@rowel2202 I think that is a fascinating perspective to take on organizational efficiency. I think the most effective organization is the one that allows the easiest communication routes and regulates the number of projects the staff has so the team…   Read more»

I don’t have any experience working in any of the organization types at the moment. However, the format that seems the most appealing to me is the Matrix structure. I like the idea of picking which staff would best fit…   Read more»

Posted by: @la82 The lectures introduce the three types of organizations. Project managers’ roles are specifically mentioned in both matrix and project-based organizations. While other posts discussed the preference of working under one or the other, no one mentions what…   Read more»

Posted by: @traceymraw Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the past? Which do you find the most beneficial or…   Read more»

Risk management is the process of identifying, assessing, and eliminating potential hazards that develop while creating a product, in this case, a medical device. While risks are identified, they are documented and kept in a Risk Management Plan. Risks can…   Read more»

Another benefit to PMS would be the continuous documentation of potential risks that may apply to similar devices or devices that aim to solve similar health issues. The monitoring of devices ensures that no other customers will experience any harm…   Read more»

The Communications management plan and the Scope management plan are the most important parts of the DDP, in my opinion. Determining the scope of a project sets the tone for the remainder of the design control and manufacturing process. It…   Read more»

The importance of taking minutes for meetings is not only to keep those who were not able to attend abreast of what is going on in the company but also to keep documentation f what is discussed during meetings and…   Read more»

Design controls are meant to not only plan out exactly what is required of the device for it to be functional once it hits the market, it serves the purpose of checking these plans multiple times to prevent mistakes in…   Read more»

Posted by: @amd29 When a medical device is clinically tested it is to evaluate the safety of such a device on the human and whether or not the desired result will be obtained from doing the clinical testing of the…   Read more»

I can see both sides of this very controversial question. For the sake of ethics and basic human rights, I would support the enforcement of the Informed Consent Form if Henrietta had checked no for the research use of her…   Read more»

I agree that a clinical background would be beneficial if you are pursuing an Investigator job. The experience of working with patients would help when communicating important information regarding the trial, and the science background would help Investigator translate the…   Read more»

Some of the advertisements I have seen have been on Youtube. Still, they are “unskippable” and strategically placed in the middle of the video to prevent anyone from clicking away and keeps the viewer engaged because their desired content is…   Read more»

I think the most creative recent advertisement was for Match.com. With the assistance of Ryan Reynolds, The company had advertised its “perfect match” algorithm by matching Satan himself with the year 2020. It brought together the collective horrible feeling that…   Read more»

Ive noticed that most technology commercials, specifically new phone commercials, usually use an all-black or all-white background to draw focus to the product. The color white in advertising reflects cleanliness or simplicity, and those white backgrounds are mostly paired with…   Read more»

I do not think the FD ai s being too strict in their regulations. Their goal is to keep the general public safe from any harm from drugs, medical devices, and food. If they weren’t as strict as they are,…   Read more»

Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example: What types of training are relevant to each and how could they differ? What types…   Read more»

Posted by: @mduru As with many lines of work, people tend to have a certain perception of what that field or role is like. What were some of your perceptions of QA/QC and have they changed after this lecture? Have…   Read more»

Animal models are essential when attempting to see the effects of medical devices in a live system. I acknowledge that the taking of animal life may be unethical in a setting without procedures, but done in a lab where the…   Read more»

Both areas of research are essential for different reasons. Researching the present can be compared to what has been done for the recent COVID-19 pandemic. Rigorous research was being done to understand the virus and treat it in a short…   Read more»