So far, this course has allowed me to see aspects from a management point-of-view, which is very useful, especially in industry. Having mostly academia-focused experience, it was interesting in seeing what some important aspects of industry-work is like. I especially enjoyed the simulations, where being put into an industry project setting allowed me to experience a bit of what it's like being a part of a medical device project team. I believe attention to protocols, deliverables, design inputs, and better team-working skills have been gained in greater capacity from this course and will carry with me long after the course. Furthermore, I agree that knowing more about project management will give you an extra boost when it comes to looking for a career in industry. Not only do you now understand the differences between Class I,II,and III medical devices, but also the procedure of planning a project successfully from start to end, which is not only useful for a future PM, but also for a project team member.
I started working in the medical device industry at the same time as starting this course, so I was able to solidify my knowledge from this class to the workplace. I am fortunate enough to use the lessons I learned from this class at work, such as the process of releasing a new product line from the research and development to the launch. It takes so much work that goes unrecognized from the product assemblers to manufacturing engineers who write the protocols and make sure they are followed. This class is beneficial for people who have not worked in the medical device industry (or industry in general) and would give them a good head start of understanding company policies and regulations, since many companies BMEs traditionally work in are regulated by the FDA.
This course has exposed me to regulations for medical devices that I wasn't aware of. Even the brief part in the course that went over the vaccines/ pharmaceutical companies' regulations did help me better understand how my everyday job is regulated and what happens before and after clinical Trials. Learning about FDA regulations and planning and executing a medical device have better understand the whole picture of Managing a medical device. I hope shortly I transition from pharma R&D to medical devices and apply everything I learned throughout this course
I agree that the course is of much help. I have worked in medical device industry for a while but had little understanding about medical device product development from business or regulatory perspective.
This course has helped me understand the intent and importance of many of the quality procedures implemented at my company. It help give me the big picture view of context within which the medical device industry is run. It also help me to broaden my view of the various type of companies from diagnostic, to implants, and different class of device. The 510K was a term I heard all the time at my company but I did not understand its history and purpose till I took the class. Basically prior to this class the scope of my understanding was being limited to being a resource during the executing phase without any knowledge of the initiation, planning, verification, validation, or design transfer phases.
I am very gratefully for this course, it is broadening view of the medical device industry.
Personally, I believe Dr. Simon’s courses are immensely helpful in providing students with no industry experience an overview of what to expect. For example, prior to taking medical device development during my undergraduate, my knowledge on the different roles in industry such as quality and regulatory were limited. Like a prior post, I was able to better answer interview questions and obtain an internship for a position I had applied for a semester after taking this course. Since the position was at a medical device manufacturing company, I was able to showcase my introductory knowledge gained from the course regarding regulatory standards and good manufacturing practices in my interview replies. As for this course, I believe it is essentially important for me as I look to enter the industry following the completion of my master’s degree this semester. In particular, I believe the simulations will be primarily helpful to better apply the technical knowledge we gain from the lectures towards real-life examples. Overall, I believe the most important knowledge I have gained from this course so far and the medical device development course is the different parts of the project life cycle and the documents associated with them in industry.
I am very thankful that I got to take this course because this is my very first course in grad school that does not deal with hardcore engineering and or math materials. I have been working in pharma for 4 years now and have been heavily involved with lab work and or technicality of the procedures that needs to be done. Therefore, I wasn't quite aware of the project management duties and responsibilities as much. This course makes me realize how the management team get to work together. I also got to learn about the roles and responsibilities of FDA and the requirements to be approved by them. I think overall, it is a great course to take as it gives a bigger picture of how a company would mostly run under the hands of management.
I completely agree with others who believe that this course is incredibly useful. Throughout my undergraduate and graduate studies, technical knowledge has constantly been taught, regardless of the track you were in. However, few to no classes have gone into detail about what students would encounter if they were to enter industry. Dr. Simon’s classes provide an overview of not just how the medical device industry functions, but also the importance of understanding project management and being able to apply it as it is used within industry. Like others, the knowledge of industry which I learned in Dr. Simon’s Medical Device Development class has helped me to be a better applicant and interviewee. Apart from this, Dr. Simon’s class has also helped me to decide whether I wanted to continue my career within industry or academia. Another important aspect to note are the simulations. The simulations from this course provide more practical knowledge. This is knowledge that no other class has really offered, in either my undergraduate or graduate degree. Therefore, I think this course is highly valuable as it teaches material regarding the medical device industry that no other class has thoroughly taught.
I have enrolled in Medical Device Development course in the previous semester and this is my second course. I can say Dr.Simon's courses provide a clear understanding of what to expect from the Industry when you start working. I have got to know a lot about medical devices which would have not been possible without these courses. I feel that these courses are a way more informative than any engineering courses. I also like the way that he makes us work on projects and simulations as real life problems. FDA regulations is most interesting topic to me so far.
I am currently a first year graduate student and this is the second class I have taken with Dr. Simon. I took Medical Devices Development (BME684) last semester and I enjoyed that class so much that I decided to take this class. It was not only an enjoyable course but it was actually so informative and informational. I was able to learn and actually carry out a device from start to finish through the FDA side of things. Even though there is some overlap between both courses, I believe this is necessary so we can go into depth about each topic. I have continued growing on the topics taught in BME 864. For someone with a limited experience, I feel like, with the information, I, at least, am able to understand what goes into competing in the industry. It is also super important to know about FDA and regulations, in general.
This course is different from all the previous courses that I have taken at NJIT in that it teaches real life situations and scenarios. The material Dr. Simon covers can be directly applied to industry, which is why I am extra thankful I chose to take this course as an undergraduate student. We have been assigned group projects since grade school, but even in college, group projects do not closely resemble how projects are executed in the workplace after college. Up until now, group projects have taught me certain interpersonal skills, like effective communication and emotional intelligence, but it was not until this class that I learned project specifics, such as project life cycle, project phases, and other project management techniques.
There are so many benefits taking this course. This is the only Biomedical Engineering Program that goes in-depth into Project Management in Medical device. Like Dr. Simon said, NJIT is the only school that offers this course. Feels like an taking an entire program in Project Management because of the knowledge been thought.
As a biochemist, having a bit of the industry, I never knew what was involved in Biomedical Engineering, more so not knowing what to expect in a medical device company. This course gives you first hand, practical ways on how to handle and deal with projects, and how to work as a team.
This course clearly and deeply went into FDA regulations, which is one of the big requirements needed to get you into a medical device company. It talks about pitfalls, challenges and issues that many medical device projects face, and how to avoid them. This prepares you on how to handle and combat a lot of difficult situations in any work-life, either we are facing now or what we will face in the future.
Today many companies are facing the challenge of meeting up with project timeline or deadline. With this course engaging us with the simulation project and giving us a deadline to turn it in, it prepares us on how to avoid schedule slippage and the embarrassment of not delivering on time thereby giving an accurate estimate timeline.
Despite the fact that we are only in week 6 of the semester I already fell like this class will be extremely beneficial in terms of real-life applications. While up to this point, I have not learned any completely new material, I have definitely gained a greater depth of knowledge for most of the material in the class. For example, while many BME classes discuss FDA regulation none have been even close to this class in detail. I do not think this class will necessarily be more helpful than capstone due to it all being theoretical knowledge rather than a practical show of skills but having more knowledge on how professional workplaces operate will still be a positive for a job application.
Like many of the previous posts have stated, this course has definitely proven to be valuable. In my undergraduate classes, you don't always see assignments or projects try to simulate a real world or industry experience. In these classes, you learn theories and concepts but may not understand how those apply when you work in industry. I currently work in the industry and it’s been great to see the lessons Dr. Simon is teaching us in action outside of the class. Not only am I able to see these lessons in a real-world application, but I can anticipate the next steps in getting a medical device to market from what Dr. Simon has taught. Additionally, these lessons also show the different areas in which project management where I work can be improved.
I also agree that this course is incredibly beneficial. Even if you are not going into industry, the things discussed in this course, such as project planning, the steps required for project planning, project execution, etc. are transferable and useful across both the biomedical engineering field and across really any field in which design plays a key function.
I also greatly enjoy how this course is run: the simulations and group projects require us to not only understand teamwork and project management but to actively test our skillsets of these things. Most of us, by this point, have some kind of understanding of the technical aspects of biomedical engineering, but many of us do not have job/industry experience and this class does an excellent job of introducing such.
Hi Guys,
So I know we all have been posting discussion questions regarding simulations and all the lectures each week. However, I wanted to get your input on what you think so far about this course?
My personal experience, I took medical device development with Dr. Simon two semester ago and currently my last semester at NJIT, I am enrolled in both of Dr. Simon's courses. I have been applying for jobs in the industry and in a couple interviews I gave in the past semester, I found out that most of the information thought in Dr. Simon's courses is very useful during interviews. Many employers do not expect college graduates in the engineering program to have much knowledge on FDA regulations, Marketing Clinical Trials, or Project Management techniques. So in one of my job interviews, the hiring manager asked me if I ever heard the term GMP or GCP. Luckily, since I was taking medical device development at the time, I was able to answer this question with a lot more detail verses someone who took only engineering courses.
What is your opinion regarding this course and what have you learned so far that you did not know previously?
I agree with you, as engineers, job managers do not expect us to know about the GMP, GDP, GCP. It is an add-on when we know about these practices and the FDA regulations.
I have taken BME304 where we touched a little bite of details about the FDA I liked the topic a lot, and I took and BME 498, where we covered more details about the FDA and device classifications, yet we never touched that many details. For a company like BMS, where they are still getting FDA pre-license observations and audits, It was important to show that I know this information in the interview. During my training period, when my trainer observed my practices, I was promoted from the culture maintenance bucket to the aseptic bucket. They also allowed me to further my training get training on environmental monitoring.
Farther more, on a personal level, I appreciate the FDA, Knowing that there is countries that does not have an FDA equivalent and "anyone" there are free to market whatever they want.
