In November 2020, The Asahi Shimbun initiated an investigation that revealed the Tokyo-based subsidiary of Globus Medical paid around 100 million to 20 doctors that convinced its employer to purchase its products. The doctors and family members set up companies…   Read more»

I have not experienced gift giving in the corporate world, but I have experienced in academics. In undergrad, my Chemistry professor had a birthday and my classmates and I thought to bring him cupcakes. He thanked us for thinking of…   Read more»

In my current role, the organization uses interdepartmental group chats to culminate inter department silos. The group chats served as a way to minimize communication barriers. For example, the manufacturing department and the microbiology department frequently has to work together,…   Read more»

@cbonvillainmsm-edu great response! I enjoy reading your input. As I was reading, my thoughts shifted to the internal and external risks that were the result of COVID-19. I’m sure the pandemic increased the internal risk with workforce decreasing for COVID-19…   Read more»

I worked in a Microbiology Lab. There were many potential hazardous situations. It was very important for us to clean the lab with bleach and alcohol solutions. A hazard would be Listeria monocytogenes contamination and the harm would be a…   Read more»

For low severity, I would choose acceptance. I am accepting the risk because that’s is my best option. In the lecture on Risk Management, the example used for accepting risk was a scalpel. The best option is to accept the…   Read more»

The consequences of insufficient design controls include poor clinical trial performance and data, failure to meet market and customers’ expectations, and denial by regulatory authorities. Without sufficient design controls, the clinical trials will lack research protocols and fail to produce…   Read more»

I think Design Validation is the most important aspect to Design Controls. Design validation checks that the inputs equates the user needs or intended use. Without validation, the device is defeats the purpose of Design Controls. Validation is necessary to…   Read more»

I think medical device companies are very adamant about corporate responsibility. There are many costs associated with putting out bad product, being unethical and having flawed design controls. Companies will lose a lot of money, risk being sued, and overall…   Read more»

The results of a study are posted on ClinicalTrials.gov. The study results includes participant flow, baseline characteristics, outcome measures and statistical analyses, adverse events, limatations and caveats, and administrative information. This site allows you to search by matching one or…   Read more»

@magan-rhodes I think blinding can occur when testing medical devices. Blinding can help lessen the bias in medical devices. If a doctor is not particularly fond of a medical device and observes adverse reactions, he could attribute those reactions to…   Read more»

I am interested in retrospective study. I think I would enjoy looking back at archived data and reports to study a disease. Retrospective studies use existing data to compare the demographics of a disease. I would be interested in analyzing…   Read more»

I think marketing and sales are great fields for social people that enjoy having conversations and interacting with customers. I worked in retail for a short period of time. I had to market music and cultural merchandise. The route of…   Read more»

I would like to have a limited liability corporation. I think I would benefit from the limited risk and unlimited possible owners. I could hire others and take advantage of the flow through taxes. I would not be fond of…   Read more»

A sole proprietorship can be turned into a Limited Liability Company (LLC). However, if the dad dies while still operating as a sole proprietor then the company dies with him. To transfer ownership, the dad must transfer ownership of relevant…   Read more»

I don’t think the FDA guarantees safety, however, I do believe that the organization tries its best to ensure safety. With both FDA-approved and Non-FDA improved, one should use their best judgement. Our bodies are different, we react differently to…   Read more»

I am currently working at a cell and gene therapy company. Recently, there was an incident that resulted in failure of a process and sterility tests. After doing a root cause analysis, upper management determined that Quality Assurance needed to…   Read more»

I think the FDA could have been proactive in informing the public of vaccine facts. The pandemic made way for misinformation to be shared, which put a lot of people in harm’s way. The FDA could have also guarded medical…   Read more»

@magan-rhodes If I were developing a device, I would finish a task before starting a new task. I like the feeling of knowing I am working towards a goal and I have checked the box and I am on to…   Read more»

@rd389 I can only imagine how terrifying that must have been. Was the overdose the result of poor GLP or a technician error? Was a study plan written and received by a Study Director? It seems like this incident could…   Read more»