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. We used to manufacture the product on site, however with demand growth and sales increases, we had…[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 who changed jobs left their industry altogether, often taking pay cuts, to comply with the agreement” Or employees may see…[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 project. However, I have found that as you work with the same people over and over again and do good work, people y…[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 device so the challenges we face and jobs we have to do are similar yet extremely different. There isn’t m…[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 the greatest impact on a leader’s ability to be successful in their current position. Each subject w…[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 set matrix of potential hazards, their causes, and mitigations. The intent of the meeting is to evaluate any…[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 major event will happen, they should understand how the company will be affected and be prepared IF the situation should…[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 account the frequency of different hazards and a factor…[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 user requirements or if re-verification is required. Similar to the design inputs the user requirements…[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 rolling and essentially gate all other downstream activities until this is well defined. They set…[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 of our devices is wireless. So there are input requirements for operational signal…[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 accept the changes. I think this contributes to the working relationship with suppliers and…[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 and what can cause time delays, sometimes I add too much detail. I understand that the tool should be dynamic and quick and easy to u…[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 Changes with as little as 2 design reviews and one I am working on now has at least 6. This project is based a…[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 sounds like the IRB role is a quality role to approve the protocol and ensure transparency with the participants about the trial details. The…[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.

Tuskegee Syphilis Study blatantly ignored this code. It was a notorious research p…[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 placebo exposes patients to the potential harms of non-treatment.
There are general guidelines for when…[Read more]

According to LegalZoom, if the sons must create a new business since a sole proprietorship is non-transferable. Once the original sole proprietor dies and the business is transferred, all of the business’s assets must still pass through probate. The sons might have to settle the outstanding debts to protect the business’s assets from creditor cla…[Read more]

I read this article about how a company was ready to go public and I thought it was interesting. From what I understand going public must be a timely decision. Completing an IPO too early can have disastrous effects on the future health of you’re the business and waiting too long might allow a competitor to steal your thunder.

There used to be a…[Read more]

Abbott Laboratories reported revenues of $6.64 billion in 2Q17, exceeding the analysts’ estimates. Abbott stock gained more than 4% the day of its 2Q17 results release, on July 20, 2017.
In 2Q17, Abbott reported EPS (earnings per share) of $0.62, compared with the analysts’ estimates of 0.61 per share.
According to the Wall Street ana…[Read more]