I think the combination of the course options we have is sufficient since we get a taste of statistical analysis, CAD design, Coding (Labview/Matlab), & medical device development. With this being said, we get a opportunity to take two classes outside the biomedical engineering department such as mechanical, industrial, pharmaceutical engineering. With this being said, it allows everyone to take the classes they need to improve their skills based on their current roles or job responsibilities. If we have all of our courses based on the technical side, a person working within quality might be at a disadvantage.Like wise for load that is heavily based on medical device development for someone that is involved heavily on design.

As someone who is starting there career within the medical device industry and applying what was learned in class, I felt that applying my knowledge from class concurrently with the application aspect helps me to fully understand what goes on within this type of industry. I personally work within the validation aspect, and it was great having the listen on validation, while writing my protocols and executing them, I gained the fundamental base of my industry knowledge from this class and medical device development, which helped my transition from my previous role within a lab to an engineering role. Ideally, I would've like it if we had covered the whole aspect of learning how to write different types of protocols or learn how to approach them accordingly. I know that each company has a set standard of writing different types of protocols/validations, but it would've been nice to apply this scenario within a simulation. Like given a simulation to validate a piece of equipment, what would be the steps to do that and write a protcol for each phase of validation.

Chris

Both versions of this course is very useful. I took both of them while working and wish I took it before I started working as they do give you an idea of what to expect in industry. Maybe it should be a requirement!

Hi All,

I would agree that both MDD and AMDD are very useful and practical classes. Working in the pharmaceutical industry, I even saw the great benefit. I believe that these courses, or similar ones, should be a mandate for students in the biomedical masters program as practical classes can be greatly beneficial. Having experience in other courses is needed as well, but having practical experience that you learn from simulations, lectures, etc, are needed.

-Andrew Nashed

After taking both the MDD and AMDD courses, the topics that are taught and reviewed within these courses are very beneficial. The courses shine light on processes that have to be followed within the work area and what the different types of positions entail. These courses gave me a better understanding as to what is expected and the knowledge necessary when working. I think NJIT should create more classes like these and make them core classes instead of electives. The material learned in these courses is very applicable. Both courses gave an understanding as to the different job opportunities there are for Biomedical Engineers. More classes like these will help better prepare students as to what the industry consists of, and will help have a better understanding as to what career path they may want to follow. These courses helped me see which positions I may not like or be interested in, and which ones suit me better.

I agree with everyone above that I found these classes very beneficial to me, and especially the topics covered in AMDD helped me gain a better understanding of process validation. The simulations were very realistic, and overall, both MDD and AMDD give you a good picture of what it is like to work in industry. I wish classes like this were offered for undergrads to give them a little direction in a career choice.

I think all undergraduate and graduate programs should considering adding courses like this because it gives students a glimpse of what it is like in the industry. My first job out of college as a R&D technical for a regenerative medicine company and I had no idea what design controls were, process validation or the various job opportunities. I entered my current position completely blind. There is a good amount of on the job training, but I believe more courses like this would expose students to concepts and common terms.
I am currently working as a manufacturing engineer and I still found this course valuable. The simulations conducted also add to the value of the course. Some of simulations were not directly in line with my daily job responsibilities so I was challenged to think outside of the box and exposure to other opportunities within the industry.

Actually AMDD very useful class. I learned a lot about the regulations and QSR in US and regulations in EU as well. Participation & Simulations great features for the class. This class took me to the real world problems in the industry. Very useful class for quality engineers, CRAs, and any one work in the industry.
I also recommend this class for all BME students.

MDD and AMDD are very good classes to get your feet wet in understanding the different aspects of medical devices and what can lie ahead in your engineering career.

As expansion to these type of courses, I would like to see a course done on the startup/entrepreneur side of medical device development. These two courses, are definitely necessary to understand and should be mandatory before taking a startup/entrepreneur class. However, working in industry and for a company is just a small part of the possibilities that are out there. Running or starting a medical device company, as tall of a task as that is, is another possibility and learning the business side would be extremely beneficial.

I would like to see taught the high level steps that need to happen after the idea and device is created. For example, proper ways to write proposals, how to create a pitch for investors, best way to find and reach out to venture capitalist, how to protect your idea/prodcut, how to determine how much your product is worth, best practices for negotiating equity, etc. All of this can be taught in medical device startup course.

I believe that MDD and AMDD have been essential to my coursework here at NJIT. I am currently working in manufacturing engineering at a medical device company. In the manufacturing department of a medical device company, it is all about what happens after Design Transfer. Because of the nature of the work I am involved in, I am more attuned to the material of AMDD more so than MDD. Overall, these two courses have provided the framework for the rest of my career in the industry.

I agree that MDD and AMDD have been integral in providing me the necessary platform not only for my other classes, but for my career. I currently work on the business end, but I am new to the medical device development process from Design to Manufacturing. I think these courses have provided me very valuable information regarding QC and Regulatory not just in the US, but Europe. Having a better understanding of all these processes, and how detailed this work can be has been eye opening. For one of my robotic devices we contracted the work develop a clinical functional prototype and they sent me so many documents and the gantt chart was so incredibly detailed that it felt like it was information overload and I couldn't appreciate why they had all of this documentation. Now understanding the DHF and regulatory requirements, I completely understand and will make sure any CROs we use will follow these requirements.

I think it would be great if NJIT included more courses like this in their curriculum.

Out of all my entire bachelors and masters courses there are only a handful of courses which gave me insight to what it is like to work as a biomedical engineer. AMDD is one of those classes, that material we learned in this course helped me understand project at work. For example, the lecture on installation qualification, operational qualification and performance qualification was so vital for me at work. I was working on validating a new fixture and that lecture helped clarify confusions that I had. No other courses within the masters or bachelor programs offered me this kind of insight. The application of simulations not only teaches you the course material but also how to communicate and work in a group.

I very much appreciate this class. As especially because before I worked in the industry my notion were completely incorrect. After starting to working in the industry I realized that this class is one of the only classes that have topics that are directly related to real-world practices. I believe this class taught in personnel can also be very beneficial to the student. This is one class that I hand down to respond to all student. Knowing real-world practices is key and this class is a good place to start.