Dr. Simon touched upon Design Review Meetings. He gave a strategy of sending documents to the expected attendees ahead of time in order to get a faster approval. Is there any other way that you can think of to obtain a fast approval in order to keep a project moving as swiftly as possible?
This question becomes tricky because these documents should be carefully reviewed to ensure the safety and effectiveness of the device. We would not want minor miscalculation to snowball into a much larger issues that can become detrimental to the whole organization. Therefore, care must be taken when approving any Design Control documentation. The purpose of sending out documents a week in advance is to provide those in attendance of the Design Review Meeting ample time to go through the details of the document. To improve efficiency of the approval process would be heavily dependent on the project team's swift response to the design change requests. The structure of a Design Review Meeting is coordinated to be as thorough as possible and made capable of running smoothly with the guidance of a moderator to keep the meeting on topic.
In addition to giving ample time for members of the project team to review documents before their approval, I think that it would be beneficial to have frequent short meetings in between official design review document approval meetings. I think that this can be an efficient way to ensure that all members of the project team are continuously on the same page, and can address issues or changes as they come up so that when an approval meeting comes around there should be no surprises because ideally all of the kinks would be worked out by then. This would require some scheduling, but the meetings don't necessarily have to be in person. The project manager can send out an email and schedule a short 10 minute conference call for a time all key members are available where they can voice their concerns if any. Constant communication is key.
Being that a medical device company usually has a large number of projects active at one time, the engineers that would attend your design review meeting have multiple amounts of documents that require their review and approval. While you may send your document for review a week ahead of time, it may be buried in a stack of files. What would help expedite the review and approval of your document would be an email from your project manager to all the reviewers to let them know the priority of this document.
In the part of the company that I'm in, my group is mainly responsible for heading DR's and sending out the required documentations for the respective parties to review. In my and other co-worker's experience, sometimes the best you can do is send documents in a timely manner (at least a week before the DR) for the parties to review. Whether or not the person will read it before the DR is another matter, of which the responsibility falls on the person. In agreeing to be part of the DR, the person is agreeing that they have the capacity and ability to review all documents and provide support in pointing out errors or potential pitfalls. If they are not able to do this by reviewing the material, then they should be delegating their responsibility to another person. I've seen people assign backups to read the material as well in the case that they don't have the time to read or get double booked on the DR time slot. Other times, I've seen people review the DR docs as the DR is happening (which ideally should not happen) but still are able to provide the needed feedback. So yes, sending the docs at least a week ahead is the best option as these people have opted in to taking this responsibility. Sending daily reminders or other measures like that to make sure people read docs will likely be taken as annoying and even offensive to some and would work against you. If problems arise where someone is not reviewing their docs, then it is up to the PM or the party responsible for the DR to reassign the role and get the proper review done.
Like yzs3 mentioned, sending the documents a week in advance could be very beneficial to allow for everyone attending the meeting to have time to read over and understand what will be discussed. In addition, the document itself must be very clear and very concise to allow for all in attendance at the design review meeting to have a clear understanding of the project before the meeting. This will increase the efficiency of the review, and overall, speed the entire design process along.
I think the best way to get fast approval from the committee at the design review meetings is to present the proper material and hold them at the right times. For example, a design review should occur with each step in the design controls process. If you break it up this way, you'll be approved faster because you're presenting your material in a timely and orderly manner. Also plan ahead. when you're drafting your design plan make sure to set the times that your reviews should happen in. The material in the reviews themselves is very important. The design review should have a purpose. If you go in with a specific purpose in mind, you will be able to deliver the material clearer and thus have a quicker approval. Some purposes should be keeping your device development on track, having the opportunity to present your device to potential buyers and receiving feedback to improve on your device.
I really don't think there is any faster way to get an approval as the document needs to be studied properly before being passed ahead, which will take time so I feel one week ahead before the meeting is enough to study the document point out the necessary changes and then go ahead with the meeting.
In my view the best way to have a design review approval faster is by sending in the documents well ahead in time to the review meeting attendees well in advance as Dr. Simon mentioned so that the attendees have well enough time to review the necessary details and have an overview of the changes needed to be made and know what would be the topic of discussion at the meeting. Also by having the design review report structured in a way that will suit the situation of the design and as Ryan mentioned about having the report clear and detailed for the attendees would help to some extent.
Design Reviews are designed to be checkpoints during medical device product development to ensure the product design is safe, effective, and progressing. In order to have a proper meeting for the design review and a project to move as swiftly as possible, I agree with Dr. Simon's suggestion by sending the documents ahead of time in order to get the approval faster. Furthermore, if there are any issues, it would be taken care of or at least it is known prior to the design review meeting.
From the standpoint of a biomedical company, I don't believe sending document for review ahead of time, would necessarily imply that your documents will be reviewed faster. Given the large number of projects that a company might have at a time, your document will mostly like be buried until its actually review date approaches. However, to expedite the review process, the project manager might consider taking extra time to review it as this might help catch and decrease the adjustable errors before the documents reach the review team. In addition, the project team might set up intermediate unofficial reviewing milestones throughout the life of the project. Those meeting might even be online if in-person meetings aren't possible. With this two approaches, the documents sent to the reviewing team will certainly have less needs for update , hence less time spent in during the reviewing process.
As someone who has witnessed some design review meetings succeed and fail, there are some things you can do to ensure success. As @vcf3 mentioned, the attendees of the meeting have a high chance of ignoring you completely and showing up to the meeting clueless as to what you are trying to accomplish. Once you get to know these people more, you will also understand that some are more likely to knit-pick your changes and challenge you. Others will pretty much go with the flow as long as the change presents no risk to them and their department responsibilities. I am not saying these attendees should be left in the dark before the meeting but they are busy themselves and may ignore you. That is a fact. What I believe the best route is to actually go and meet with the more scrupulous members one-on-one to ensure they are on board with your changes. That way they will call you out and object in a more private scenario as opposed to in a meeting with 5-10 other people watching. This will avoid a lot of embarrassment and speed up the process at the same time.
Dr. Simon touched upon Design Review Meetings. He gave a strategy of sending documents to the expected attendees ahead of time in order to get a faster approval. Is there any other way that you can think of to obtain a fast approval in order to keep a project moving as swiftly as possible?
Best way to get the fastest approval is to pull rank!
Send out a meeting invitation to all the required approvers, and copy their boss, their bosses' boss, and their bosses' bosses' boss (VP of R&D/VP of Operations). Design approval is a high visibility milestone.
Baring any new information between the time you set up the meeting invitation and time to approve the design, the meeting should go smoothly. If an approver waits UNTIL the meeting to raise the issue, it will be as clear as day that they are the reason that the project is delayed (again, baring any new information during the design review). 95% of the time, this will work. You will definitely build a reputation as the person who always copies the boss, but that doesn't matter because your projects get done well and on time!
Input, verification, validation and transfer stages have design review meeting at the end to ensure that the past stage is done satisfactorily with all approval, so the next stage will start. I think it is like a closing meeting for every stage. For me, share the paper with the meeting's members prior to the design review meeting is the only way to get the approvals fast, so if there is any suggestion, it can be considered before that.
Distributing documents well in advance before a meeting is the best way to ensure a meeting runs as smoothly as possible. Coming into a meeting with as much knowledge and background about the project as possible ensures that the meeting will be productive rather than an introductory meeting making it more time efficient. Another benefit to sending all pertaining documents out well before a meeting allows the team to compile their comments and feedback as well as solutions. Another way that can supplement the current method of sending out pertaining documents to obtain fast approval in order to keep a project moving as swiftly as possible is to ensure all of the involved engineers and team leads are involved in the meeting and offering their inputs as well. By providing a range of opinions and expertise of the lead engineers on the project, there will be a more convincing case to continue running the project as planned since it shows that everyone is on board and in agreeance with the current plan leaving little to no room for any doubts.
