we set for it or not. It's important that the requirements are met because customer input is what we used to come up with those requirements. If our product design can't meet the customer needs, then there's no purpose of making that product in the first place.
From working at my internship I have had meetings in general and not at all related in terms of medical devices however, I notice that when meetings do take place they can be either exciting or boring. People from internship say that managerial meetings are boring. On the contrary when I was in the meeting it helps to understand everyone’s opinion, scientific input and wisdom to solve a problem. Now when it comes to Design Review meetings its obvious that it needs to be done, because it will improve the product and a by-product of these meeting will provide insightful opinions from others.
Truth is: I have never worked in industry to participate in Design Review Meetings. However, if such a meetings is to produce any useful results for the company it must be aimed at ensuring that a project is moving forward and if it has anything to do with a project then it must be designed to cover a phase of the project.
This is a project. It is therefore be on budget. This meeting is designed to ensure money is not wasted doing things that have not been budgeted for.
Projects are very defined action plans to end up with the production of a medical device that is placed in the market. So the Design Review Meeting must follow the nature of the project.
1st and foremost a project manager must have developed a Gantt chart with an associated Pert chart. Gantt charts are sectioned to mark the units of the project; the end of each unit is the milestone of the project. The purpose of the meeting is to see how well the team is doing in getting the project moving forward. The team should comprise the engineers, the regulatory personnel, and the quality experts.
An agenda should have been drawn out by the project manager.
During the meeting, each section of the team should be given a chance, following the agenda, to present its aspect of the project in accordance with what has occurred during the course of carrying out chores involved in the phase of the project. After each presentation, the team should fully discuss the presentation in accordance with the needs of the project. After each presentation any suggestions, or ideas relevant to the project are discussed, guided by the project manager; failures and successes by each aspect of the project team should be reviewed carefully, plans to fix failures and improve on the successes are also addressed.
Only what is relevant to the project is allowed to be discussed here.
The Manager should lay down the plan to ensure success on the next phase of the project. All this while, the FDA standards are ensured during the presentations by the individual representing the FDA interests.
On the last Design Review Meeting paying all to be payed is moved out of the way and the product brought to a successful completion.
While I have not been able to attend design review meetings as my job function doesn't include doing so, I have had interactions from the results of a design review meeting. Once a design review meeting has occurred and sufficient revisions are made to the product based on feedback, the product can start the process to go into production. Particularly, I've worked with data from design reviews of existing products (implementing some kind of change). Once the product is good to go, a document called the Design Change Notice (DCN) is issued detailing all the changes, timelines, and product data to be used. This data is critical to ensuring that the product goes into production as it outlines allocation, how a product is to be made/where, and many more factors. While the design review may be the last step from the product designers/engineer's perspective, there are still a great amount of work that needs to be done before the product can hit the market from a supply chain and planning perspective.
Design review meetings are very necessary for ensuring that the present design meets the project objectives, because without doing so, nobody would attentively look for a possible deviations that could have occurred within the design part. Besides, these meetings are helpful for facilitating the process of the design corrections if anything wrong for example, engineering errors could further cause bigger problems and verification failure. Also, meetings will recapitulate the technical goals that this design must address for. Then, anything that changes in the design will be documented into the DHF file.
I have not worked for any industry but I did attend design review meeting during my capstone project. It is the time where we discuss the progression of my team design. Are we missing any goals? What did we accomplish this week? These meetings helps us be alert on our weekly task and product progression. If there is an error these meetings help us create a strategic plan to get back on schedule. These meeting helped make sure everyone is doing their part in the project for example, market research, technical research, test plan, fabrication of product. These meeting helped us discuss if there was anything we can do to improve.
I have not been part of or viewed a design review meeting, however, I feel that these meetings are essential for production. As processes, procedures, and products are changing or being introduced, every step of the way needs to be scrutinized. While certain engineers are focused on their part of the broader change, there might be some new information passed around to those who aren't involved with every step. This is a good opportunity for project managers to be updated on how the project is running and to initiate actions based on performance. In these meetings, problems are identified and plans are put into place to rectify those issues. This can save valuable time from any possible bump in the road.
Design review meeting is a technical meeting that is held at the early stage of the project. A design review generally involves a presentation of a planned design, at a time early enough in the process to allow for changes if it necessary. It ensuring that proposed design will meet the requirement, Insure that the design can be implemented in the required time. Design reviews are useful in making sure that all participant in the project development process are on the same page. Design reviews are useful in identifying design deficiencies and improvements or alternative approaches to the design.
In my experience in design review meetings, it is important to be well prepared. Depending on the phase of the design review, the person leading the meeting will send out an agenda with the meeting invitation. He or she usually also sends out a copy of all of the documents that are being reviewed in the meeting so that everyone has a chance to review them before the meeting. The design review is attended by representatives from several departments as well as an independent reviewer. The independent reviewer is someone who is not involved in the project, and is able to provide a perspective from outside the project team that all of the necessary deliverable were met for a given phase. If any items are brought up during the meeting which require completion before completing a given phase, the leader of the design review can write them down and then send out the meeting minutes for signatures once those items have been completed. This is a useful practice because it does not require all of the participants to meet again and discuss the same phase.
Based on my internship experience, I think the design review meeting is very important. In this meeting, everyone will discuss about the part that they are responsible for, and at the same time, they will have enough understanding of each part of the project. This will ensure the smooth progress of the whole project. In the meeting, the person in charge of each part will also have a clear timeline plan, which makes the whole project clear and orderly. The meeting will also serve as a reminder to finish the work on time.
As mentioned in the lecture, design review meetings happen at the end of each stage in the project. They are critical because they facilitate communication between the design team, management, and the customer. The design team provides information about the status of the project to the manager and customer and also receives feedback regarding the development and changes that need to be made. Any problems that occur during each stage is addressed here as well. Reviews can be formal or informal, require a well-prepared agenda, and can last hours, days, or even a few weeks.
Has anybody who has worked in the industry been able to participate in such design review meetings, and provide any insight about them? Can you provide any additional points about their importance in the product development process?
Successfully executed design review meetings are crucial for the overall success of the project. Typically, specific deliverables will be defined that need to be completed prior to each DR, and the purpose of the DR meeting is to speak to the status of each deliverable. Managers, Directors, and lead engineers within the company are usually the audience at these meetings, so it is very important that the presentation is organized and well-prepared, and that the presenter is able to answer any questions they may have. The design engineer will usually lead the design-related DRs, the quality engineer will lead the risk/quality-related DRs, and the operations engineer will lead the manufacturing-related DRs, so a single team member doesn't need to lead every single DR on their own. Coming out of a DR, there's usually always questions, so it's important to take detailed meeting minutes so you can address those comments later on.
I had the opportunity to sit in on a design review meeting during one of my internships. Something I noticed was the fact that representatives from various departments were invited and they each brought a new perspective to the table. It seemed like Post Market Surveillance's opinion was weighed heavily as this department oversees all current complaints received for similar products which factoring into the design process of a similar product can prove to be highly beneficial in the long run and a better use of the team's time. They will be less inclined to make revisions or recalls to the product by leveraging the already existing data.
I have not participated in a design review meeting, however my friend has participated in multiple design review meetings and has shared her experiences with me. The main goal of a design review meeting is to facilitate a shared understanding of the design (especially if it is in the earlier stage of development). Additionally it is important to identify any challenges or obstacles and receive feedback from key stakeholders. Meeting minutes should be taken digitally in real time during the meeting and should be sent out immediately after the meeting is over. This is important to document the topics discussed and confirm alignment/next steps. After the meeting is over, the core team should have a follow up meeting to discuss feedback and prioritize next steps.
I had the opportunity to attend a design review meeting between multiple departments in our specific department. One thing that I noticed that was striking is the structure of the meeting. There was a specific agenda with specific timeline that everyone had to adhere. And i learned the importance of having such structure is to make sure that everyone is on schedule and that any discussion stays within the topic that is being presented. This is to ensure that everyone is on the same page and that there is no time being wasted or any important topics being missed because of side conversations and discussions. There was a section of question and answers and a specific time for everyone to present who were presenting.
