Hi Himang,

Although i don't have experience but i do research and from that I know the following:
There is usually a chairperson who is responsible for coordinating the preparations for the design review and managing the review meeting.
A design team (usually engineers) whose responsibility is to provide details regarding the design and its process and receiving feedback from the subject-matter expert on any issues to resolve it. The Subject-matter experts can be regulatory experts, manufacturing experts, quality, marketing, etc. and majority of the time not directly involved in the development of the design.
The review process usually consists of introduction, design review purpose and process, some background, detailed product discussion including discussion of the project, and wrap-up. The design teams/engineers usually prepares the Design Review Meeting Minutes at the end to include all the feedback: decisions that were made, issues that require resolution, conclusion made from the teams to incorporate any changes that may require.

Hi,

A design review is a milestone within the product development process whereby a design is evaluated against its requirements in order to verify the outcomes of the previous activity and identify the issue and correct it . There are different ways to conduct a design review 1. physical test 2.examination (walk-through).The ultimate design review, if successful, therefore triggers the product launch or product release.
Design review ensures that
1.The proposed design will meet the requirements.
2.The design can be implemented in the required time.
3.The design will be consistent with technical goals of the organization.

Thank you Himang for the great question. I don't have experience conducting design review meetings. But from experience in review meetings as a whole, I can say it is best to keep the number of invitees medium sized since when too many people are included sometimes the conversations can be unproductive. Usually teams consist of one representative from each function.
Also, the agenda should be lean and include the most important topics such as Design Review agenda, purpose, and goal. I am a bit alarmed that a design review meeting could go on for weeks.

Design review meetings consist of many things. They review updates and changes that may be necessary and make a decision on said decision. Usually in these meetings you have a representative from each department, such as Quality, Regulatory, Marketing, and R&D. These changes or update to the development of the product consists of inputs from all the departments where all changes and discussions are drafted in meeting minutes. This is used as formal documentation that details the discussion of the decision being made. Also in these meetings, Design Input Requirements are reviewed and signed off on due to changes as well. The reason for having each member from each department present at these meetings is to assess the impact against the market, the user, feasibility wise by the engineers, and if it meets FDA standards.

In terms of design meeting, several points may be addressed: What tends to happen whenever a project issue arises? In most project review meetings people immediately begin to discuss the issue. What is the chance that this will be the most important issue to be discussed? What is the chance that everyone in the room will share a common understanding of the issue? What is the chance that the right people will be in the room to resolve it? What is the chance that all the right information will have been gathered to address the issue? And, yet, the desire is to discuss it and try to resolve it.

Effective project-oriented organizations have identified two different types of project review meetings: the project status meeting and the resolution meeting. The project status meeting identifies project-related problems and opportunities; the resolution meeting identifies the right people, gathers the right information, and resolves the issues identified in the project status meeting.

I haven’t had the change to have a design review meeting in an industry but I have done it when I was doing my Capstone project, we used to have a lot of meeting because we used to keep changing and updating our documents to make it better or maybe we forgot to add or fix some stuff, like Dr. Simon said in the lecture this is going to be a lot of meeting maybe 1 or 2 times a week, for me we used to have 1 every week because we were always missing something this allow us to be in the same page so yes this is really important to have because it can solve a lot of problems that someone might have missed or also to help to put a input to make the project better.

Hi

I don't have an experience with them, but I can imagine if they don't exist how hard is it to implement a change or realize when a mistake is happening. If you don't have a review meeting after every important milestone in the process of the device development, then it will be really hard to process a change. As mentioned in the lecture, change requests usually are mentioned in those meetings as the whole team is present. Similarly, if a problem has been detected by one of the team members, those meetings are a good place to discuss them. A company doesn't want to spend money on research for example or a step that is followed by a faulty initial design.

- Lamiaa

I unfortunately do not have industry experience in a design review, but I can imagine how these meetings impact the development of the project. During these meetings it must also be important to stay on top of the changes that need to be made to the documents or else it may become overwhelming. Also, with some many different opinions, it may be hard to come to a conclusion some times. When a change needs to be made does that person need to provide some sort of reason as to why these changes are being made? Do they supply some type of research to back up their reasoning? I would assume it would be necessary to provide reasoning or documentation as to why a change should be made.

Hi,

I never attended design review meeting. Although it’s very similar with other meetings summarizing activities during a project. It’s very important to meet while the milestones are done to review the situation. During the design review meeting people can meet face to face and ask questions. It’s very important that everyone who is working on project is on the same page. It’s essential to invite the right people. The information such as date, design and people attending the review should be recorded in the DHF which is Design history file. All design controls such as design input, output, verification etc. should be part of the design review meeting.

Thanks

I have never actually been involved in a design review meeting, but I know from my experience within R&D and now in manufacturing. To me meeting minutes are essential with regards to project deadlines or even addressing potential issues or concerns with respect to certain products.I guess the only type of meeting that is similar to the design review would be a meeting I had with marketing, when I was working in consumer product development, they had a concern with a fragrance that didn't match their claim on the label and as a result, I had to reformulate to adjust to that claim. The reformulation process consisted of making several batches of that particular product but with different experimental fragrances until marketing approved of one. Lastly, one frequent type of meeting that I have at least once a week are “project status meetings” where I update my manager on the status of my project, and relay concerns if applicable.

Chris

Hello,

The meeting structure is very organized, with a moderator and someone taking notes to reference in later meetings who said what. It is essentially a time to get everyone in one room to work on and discuss the progress of the project and the necessary items that need to get done as well as the next steps and issues that arise. It has to do with good communication and from the design aspect is crucial. Some of these meetings are where you show your progress to the boss and request further plans of action, this is where the design meets the budget as so forth.

I do agree with you “Reviews can be formal or informal, require a well-prepared agenda, and can last hours, days, or even a few weeks.” However, this is not always the case. At the company I am currently at we have something called out in our design review SOP called an abbreviated design review. This type of review is usually only one or two meetings at most. They are generally used for changes that provide enough justification to not require V and V protocols. Now if something is discovered to not necessarily meet justification in the meeting and you discover a V&V is required. A full Design review must be held.

Himang,

I don’t have personal experience with design review meetings however; I have a friend who has some experience in such meetings. The design review process itself could happen in stages. As you mentioned, a design review could last hours to weeks depending on the complexity of the project and interests of the stakeholders involved. A good design review lasting only hours with all parties in agreement means the design was well formulated and presented to the team, management, and customer with only a few minor pieces of feedback for improvement. A poor design review at the end of a stage of a product could last weeks if the design did not meet expectations or requirements and involves stakeholders who wish to add to the design rather than stick to what was presented.

I was lucky enough to have the opportunity to work on a Test Method validation that went into a design review. One thing I have noticed is that people will often make it seem like they have something to say even when they do not. I was not personally in the review but the engineer I was working under told me it can either be an extremely helpful amount of information or it could end up being just people correcting your grammar. I understand the need for the review, but I also think it is important to understand that someone doesn’t always need to offer a correction. If you have nothing useful to say please say nothing at all.