Dr Simon,

I have learned a lot from this course. It gave me knowledge about the Regulatory affairs, Quality Control and Quality Assurance. It has helped me put the knowledge at work and I have been using your presentations to learn more about implementing at my work place.
Not to forget the midterm paper proposal, it has made me aware of technology advances in medical device development.

Thank you very much Dr Simon.

As a person who has been working in the medical device field for multiple years, before I started this course I definitely was not sure what to expect as far as the class content / structure. I can honestly say that I did learn many different aspects about medical device development that I did not know before taking the class. The vast majority of my job experience has been focused around R&D, QA, and operation roles within medical device development. I really appreciated the way the course was structured to allow students to get insight into the different functions (roles) that are needed in medical device development. I would definitely recommend this class to others, especially to those we do not have any industry experience. I look forward to taking more classes of yours during my Master’s Degree at NJIT.
Thank You

This course has shed some light on the medical device industry. This course gives you the opportunity to have some understanding of what is expected of you when you work for a medical device company. When I took my first job after my graduating from college I had no idea what to expect. All I wanted to do was to get a job and start making money regardless of what I did. This course gives you the opportunity to have a feel for what is out there and what is expected of you. It gives you the opportunity to make a decision based on what you know and not what you are hoping for. Hopefully NJIT will introduce a couple of these courses for their undergrad program. On behalf of the class I say thank you for this experience.

I liked this class a lot for the sole reason I got to know where to work and what things are needed to get to the position I like. The other thing that really I found useful that this course was more from Industrial point of view that let you to have insight into the workflow and it helps us in a way to get internships by already knowing the workflow and not going in completely blank. Even making our own document as per industry standards helps us have better learning in what we want to pursue our careers in. All this made me select your Advance class meet you there again.It was overall a good experience!!!!!!!!!!!!

I think every one studying BME should take this class. I have learned a lot about medical device development. This course helped me to learn a lot about the regulations in and out of US, how to make a design control, quality assurance,...the material is very good and explained in a professional manner.Also, I think its a great idea to take the Advanced medical device development course too.
I liked the "Class projects" idea, so we can show what we have learned from the course as a practical example.
Thanks Dr.Simon for your time and your hard work.

This course was excellent in giving a high overview of how the medical device industry functions. The lectures were really informative and gave me a better understanding about departments that I work with directly. It also helped me weed out some departments I wouldn't be interested in pursuing. I think NJIT should actually offer this as an undergraduate class to be taken early in the freshmen/sophomore years within BME (if it isn't already). As a graduate student who is already in the medical device industry, I would have killed to have learned most of this early on within my undergraduate years. Also, it'll be more beneficially for people in early undergrad to take this course so they can have a more complete idea if they truly want to enter this career path.

Thanks!
-Scott Avery

Thank you for teaching this course. What I love most about it was the information-rich lessons and flexibility. The lessons were organized in separate topics and videos for each week so they are very easy to digest. I love the fact that I can watch this when I have time and can rewatch the videos. I found all the templates very helpful. Thank you for always responding quickly via emails. Overall, it's a very well-rounded course. I am very happy to have taken this course. I am sure I'm going to use most of the course materials in the future (and also right now). I will take your advanced course as well. See you next year!

I enjoyed taking this class. I feel like you are one of the only professors that prepares students for the real world. Even though NIH strongly encourages institutions to provide career services and help students plan for the future (usually through IDP's and other means), I feel that a lot of institutions do not provide the support. These classes help students understand their options when they graduate and helps them make a solid plan for their future. For future students who take this class, I would like more information about how to put a formal 3-5 year business plan together (for those students who want to start their own business).

I really enjoyed this course. The course is well structured and provides pretty good insight of the device development process and design controls. As a professional with multiple years in the pharma-med dev. industry I have learned from this course and find it to be an invaluable course. I particularly enjoyed the final project structure in which students pick roles to represent and collaborate with other functions. It was fun. I would definitely recommend this course to others, especially to those students that do not have work experience. Thank you for teaching this course!!

This course really opened my eyes to how the world of medical devices really operates. As a biomedical engineering student, most of my education was focused on theoretical design and processes of medical devices and instruments. However, this course taught me a lot about how these devices are put out into society and what it takes for a product to be approved legally. It shows us a lot about how medical devices are developed in the industry outside of a laboratory or classroom setting. I learned a lot about topics relating to regulatory affairs and quality control, that are not covered in as much detail in other courses. Through the lectures I also gained more insight into the many operational roles and responsibilities involved in medical device development. I was able to relate a lot of the knowledge I acquired to my current position in R&D where I work.

Like many of the students have stated previously, I expected this course to include a thorough technical look at different industry roles associated with Biomedical Engineering, as well as the general process of medical device development. 3 months later, I am glad it didn't. Those aspects are things that are covered by almost every other course we take as Biomedical Engineering students, while this one introduces us to an aspect of the industry that is essential to all employees, but is rarely covered in school.

As a premedical student, I can appreciate from afar how useful this course is to future industry students. To them, however, this course can be a life-changing experience that increases their value to employers and helps them advance in the industry. Despite being a premedical student, I am glad I took this course, and greatly appreciate Dr. Simon's teaching style and methods. He is doing a great job filling a niche role, and I hope future students of his enjoy and appreciate his course as much as I did.

Throughout my undergraduate experience, there has never been a class that helped relate what I learned in the classroom to real life. I did not have first hand knowledge of the various opportunities engineers have coming out of college. This was one of the main reasons why I took this course as I wanted to understand what happens after college. I thoroughly appreciate the different job opportunities discussed in this class, especially the fact that Dr. Simon showed both sides of the job. He just didn't focus on the positives, he showed the negatives of various jobs and this helps tremendously with choosing future jobs.
Being a premed student, understanding the engineering side of medicine is one of the main reasons why I chose to do biomedical engineering. This course provided me with a great background and hands on opportunity to understand the working life of biomedical engineering.

Dr. Simon,

I did go into this class thinking it would be like the rest, but I do believe your consistency is putting up lectures and keeping them interesting was why your course was different and little bit more to my taste. As a pre-med student, hoping to enter medical school next year, I believe this course has given me a bit more understanding of the industry and what goes on in order to get clinical trials approved as well as this week's lecture on the NDA and agreement forms.

As I enter into the profession years (maybe after 5 years), I hope to keep this knowledge and use it to my advantage. It gives me a great background of the field I am entering, especially as a biomedical engineer. The final project also gives me a bit more hands-on learning on just what needs to be done to develop a product into this competitive market. Thank you for teaching this course and making it interesting!

Dr. Simon,

I really enjoyed this course. I found the Regulatory and Quality lectures to be very informative and useful. I work more on the business side as Licensing Associate and getting a better understanding of the other roles/departments involved in device development through the lectures, midterm, and final project have been very helpful. Since starting this course, I've even reached out to some of the groups Regulatory and Clinical to learn more about out their departments and our processes at Sloan. I've learned a lot and I plan on moving forward with the Advanced MDD course. Thank you for creating such a unique course that translates into actual real world scenarios.

Thanks,
Alex Buga

I agree with all of the participants in this post regarding Dr. Simon’s class. This is my second semester as Masters in Biomedical Engineering and also second time taking a class with Dr. Simon. Previous semester, in project management class, I’ve learned a lot in terms of FDA regulations and project management. During this course, it was more of executing the items learned in previous semester. I understand that technical engineering classes teach the skills, however it is barely used while working in the professional work force. One of the exciting part of this class, is the DHR project. We’ve learned the entire process of how to effectively launch a successful medical device product in the market. All in all, this is a great class as it gives one the complete understanding of design controls and ISO 14971, risk management within the medical devices.