certainly, I agree with most of the participants in this post regarding Dr. Simon’s class. This is my first time taking the class with Dr. Simon. I am glad I took this course. I found this course helpful, therefore I took Dr. Simon second course as well for next semester. During this course, I learned more about all the inside position and the development process in the medical industry along with FDA regulations and rules. I like how this class has audio lectures along with slides. Audio lectures are much better to understand the slides. Furthermore, the project team is a great experience to deal with different people with a different department and also working with team members. Dr. Simon, your course was the best. Thank you!

This was my first online course in my Master degree, and I enjoyed it a lot, and never regret taking it. I like how we learned about different aspects every week, and how this course taught me a lot about the pharmaceutical industry as I don't have any experience yet. I think this course should be a core BME course, and all students should take it in their undergrad as it will prepare them to real life. Many confusions were explained to me and now I can better know my rights, my tasks, etc. as an employer.
The project was very useful as it connects students with each other as a team member, and having the time to spend as in a company. Thank you so much for this great course professor!

This was such an awesome course! Taking this class parallel to my internship really helped. It helped me understand more about my company (and other medical device companies), its structure, and departmental functions, as a lot of topics covered, I was able to experience first hand. I also love the way Dr. Simon explained each topic in detail, it made me understand them easily. They were interesting and very real to what goes on in industry.
The project was also a good experience. Having to manage a team taught me a lot about how to work in a team and be a good team-player. I learned to be open to every single department's opinion, concern, and question. The better the team coordinates and communicates the faster the project can move. This is exactly how it works in industry as well, so I am glad to have this experience. Thank you, Dr. Simon!

Dr. Simon,

I really enjoyed taking this class. I feel that I learned a lot, especially while working on a co-op in the industry. This coursework complemented my learning in the industry and now I feel that I have a firm understanding of how the industry works and I see it all around me now. I had previously worked in academia and learned on my own that the style was not for me. Walking out of your class, I know confidently that the industry is for me. I enjoyed working on the group project with my classmates and understanding what it means to work in teams comprised of different departments. I am looking forward to taking other classes of yours at NJIT. All the best!

-Yonatan (Yoni) Sheer

This course was really informational above all. The lectures did a good job of explaining everything and the discussions made it easy to see how it applies to the real world. I learned a lot about medical device companies and how they operate just by reading other people's experiences. The discussions work well to reinforce what was said in the lectures.
Working in teams on a project allows me to appreciate how important each department is in preparing a product for launch. I remember what I learned from the lectures when I review each of our documents. A few of my team members also have their own experience which helps us create our documents. I think this class is a great class because it is application based.

Dr. Simon,

I appreciate the material that you are teaching in this class as it is extremely applicable to the industry. This course has allowed be to expand my knowledge in my current position and has allowed me to use what I have learned in this class directly in the industry. Thank you for educating not only myself, but my peers in medical device management and in the development and requirements of the design history file of a project. MY only criticism is that I had some technical difficulty submitting a few of my posts and I wasn't quite sure why - I attempted rewriting and submitting in different formats too.

If you have any classes internally or externally with NJIT regarding the new MDR/IVDR regulations that will be in place 2020 and 2022 or MDSAP audits, please let us know - I would be very interested in taking such courses.

Sincerely,
Elizabeth Snedeker

Class,
Thanks for the great 2018 comments. I do take all your words into consideration.

This is an interesting time in medical devices, as you will soon find out in your jobs or in my future courses. A lot of updates for my course material are forthcoming, so stay alert. I have just accepted an additional adjunctship to teach this course at the Morehouse School of Medicine in Georgia, USA. Of course, it will be completely online, and hopefully you will be lucky enough to interact with those students on this forum starting next Summer. As part of creating this course for them, I will be back-updating all my old courses with new information. It's been a hot minute since I've done that and with all the new activities on both the FDA and EU side, it is needed.

For those that need information on the new EU MDR, I do teach a course outside the university for a company called Oriel STAT A MATRIX, which is a training/consulting company that I have as a client. We will cover a little bit about the EU in the Advanced Medical Device Development course, but it needs to be updated and it will not go as in-depth as the Oriel course does. You can find that course here:

EU MDR Training

Other than that, I look forward to seeing all of you in the next courses and beyond.

This course left me with the idea that medical devices are not just devices; they are essentially entire departments made up of people of different backgrounds working on a project to make this device possible. A company is thought to be made up of departments separated by job title; your marketers, researchers, salespeople, etc. But larger companies will have a group of people, many times plucked from each of these departments, to form a project with an idea for an eventually device on the market. My idea of working in industry was only based on word of mouth from fellow colleagues with mixed reviews. I never really understood what many of them meant by their idea of an industry workplace environment until this course. I have been exclusively in academia but I have opened myself to industry for the opportunity to expand my career past just research.

Since, I am taking this class as an undergraduate in my final year, I can confidently say that this course was very beneficial for me. Prior to this course, I must admit that my knowledge on the different roles and responsibilities in the field of medical device development was very limited. Therefore, throughout the duration of this course, I not only learned about the different roles, but also became more self-aware about the roles that I had a greater interest towards. As a result, while currently looking for job opportunities before my graduation next semester, I am more aware of which job listings are more inline with my personal interests. As for the organization of the course itself, I believe it was very effective in allowing students to not only learn about a certain topic, but then also allow them to express their thoughts and opinions on it through the forum posts. Overall, this is a class, I would definitely recommend to other classmates because it helps prepare students on what to expect post-graduation as biomedical engineers.

I enjoyed this course a lot, I found all of the information very useful and it gave me a good idea of what types of positions I might be interested in working in within companies. I also liked the order of the lectures. It was very helpful having gone through all the positions before choosing project teams. In addition to that, I found the design control lectures very interesting and would have liked to learn more about those. 

The only improvement I would suggest is for the quizzes, consistently using quizzes that cover two weeks of material rather than some that only cover one. I thought the two lecture quizzes covered the most important information while the quizzes of only one lecture sometimes had multiple questions on the same topic. 

Overall, I really enjoyed this course, and will definitely recommend it to other students!

Taking up this course I learnt a lot about how things really work in the industry and Dr Simon did a really tremendous job he structured the course really well in an organised way which ensured me to learn at my own pace. The course material was very good and simple to understand.

I personally felt that this course was very helpful to me, since it provided me with more insight into all the steps required to develop, manufacture, and release a medical device. It was interesting learning about the different departments and factors to consider within a medical device company. I also felt that the course was well paced with the weekly introductions into each component of a project team. I appreciate how the final project will also give us the opportunity to apply our acquired knowledge with a more hands-on approach (as opposed to just completing a exam). Overall, I was satisfied with the structure and content of this course. 

I am glade that I took this course because it covered how development of medical device works and gives incite into what biomedical engineers do. I liked how this course covers about different aspects of medical device development and engages students in thinking about these different aspects by encompassing all of the course material in project. These allows students to figure out what they department of medical company they like and dislike so they know what to pursue and what not to.

Most importantly I liked how professor compared academia and industrial sides of engineering because it gave me new perspective on what I want to do in future. It also helped me understand how each profession works when it comes to innovation.

This course in generally as been an eye opener to the Medical Device world. This explain in details all you need to know about the industry and how each roles overlap each other. I am excited I took this course, apart from the knowledge gained, it gave me an insight to other roles and opportunities to branch into.

Also, I love the fact that we get an interchange of knowledge through this forum. Reading everyone’s idea and how they see things kind of make you broaden your thinking and try to look at things from every angle. Like Dr. Simon would say, there is no wrong answers, or one over the other. Just the way people see things from a different perspective and their opinions varies. 

In all, I would say this course was good. I love the fact I could listen to the lecture on my way to work. Am more of a listener than having to read the slides. Just some lectures that will have to be updated to reflect what is on the slides and also, some changes has been made over the years with the Medical Device industry and their Regulations, and these changes needs to be reflected on the slides. Short of that this course was something I enjoyed and was more practical for me and I look forward to the Advance Medical Device Course. 

I really liked the practicality of the information taught in this class. For those wanting to work in the medical device industry (or already do), this course teaches each step of medical device development very clearly and gives practical advice and knowledge. The most important aspects were emphasized well, while unnecessary details were left out. Although I don't have any industry experience, I felt as if I got a very clear picture of how the medical device industry operated, from the type of industry organization, to the interpersonal relationships and all the paperwork involved. 

Overall, I am very happy I took this course in addition to Dr. Simon's course on Systems Management in Medical Devices. I feel a lot more equipped to join industry after these courses. Also, this course opened my eyes to all the possible roles in the medical device industry, whereas I previously only had my eyes glued to the R&D part of medical device development. I also really enjoy the projects which Dr. Simon assigns, since we sort of simulate working as part of a team in a medical device company, which is practical and fun. I would highly recommend this course to other students!