I don’t think it is worth increasing the risk to shorten the time span. It is understandable in some cases that time should be decreased for emergency reasons and stuff. Nevertheless, if the project fails then the project will be prolonged all over again. Then the team will have to compensate for the rush and the insufficient work which defeats the purpose of shortening the time span from the first place. It will cost more money and resources.
In the case of the MiniSim, passing results were obtained after shortening the length of the animal experiment. This resulted in an increased risk and reduction in quality of the results. I think some ethical points should also be considered and it should be kept in mind that these devices are going into people's bodies. If shortening the time of the experiments is proved to not increase the overall risk of the product then maybe it's worth it. But in terms of this mini-sim, a longer experiment could help detect potential side effects that are not seen within the 4 weeks. The take away message for me is that while these companies are trying to reduce costs and cutting down time, their main concern should be the safety of their customer, and extending the deadline for a crucial experiment should be a no brainer if it's needed, regardless of what management originally demands.
As stated in previous forums and lectures in this class,, communication is the key to a large part of the product development process. In the case of the miniSim, both major delays seemed to have the best outcome, when the rational discussion between all parties involved was selected. As for your animal testing question relating to the relationship between decreasing testing time and increasing risk, I think, as with anything, there is a balance. It is key to find the balance between this in order to solve the problem successfully and move on in a timely manner with the product development.
I think that there are some cases where shortening the time frame of a study is a good option. Using the bone void filler syringes from the last simulation as an example, we needed to verify a two year shelf life for the product without having two years to spend on the study. Yes, running a stability study for two years would give us accurate data, but by changing the storage conditions we could simulate long term aging within a shorter time frame and as long as there was no significant changes to the product in the accelerated conditions then it would be okay. So in cases where a study is acceptable or has been previously proven to be acceptable under accelerated conditions I think it is perfectly okay to do so.
When a calm and productive resolution can't be reached in a situation like this, it is most important to try and stick to the facts and reconcile with what reality is. If something is impossible to be done in shorter amount of time without reducing quality and the deadline is short, then reality must set in that the original plan was not a good one if it did not take this time into account. Once reality and the facts are seen, working off of that a new plan must be made (Ex. A good study takes 6 months, but they want it in 4. Do it in 6 because that is what is best). Trying to push something that is impossible to fit into a small timeframe often leads to double work later and more frustrations. I've seen this where manufacturing plants are asked to do impossible things (like produce and quality check whole lots of product within days) and are given flak for not delivering. It was not until they explained the processes what was feasible to the management that they had the pressure lifted off of them.
As we learned earlier in the course, emotional intelligence determines approximately 70% of success, which without a doubt applied to the MiniSim. The only real way to fail the first part of the MiniSim was to take a condescending approach to your liaison knowing that she had the least friendly characteristics in comparison to the rest of the team. Failure to properly communicate a delay can not only result in the project being dropped, but also a setback in one's personal career.
In terms of increasing project risk by cutting down experimentation time, it may initially seem undesirable, but may prevent excessive time and money from being exhausted. Cutting down the pre-clinical time from 16 weeks to 4 weeks was ultimately a success based solely on the fact that the project's product was already prominent on the market. Therefore, since this product has already had extensive research conducted on it, your company CaPoss was able to save time and money by trimming down the preclinical stage. This doesn't go to say that this is always the case, as cutting corners always presents risk. That being said, it is rarely ever worth shortening a project's time frame to the extent that significant background knowledge is present.
The calcium phosphate product we worked with in the MiniSim was a Class II device, but would there be a way to shorten a Class III bone void filler's pre-clinical duration in the same manner that we shortened this one? Do you think it would be justifiable to apply emotional intelligence towards an FDA inspector in this case to pass/approve the Class III device? In this MiniSim, many of the team members had friendly, outgoing personalities. Would this project run as smoothly if the majority of team members had more isolated characteristics?
No, personally I do not believe it is ever okay to shorten time frames if it means risk will be increased. In the simulation there was an option to shorten testing, and it was all luck that the FDA over looked the testing periods. Realistically, if the FDA was doing their job properly then they would have questioned the periods of observation. A simple google search will show that full bone growth takes longer than 4 weeks to be completed. Sure, if you chose the option to cut the 8 and 16 week observations it ended up successful, but this was a mini-sim. This assignment was created to give you an overview of what being a PM is like. In the real world one is less likely to get away with taking shortcuts. I believe that the more work you do now the less you have to do later. Therefore, it is never worth taking a shortcut because sooner or later you are bound to get caught. In the medical field where people's livelihoods are at risks it is definitely not worth cutting time due to a rise in risk. If a shortcut is taken, and a customer gets hurt it is possible that the company will be sued; which would make the shortcut even less worth the time it saved. In conclusion, no saving time is not worth it if the consequence is a higher project risk.
I believe that time frames should not be shortened if it increases risk. While it may seem beneficial at first to quicken the development or clinical study times of projects, you do not want to face the consequences of high risks for your product. I would always recommend mitigating risk as much as possible, even if it means lengthening your project. In regards to the other question that was asked, I believe that if calm and productive meetings among team members do not go over well or do not provide solutions, then it is important to go speak to management regarding the current staff on your team. When issues arise, everyone needs to be on board with coming up with a solution that is in the best interest of the company and the project. As seen in the mini-sim, most of the time, meetings go over well. However, sometimes, more people need to be included in the meetings in order for the correct information to be passed around.
In the case that a calm discussion does not easily resolve a situation and two or more parties are still in a disagreement, it is the PM's responsibility to put his or her foot down and make a decision that would benefit the project the most. This is the reality almost all PM's must face. In addition, from my experience, doing whatever it takes to avoid and decrease risk is always a favorable and beneficial route. However, I understand how important meeting deadlines is. Not to mention that extending timelines often comes with its own risks as well. Nevertheless, if extending timelines is possible, I believe executing tests the right way from the start is the safest and smartest move. When tasks are not completed as they should be at any point in the project, they can often manifest and grow into much larger issues down the line which would inevitably delay the project anyway but along with dissatisfaction from upper management and other negative outcomes as well.
Although time is an important factor in any project because extending a project not only makes it more expensive but could also lead to a competitor putting out a similar product before you could, product quality should be more important than avoiding delay in time. It will be preferable to a project which is delayed but somehow still manage to have a high quality in production, then to have a project completed on time with poor quality. However, neither case should the norm, as with the limited funding and staff's unexpected variance in availability, a delay in time will most likely hinder the overall quality of the project as well. To overcome these issues, proper communication should be established from the very start of the project initiation. Constant logging of project progress must be done to have an overall appreciation of the project in term of the timeframe and in term of the different milestones to be accomplished.
I do not think it is worth shortening the time if that means the risk will increase. If time is becoming an issue it should not be taken from the animal trials. The project will never succeed if the risk is increased. It would be smarter to just add time but know that the risk is lessened and the chance of the project passing is much higher. But after reading Srg36's reply I understand the other side of this debate. It would be smarter to increase the risk if the project needs to get to the market quickly or it will be useless. In that case I would understand why the project would have to be kept on track and increase the risk. But again as Srg36 stated the team would need to understand this additional risk and have a back up plan to accommodate for this risk or the project will definitely fail.
In the case of this mini-Sim, I believe it is not worth it to increase the project risk by decreasing the duration time of the animal studies. Since this is a medical product that will be used to treat bone defects, the completion of the full animal study may prevent potential delays with the FDA later in the project. This example helps showcase the importance of taking into consideration the inputs from the individuals on the team who will be managing or performing required tasks during the creation of project timelines. In addition, this mini-Sim did not mention any reason as to why it is crucial for the animal studies to be done in a shorter duration of time, which is why I believe it is not worth increasing the project risk. For the path I selected in the mini-Sim, the result was an acceptance of the change in schedule following a meeting with the research scientist. On the contrary, the decrease in duration time of the animal study would only be acceptable in situations where the project at hand is not novel as indicated by the other accepted path in this mini-Sim.
The minisim did a great Job trying to provide us with an actual scenario. However to answer the question asked, I do not see any situation in which poor experimental data is acceptable for sticking to the project time line. Because of poor data, we might get a poor quality product which would result in any regulatory agency denying approval and that delay would be more costly and longer than the data caused by adequate experiment data gathering.
The time from the animal experiment should never be decreased under any circumstances. Without proper results from the animal trials you can never get the approval for the projects. It is better to spend time on every aspect as much as it is required to reduce the risk of failure of the project. No time period can be reduced as it increases the risk of failure of the project.
I agree with others who stated that shortening the time frame, especially for an animal study, is not worth increasing the project risk. Almost any product with an animal study will need FDA approval, and not having sufficient or valid data will be a larger setback than taking the initial time to conduct good animal studies. More than this, I believe its important, especially in the medical device industry, that projects have good quality, even if that means a longer timeline. This is overall safer, and the more ethical option, compared to putting the projects quality at risk to finish the project sooner.
The original prompt also asked what should be done if a decision cannot be made after a discussion. At the end of the day, the project manager will have to decide in terms of how to move forward, even if that means going against certain team members. I think it would be wise to discuss with others, if possible, and receive feedback, but the project manager must ultimately make the decision and it is their responsibility.
