Overall, I thought that the content of this course was excellent. One thing that I particularly found helpful were the lecture presentation slides. The content in the slides were pretty clear and concise. This is my first online course in my academic career so it was a pretty good experience in being an online course. I liked the fact there was no prerequisites and no required textbook for the course. The final project is a great way for people to learn how to work on a team and what paperwork on medical devices look like and how to fill them out. One suggestion for course improvement would be to have a scheduled in-class lecture session to help address any questions or go over any important concepts that should be emphasized. Also, another recommendation that I would make is to release all of the course material at once so that students can plan out and look ahead in the course so that they can complete some work ahead of time. I think that releasing all of the material in the beginning of the course will help students indefinitely in time management because they know how much effort they will need to put into understanding a certain section or topic.

When I first saw this class I thought it was going to be about medical devices and how to build them. But I had no idea it was going to be an entire course on how the real world would actually be. This class has opened my eyes to exactly what I want to do when I start my life in the real world. As we said in the beginning of this class, academic courses are important because we have to understand what we are doing but practical courses are as important because we have to know what to expect. We have to know what roles will be out there when we go to find jobs. This final project honestly is going to teach us a lot about how working in a company will be like. I never knew we had to worry about if our department members finished the work or not. Learning how to work on a project and with your department will benefit us in the long run. Very happy with my choice to take this class and it will help me when I start in the real world.

Prof. Simon:
perhaps it will make more sense to say if I had not taken this course, I would unknowingly have passed up on a great learning experience as a Biomedical Engineer. It was critical to learn what the engagements of a Biomedical Engineer out in the field are while still a student. This knowledge is irreplaceable.
In this course, a Biomedical Engineering student is brought in directl contact with their engineering environment, they get involved in and are shown the processes therein. Just to site a few examples:
- the nature of the possible organizational setups: the functional, project-based, and the Matrix-type
organizational setup
- processes called into play whether they be (a) administrative or (b) regulatory
- the roles played by the engineer and understanding the relevant templates and documents maintained
- information on such practicalities as when to avoid trying to re-invent the wheel
- the very process of engineering a medical device:
: from proposal following pre-clinical and clinical studies (where applicable) through verification into
validation
: the various approaches adopted to place a medical device in the hands of a customer, and
: the different routes taken to have a medical device approved by a regulatory body depending on the
classification of the device
All of the above take out the fiction from the realities of the Biomedical Engineers' activities in the field; thus placing the student engineer on the comfortable seat of an experienced engineer.

The Forum
Nothing quite like it elsewhere - a great learning resource to tap from on any biomedical engineering topic discussed. Like in the Matrix-type administrative organization silos are extinct. Here a field-experienced students love to share their knowledge and gently guide the in-experienced student engineers as they discuss various engineering concepts, and technical engineering problem solution tactics. Here students take ventures into exploring engineering problem resolutions.

We all believed Dr. Simon when he stressed at the very beginning of the course that he was not here to bust a student's CGPA, rather that he was here to teach a student the realities of the engineer in the real world. This course builds maturity into a student such that the student moves from the childhood phase to the maturity phase when an engineer knows where and what they are standing on.

From this course, I see the engineer strives to produce the safest and most practical medical tools for the physician to employ in their everyday practice with the intent to help eliminate human health woes; but in real life the physician is not really interested in eliminating human health woes considering that all the physician wants to do is employ pharmaceutical drugs while they enrich themselves by billing the patients insurance companies. The physician knows the drug will not eliminate the ailment for which it is being prescribed. But the physician prescribes it any way. That the drug will fail to eliminate the patient's problem guarantees the patient will return for more of the drug which give the physician another opportunity to bill the patient's insurance company. This is the game the physician want to play while the Biomedical Engineer strives to provide more smart medical tools the physician can use in their practice.

Our body is designed to heal itself (repair damage it may have sustained). Only few physicians (like late Dr. Nicholas Gonzalez) know this; i.e., only few physicians actually want to help a patient's body heal (repair) itself. I.e., only this few physicians want to see a disease eliminated.

To really understand what I am actually saying it may be necessary to study the work of such physicians as late Dr. Nicholas Gonzalez and Dr. McMakin of Portland OR.

So, while the Biomedical Engineers work is striving to eliminate human health woes, the physician is going
in the opposite direction considering that their strive is to get richer on the backs of the patients that go to see them with their problems.

So there is a chasm between the Biomedical Engineers quest to help eliminate human health woes and the physicians pursuit for great wealth hinged on the patients' need to get well.

Will this chasm ever get to disappear? There should be a course to examine this problem. Unless this chasm is eliminated, human suffering will never get taken out despite the Biomedical Engineers effort.

Dr. Simon, your course was the best.

Andrew Disame

Sir, this is my first online class in master program and it was new experience as I never had such learning experience before. I was not sure about the opportunities about various profile in the market but after studying the subject I learnt about various opportunities. Project is giving another new learning experience and able to interact with other students. I wish this subject was a regular class subject as it would have given more things to learn about by interaction and by sharing experience with other students and you. About the study material, I really liked the videos and presentations which gave feel of class teaching. Overall, an interesting subject and lots of learning. Thank you Sir.

Honestly, this was a really informative course. I have almost 3 years of experience in the med device industry now and there was a lot that I didn't know or didn't have the specifics to. My work has also been in the design side, with some regulatory, quality, and manufacturing exposure mixed in. As such, this class helped me learn a lot about the other job functions and what goes into doing their work. I also liked the material and presentations provided so that I'm not only listening to you lecture. I can follow along and go at my own pace. If I want to learn more about a certain topic, I can pause and do a little research before getting back to the lecture.

I e-mailed you previously about this before and you said that it would be in the advanced MDD course but I would like some information regarding EU MDR included in the regulatory section. It's more niche but since it will be fully integrated soon and because it requires a lot more work for companies, I think it will be helpful to future students.

Dr. Simon,

As someone who has been working at a medical device company for almost a year, I found this extremely relevant and helpful. It sort of reinforced some of the ideas I already had about the roles of certain departments and how they interact with each other. I do wish you went into like manufacturing engineering (my current job) and described process validation a little but I understand the massive amount of content you attempted to reach. Regardless, this is the type of knowledge you need going into any industry job interview to show a company you understand the basics of what is going on. I learned about the intro to design controls in my senior capstone course and I know the engineering manager who interviewed me for my current job was impressed I knew so much about them. Looking forward to Systems Management next semester!

-Mike Mattie

As a master's student approaching my last semester, I can say that this course is unlike any other course I have taken in that it provides an alternative and even a more practical perspective on the medical device field. We were first educated on the distinctions between working in academia versus industry, which gave us insight to the first steps we will need in pursuing a biomedical career. We were then introduced as to how medical device-based projects take place as they are put through the design cycle, which also applies to how these products are generated in corporations and what must go into them to make them viable, safe, effective devices intended for saving lives. To go more in depth with this aspect of the course, I personally found the education regarding the design process to be the most vital. I recently started working at a clinical research company that has the aspiration of bringing its products to market and going global as it deals with recent breakthroughs in immunotherapy. This course alone has taught me more about my company and what goes on than I could ever learn from any other course. Most importantly this course taught me what to look out for in such a company, such as having to abide by federal codes and regulations that must be followed not only by me but by my entire company.

What seems to set this course aside from the rest is how it offers insight to the business side of the medical device field rather than just cram knowledge about the science behind the medical device itself. The final project is a very effective way to not only test our collaborative capacity, but also to give us sufficient exposure in what to expect upon entering our first biomedical career. For example, the final project consists of a wide variety of paperwork, which in turn it prepares us for understanding how medical device companies consolidate the safety/effectiveness of a product. We know by now that medical devices are not simple commodities purchased at convenience stores, but complex, intimate devices that can either save a life or have disastrous consequences if not designed properly, and the final project along with this entire course exemplifies that concept in a way that can hopefully be unraveled more in the Advanced MDD course. In conclusion, thank you for a fulfilling experience and we look forward to applying what we learned in our future endeavors.

-Ian Hinnenkamp

I believe this course was beneficial for an overview of the medical device industry as well as academia. I learned a lot about which departments I would not be interested in but also realized some departments that could be of interest to me. I do plan to investigate that further. I wish some parts went more in depth with the roles or more resources were added to see what the roles were like, but this course is also only a semester, so I understand. This course was definitely a big learning experience for me even as a student who works. I do wish this course was not just an elective or the future classes weren’t electives. Project management was a great lecture because it gave an overview of what its like and how to handle it, but I do believe that this lecture could come after the other ones since project managers work with all the other departments. Taking this course really taught me that there are more positions than just industry and clinical based positions as a biomedical engineer. Thank you for a great course!

This course was definitely beneficial in giving us an idea of what to expect when we go out into the real world. Dr. Simon did a good job in keeping us all engaged throughout the semester by asking us to participate in these forums. It was helpful to read other peoples' comments and opinions for when I was struggling to understand a certain concept in the lecture. I also think that the final project is a great way to end the semester because we get to finally put everything we learned over the past 3 months into a real life situation and fill out forms that we normally would if we were actually a company developing a product.

This is my second online class with Dr.Simon and I knew I would not be disappointed with the amount of information obtained form Dr. Simon. In particular to this course I learned the following:
- Medical device development has a plethora of jobs associated with it.
- I learned of job descriptions that I could research to understand if it was something I wanted to do. Such as CRA, Clinical Associate, clinical data manager etc. )
- I grew a better understanding as to how project management fits into Medical Device Development.
- Learned about regulatory guidelines such as CFRs,ISO that are required to have knowledge/experience in order to get certain job positions in industry.
- Expanded my knowledge prior to taking Senior Capstone of the documents needed for a Medical Device to be established.
- The Final Project for this course was crucial for me to understand the practical application as to what would be done in industry, the amount of time it takes to do research on various how to classify a device, what ISO standards must be meet to satisfy the FDA.

In terms of the class I have one minor improvement:
- It would be better delete previous response from years past on the forum posts because about 75% of people had similar responses. It be more beneficial if the next class saw only the responses of those in the class currently because for me it was a challenge not to repeat what others had to say.
- The forum post did not allow for some people to post links to forum as well which made it a challenge to cite a source. When using Moodle you can simply paste the link and it works.

Like many of my classmates have said, this course has provided me with a lot of useful information that goes beyond the BME curriculum, and teaches practical skills that is needed in the workforce.

The lectures provided very useful information regarding the role of each department in a company. The forums allowed us to take the information we learned during the lectures and discuss real world applications. Through researching a company's income statement to investigating the anti-kick back regulations, I found the discussion posts very interesting. Lastly, the final project really allowed me to see what goes behind the scenes when developing a device. Additionally, it offers insight into what department we may like to work in our future careers.

Overall, I really enjoyed this class and know that I will be able to use this knowledge I gained in potential interviews and future career.

One thing I really enjoyed about the course is that we got to explore so many of the other positions available in industry. I have only been in the industry for a year or so and did not realize how many different positions there are. I also learned about which direction I would like to go. I enjoyed the final project because we got to learn what part different departments do and how it is done. I got to see how it is doing clinical work, pre-clinical, regulatory, quality, and so much more.

This is good course for getting experience in the start development of medical devices. This course shows how each department work in the development process of devices and what documents are required. Prior to this class I did not know what group were involve. I really enjoyed this course because the final project helps show how the group departments work together. I also enjoyed having audio and powerpoint presentation because it gives the option of how you would like to review the weekly lectures.

This course has provide me with a lot of information that I need for my future career. Even the discussion was helpful and it helps me to engage more with my classmates and to learn about the matrials. It also gave me an idea about the world outside the college. I enjoyed that class and it's lectures. Thank you for the great course !

I am very glad I took this course. It gave me the overview I needed to understand more of how things work in the industry. I know certain topics are more complex than others and they could even take a course to actually study them deeper, but this has been a great overview of the essentials. I truly learned a lot, many topics took me back to my previous internship and made understand why things were done a certain way, while at the moment of my internship I didn't know.
To say more about the class structure, I like having the option of audio and the powerpoint slides as well. I also enjoyed the discussions because they talked about different topics relating to one, and you can read and learn from the experience of other, not just the classmates of that semester
I really enjoyed the course! thank you so much.