I think that both functions of the regulatory department play an important role in the overall process of releasing a medical device/drug to the public and maintaining its FDA approval. However, the product development function has a more significant impact on the project as a whole. In addition to the fact that this is the stage where a device is developed, it is also when all documents (e.g. 510(k), pre-market approval, etc.) and communications needed for FDA approval are completed. Without proper approvals obtained in this phase, the company designing a medical device/drug will not be able to go forward with fully marketing and releasing their product to the public (unless proper authorization is provided by the FDA, such as in the case of a public health emergency). Post-market management is also extremely important because during this stage, documentations on the status of released products and FDA inspections occur. Although these tasks are important, they’re more of maintenance on already released products to ensure they are performing desired functions. Tasks in this stage do not require intense documentation like those required in the product development process. 

Problems can arise in both stages of the regulatory process. However, due to the greater number of tasks required to actually release products to the public during the product development phase, I think that more time-restricting issues may arise during this stage. For example, problems with the required documentation within this stage may result in delays in product approval. What do you think are other issues that may occur in this stage?

This is a great topic focusing and highlighting the main functions of the regulatory group. While their functions are broken into two main groups of product development and post market management, it is difficult to decide whther one of these can be more important than the other. I would like to highlight the impact of the both overall function groups, but I want to state that if I absolutely had to select one of the two functions, I think the product development segment is more important to the project because it is essentially the base of foundations for the post market segment. By this I mean that more problems can possibly arise in the post market functions if the product development phase is not correctly executed. 

However, I am currently in an industrial role on the LCM (life cycle management) side of roles and I have learned the importance of life cycle management of a product, which includes the post market segment heavily. This includes risk analysis of the product 1 year, 2 year, 5 years, or more after its release. This is just as important as product planning because it is difficult to imagine the possible issues of a device or a biomaterial after a certain amount of years of exposure to the body. Additionally, the post market segment also focuses on the claims made for the device, which ofcourse can change over long periods of time and need to be strictly managed. 

While its easy to agree that the product planning phase is the more vital phase for regulatory, I think that the importance of the post market phase can be easily overlooked and has many potential problematic issues that come along with it if its not properly handled. 

Others in this thread have touched on this but I think that product development is more important. Obviously, both are vital and necessary, but that is only because things can always go wrong and mistakes can happen. The reason that product development is more important is because if they do their job perfectly (which is obviously impossible) there is no need for post-market management.

To extend this argument, knowing that it is literally impossible for product development to foresee every issue and develop a product perfectly, we have to conclude that it is actually post-market management that is more important. Even though post-market management only exists because of the issues caused by product development, it is then vital to the function of the whole system. It allows product development to have an end in sight, letting post-market management fix any issues that can arise, so product development can move on and develop other products.

As mentioned above, both functions of the regulatory department are crucial and equally important to the operations of the company. Both functions control different stages of the product lifecycle, therefore the one that would be more important would depend on which stage you believe is more important. Personally, I believe that post market management is the stage to have more issues primarily because during this stage the drug is being used by patients in real life situations. During the development stage the drug is tested in a laboratory setting by scientists, therefore, while there are issues it is possible that they can be mitigated or avoided entirely if the scientists are able to predict it. During the post market stage the patient is using the drug without the supervision of a scientist so there are more ways for patient to misuse the drug or for other problems to arise with the drug usage. 

Q: Which of these two functions do you feel has a more significant impact on the project as a whole? Where do you see more possible issues arising, during the development of the product or after it is on the market?

A: When it comes to the Regulatory Department functions, I believe that both functions are important when it coms to the development of a project overall. I do not believe that one function is more or less important to the project as a whole. Each one affects the projects overall cycle and development so I  can't necessarily say that one function is more important than the other. I will say that the issues that could arise would be more noticeable in the post-market phase. I think this way because once the product is on the market, developers would be able to see real-world drawbacks and issues within the device itself and the project would be able to be assessed more concretely and thoroughly. That way, developers would be able to assess and work with the Quality Department on more evidential adjustments to the product so that it could be revamped as time went on. 

Regulatory affairs experts are involved in all phases of development, and even after drug approval and commercialization. They have a unique mix of both scientific and management skills to reach a commercially important goal within a drug development organization. The regulatory affairs department provides strategic and technical device at the highest level in many companies. By this, they make a significant contribution, both commercially and scientifically, to the success of a development program and the company as a whole.

The main impact on the project is product development as opposed to post-market management because of the nature of the project. In any project, most of the work is done during product development, but because this is regulatory work, most of the focus is spread out before, during, and after the project due to the high sensitivity to safety and effectiveness. During the project, the FDA as well as other regulatory bodies are constantly wanting information about the product as well as data in order to complete milestones and bring this product to market. The other important part is that issues constantly arise throughout projects that require attention immediately; if not, then the project can be delayed heavily. Further delaying the project, which already takes years as it is, is not very fortunate and is something most companies want to avoid. The most important issue I find is that product development is a new ground for any company that seeks to venture into this opportunity. In post-market management, there are fewer issues that arise because of the years of testing and development that went into creating this product. After creating the product and bringing it to market, the development of the product becomes necessary, but the main focus was on the development of the product.

Both product development and post-market management are critically important to the regulatory process, but they impact projects in different ways. Product development is important for ensuring medical devices are safe, effective, and meets the necessary regulatory standards before it reaches the market. This stage includes testing, clinical trials, and compliance with rigorous regulations, which can uncover significant issues that need to be addressed.

Alternatively, post market management focuses on monitoring the product's performance and safety once it has been sold to consumers. Oftentimes, issues arise regarding the long-term effects of these products, possibly unforeseen adverse events, or real-world use that was not fully testing in clinical trials.

While both stages are important and present their own challenges, I believe the post-market management has a more significant impact on the project. This is due to the fact that even well-developed products can face serious issues once they are widely used in the public. This leads to recalls, lawsuits, or possibly damage to their company's reputation. A product may have performed well in a controlled clinical trial but there were unforeseen complications or safety concerns once the product was used on a mass scale with a diverse population.

Although it is tempting for me to say that post-market management is where the issues arise, I would argue that product development is the single most critical phase in determining a project's success or failure, as this is where the most significant issues actually arise from. Imagine how a poorly designed regulatory strategy delays market approval as well as plants potential seeds for post-market problems. If a company fails to account for regulations and decides to cut corners during the development phase, they are more likely to be set up for recalls, safety issues, and FDA corrections down the line. 

As for post-market issues, I believe that they are symptoms of a flawed development process. Without ensuring rigid product development strategies, post-market management essentially becomes a form of damage control! The reality is that most post-market issues can be traced back to decisions or mistakes made in the development phase. This can include design flaws as well as flawed risk assessments and validations. The post-market phase is surely the phase where problems become visible, but not where they start. 

Reading through the comments on here, I'm going to go against the grain here and say...post-market management is equally, if not even more important than the product development stage. Both are critical. However, in the product development stage, the 'safety net' you may have in some instances with certain companies is that they'll want to provide a good and working product. Some companies are concerned with their reputation to the public, but also the FDA, coming out with a poor product could impact future sales and future dealings with the FDA, making things difficult for the company. Post-market management is very crucial in the fact that what can happen post market...is often unknown. The device can unexpectedly fail and need to be recalled. A device can be used improperly due to being improperly labeled. Many of these instances happen unexpectedly, but are that much more dire because there's a high possibility of there being a direct impact to a human life.  

I think post-market management may have a more significant long-term impact compared to product development. While both play important roles in projects, the main focus of product development is meeting regulatory standards and checking device safety and efficacy. While this is very important to the creation of the product, post-market management is important in tracking performance and compliance. While problems may arise during the development phase, once the product is out of the lab and being used by consumers, real-world factors start to come into play such as recalls or device malfunctions. These can lead to huge consequences for the company if they are not managed accordingly. Post-market surveillance brings continuous monitoring into the picture, potentially leading to discoveries that were not considered during development. For these reasons and more, post-market management has the potential to impact the project more over time.

I agree with others comment. I think both of the steps are important. In the overall project, both two major functions has significant impacts. However, i think prodeuct development will be slightly more significant. SInce it determines whether the product will ever make it to market. Secondly, unexpected issues can arise in both functions. However, I believe that more unexpected issues tend to arise after the product is on the market. Real-world use often reveals flaws or side effects that weren't apparent in controlled testing environments.

Although both major functions, product development and post-market management, have their own unique impacts on a project as a whole, I consider product development the more significant of the two. The uncertainty and approval surrounding the product development process makes the phase ultimately determine the feasibility of the project overall. The following outlines the FDA-contact alone that is required throughout the product development process: 

In the event that the product is considered a combination product, an RFD must be created and sent to the FDA, who determines the appropriate FDA regulatory center for the product. A "pre" pre-IDE then must be presented to the FDA to introduce the product, followed by a pre-IDE that proposes the clinical research required to begin a human trial. It is during the pre-IDE meeting that the FDA typically determines the class (I, II, or III) of the device. Then, an IDE must be submitted to and approved by the FDA to allow clinical trials to begin. Depending on the determined class of the device, a PMA or 510k must be approved. After this extensive process, the product can finally be marketed. 

The post-market management function then ensues, which consists mainly of maintenance and labeling procedures, which are not to be minimized. However, product development unarguably has much more of an extensive and rigorous process, which is why issues are more likely to arise in this phase, as well.