Task scheduling has four important date types: early start (ES), early finish (EF), late start (LS), and late finish (LF). Projects that can achieve project initiation on the early start date and completion on the early finish date are preferable. However, that is not always feasible.
Provide one example each of a specific medical device’s development that is likely to be completed by the (1) late finish and (2) early finish.
- Late Finish Date:
Example: Development of an Implantable Cardiac Defibrillator (ICD)
- Implantable cardiac defibrillators are complex medical devices designed to monitor and regulate heart rhythms, especially in patients at risk of sudden cardiac arrest.
- Due to the intricate nature of their design, rigorous testing requirements, regulatory approvals, and potential complications encountered during clinical trials, the development timeline for an ICD could extend beyond the initially estimated timeframe.
- Factors such as unexpected technical challenges, regulatory hurdles, or delays in clinical trials could contribute to the project being completed closer to the late finish date.
- Early Finish Date:
Example: Development of a Portable Blood Glucose Monitor
- People with diabetes use portable blood glucose monitors, which are relatively straightforward medical devices, to check their blood sugar levels.
- Compared to complex devices like ICDs, the development of a portable blood glucose monitor may involve fewer regulatory barriers and clinical trial requirements.
- With advancements in technology and streamlined development processes, coupled with a clear market need and established design specifications, it's plausible for the development of a portable blood glucose monitor to be completed ahead of schedule, achieving an early finish date.
While there are various types (and hundreds of thousands) of medical device projects that are ongoing every year in med device companies, something common between them is the tasks in the project management process. As detailed in the lecture, the latest finish date would be tracing the path backwards and subtracting the durations, whereas for early finish it would be tracing the path from the beginning and adding durations.
A good example of this would be building upon the two examples provided above by @ma2726 and that a specific task in each that could be completed by an early finish is something simple that both could have in common, such as market research on the project. Both devices would require market research, whether clinical or financial or competative, in the planning phase. This is something that may not even be on the critical path and it is likely to be completed in an "early finish" fashion.
However, both of these devices would still require some clinical studies and these may have some setbacks (some examples in the lecture were regarding resources and time management to ensure the members responsible for these tasks need to be available at this specific time of the project). Because this is a task that would certainly take longer than market research or a task that would be in the earlier stages of the project, it is more likely to have a late finish.
An example of late Finish: Rare genetic disorders require the creation of gene therapy, which involves complex research, pre-clinical trials, and extensive testing to ensure safety and efficacy. There may be unforeseen challenges during the process, such as unexpected side effects or the need for additional studies to meet regulatory requirements, which can contribute to delays. For example, if unexpected toxicity arises during animal testing, it may require further investigations and adjustments to the therapy, thus extending the project timeline and resulting in a late finish.
On the other hand, for the early finish (EF), improving the diagnostic test for commonly known infectious diseases has a higher chance of being completed early. If the project uses existing knowledge and technologies, and the regulatory approval process is relatively simple, the development team can move efficiently through the design, testing, and approval phases.
Late finish:
Example: development of novel approach of vision therapy for convergence insufficiency.
Well, this is one of my research projects. In this project, I will develop a novel vision therapy. I will develop a new device where I will use virtual reality-based video games. patients will receive therapy by playing this video game. It will reduce so many drawbacks of concurrent vision therapy. Additionally, it will also open a new option for the patients. I estimated the timeline for each research project task as mentioned in the lecture. However, unexpected challenges may also arise. The estimated timeline will not be applicable. Then this project will have a late finish. However, this project can also have an early finish if everything goes well.
Early Finish:
Example: Investigating different machine learning models for lung cancer detection from CT scan images.
In this project, I will use different machine-learning models. I will also collect CT scan images. During this project, the chances of unexpected challenges are very low since there are so many CT scan images available. If I face any challenges in collecting images, I can also use the online image dataset as an alternative. Therefore, this project task may be finished during the estimated time. Therefore, it may have an early finish. However, this project can also have a late finish if something uncertain happens.
I think this is an interesting question because there are probably general trends relating to the expected project timeline based on the type of medical device. It would be interesting if there were statistics that can describe this (I don't see anything reliable online). However, when it comes to general trends, I would probably expect that Class II, especially Class III, medical devices would be more likely to finish around the Late Finish (LF) date. These types of devices require more rigorous testing and often clinical trials, which can fail at certain phases and cause delays. For example, once you make it past Clinical Trial I and II, the major validation and safety tests were satisfied and it's "easier" to move through final phases. According to the IAU, more than 69% of clinical trials in Phase II fail; compared to only 39% in Phase III. Although this is a generalization, it would probably make the most sense to build more project slack time in the earlier clinical trial phases.
Nonetheless, I would imagine that even though most companies will plan for a Late Start/Late Finish, it would probably be ideal to always finish on time. So we can try to make generalizations about the project timeline for different medical devices, but most groups are probably trying to build their project timelines in a way that they give more than enough buffer time to finish the project early rather than close to a deadline.
(1) A specific medical product that is likely to be completed by late finish is any pharmaceutical drug. All pharmaceutical drugs require extensive preclinical research, clinical trials, FDA approval, production, and post-market surveillance. This thorough process makes it likely that the initial projected timeline will be altered and result in a late finish.
(2) A specific medical device development that is likely to be completed by the early finish (EF) is a surgical scalpel. Scalpels are small tools used for making incisions during surgeries. These tools are manufactured in bulk and constitute a relatively simple manufacturing process that is unlikely to cause any inconveniences or delays in the product development.
After reading through the replies to my original post (the topic starter), I noticed a trend in medical devices suggested by previous posts that is likely to have a late finish and early finish. As the complexity and newness of the product increases, the more likely a late finish date can occur. Another factor that can impact the finish date include resource availability as mentioned by another user. A lack of historical data for novel products may extend a project timeline as there may be little literature to reference. In addition, improper planning and budget allocation, no matter the complexity of the project, will likely lead to a late finish. Insufficient planning can also include creating a vague project scope. Failing to clearly define the requirements can lead to a late finish as the team is unsure how to validate and verify the product.
What are other factors that can contribute to a project’s late finish?
