I think this would be a critical part of the entire scheduling for the project. The balloon did not do what it was supposed to and as a result, whatever comes after in the schedule will be delayed. In terms of the Gantt chart, the project manager will have to allocate more time for R&D to do further research and figure out the best possible course of action after this failure. Also, they might have to make certain sections longer just in case another issue comes up again so that the critical paths do not get effected too much. Whenever a problem does arise, a lot of times the project will get delayed. In this case, since a key component of the project failed, they will have to allocate a lot of time to further research and complete an investigation as to why it failed.

Adding to what Hiren Rana said, not only will the project manager need to allocate more time for R&D. The test protocols may need to revised. This would take more time and causing a delay in the tasks down the line. If the test protocols are changed, than some changes in the paperwork or times of certain tasks may also have to be changed. This also points to the importance of your first phase in any project. If the first phase or part of the project fails, it will cause delays in the rest of the project.

Also pointing to another major issue, as we learned in the past lectures, this is one of the reasons some projects are over the budget or out of the budget because the project manager is not given the budget information.

As others have already stated, a lot of the time and effort into Research & Development and modifications on test protocols and exploration on how to fix this issue will be necessary. One thing I would like to bring up is if this type of occurrence was already accounted for, then it would have been considered project slack. Depending on how much slack was considered for this type of failure in this test protocol, then this may not have affected the Gantt Chart all too much. If there was a marginal amount of time planned ahead of time for Research and Development to fix this test failure, then the project Manager could continue with the dependent tasks on the Gantt Chart.

If there was not a lot of slack accounted for then the Project manager will definitely have to reallocate the time into Research & Development and modifying test protocols.

If it immediately popped, I feel they need to go back to the beginning. Their design controls failed horribly. It states that the test is "to ensure the balloon system does not pop in an artificial casing that mimics the stomach after 10 days of placements.". It also states that its removed after 6 mos. Why not test for 6 mos or even longer than 6 mos if its going to be in place for that long? They probably didn't even consider decay and the stomach is a very acidic environment.

When revising the Gantt chart, the project manager needs to account for them going through most, if not all, of the nine design controls again. This project requires new inputs and outputs and this will have an impact on everything after that.

When a test on whether the balloon system pops after 10 days fails for a device such as ReShape Integrated Dual Balloon System it creates a stir in the office. I would like to share my experience on when a test fails in the medical industry for a different device. I work in company that is known for their product of IABs (intra-aortic balloons). I got involved in a CAPA which claimed that an IAB was leaking. For a FDA class three device to get a complaint on the balloon leaking it means that all the documents associated with this device have to be revised. But that is not the main concern, its actually trying to figure out whether or not the balloons are leaking and if they are then why. The engineers will run numerous tests using pressure gages to analyze numerous amounts of IAB’s. If the realize there are leaks then they have to figure out a way to stop it. If there are no leaks then they have to statistically prove that the product is safe. These steps include research, testing and evaluating. The project manager is required to analyze what’s the critical path and budget to figure out an outline to solve the issue on time and within the budget cost. The project manager will modify the Gantt chart to include testing, research, meetings with engineers and sponsors and time to revise all documents.

Missing a milestone might be the worst thing that can happen to a project. A milestone defines the completion of an important step in a project's development process and task times are often dictated by it. If a milestone is missed, the first step for the project manager is to identify why. In terms of the Gantt chart: Was the milestone deadline too early and the balloon popped because there was not enough R & D? Was hiring done too quickly and the right skill set was not hired? Where there too many vacations and less time spent on the project? Where tasks changed among workers? Was there not enough time spent on acquiring funding and there are not enough/poor quality resources/vendors? As time is the running theme among all these possibilities the easiest solution is to extend the completion deadline. If deadlines are beyond control, compromises would have to made on the result of the project. Negotiations would have to been done between the customer and the company, and if it is internal, between the company and its employees.

As stated by previous responses R&D would be a factor that extends the Gantt Chart and timeline of the project. However, another important aspect of the balloon system popping immediately may cause upper management to re-evaluate the project entirely. This would be a major setback to a project of this magnitude and something that would have been addressed before deciding to even start the project. If the balloon system was not able to meet the requirement of 10 days by even 10% it is likely that this project would have never received the go ahead to begin, since R&D is usually never this far behind before the initiation of a project.

Certain factors may include any of the following: Time, Budget, Contingency Plans, and any inspection dates.

For time, the PM needs to readjust the gantt chart in order to make up for lost time because of missing a milestone. He has to consider the importance of certain characteristics during development and allocate time to focus on those requirements. When a milestone is missed, priority for certain aspects have to be re-evaluated.

For budget, the PM may have to consider scrapping certain goals on the gantt chart because the budget might be too tight. Other milestones may be axed if the budget is very constricted by the company.

Contingency Plans are necessary if the company is niether will to risk time nor budget during the development of the project. Therefore, the PM may have implemented a contingency plan within the gantt chart where issues like this can be resolved. This proactive mode of thinking of assuming the possibility of failure can save time and budget for the project.

Since this is an FDA approved device that will act in vivo, inspections will be required. So, on the gantt chart, there may be certain milestones that have to be reached before the product can be ready for inspection, so the PM has to be mindful of that.

Interesting topic, but is the balloon popping an isolated incident or does it happen all the time? I do agree that more time will be needed by R&D to address this issue, but is this product already in the market? if so manufacturing engineering will also have to address this issue as well. There could be a mishap in materials or in production that caused this effect. Either way the project manager would have to modify the Gant chart to include the testing of this device and revise the corresponding documents.

Chris

You make a good point tn58. This will certainly affect the overall project and may require reallocation of time in the preliminary steps of the project schedule. Not only R&D, but other phases such as testing and verification will need to be altered. This could create a significant delay, but the reconsideration of what criteria the device has to meet may end up salvaging the situation without starting from scratch. This was the case with our first simulation, in which the verification testing was using an unnecessarily high temperature. And instead of getting new adhesive, labels etc. The tests were modified and allowed for the appropriate verification of the project.

When revising a Gantt chart due a missed milestone, like everyone has stated, resources and time should be centered around R&D to make up for the missed milestone and to ensure that other milestones are reached on time successfully. The factors that the PM must take into account are the remaining time for the project, how much funds are still available, and how long will it take to find and solve the issues that caused the milestone to be missed.

I think this would be a basic piece of the whole booking for the venture. The inflatable did not do what it should and thus, whatever comes after in the calendar will be deferred. As far as the Gantt graph, the venture administrator should assign more opportunity for R&D to do additionally research and make sense of the most ideal game-plan after this disappointment. Likewise, they may need to make certain segments longer just on the off chance that another issue comes up again so that the basic ways don't get affected excessively. At whatever point an issue arises, a considerable measure of times the venture will get deferred. For this situation, since a key part of the venture fizzled, they should apportion a great deal of time to further research and finish an examination with respect to why it fizzled.

It seems the company has a lot to worry about and updating the Gantt Chart may be the last of their worries. The balloon pops immediately instead of lasting for days could be a catastrophic issue and could result in termination of a program if the problem is not resolved. Unfortunately the link provided at the starting post is no longer working so I could not read about the details. Assuming the issues happened at design verification, I agree with others that all of testing might have to be redone. However the first thing the engineering group would need to do is identify the root cause of the problem. This would require research, testing and evaluating. Maybe the test method was not followed adequately (e.g. certain steps were not followed or performed incorrectly) which resulted in failure, or the unit was not stored/ handled adequately prior to the test, or a subcomponent failed which resulted in popping the balloon, etc. There could be many things that could have happened to cause the failure and hopefully is not a design flaw that requires going back to sketch board/ concept phase. Once the root cause is identified, the engineering team would identify solution(s) to the issue and then the PM could re-assess the Gantt Chart based on the solution that the company pursue.

As everyone stated this is very bad because it is a critical part of the device's function. The first thing I would do is check the deadline because I need to see how much time I have left to see what I can do. For starter find other test that would be able to reduce and replace other test that was scheduled so that the team can go back to R&D to fix the issue. We can also two team, one team run test/other phase that does not need full device while the other team fix the device. The team needs to work as twice as hard. There could be two options that could happen if we don't complete in time which is the customer ending the project or extending the time, this will cost a lot of money and the company reputation will be affected badly.