I would have to agree with you. I’m an undergraduate BME student and this is my first time taking the course with Dr. Simon. The only time learned about FDA regulation was in BME 304 Introduction to Biomaterial course with Dr. Collins. Afterward, I think I only touched upon project management topics that we are learning in this course a little in my capstone class, where I learned a little about FDA regulation, how to write a requirements document, manage a Gantt Chart, and write a test plan. Also, my capstone class had to take part in “design review” meetings, where we critiqued other group design requirements and the possible aspects that should be improved. This is the first course that I’m learning about what is involved medical device development in a greater detail such as the different phases of project development, risk management and about different documentations that I never heard about before. Moreover, I have not worked in the industry, so I do not have any inkling what it is like, except what I learn from college. I think the simulations in this course really helps reinforce the what I learned and how to I would approach the challenge given to us. I think it is not only important to know the technical knowledge in BME, but it is also important to have knowledge of what is involved in developing a project, which makes it a viable project for a company.

As an undergraduate student here, I never talked about the FDA from my freshman to junior years. However now in my senior year I have been able to understand how projects are actually done in the Industry because of this class. I had taken Dr. Simon previously for BME684 which is development of Medical Devices and I was able to learn a lot of things that I did not touch in my other courses. The only professor who briefly explained some regulations about the FDA was Dr. Schesser. I haven’t been interviewed for any jobs yet but a lot of friends who already have a job tell me that knowing regulations of the FDA is key when obtaining a job. In addition, I think this course is way different than what Engineering students are used to.

Let me know what you think.
Sincerely,
Roberto Pineda.

I 100% agree with the two previous comments that this course is by far the most useful and applicable course I have taken here at NJIT. Before this course, I only had a brief background of what the FDA was and all the different area it regulates from Dr. Collins 672 Biomaterials class along with personal research. Now, I am starting to realize all the details, steps, and processes that are implemented in a successful medical device setting. I view this information as generally more useful in the industrial setting than other core classes because every medical device company has to follow these strict guidelines imposed by the FDA. Not every company will require such a broad range of specialty skills such as signal processing, the details of tissue engineering, or computer modeling (although knowing them can’t hurt).

My experience applying the knowledge of the FDA I have learned in this class to industry has also been very beneficial. Because I hold an undergraduate degree in biochemistry, I thought I had a disadvantage when applying to BME internships/ jobs these past few months. However, with my growing knowledge of the FDA regulations along with the steps to validation and verification, I was able to thoroughly impress the interviewers when they asked about FDA related questions. In the end, I would have to credit Dr. Simon’s class with being one of the main reasons I recently received my job offer.

Since starting at Maquet I never actually knew what I would be doing as a manufacturing engineer in industry. I heard about the FDA maybe once or twice as an undergraduate.This course taught me so much about working as an engineer in industry compared to a majority of other courses I have taken in my undergraduate career. The first weeks lecture on classification of medical devices was vital for my understanding of Maquets products within the first couple of weeks at work. Maquet is mostly known for their IABs (intra aortic balloons) which are class three devices. But before I attended this class I had no idea what that meant. The FDA regulations and hierarchy break down is so vital to understand when working in industry. These concepts were only brought to my attention through this course. Engineering students focus a lot on STEM topics in college but their should be an undergraduate course which covers these basic concepts so that students will be able to understand their work environment.

The beauty of this course is that it's more practical than it is theoretical and really gives students an idea of what's going on in the real world. Even if you may not be a Project manager and just a regular design engineer, it still gives you a grasp on what goes on behind the scenes while your career path may be focused more on Research & Development, Design and Engineering, or manufacturing. Its helped me in my career while I do my task and duties for a certain project, how other tasks from different departments are dependent on what I do and how I carry out my job. The course really paints the big picture on how not only engineering, but marketing, management, quality, manufacturing may be integrated all under one project. While I may not be from a Biomedical background, I find the topics regarding the steps for creating medical devices interesting like FDA approval, 501k process, etc. Also learning about design controls is a topic that can be carried over into any industry. I didn't even realize I was doing some part of design controls while working one of my past internships for an LED lighting fixture company until I learned about it in this course a year later. Overall, this course has really allowed me to view my job and career in general from a whole new perspective.

The biggest thing from this course that I've learned is knowledge about the regulations and the bureaucracy involved with creating a medical device. During my undergraduate coursework, I never really went into detail about such regulations and what it actually took to have a device on the market. Capstone taught me the design and prototype phase, but the testing and commercialization phase was unfamiliar to me. Throughout this course, I've learned a lot about things like validation vs verification, design controls, and standard procedure. This information is so vital in industry because an engineer who knows about all the steps of the medical device development process can be a greater asset to the company or research lab than an engineer who is simply skilled in engineering design. Overall, this course has helped me broaden my knowledge of the industry and has made me even more interested in how my career choice operates.

The most impactful lesson I have learned from this class so far is how applied research/basic science (that is, what we learn in our core classes) is just a small percentage of research and development and R&D is just a small percentage of actual product development. As several of the posts above have mentioned, knowledge in project management, regulatory policies and procedures, shareholder/stakeholder interests, manufacturing practices, interdisciplinary communication, marketing, funding acquisition, and more are also heavily involved in product development at an industry level. It is concerning that not enough of our BME curriculum stresses teaching these skills especially since NJIT is reputed in catering to working class students. However, if we take initiative, there are classes available; for example this class, the Capstones and electives offered through the School of Management; I also found several of my biomaterials/tissue engineering track classes to explain FDA regulations and almost every BME class involved team projects that help build communication and interpersonal skills. I took this class to gain knowledge about the inner workings of how to navigate through and succeed in industry and so far it has delivered.

This is my first course with Dr. Simon and since I work in industry I had experience in most of the topics that we are learning. The greatest benefit this course provides for me is the thought process on management. This course along with the book give good fundamentals on organizing and managing projects that can be applied to all any industry sector. Moreover, actually giving a name to project management steps helps in understanding concepts of project management better. By this I mean that many of the steps that Dr. Simon mentions in lectures and that are in the book are steps that we follow within industry, but because of I never took formal courses in the topic, for certain tasks you know what you are doing but not necessarily why. With Dr. Simon's lectures it clears up this disconnect that was present and the concept of project management flows.

This is also my first course with Dr. Simon. I am currently in my last semester of my undergrad and I have had a couple of interviews for full-time positions. In all of those interviews I've been asked about FDA regulations and in some cases questions based on how I would handle a project. I can say without a doubt that this class has helped me tremendously in answering those questions as well as making me confident that I can handle a lot of industry based questions. A lot of the times we learn all these technical things in school and believe it or not, but you barely use any of that information in the industry. However, key things like the content in this course are really what full-time work is all about. Yes, the technical work helps a bit but there are other things more than that. To give you an example, one of the interviewers had asked me a question "how would you manage a project". Easy question after taking this course.

I could not agree more. I had started interning in industry before taking any of Dr. Simon's classes. I entered not knowing anything about the FDA, GDP or the design control process. Through my experience I learned what I could from the limited facet that I had interacted with. In taking Dr. Simon's Medical Device Development course I was much more able to understand various aspects of the industry. This was clear through many of the conversations I would have with my superiors and with interviewers. I would explain various aspects I had learned in the course and could tell that this was something that stood out. This course takes the experience even further with these realistic simulations. These are situations that are extremely realistic and look for real life solutions to solve them. I believe that this information is invaluable for us as we enter industry with knowledge that not many entry level individuals have.

I agree the comments above, with the support of Dr. Simon's courses I feel that his courses provide a real world approach and look within industry. There have been countless of times were I refer back to my lecture notes to fully understand why a particular approach was initiated within my job and my lecture slides provided me answers to those questions. Particularly in the area of validation and verification, which is what my job mostly focuses on.

Chris

I agree with all of the participants in this post regarding Dr. Simon’s class. This is my first semester as Masters in Biomedical Engineering and also first time taking a class with Dr. Simon. In my bachelors at NJIT, I was briefly exposed to FDA regulations in medical devices and most of it I learned through my professional work experience. This has been a great class as it really teaches me project management skills used in the industry. Also, I have been looking for full time positions and during my interviews, without a doubt I use the skills learned in this class to answer questions such as, how do you handle a project under stress? I feel that this is the class that prepares you well for the industry. I understand that technical engineering classes teach the skills, however it is barely used while working in the professional work force. All in all, this is a great class as it gives one the complete understanding of project management and FDA within the medical devices.

I concur the remarks above, with the support of Dr. Simon's courses I feel that his courses give a true approach and search inside an industry. There have been incalculable of times where I allude back to my address notes to completely comprehend why a specific approach was started inside my employment and my address slides gave me answers to those inquiries. Especially in the region of approval and check, which is the thing that my occupation, for the most part, spotlights on.

This is my second course with dr. Simon. I previously have taken Medical Devices Development (BME684). The amount of information I learned about the paperwork and all the requirements to carry a project in real life. This has encouraged me take this course as well. Although there is some overlap between both courses, I keep learning new and more definition about projects and the industry overall. For someone with a limited experience like me, I feel rich with the information I feel about the industry from this course and the one before. I also agree with all who mentioned the importance of knowing about FDA and regulations, our industry requires a good knowledge of it and this course truly helps.