I do have experience attending a few design reviews and also leading one. From my experiences design reviews are exactly as everyone has been describing. They are important milestones within the medical device development cycle, and are a part of the required design control process. Design Reviews do require a lot of preparation, and the way in which you present the information in the design reviews is also very important considering some of the audience is most likely unfamiliar with your project (i.e. independent reviewers). I do not think anyone has mentioned the concept of an independent reviewer in this thread yet, and I am not sure if they are required by the design control procedure. At my company multiple independent reviewers are required to attend the design review. These independent reviewers are not a part of the project that is being reviewed, and each have different areas that they specialize in (technical, quality, etc.). All of the independent reviewers must agree on all of the design review content being presented and sign an approval form. If any of the independent reviewers have questions or concerns that cannot be answered or addressed during the design review they become open action items that must be completed before the next design review.

I do not have an experience with design review meetings in the industry, but I will share my experience participating in the design review meeting for my senior design project. A couple of weeks before the design review, each of us had to read the other team’s requirements document for their project and comment on how to make it better. During the design review, we had to tell the moderator the amount of time we spent on reviewing. Then, the moderator would begin going through the document and asking if anyone had a comment. The scribe would have to write down all the comments said. I was the scribe for one of the design reviews and it was challenging to keep track of the comments. Once the design review was over, we each had to give our comment to the team. All in all, it was a good experience as it was very efficient and productive and made our final design requirement document very easy to understand.

As mentioned above, design review meetings happen at various points during a project, usually towards the end. In my experience in production engineering, however, design review meetings are conducted once a week and attended to by every engineer and upper level managers. These meetings are to establish the current status of smaller projects and to approve or disprove of production changes. It is essential to the functionality of the production line because it allows everyone to be in communication about a certain change or update. This ensures that the design changes are approved by everyone involved, and it facilitates a smoother transition. Design review meetings ensure that changes are not implemented without everyone's knowledge and reduces the chance of resistance to change.

Design review meetings are critical for the success of the product. At my old company whenever I held a design review meeting, I would send out all the materials a few weeks before the actual meeting. I would ask the recipients to review the material and give back comments within one week. Within 1.5 weeks, if I haven't received any comments, I call and make sure they are ok with it. If they do have comments, I resolve them before the meeting. The meeting is just getting everyone in one room to go over the design one last time. It usually doesn't take long. I bring up any comments that I received and how we resolved it. By this time, everyone is ready to sign off on the design. The design review meeting has always been the last step that ensures everyone is on board and all comments and concerns have been resolved.

Design reviews are very important in the success of the product and the company. I have had the pleasure of sitting in a design review meeting in my past internship. The project manager and the engineers involved in the project come to the meeting and review the past and present actions and any complaints or issues that have showed up since the past meeting. Because the company I had worked for was very small, the project manager was also the head of the quality department, so he had created the powerpoints for the design review. He would then review with the participants and cover any of the issues presented and how they could be solved. These points would be marked down for action plans and they then would be reviewed at the next design review.

I have not been part of designs review in industry. However, last year a group of BME students and I applied for a URI grant and wanted to start our own project. We had design review meeting for each stage, first for our design schematic, second after the finalization of our parts and projects designs and again after reaching each milestone. These meeting helped by comparing our future endeavor and comparing it to past successes and failures. There were 3 professors involved in this project and this gave is different levels of reporting and assessments to do. Whether it was our direct professor or the head of each lab. The procedure is different then what goes on in industry but the similar aspects can be in the presentations that are done and the reviewing that occurs in academic product development.

Design review meetings are essential to ensure that the design adheres to both each stage of the Product Development Process as well as provide feedback per each stage. One of the design meetings I went discussed the whereabouts of the validation of the project. The meeting was held by several members of the team. One of the lead engineers discussed her process when validating the functionality of the product. Our director provided feedback as to whether more testing is required. Also one of the main topics I remembered being discussed heavily was how to structure each subsystem effectively. A resolution was then agreed upon in about 20-30 min talk amongst the senior engineers. This meeting allowed for other folks of the team to be aware of what everyone is working on because not many know knew what anyone did since the team was rather large. Since the structure was in question, some of the senior engineers had run across this issue and were able to provide relevant solutions to fixing the problem.

I personally don't have any experience in industry; however, we've had design reviews for our capstone project at NJIT. The way these meetings go is that each team has their requirement documents or test plan reviewed in front of all the other teams and every other team has to pick apart nuances in the document for the purpose of helping the project team develop a better document. My capstone professor has pointed that this is how it essentially works in industry; where the project team has to sit down and listen while their colleagues constructively critique the document. This also applies for a product's design. The point of these meetings is to assure that everything is in check with the product's design and that everything follows the customer's needs and is following the proper regulations and protocols set forth by the FDA and such. I feel as though these meetings are very important for this reason since the project team may be blind to the faults in their design for one reason or another. These reviews can also let other people such as management know how the project is progressing and is good communicator for everyone involved.

The Design Review process helps with other challenges of an engineering team like:
Inter-org communication. Often people don’t know what other folks are working on. With very large teams you might even have two different engineers working on the same problem and not realize it.
Surfacing legacy work. Due to having design reviews, engineers can know that a particular technology problem had already been solved in the past.
Onboarding new engineers. Always a challenge due to legacy systems but design docs and reviews create easily digestible documentation.
Productive contribution. Design Reviews make it easy for a whole range of engineers to contribute thoughts towards a design. Often times little details are caught because someone with a different point of view jumps in. It also helps make it easier for shier engineers get involved due to the Questions Doc (detailed below)

Project review meetings bring together the best employees the company has to offer. The idea is to evaluate the design against its requirements in order to verify the outcomes of previous activities and identify issues before committing. The design review evaluates a design against its requirements by taking into consideration the physical tests and engineering simulation. The review is to make sure the design meets all system requirements with acceptable risk and that the design is within cost and schedule constraints.

Although I have no been involved in any industry jobs, I had the pleasure of having design meetings with my capstone group in order to create a product for an outside company. I plan to continue to work with this company and recently we had our design review meeting in order to create a specific structure and design for an implant in the body. There were multiple designs at this meeting and they were either evaluated or scrapped for a better one. The customer also wanted something much more specific and re-evaluated the design requirements, giving us a more specific aspect of the design to work on to make more efficient progress. After the project manager made specific comments, it was marked down, and our group made sure to make changes to the design and come prepared for the next meeting in order to be re-evaluated or completed in terms of designing a product that worked with the customer. These design review meetings are very helpful for guidance and allows us to cater to the customer needs and specific requirements that are needed.

During my capstone project, I engaged in regular project design review meetings. These were incredibly essential to making sure that our project was a) turning out to meet customer needs and b) was feasible and developing well. Every week, we met with a "customer" and advisors, both of whom helped shape our project into a successful product.

For example, we created multiple (4) designs and created a weighted chart to determine which one to use. The weights were of course based on discussions with the customer, and the design details themselves were chosen based on advice from our advisors. Without either of those, we could not have arrived at our final product. Although this was for a class and not a real project at a company, it functioned as a microcosm of how medical device review meeting ought to work, and how they help shape a project into a successful product.

Feedback plays a critical role in the design process. In order to make sure the review meetings go smoothly, the attitude of the team needs to be in order. The meetings should not devolve into firing lines where the team members are giving criticism without any basis. It should not also be where the lead is giving an elaborate presentation to win over the team and converting the meeting into a pitch session. The review meetings should stay on point and materials to be reviewed should be sent out beforehand for the team to be prepared. Each team should develop a method of how the meetings will be conducted and should stay consistent over the length of the project. This way the team shows up well prepared.

I don't have any experience in the industry, But I have similar experience in my senior year of Undergrad. In capstone class we have the status meeting every week with our professor and our adviser where the professor is our project manager and the adviser is our costumer, and we have to give him the status of the project and discuss the development of our project and is their is nay changes needed to be made. And also if we having any problems with the project development that what steps are we taking to overcome those problems. In addition to that we also have the design requirements review meeting with the entire class where we review other group requirements and give them a feed back that what needs to be changed, and I will say from my personal experience that this is very help because sometimes you can see your mistakes. And just like requirements review we also have the test plan review.

I am a production engineer at Getinge, and last week was my first time leading a design review meeting. The preparation for my design review meeting was intense since I was covering phases I-III in one meeting. I had to create a design review proposal, agenda, checklist plan. Along with getting regulatory’s feedback on the project proposal and first article requirements form. The project lead will show and explain these documents in a design review, while a design board evaluates your work. They will determine if an action is required to move forward with the project or to reject the project. It can be very intense because everyone directs questions about the project to the project lead. After a design review meeting is completed for each phase, a design review report must be completed and signed by the manager and quality lead to verify what agreements and disagreements were made within that phase of the design review.