Medical device trials and drug trials share certain commonalities but also differ significantly. Medical device trials primarily check for the safety and performance of the device and, as a result, have far more patient-focused outcomes than drug studies, which also…   Read more»

I have never personally encountered a circumstance like this. I believe that skipping processes is unethical and immoral, especially in an area like medical devices. This contradicts several guidelines that were established throughout the product design stage. Patients and customers…   Read more»

Design verification, in my opinion, is the phase that needs the most significant attention after reading and evaluating. It entails developing a verification protocol with tests for each output. It’s crucial because, for instance, you might need to do a…   Read more»

I would assume the position of a clinical investigator. The rights, safety, and welfare of human participants in their investigations are the responsibility of clinical investigators. The study’s initial and ongoing ethical examination must be carried out by an Institutional…   Read more»

Doctors use clinical trials to determine whether a new drug, treatment, or combination works and is suitable for human consumption. Developing novel medicines for acute diseases like cancer depends on clinical trials. Clinical trials demonstrate what is effective (and ineffective)…   Read more»

A double-blind study is a randomized clinical trial in which neither you, the patient, nor your doctor knows whether you are receiving the experimental, standard, or placebo. When doctors assess the results of their patients, bias is avoided by double-blind…   Read more»

In recent years, I’ve observed an increase in large brands that invite customers to interact with the goods/devices they sell. Making use of social media is one way to do this. Companies will provide products to people with millions of…   Read more»

I would opt to join a Limited Liability Corporation (LLC). LLCs are frequently utilized to shield a business owner’s assets from legal action. An LLC may be taxed as a partnership, S Corporation, or sole proprietorship. Unlike an S-corp, limited…   Read more»

I know this post is old, and there is a good chance that you will never see this, but I am commenting on it because I hear stories like this daily. I am a biotech venture capitalist and spend my…   Read more»

The de novo request offers a marketing route to categorize novel medical devices for which general controls or general and special controls offer a reasonable assurance of safety and efficacy for the intended application but for which there is no…   Read more»

The COVID-19 outbreak is one example of a disease outbreak that comes to mind. I believe that the United States should have made better use of data analytics and predictive models to aid in curbing the virus’s spread. Governments and…   Read more»

One of the roles that I see in the space is a quality control manager. I could see myself in this role as there are a lot of pros to working in this position. Quality professionals have access to a…   Read more»

For me, conducting study and finding solutions to issues that affect the future generation would be of interest. I have always found it exciting to work on cutting edge technology while trying to tackle a problem that has no real…   Read more»

There has been a long history of animal studies. The ability to produce data that will help treat human disease is one of the main justifications for using animals in research. There are other ways to generate data, and I…   Read more»

At this stage in my career, if I had to choose between industry and academia, I would choose industry. Researchers in the industry is working toward a bigger, common objective. Collaboration and teamwork skills are essential for researchers. In the…   Read more»

I have been working remotely for the past two and a half years, and I intend to continue doing so. The office workplace’s distractions are eliminated when working remotely. I work in finance, which is a less regimented atmosphere, making…   Read more»

Since I’ve worked in project management before, I can declare with certainty that this is a possible scenario and that there are steps project managers can take to prevent it from happening in the future. I’ve always utilized an activity-based…   Read more»

This is a question I’ve asked myself countless times in my very brief career thus far, but I’ve come to the conclusion that having the absolute least requirements is preferable. If I am overqualified, I don’t think I would stay…   Read more»