In this course, the things I learned are FDA regulations and how these regulations affect the project management process. I did not know much about the FDA previously and taking this course has given a much better picture into how the FDA functions and the different ways that medical device companies approach this system. Given this, I think that this course will prove valuable to me in my future career as I will be better able to understand a company’s procedure and thus be more desirable.
For someone that has been in industry for a couple of years, I cannot stress this enough for people to understand the design process and how project managers work with this in mind. Although not everyone will be constrained to each step and each phase, there are many who will step into an area of the design process if you go into the medical device industry. I would suggest this type of course be taught at an undergraduate level to help them further their knowledge where many who have wrote in this thread understand the importance this information can be during an interview. I was fortunate to learn this during my career, but this would have been great earlier in my life. I'm enjoying this course now as it helps me further my understanding of my coworker's mindsets when leading a project from project initiation to post-market.
I love this class because it is more practical than anything I took before. It really highlights the real life situations that we are going to face in the industry, not just academic material that won't be very valuable once we start working. I am currently a part time student and working full time at BD and most of the terms that I hear everyday at work I see in the slides and the simulations for this class. The class explains many of those terms and forces me to do some research if something is not clear enough to me, which helps me in my carrier more than my grade. I am benefiting a lot from the materials taught and the real life situations presented in the simulations, because it explains exactly what would be the process to ensure a successful project. Even if someone is not interested in being a project manager, it is good to understand how they think and how they approach things in order to be proactive and perform your tasks the desired way. On the other hand, the class explains in details some major R&D tasks that might be beneficial to understand how they are performed and completed, which will definitely have a value at some point in anyone's career. I personally prefer those kind of practical classes over academic classes with a lot of memorization since all those information might fade away as we grow older.
So far, I feel that the information from this course has really allowed me to understand the behind-the-scenes activities in a medical device company, as well as the rules and regulation of the FDA. Prior to taking this course, I had taken Medical Device Development (MDD) which actually had factored into landing me my first job. During a job interview regarding a Quality Engineer role in the Complaints Department, I was asked if I had any idea on how the risk management process worked, and questioned on how a risk document is created. And being that I had prior experience “working” as a Quality Engineer in an MDD group project, I was able to answer such questions with full confidence given the background knowledge I had creating the risk document with my group. From my “prior” experience and background knowledge working as a Quality Engineer, I believe it was a major factor in getting the job. I feel that this course gives students an edge over other candidates in terms of getting a job in the Medical Device Industry as we have practical knowledge on what actually goes on in the company. Additionally, this course in specific, grants students an edge in terms of project management which is a very sought out position that many can really enter with previous real-life experience working on projects. Has anyone else used what they learned in this class when applying to jobs? If so, what were your experiences?
I think this course has lots of benefits such as: having in-depth look at the various phases of the project management process, including: initiating and planning; developing and managing cost estimates and budgets; planning for quality, staffing and communication; analyzing risks and planning responses; executing and managing; closing out the project and next steps.
I must say that Dr. Simon's courses involve the teamwork project or simulations, which develop the teamwork skills and that what the job required. Also, this course improves the project manager skills with emphasizing on the medical devise field, and it has the simulations that make kind of preparing for real job predicted problems.
At the midway point in the semester, I feel I have learned a tremendous amount of information. Before taking Dr. Simon this summer, my knowledge of the FDA was limited to the basic understanding of their role in regulating food within the U.S. The course over the summer was fast-paced yet loaded with key takeaways. I love going through a semester with the information I feel more comfortable with honestly believe I am learning and understanding each process involved in project management and making medical devices. As I was looking for fellowships last week, I came across a post requiring knowledge of FDA regulations. I didn’t feel intimidated by the description, so I added it as an option to my application list. This course has paved the way for me to consider more job options than I initially thought I would be able to apply.
That is great news! Well, I am actually a Biotechnology Major and my goal is to actually become a Research Scientist in the field of Biomedical Science. I am taking Dr. Simon's course out of necessity. I really was not sure of what to make of this course being informed that I would have to take it however, as I have progressed in my Master's program, I have become appreciative of this course, if for nothing else to learn how to manage projects that will be very important in my career. I have to say, these first four weeks have started to gel together to give me a solid foundation of the importance of medical devices. Just like Biomedical Science provides Doctors with foundation knowledge to understand the human body as they craft their discipline, I am learning that Project Management has thus far taught me the importance of understanding the fundamentals of the regulatory process for biologics and devices. As well as the difference between projects and products. How they intertwine and how to effectively manage them. Learning about how to create and regulate products and projects in this course literally has me thinking that there may be a day one day that I can contribute to the Biotechnology world by patent a project for red-biotechnology. Finally, we are only halfway through the course so I am excited to see what else I will learn but I must say, my initial opinion of project management has started to trend from neutral to positive.
This is my first class with Dr. Simon. I had taken a course in project management and another course in production planning and control from my home school in Sri Lanka. But this the very first time that I am getting introduced to PM in Medical Devices. Getting to know the FDA requirements for design controls was very interesting. Also, I find the simulations very useful. Particularly they allow us to explore experimental design. As someone with an ambition to be a research scientist I find the simulations very valuable. I feel much more confident after these weeks of project management. I am looking forward to the final part of the course too.
This course has provided me with additional knowledge, skills, techniques, and tools to successfully manage or deliver projects and programs. I believe a potential employer is looking to have people who have these skills to enhance excellent communication and decision-making within the workplace. I have previously taken a project management class, but it only scratched the surface. This course was able to delve into different aspects of project management that will help me, specifically in the Biotech industry. It will help me as an employee, solve problems, build policies that improve productivity in my team. Learning more about the different centers within FDA and regulations has been a great learning experience. I hope to be able to take more classes in the future.
This has absolutely been ad huge benefit to my understanding of how biotechnology is produced and processed. Taking Dr. Simon's accelerated PM course over the summer gave me a good general overview of the PM processes and how they can be applied. Having the opportunity to take the full course this semester has benefited me by allowing me to learn a more extensive version of both the Product and Project cycles. This course has given great insight into how this portion of the Biotech industry functions and served as a guide to understanding how these products are made. Now that we are towards the end of the course, I feel prepared enough to know what to look for in project teams and how to guarantee a project's success.
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 am also taking this course with Dr. Simon, and I think there are many benefits to this course. Project management to me isn't just a job title but it is a skill set that can literally be applied to every aspect of your life. So even if you do not want to go into project management as a profession the same concepts, methodologies, skills, and mindset can be applied to multiple things. Another benefit of this course is that it forces you to think critically as well are articulate your thoughts and opinions. Specifically, writing in these forums has helped with my overall communication skills and also my confidence in being able to analyze and interpret others' thoughts and then share my thoughts.
This course has given me a better base of understanding of what processes are involved in project management. I did not realize the steps and team members necessary to carry out a successful project. In this course, I have learned about the project management life cycle and how project management looks in different sectors. This information has been beneficial because I can see myself being in the project management field. I am looking forward to continuing to learn how project management functions across different fields. I am in a position to transition out of teaching into a new field. I can see myself working my way up within the field as well.
I too am looking into a career as a research scientist. This course has been a great guide of project management in different sectors. Medical devices and drug development are two good sectors that this course has provided information. Dr. Simon does provide great detail and resources to get through the course successfully. This is a beneficial course for understanding project management.
The one thing that I’ve come to realize is that project management is such a valuable skill set to have in the workforce. I was recently on a call for a nonprofit organization that I volunteer with and they were actively looking for folks who had project management certification to help out with future projects that involve international affiliations which was exciting because many of the skills that are taught in this course directly reflect the opportunities that I was recently presented. I don’t think it can be discounted how useful project management is in the application of medical devices, vaccines, therapeutics, and biologics. Learning the skills during the pandemic has made it even more relevant given the breath of work being implemented in the vaccine space. So to answer your question I’m very grateful for the opportunity to be in this course and to learn all that I can so when I’m tapped for an opportunity to lead a project I’ll know a thing or two because I trained on a thing or two.
