I am not very familiar with my companies marketing strategies. However, I do think we use a participation approach. At one of our all employee meetings last year a representative from the ER department of one of the largest hospitals…   Read more»

I currently work for a Point of Care medical device company. My company focuses on the hand held type instead of the larger models. Based on my understanding of the market, PoCT is slow to launch new test types because…   Read more»

I think this course was very relevant and valuable. I currently work for a medical device company, so it was cool to see how things I do in practice aligns with regulation and applies to general concepts. I didn’t have…   Read more»

I work for a medical device company that manufactures blood analyzers. From my understanding of contract agreements, I believe my company would have to have contracts with Singapore as they are the main manufacturing location for one of our products….   Read more»

I have not experienced this but there is an article on NJ. com that really dives into non compete agreements. It talks about the impact of these agreements on people who are seeking to switch jobs. “One-third of the engineers…   Read more»

Personally, I have found it difficult to work with people I have friendship level relationships at work. We always get things done, but sometime you may need to critique someone’s work or push back on something to advocate for the…   Read more»

I think my company operates with a functional organization structure where most of the decisions are made by the managers. There is also little communication between silos within my own department. We work on 2 different models of the medical…   Read more»

I read a Forbes article that sought to use a data driven approach to analyze if there are different skills required for senior executives. They asked 332,860 bosses, peers and subordinates to indicate which competencies, if done well, would have…   Read more»

I work for a medical device company as a manufacturing engineer. It is part of every design change procedure to conduct a Cause and Mitigation Impact Assessment where we evaluate the risks associated with the proposed changes. There is a…   Read more»

I agree that trying to predict extreme events is a critical mistake in risk management. Instead of trying to predict extreme scenarios, I think it would be better to focus on the consequences. Instead of trying to predict when a…   Read more»

Another method used is Expected Damage-Cost Analysis (EDCA). This method evaluates how often different hazards occur and ultimately estimates the damage cost per year. Results also include suggestions for precautionary measures such as investments and design/planning. This method takes into…   Read more»

At my company, we document user requirements in its own document. The user requirements also drive design input requirement and are linked via a trace. When an input requirement is changed or modified, we also evaluate potential impact to the…   Read more»

From a professionalism stand point, I think the gantt chart and team expectations are important, but I believe the risk management deliverables and the combined effort to identify input requirements. In my opinion these two things really get the ball…   Read more»

I work for a company that manufactures handheld blood analyzers. In addition to the verifications performed to ensure the device reads samples within given limits. There are some general functionality input requirements that the device must meet. For example, one…   Read more»

In my experience, Supplier notification for custom components is extremely important for companies that outsource some of their components. At my company, it is required to send the supplier a notification of the updated specifications and they must sign to…   Read more»

I currently work in the industry but I’ve had little experience creating and managing Gantt charts. One issue that I face EVERY TIME I make a chart is adding too much detail. Because I know so much about the process…   Read more»

Of course in the medical device industry they say “if its not documented, it didn’t happen.” So capturing decisions made and the logic behind the scope of the discussion is always valuable. In my personal experience, I’ve worked on Design…   Read more»

Similar to some posts above, I would also like to be an investigator. It seems like they are directly involved in the meat a potatoes of the trail. But I also think the IRB role is interesting as well. It…   Read more»

According to Johns Hopkins, in the 1950’s the practice of obtaining informed consent from cell or tissue donors was essentially unknown among academic medical centers. But the Nuremberg Code was in place by 1947 as ethical principles for human experimentation….   Read more»

I agree with the posts above that placebo trials are needed. However, the experiment design must be controlled in a way such that ethical concerns are mitigated. Ethical concerns arise when a proven effective treatment exists for fear that the…   Read more»