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Quick, Fast, Good? Pick Two

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(@knd26)
Posts: 78
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Topic starter
 

When planning a clinical trial, you cannot have it all. In the lecture, Dr. Simon states that you have three options when creating a clinical trial: Good, cheap, and fast. The catch is that you can only pick two of these. If you could pick two of them, which would you pick? Has anyone ever been part of the planning process? This could come down to the needs of the project not leaving as much of a choice depending on the financial state and the finality of a deadline. An important aspect to me of the three is the quality of the study. I feel that if you do not complete a quality study you could need to re-do it or be putting people at risk due to the nature of biomedical products.

 

 
Posted : 19/04/2022 4:25 pm
(@hodafattel)
Posts: 78
Trusted Member
 

I agree that most of the time the project depends on its financial state and deadline, and that’s the driving factor of which two options are chosen. However, if I don’t have any financial restrictions, then I would choose good and fast. Having a good quality project is extremely important in order to not have any problems and further costs in the future. Good quality comes at a cost, but poor quality will almost always cut into the project’s profitability. Managing quality improves every aspect of the project, and neglecting it makes it harder to deliver a successful project. Moreover, I would like to finish the project as soon as possible so that the product can be out on the market. This allows the project to become profitable as soon as possible. 

 
Posted : 19/04/2022 6:27 pm
(@ama224)
Posts: 59
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As mentioned the financial state and decisiveness are key components when making this decision. Quality in my opinion should never be the one to be sacrificed especially in this industry so I'd have to say good and fast. If you optimize production speed/output and quality then the price tag will never be questioned for what you have to offer and if it is then you'll just have to find the next best buyer. And as mentioned if you are able to output a larger volume in a quick amount of time your return on investment will be worth it. 

 
Posted : 20/04/2022 1:07 am
(@mmd55)
Posts: 80
Trusted Member
 

In my experience in observing clinical trials where I work, the emphasis usually tends to be on the "Good" and "Fast". Quality is very important and running an appropriate study is necessary to get a medical device approved, so sacrificing Good for Cheap can ultimately come back to haunt the project if it fails to get past the FDA, resulting in it being more costly to redo the study. I've also noticed that some projects have "Unlimited Budgets" when trying to get a product to market because there is a clinical need for the product. Thus, Fast is usually preferred to cheap, since the faster to market means the faster the product can start to earn revenue.

 

Thanks,

Matt

 
Posted : 20/04/2022 2:13 pm
(@alextzalav)
Posts: 27
Eminent Member
 

I agree with all the previous points. I just want to add that those traits are not binary. They rather live on a spectrum. So you might have a product that is good and overall satisfies its goals and requirements but could have been better. The reason that it was not was to cut down some of its expenses or to build it faster. 

 
Posted : 23/04/2022 1:22 pm
(@leshan)
Posts: 33
Eminent Member
 

If the product is going to be inside human body or used on a human, good will be first priority. then pick either one based on how the project went. i believe safety of user should be the our main force for any kind of engineers. if the project is just to upgrade a existing product than i will choose fast and cheap.

 
Posted : 23/04/2022 8:47 pm
 AJY6
(@ajy6)
Posts: 82
Estimable Member
 
Posted by: @knd26

When planning a clinical trial, you cannot have it all. In the lecture, Dr. Simon states that you have three options when creating a clinical trial: Good, cheap, and fast. The catch is that you can only pick two of these. If you could pick two of them, which would you pick? Has anyone ever been part of the planning process? This could come down to the needs of the project not leaving as much of a choice depending on the financial state and the finality of a deadline. An important aspect to me of the three is the quality of the study. I feel that if you do not complete a quality study you could need to re-do it or be putting people at risk due to the nature of biomedical products.

 

When creating a clinical trial, I believe good and cheap should be at the top of your list. If your product is good, you will not have to worry about making it fast since the buyer will instead have a good working product at a slower rate than a bad non-working product at a fast rate. Also, money is a huge factor when creating devices since you have a budget and want to stay under the budget. So if I were to choose two out of the three, I would have to go with good and cheap since fast doesn't mean the product will be fully functional. 

 
Posted : 24/04/2022 12:51 pm
 tgt6
(@tgt6)
Posts: 79
Trusted Member
 

I strongly agree with what others have stated in this thread, especially when they mention that while it is true that only two of the three options will be the most predominant, all three together do create a spectrum. Even if the clinical trial is both good and fast, it does not necessarily mean it will be way too expensive to accommodate the budget. While it is true there could be other methods to make it cheaper with a tradeoff in quality or time spent, it is important to realize that there can still be some of the third options while the other two are most prevalent. When dealing with medical devices, it should be a priority that excellent clinical trials are done since these materials will most likely be going into the human body and can have detrimental effects if something goes wrong. At that point, it becomes a question of how much of a budget and time the team has for the remainder of the trials. Each project will be different than the last so this will be a case-to-case decision and something the entire team needs to take into consideration.

 
Posted : 24/04/2022 12:51 pm
(@sseal98)
Posts: 75
Trusted Member
 

I believe that in a biomedical application, the most important factor that is necessary is to make sure that the product lifecycle is good and cheap. The quality of being fast is a plus, however in my opinion for a biomedical device being fast can often lead to imperfections and recall, and the company that typically comes out with the product first usually suffers from major drawbacks and flaws and often times loss of monetary value. This can be seen many times when looking at product launches from apple and Samsung with new features. Samsung has the tendency of launching new and innovative products new. However often times those features and new technological advancements are not refined and are often the cause for mass recall. Whereas apple focuses on providing quality items at a later time and date when they can assure that the product works and is flawless. However for something like the COVID vaccine, it can be seen that the fight to who could develop the product first and was cheap and good quality was Importnant.

 
Posted : 24/04/2022 1:56 pm
(@terril_vallikalam)
Posts: 39
Eminent Member
 

I believe the best choices for this would be a good and fast study. Having an expensive clinical trial is not idea, but I feel like medical device companies know the prices of these trials and what's at stake if it fails. In addition, they typically want results fast so they can submit them to the FDA. Thus, it is important to have a good and fast study rather than any other combination of good, fast, and cheap. A good study ensures that everything goes smoothly and as it should; having it go fast will ensure that things are completed in a timely manner. The only caveat with having a fast study is that some things may get overlooked or swept under the rug since there won't be time to execute them or research them further. Redoing portions or all of the trial will only prolong the time it takes to complete it and can jeopardize the completion and submission timeline. By doing it right the first time around, that should not be a factor in it.

 
Posted : 24/04/2022 3:01 pm
(@nk434)
Posts: 40
Eminent Member
 

When determining which factors of the the to pick, the product deadline and situation is important to consider. Usually, I would side with developing a product which is good and cheap, as it would take minimal financial investments and the quality of the product is good. Fast would only be necessary if the situation to develop that product was dire (such as the COVID pandemic). But nowadays, product development usually revolves around money and how companies could save and eventually profit, so cheap is always one of the two choices. Then the other choice comes down to whether the product needs to come out fast or not. Quality should never be dropped in my opinion, but sometimes decisions are made to put a product out fast. 

 
Posted : 24/04/2022 3:27 pm
(@pv223)
Posts: 76
Trusted Member
 
 

One of my choices will always be good as I am a firm believer that if you are conducting trials to portray the viability of a new product than the test that is being conducted in order to prove this needs to be a quality test. My other choice will be dependent on the amount of funding that is left available to me by the time the project reaches the clinical trial phase. If there is a sizable amount of money available, then I would opt for good and fast as I would not be opposed to spending a little extra to get better results more quickly. However, if I am reaching a point where money is something that is beginning to take more weight into the decisions that are being made, I would go with good and cheap, even if the results take longer. Like the others have mentioned, the deadline of the project is also something to take into account as well.

 
 
Posted : 24/04/2022 4:11 pm
(@lei-hao)
Posts: 35
Eminent Member
 

In my opinion, quality is the most important factor for a project. If the quality of the final output is poor, it might be a waste of time and resources. “Good” will always be one of the two factors I will choose under any situation. For another factor, I would like to say that might depend on the situation of the project team. For example, if the budget is limited but the schedule is pretty flexible, the project team might need to choose “cheap” since it might be meaningless to finish the project quickly under that situation.In the other hand, if the budget is robust but the time before the deadline is limited, the project team need to finish the project as soon as possible. 

 
Posted : 24/04/2022 8:19 pm
(@ahmadfarhan)
Posts: 32
Eminent Member
 

Having worked in a lab that was currently working with investigators to collect preliminary data regarding traumatic brain injury, usually "good" and "cheap" are selected over fast. It is usually well expected that to collect the data necessary to show a significant power it takes time. Many times this is because of the lack of man power due to trying to target a "cheap" study, since the lab usually has limited funding. Furthermore, most studies like to go over the data with a fine comb multiple times, sometimes this is done manually to make sure that there are no outliers that are throwing the data off significantly. 

 
Posted : 24/04/2022 9:49 pm
(@ma818)
Posts: 28
Eminent Member
 

I agree with all of the claims that you made. It is evident that the choices that a project manager makes should depend on the specific task at hand: Is the company financially flexible, is there a strict deadline that must be met, and how crucial is the device's proper functionality for the population? I believe that all medical devices should obey the "good" aspect since the device's functionally and safety are key components for a successful project. Furthermore, I believe that the project manager should target developing a relatively cheap/inexpensive device because it may be more accessible to the target population while not costing too much to produce it.

 
Posted : 24/04/2022 10:17 pm
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