One of approaches to take would be to look “easy” fixes first (e.g. improve packaging configuration first, then propose modifications to the device, then propose modifications to the combination product) so we can try to identify the root cause, followed by quick lab tests that can provide objective evidence about the root cause identification and mitigation. These tasks would be part of the project management and would be prioritized by support from management. For example, one item at a time would be evaluated as follows:
Proposed Packaging Configuration: syringe packaged in Tyvek sealed blister to control humidity.
Perform Accelerated stability study in support of DSD shelf-life requirement. This study will give an idea if the packaging configuration helps protect the product against humidity.
Accelerated aging testing to be conducted in accordance to ASTM F1980, and ANSI/AAMI/ISO 11607-1 under the following test parameters/ conditions:
Proposed redesign of syringe to include dual chamber: this device allows users to reconstitute the protein suspended in carboxylmethyl cellulose (CMC) with calcium sulfate dihydrate just prior to the injection. Both syringe chambers are sealed from each other to prevent premature reconstitution. The syringe with dual chambers is packaged in Tyvek sealed blister to control humidity.
Quick functional test will be performed with 5 syringes that will be reconstituted and injected (into a beaker) using Instron to measure injection force. The syringes will be injected after reconstitution at the following times: 1) time zero (immediately following reconstitution), 2) 5 minutes, 3) 10 minutes, 4) 30 minutes, and 5) 1 hour. All samples will be assessed to evaluate whether the content was expelled.
Proposed change in carrier from calcium sulfate dihydrate to Chitosan. This combination of Chitosan and CMC with growth factor will be tested as combination product following approach #1 and #2 aforementioned.
One approach is certainly decreasing the time for animal studies. Reduced clinical trial can save some time to finish with the project as they take a lot of time for clinical trials and their results. Project risk comparatively increases. A second approach is to set storage conditions or chage the material of the syringes. At the same time the growth factor has to be maintained.
The first thing that I would do is identify what issues are currently being faced. In this case, the product was clumping and the CMC was leaking out. With that identified, small fixes would be the next step(changing storage temperatures, etc). Simultaneously, research should be conducted in changing larger aspects of the product (carrier system, etc). If the smaller fixes resolve the issue, then that is great and you can move on to the next step in the device process. If not, you will already be looking at larger issues and saving time.
To have the deliverables ready in time, as a manager, you need to take certain steps and plan ahead. First you need to be a very organized and communicative manager. You need to set deadlines, communicate with the different teams and be able to keep track of progress. I believe the most important step in delivering everything on time is setting deadlines and holding people accountable to them. Deadlines drive and motivate people to work hard towards a goal. It helps them keep focused and in line with what needs to be done. Setting a deadline also lets people know the seriousness of the project or task. Setting deadlines on a frequent basis, with small steps to get done is much more effective than setting further deadlines. These act as little checkpoints in the project and help get everything done before the final deadline.
What I would do is hold a meeting between research group and other departments. Here we will discuss, what methods we can use and make a new time schedule so we can be able to fix the problem on time with less risk in take. The meeting will help departments communicate between each other and make a new plan faster because they will see which plan is not time consuming but is efficient. If the research department need more, I will also find other team members that can be able to assist the research department so they wouldn't fall back further. Everyone is working in separate departments but we all are working in one project getting assistance from other department will help solve and manage time.
It is already half of the semester, and till now we have been studying all different methods and documents that support in managing the project. According to me, the best way to meet the deadlines in this scenario is to give the planning phase of the project manager to consider and devote as much time possible to research. When developing a solution, in that case, we need to define the problems that we are facing, and the problem we are trying to address and the factors that we are putting into and considering to resolve that problem. The Project manager should communicate with the team members in handling the research method before setting up deadlines
Meeting a deadline means that you were successful in fulfilling your task before it was too late. There are essential tips for meeting a deadline: 1- Care about deadlines, This is the first step, as many people are very lax about deadlines. 2- Keep a list of projects& deadlines. 3- Communicate a clear deadline. 4- Work in a cushion. 5- Have a clear outcome 6-Break down the project.
If you are using a Gantt chart to create a project schedule, it should be relatively easy to develop a project schedule. Review the Gantt chart with the entire team and make sure that you have a complete purchase before starting the project. Everyone should understand their role in the project, and they should be able to commit with confidence to a schedule. The project manager should have careful monitoring of project status and verify that the activities are completed on time and within the scope
Be as prepared as possible by speaking to various process groups and working on block schedules. Having a gnatt chart in place would be really hopeful as you can observe the overall time line of the projects for tasks that do not need to be done immediately or on the critical path we and use extra times as buffers which can be used by the PM to allocate time to other points of the project. This helps to have a plan for failure.
There has been a lot of research and time put into developing the one carrier for FactoSet and deadlines are approaching but an effective method is to make sure to reference the Gantt Chart that was created when first starting this process. There may be a lot of time and research put into developing that one carrier so the extensive research for it should be available to figure out why there is clumping or leaking happening to the mixture. What would need to be done is to go back and look thoroughly through the research to see what could have affected the carrier without changing it. There may be some minor changes that need to be made to the protocol. Issues can always arise during test protocols like this which means when making the Gantt chart that there must be enough time given to make the adjustments to fix the problem. Another thing that should be considered is overestimating the budget in case something does go wrong and you need to change the carrier completely. There are extensive research done but there is always room for error which needs to be accounted for in the budget and timeline.
Deadlines are the most important ones in moving the research in a successful and balanced way. Gantt charts provide an easy way in making out the project/research in time. Reducing time period for preclinical trials could save some time. But it also involves some project risk. So everyone in the team should perform their task in the efficient way to make a successful research in the estimated deadline.
In most cases, the project manager is the individual who produces the plan project which includes the work breakdown structure (WBS) and schedule from the requirements that he or she receives. However, in many situations, the project deadline is a key restriction, a non-negotiable fixed date.The progress of the project needs to be monitored so that corrective actions can be taken after any gap.
This project simulation was quite tasking. We started off well by changing of the carrier of the bone growth factor and the syringe, however, along the line, we went to deep by proposing to carry out an animal test for 2 years which will require sitting around waiting for 2 years under the probability of the experiment either passing or failing which can end the project and be a waste of time and resources if it fails thereby losing our partnership with FactoSet.
That been said, this really happens in the industry whereby the team assigned to a project goes beyond the deliverables and this is where the project manger comes in to stop the process and put the team back on track, letting the team know what is required and not to deviate from the actual reason the test failed.
Therefore, constant communication and update from the team to the project manager on every step of their protocol is required and will help the project manager to know when their team goes beyond the deliverable and also, to let them know what steps will be approved or not based on the project timeline or budget.
In this week's Simulation 2, we are working for a company called BoneFix, which is partnering with company called FactoSet to create a competitive product that delivers a growth factor that aids in bone regeneration. BoneFix has obligations to meet certain milestones in order to be able to maintain a partnership with FactoSet and to continue using their growth factor. The challenge has come up where the carrier that BoneFix has been developing is not meeting the shelf life requirements because it is clumping and leaking. In the simulation, we are part of the project as members of the research team.
If you were the project manager of this project, what tools would you use to keep this project on pace? Valuable time has already been used up developing one carrier, and the deadline to meet the obligations to FactoSet are fast approaching. On the other hand, rushing research activities like shelf life tests and animal studies can lead to misleading results. How would you manage the project team to still be able to have all of the deliverables ready in time?
There can also be serious consequences for failing to meet a deadline. On a personal level, it can damage your reputation and harm your career prospects – especially if it happens more than once.
It can also be extremely damaging at an organizational level. Missing a deadline will likely impact your company's reputation, and it can have serious financial implications if your delay triggers a penalty clause in a contract.
There are two main areas to focus on when you have to hit a deadline: managing the deadline, and managing yourself.
I would eliminate the unnecessary tests and apply strict deadlines to the timeline of the project. This helps in moving the project at a fast pace and still maintaining the necessary requirements. The timeline and communication with the team plays a major role in the completion of the project. It is very important to stay in regular contact with the team and update on the project events at every stage. Unnecessary studies and tests has to avoided to save time.
