From what I understood, due to the circumstances the vaccine development process was able to be expedited through cooperation between the company and the FDA. The companies most likely prioritized the vaccine project above any other projects, thus funding and support was easier to acquire. In addition, the FDA made the process easier for the companies allowing multiple phases to occur at the same time and authorizing emergency use for the vaccines after they passed certain benchmarks.  

I agree with @DevDesai about how the FDA allowed multiple phases to occur as multiple researchers, scientists, and governments were internationally collaborating in order to develop and distribute an effective formulation of the COVID19 vaccine. The vaccines were developed rather quickly, but the effectiveness of the vaccine preventing fatalities when contracting the disease was present and therefore approved to be rolled out. Additionally, there was a plethora of prior research regarding coronavirus vaccine research and mRNA treatments. Because the treatment was an mRNA vaccine the materials required for the vaccine were all easily produced in a controlled laboratory setting. This allowed for fast production and distribution as well when the entire world was suffering from the pandemic. 

You can read more about it here:

https://www.houstonmethodist.org/blog/articles/2020/dec/how-was-the-covid-19-vaccine-developed-so-fast/#:~:text=But%20mRNA%20vaccines%20and%20other,them%20very%20quick%20to%20develop.

As mentioned, the COVID-19 vaccine development seemed to meet the fast/good/cheap criteria due to unprecedented global collaboration, funding, and existing research on coronaviruses and mRNA technology. The FDA allowed simultaneous trial phases and that sped up development. mRNA technology enabled faster production and govt subsidized costs making the vaccines more affordable. This unique situation allowed for rapid development without compromising safety or effectiveness

To address the aspect of speed in relation to the COVID-19 vaccine program, a great topic to consider was Operation Warp Speed. This project had a goal of accelerating the COVID-19 vaccine development, and saw success primarily because clinical trial phases and animal studies were analyzed to identify points of overlap.  With identification of these areas of overlap, the  vaccine pathway was then optimized for speedy development. There was also risk involved in operation warp speed, such as large-scale manufacturing during clinical trials, and the combining / concurrent run of clinical trials as well. Problems that could have come up in these project stages had the possibility of being more costly to address. Overall, decrease of time via optimization during project planning and increase of risk for the timeline led to the quick development of these vaccines. Considering the risk that was involved with this project, do you believe actions such as large-scale manufacturing during clinical trials were a wise decision to make? If so (or not), why?

The cheap aspect of fast-good-cheap is one topic that may be up for discussion. More specifically, much of the financial aspects of developing a vaccine was subsidized by the government and FDA instead of the pharmaceutical companies. The financial planning was shifted off of the company and allowed them to focus on speed and quality of the vaccine. When finances aren't much of a "problem," companies are able to do a lot more with efficiency. One benefit of the vaccine was that the three main companies which mass produced their vaccine already had well-established vaccine profiles, so it can be assumed they had to put forward minimal monetary resources to produce the vaccines. The government essentially made it clear that there will be a guaranteed market for the vaccine. Many times, the development of vaccines may be risky as it is unknown how it will perform in the market. Additionally, the cost to administer the vaccine was fully subsidized by the government. While "cheap" may have been the case for many of the pharmaceutical companies which manufactured the vaccine, it for sure did not come cheap for all the government entities subsidizing the vaccine costs from development to administration.

The Covid vaccine was shown to be good, cheap, and fast due to several reasons. Under normal circumstances, it would be nearly impossible to fulfill all three. During the pandemic, the government passed an emergency use authorization which took a large portion of Taxes to Medical Device companies in order to boost their vaccine development. This involved a lot of time deviated towards cooperating with the FDA to comply with their requests. In emergency cases such as these, a Medical Device company is sometimes required to complete projects funded by the government, which precedes importance from all other projects in the same time. With the money received, the vaccines can be made immediately with the most advance technology the company currently has, and very quickly. Large companies also have many lag projects that designs technology for planned emergency events.

The COVID-19 vaccines were generally able to meet all three notions due to the level of attention and demand the development of the vaccine had globally. Due to the pandemic, the world was rushing to find a way to stop COVID's progression, the government especially supported the time for production and research by securing funding. The FDA similarly worked closely with the company, allowing for the product project to progress at unprecedented speed. Obviously, the product had to work, so testing and manufacturing scale up was crucial. Due to the FDA's support, the product was passed to emergency testing, at an expedited speed. Overall, it was due to the demand and support the company received, a lot of constraints such as finances and waiting were removed. 

The "cheap" argument doesn't hold up under scrutiny: governments absorbed development costs, guaranteed markets, and funded distribution entirely, meaning the cost didn't disappear; it was shifted from pharmaceutical companies to taxpayers. Similarly, the speed was real but came at the expense of front-loaded risk; overlapping trial phases and large-scale manufacturing during clinical development meant that a late-stage safety failure could have been catastrophic. The COVID-19 case wasn't a breakthrough in project management logic so much as it was a product of an entirely exceptional resource environment: unprecedented political will, public financing, and decades of prior mRNA research converging simultaneously. The real takeaway is that the fast-good-cheap triangle doesn't break under pressure; it breaks when a third party steps in to absorb the constraints that would otherwise force a tradeoff.

I do not think the COVID vaccines are a situation where the “fast, good, cheap–pick two” rule has been broken; they are a unique set of circumstances where a significant amount of money was invested in shortening how long it takes to develop a vaccine. The vaccines were produced quickly due to the use of emergency authorizations, multiple clinical phases happening at once (to allow for less time to pass), and a globally coordinated effort between multiple countries. They were considered to have been produced in a safe and effective manner due to the large clinical studies performed on these vaccines and the ongoing monitoring of their safety and effectiveness post-marketing. However, because of the large amounts of money from countries and organizations that were spent on research of the vaccines, I would contend that they were not produced at a low cost in a traditional sense, but rather had their costs subsidized on such a large scale that they were able to exceed the funding that would typically have caused the timeline to take a long time to complete. 

Because of this unique set of circumstances, a combination of previously completed research, the global level of urgency, and risk sharing has allowed for overlapping of activities that typically occur in a sequential manner. Furthermore, it provides interesting insight as to whether or not some of the accelerated processes instituted during the pandemic (i.e., overlapping phases, earlier manufacturing investment) could be adapted for more widespread use in the medical development process without compromising safety. Do you think the pandemic changed the rule itself, or did it simply show what can happen when enough resources are used to bend the usual constraints?

I don’t think the COVID vaccines truly broke the “fast, good, cheap - pick two” rule, it just looked that way from the outside. They were definitely developed fast, but that speed came from unprecedented global funding, existing research on mRNA and prior coronaviruses, and overlapping trial phases rather than cutting corners. In terms of “good,” they still went through large clinical trials and regulatory review, but with emergency authorizations that allowed earlier access while data was still being collected. As for “cheap,” I’d argue they weren’t inherently cheap to develop - governments absorbed much of the cost and risk, which made them accessible to the public at low cost. So to me, the trade-off didn’t disappear, it was just redistributed through massive collaboration, funding, and urgency during the emergency.

COVID-19 is a special case where vaccines were able to achieve that "fast, good, cheap," result compared to how it works traditionally. One difference is that instead of resolving all uncertainty before the approval, there was risk that was acknowledged, and the data collection was moved into the post-market phase through a large-scale real-world monitoring initiative. Instead of eliminating the constraints, they were actually redistributed through the timeline. Therefore, this allowed vaccines to be distributed quickly and at the same time maintain a long-term safety and effectiveness of data results over the period of time. Additionally, the effectiveness of the vaccine was defined later on since the priority was for there to be rapid protection against the illness and potential death instead of long-term immunity. For this reason, there were multiple dosages of the vaccine, which made the authorization of distributing the vaccine much more feasible.

Also, the situation relied on heavy innovation, and the most convenient part is that there is already infrastructure to distribute the vaccines. There are also resources such as adaptable mRNA platforms and global surveillance systems. Due to this, there is a lower number of bottlenecks, but it didn't entirely remove the constraints. There is already a system more flexible under pressure. Instead, the pandemic showed us that there is enough coordination, risk redistribution, and technological maturity. Therefore, the boundaries of that rule can be pushed further. Do you think if models like these, where approval happens earlier and validation moves forward, can become the new norm for the future of medical device distribution?

I think the question of whether or not the model of accepted risk can become the new norm for medical devices is worth examining, even with the plethora of differences that exists between vaccine development medical device development.

With vaccines, the primary endpoint is to gauge whether a patient can develop immunity to a particular/targeted illness, something which is measurable at a population level to a fairly quickly extent (Through the use of real world monitoring). Medical devices on the other hand, have more complex and varied failure modes. Devices such as a LVAD, ventilator, or infusion pump all have varying ways that they can fail in highly patient specific instances, which can be sometimes difficult to attribute and even takes years to show from initial development/use. The feedback loop between deployment and meaningful safety signal is much longer and noisier compared to that of a vaccine. So the idea of acceptable risk is something that, in the instance of medical devices is something that can't and shouldn't be accepted, neither by the OEMs or the FDA. There are simply too many points of failure that cannot be anticipated or planned for in the product timeline compared to a vaccine. 

There's also the question of the conditions that made the COVID model work. aca touched upon the mRNA platform, the global surveillance infrastructure, the extraordinary level of international coordination, and most importantly; the political and public will to move fast. Those conditions were primarily why this model was able to succeed to the degree that it did. It isn't clear that the same ecosystem exists for most medical device categories, where regulatory bodies, manufacturers, and healthcare systems are far more fragmented, and the public and political just isn't there for this field.