Product development and post-market management are the two major functions of the regulatory department. Out of the two, which one would you want to work for and why? Also, which one seems to be the most important.
I would want to work in the product development portion of the regulatory function because they work directly with the team developing the device and help ensure that the device claims meets FDA guidelines. This role seems intrigues me more because it allows me to be active in the device development process, as opposed to post-market management where I would have to keep the filings up to date after the device is already in the market.
I feel that the product development function is more important because as I mentioned above, it is more actively involved in aiding the team developing the device ensure that their claims are legally allowed and meet FDA guidelines and requirements. This role is what allows the device to be sold to the public which is why I feel it is more important.
I am more intrigued by the post-market management, and I would like to work there. I'm more of a hands on person in the sense that I want to see the effects of the product on the patients and the population. I would love to maintain correspondence with the FDA and the customers based on complaints where I can monitor the product's effectiveness. Moreover, at my previous job I got the taste of inspections by FDA, auditors, and vendors, and I enjoyed managing the readiness of the departments as well as writing all the reports.
I don't think it's fair to categorize one of them as more important than the other because i believe they are both equally important. They are both crucial roles of the regulatory department that ensure that the product is within the FDA regulations; both are needed to have a safe and effective medical device on the market.
Product development and post-market management are the two major functions of the regulatory department. Out of the two, which one would you want to work for and why? Also, which one seems to be the most important.
Of the two regulatory roles, I would want to do product development. For me, I think it comes down to interest. Both roles are incredibly important, and I don't think I can back the claim that one is more important than the other. Personally, I see the product development regulatory role as someone who helps steer the ship and hit all of the milestones needed for getting a product to market. They are a crucial team member and need to be incredibly knowledgeable/diligent to make sure timelines are being met. I would have a more enjoyable time doing that, opposed to managing labeling or post market surveillance.
Thanks,
Matt
Between product development and post-market management, I would like to work for product development. I feel like this role allows you to work closer with the product and ensure that it meets the required end goal. From start to finish, I would be able to make are that each and every detail of the medical device is as it should be, as well as following FDA rules and regulations. I think it would be very interesting, especially, during the initial/brainstorming phase of product development to see which ideas are used and which ideas get rejected and why they do.
In terms of importance, I believe that both are equally important. I feel like it should rather be looked at as "pre-patient use" and "patient use". During product development (pre-patient use), engineers are making sure that the medical device is able to accomplish the task that it needs to while still adhering to FDA specifications. Post-market management (patient use) ensures that the function is still performing the job that it needs to and not harming the patient and there is no need for a recall of the product. Product development and post-market management go hand-in-hand to make sure that the medical device is what it should be.
I think it is difficult to conclude which department is more important because both departments are important.
I would like to work in post-market management. I have heard from developers before that very few products continue to survive on the market after products are released. Through him, I realized that developing a product is important, but it is also important to ensure that the product continues to survive in the market. Also, I think that the work experience would give direction to what new products to create in the process of managing a product to continue to be managed and sold in the market. So I would like to work in post-market management first.
This is a great question! I think I would prefer to be working in the product development side of the regulatory department, because I love the design process. Playing a part in the design of a product that will, hopefully, help other people seems like a fulfilling job choice. Working through problems that are bound to come up and thinking of ways to better create something is important to me. In terms of importance, I believe both are critical and you cannot have one without the other. If the product design team cannot create a product within FDA regulation or that correctly functions, the post-market management will not have anything to market. In the same light, if the product team creates worthwhile projects, and the marketing team does a poor job of marketing no one will be using the product. I think like everything in life there is a balance.
Do you think it would be beneficial to have employees rotate through both roles before they pick one? To ensure that the post-marketing management has an idea of the design process when they create strategies for products and to ensure the product development team know what to include into a product to make it more useful for their intended audience?
Choosing between those two roles, I would choose product development because the management side of a team does not interest me. I honestly could not see myself choosing either of those positions as a career. Compiling reports, working with the FDA, and following the market, seem to be repetitive computer work. I believe both sides to the regulatory department are important; one cannot be declared as most important. A team that collects market feedback and another that acts upon that feedback, is harmony. They would have to be equal because the team is only strongest as the weakest link.
Regulatory affairs specialists play the role of mini FDA regulators within their company. It is important that they act and think like an FDA regulator would in order to ensure their company's products are truly safe and effective. I think it would be interesting to work for either the product development team or the post-market management team within the regulatory affairs department. However, I would ultimately choose to work within the product development team of the regulatory affairs department. Being part of the product development is rewarding because you are able to see the entire life cycle of the product from start to finish. Additionally, you are able to play a crucial role in the design of the product. It is important that the product is designed with FDA regulations in mind so that the product is safe and effective. Also, within product development regulatory affairs specialist might have the opportunity to be part of a human factor study or clinical trial. This would be rewarding to see how the patients interact with the device. This kind of opportunity is not as available within the post-market management team of the regulatory affairs department.
As an engineer, I would prefer a regulatory role in the product development phase. During the development, regulatory must give the engineering team guidance to ensure their activity meets FDA requirements. In this role they can outline the requirements to bring the product to market. The classification of the product is an important decision and can impact project costs and timelines drastically.
I think a regulatory presence is more important in the product development phase rather, than post-market. Doing an excellent job during development will lead to an easier time dealing with regulatory issues post-market. If the risks are extensively detailed during development, they will be much easier to resolve later on.
I would prefer to work in Post-market management because it serves a very important role of risk management. When a device is launched to market it is necessary that it behaves in a manner intended in a environment different from the labs it has been tested in. Most medical devices are not subjected to the wide variety of challenges they may face throughout their life cycle. Hence, it is necessary that should something unexpected occur their exists a way to track these anomalies and figure out what might have went wrong. It also puts pressure on manufactures to consider the ethics of selling devices that may need a recall. Post-market management works to make sure both the device and the manufacturing site are being tracked and recorded should something go awry.
Since I am more interested in research and testing, I would choose the product development phase. I feel like I would enjoy this part of the regulatory department because I would like to be more involved in how the product would function, if there is any possible issues that could occur, or testing different characteristics to determine whether the device would be safe within the human body. I also would like to be more involved in the production so that I could make sure that the device is safe and efficient before it enters the market. I think product development is very important because this is where the device is developed and changes are constantly being made to make sure that the product is safe and efficient.
I would prefer to work for post-market management because documentation is very important for the industry that you are working for. The product launched to the public could face some challenges that can compromise the integrity of the product and the company itself. It is crucial to maintain all the data collected from all the scientific analysis performed about the device that is in the marketplace so that way you can ensure the device remains to be available for the public. Developing a product costs a lot of money, but maintaining a product in the market can make the company more profitable and therefore, possible positions might be available for recruitment.
I would want to work in post-market management as I believe this offers the most opportunity. I can take the feedback from the market and bring it to the product development team and help them work on improvements and help asses if the feedback is being addressed or is not applicable. Additionally, once a product is in the market, there are so many other facets that are responsible for maintaining it in the market. I currently work at Getinge (a biomedical engineering company) and as a company, we do work sustaining products that currently are in the market as well as some product development work. However, the product development work is often on ways to upgrade our current product. Additionally, any new product in the market will need to have a post-market management team to monitor its progress for however long it is in the market. Nonetheless, I do acknowledge product development to be significant as products would not exist in the market without it; but I give more importance to post-market management as they can help with further development including upgrades and continuous monitoring of the product in the market to ensure it still meets market requirements.
Choosing between product development and post-market management is difficult because both roles are important. Roles in product development focus more on designing the product while following FDA regulations. On the other hand, post-market management roles maintain decisions that were made during product development by the regulatory department. Employees in post-market management refer to customer reviews, surveillance reports, etc. to understand how products are being seen on the market and if there were any adverse events reported. I would prefer a role in post-market management, particularly because I would work directly with customer opinions to make decisions on how to improve devices. Specifically, employees with this role quickly act to correct potential issues with products and ensure that manufacturers are following procedures and designs correctly. In the long run, I think roles in post-market management provide many more opportunities to help both the company and individual employees grow, which is why I prefer this side of the regulatory department. Within this role, I would not only maintain, but also attempt to improve my company’s success and profits by ensuring that devices are functioning properly and accepted by customers.
Employees in post-market management, together with the FDA, may even issue recalls preventing further harm to customers. Is the product development side of the regulatory department involved with these in any way, and if so, how?
