In my opinion, I feel like there could be a variety of reasons that could cause an interim design review meeting. I feel like one of the main reasons a meeting could be called is that there was a design failure and a section of the device needs to be re-designed for safety. I feel like another reason could be that during trials, it was seen that the device could have caused some adverse reactions within or outside of the body and materials need to be changed or something needs to be done to lessen the effects. I also feel like sometimes these meetings are needed so that the project lead can reconnect with the team and see how progress is flowing. I definitely think that if the product is already released, engineers and marketing/sales reps should be included in the meetings. I feel like the marketing/ sales team can give some insight into how the customers view the product based on reviews and feedback that they received and the engineers can be there to hear whether the design needs to be altered to fix major issues. 

It would be crucial to have the project leader at the meeting because they lead the meeting and ensure that everything goes smoothly. It would also be important to include anyone else who has a say in the design. Representative/s from the engineering team would be helpful in any information about the manufacturing process and give more details about timing and materials due to their experience. It would be important to ensure that the customer is there as well because on some occasions a design may need to be changed. In the event that the customer wants to make a change the engineering team would be able to tell them the possibility and anything they would need to add/subtract from the current design to incorporate the customer's changes. In reverse, if something changed on the manufacturing side it would be important to have the customers know right then and there and it would be helpful to have the engineers there to tell them the exact issue and possible solutions. As for ‘interim’ meetings, they can occur whenever there is change that needs to be addressed. For example, a change to the design due to supply chain or seller, or if something happens and there is a change in budget. If there is anything that does not go by the timeline set and would affect it in any way, there would need to be a meeting with the people who it affects.

Some other important people to include in design review meeting should include stakeholders who overall have the final say in the approval of the product. Aside from the people who are directly working in the product development stages of the project it is important to not forget to include stakeholder's who is paying for the product they want. Another important thing to remember for a design review meeting is that you should also think about limiting the amount of participants for these meetings. Limiting participants will allow everyone in the meeting to voice their valuable feedback in a mannerly time. Too many voices in a design review meeting can make the meeting overwhelming, therefore it is extremely important to figure out who is most important in these meetings.

Like my prior classmates have stated, 'interim' meetings can be called anytime through out the development process when there happens to be failure or a change that needs to be addressed. 'Interim' design review meetings are almost as important as regularly scheduled design review meetings. These 'interim' meetings are important because it emphasizes communication on a project to ensure everybody is on the same page. Therefore it is never a bad time to call an 'interim' design review meeting.

This is an interesting topic because I have recently started learning about design controls in my industrial role at a medical device company. I learned that there is usually leaders for different projects and also a project leader that guides the overall progress of the design change controls. The part that surprised me the most is that at the design control meetings, every single member present involved in the process has to be physically present at the meeting and approve each output. Reading the other replies as to interim meetings or urgent change meetings along with everyone including the marketing/sales team was interesting as well because I have no experienced the full design control process yet. I am excited to hear about the experiences of others in industry roles and hope to share the new aspects I learn about the design control process in my future. 

@knm7 Just to add onto what you said here, I agree that if the product is already released, marketing should be at the meeting, but I think they have a place in these meetings before the release at all stages of development. This is because the marketing department is the most connected to all parts of the company. They have a different view of what is possible in manufacturing and also importantly what customers need and what the sales team wants to sell. This information can be hard to see if you are an engineer, and having marketing there early may allow them to point out something that could be changed early to make the device easier to sell in the long term to avoid extra work or redesigns later.

Echoing @ag2357, I would bring in marketing to all of these interim meetings, especially if the marketing represenation is the product manager. They can solicit information from their sales force as to market interest, and how the proposed change affects market interest. Additionally, I have never been in these meetings when a representative for manufacturing, a R&D scientist, and a supply chain representative is not present. Each discipline brings a unique perspective as well as blind spots that can be complemented by the others' expertise.

I am in agreement that when there is a change deemed substantial, there needs to be an interim review. I would just like to add that the thresholds for "substantial" depend on the company, and usually determined by the risk the change presents.

I think that both a customer representative and manufacturer should be included in the design review meetings when possible. The customer representative could offer insight into areas overlooked by the designer. The representative knows what the consumer likes, what they don't like, what they wish could be changed. The manufacturer knows the limitation of their production area. If, for example, during the design review meeting it was brought up that the dimension of a small piece needed to be even smaller, the manufacturer would be able to discuss if they were able to create that or not. Depending on the machinery the manufacturer has, they may not be able to reach the required level of precision. Another thing that the manufacturer could discuss might be how fast they could create these products and how a change might impact the production timeline.

I think it would be beneficial to have the project manager, project leader, and anyone who is actually helping design the product participate in the design review meeting. I think a design interim meeting would be necessary if something is not going as planned with the design and production such as a glitch in the product, timeline being missed, defect in some aspect of the project. This meeting helps to have a shared understanding of the solution. The objective of these meetings is to guide the creative process to ensure the final design aligns with the product goals.

I think that everyone involved in this project should attend the review meeting. It's hard to always keep the design on trial, and it does not have to be a significant change. Members who participate in these little changes need to attend this interim meeting. People will figure out where the problem is and make a solution. After that, the record report will be sent to the superior or others who are related. The board or client can understand how the project is based on these reports. They will hold another interim meeting before the review meeting if they have any suggestions. Ideally, when the manager attends the review meeting, everything should be done, and everyone will approve the project because they already know the process according to the interim meeting.

In the design review, multiple departments are included to cover all their bases in different aspects, including design, quality, and manufacturing, among others. Having multiple people with experience in these reviews gives the product the optimal rate of success, so the project becomes successful. In most cases, these design reviews seek to tackle this project from different angles to find out any issues early on as well as as they progress into the later stages of the project. Interim meetings can be held from the scheduled times to times where urgent concerns are raised by a member of the team developing this project. If a member finds out there is a safety concern or that there are problems with the finances of the project, these are concerns that need to be brought to the attention of the members on the working of this project. These scheduled meetings are held in order to loop everyone in to let them know of the progress on the project and to get input from multiple members to resolve any issues before they become problematic. Having multiple view points helps to resolve any issues that these members might have through these meetings, and by having interim meetings, urgent issues are resolved, thus bringing development to the project sooner rather than later. Developing any product, there can be multiple years of testing behind it, but issues can surface later on, and appropriate actions are taken to resolve them, such as a recall for drug development, which similarly helps in these projects.

In my perspective, there can be numerous compelling reasons for an interim design review meeting. A significant rationale for such a meeting may be the discovery of a design flaw, necessitating a redesign of a specific component to ensure safety. Furthermore, if trials reveal adverse reactions arising from the device, whether internally or externally, adjustments to materials or other measures may be necessary to mitigate these effects.

Moreover, these meetings can serve as a mechanism for the project leader to reconnect with the team and evaluate the progression of the project. It's also crucial to engage engineers and marketing/sales representatives, particularly when the product is already in the market. Marketing and sales teams can offer valuable insights regarding how customers perceive the product based on their reviews and feedback. Simultaneously, engineers can participate in resolving any major design issues that may arise, while also aiding the supply chain in identifying its specific needs. Additionally, these meetings can help manufacturing determine the manufacturing time required for each part, streamlining the production process.

Within a design review meeting, it is important to ensure that each department involved in the project should be represented at the meeting. This may include the project lead as well as the quality lead, regulatory lead, research and development lead, marketing lead, manufacturing lead, as well as other departments involved. If the project team is smaller, it could make sense to have the whole team involved in the design review meeting, but in the case that the team is very large, it could be difficult to have the whole team involved. In this case, the meeting could consist of the leads for each department and each lead would relay the information to their teams as well as raise concerns or comments at the meeting on behalf of their team members. Interim meetings could be raised if a customer need has been changed or if the team finds a potential fault in the device. For example, in the department I work in, there is a team called the characterization team, which conducts testing on the devices to attempt to find out how the device can fail. If an issue is found that could have a big impact on the performance of the device, an interim meeting could be held to discuss how to move forward with the device and project and whether adjustments have to be made. 

Interim design review meetings are frequently brought about by the requirement to be flexible and adaptable to changing conditions as the product is being developed. An interim design review meeting may be scheduled for a variety of reasons by a team member. For instance, a team member may schedule an interim meeting to discuss and quickly resolve any unforeseen problems or difficulties that may come up during the development process. An interim meeting may also be called for as a result of enhanced teamwork and communication. Project efficiency can be increased overall by making sure that everyone is in agreement and resolving any communication gaps.

Hello,

In addition to the project leader, design review meetings should ideally include key personnel representing various aspects of the product development process. This may include representatives from the customer or end-users to ensure that their requirements and expectations are accurately reflected in the design. Engineers and designers responsible for the technical aspects of the product should be present to discuss feasibility, functionality, and potential challenges. Manufacturing and production experts can contribute valuable insights into the practical aspects of producing the design efficiently. Quality assurance and testing team members are essential to ensuring that the product meets specified standards. Additionally, involving members from marketing and sales can provide a holistic perspective, aligning the design with market demands and strategies. By assembling a diverse group, design review meetings can foster comprehensive discussions, surface potential issues, and ensure alignment with the project's overall goals.

Interim design review meetings may be scheduled for various reasons. One key factor is the emergence of critical issues or challenges that require immediate attention. If team members identify unforeseen obstacles, technical complexities, or changes in project scope, scheduling an interim meeting allows for timely problem-solving and decision-making. Changes in project timelines, resource availability, or external factors such as market shifts can also prompt the need for an interim review. Effective communication and collaboration among team members are crucial in recognizing when circumstances necessitate an interim meeting. It's a proactive approach to address issues promptly, ensuring that the project stays on track and minimizing the risk of delays or deviations from the original plan.