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…   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…   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,…   Read more»

Based on my experiences in the industry, the risk to quality isn’t because of incompetence or neglect. I believe it is mostly because of the pressures from project deadlines and teams not incorporating all relevant departments in project planning. For…   Read more»

I have not participated in an audit from an audit stand point but I recently attended a weeklong training on the FDA’s Quality System Regulation by AAMI University. The trainings were hosted by FDA, consultants, and at least half the…   Read more»

I also work for a medical device company and I agree with the concerns above. I would also add a challenge that we face with design control quality is that they constantly make up new rules for us to follow…   Read more»

I just became aware of all of the complications surrounding Johnson and Johnson’s vaginal mesh so I did some more reading. Transvaginal mesh products are sometimes used during hernia surgery or to repair pelvic organ prolapse or stress urinary incontinence….   Read more»

The FDA posted an article 3 days ago entitled “FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration” The FreeStyle Libre Flash Glucose Monitoring System is a class III device by Abbott Diabetes so it…   Read more»

Another combination product on the market is a catheter with antimicrobial coating. They are used to lower the risk of catheter colonization and infection. The Foley catheter, for example is describe as “flexible tubular device that is inserted through the…   Read more»

I have a friend that is currently transitioning from academic research to industry research. She said she is happier in her new role because she feels like she gets more feedback on her performance. Her job evaluates her performance frequently…   Read more»

I haven’t worked on any clinical trials or clinical research. But I came across this website that graphically describes the reasons for clinical trial failures from 2013 to 2015. It seems like “efficacy” is the most common cause of failure…   Read more»

I read through many of the posts above and for the most part, everyone is interested in the immediate results. It makes perfect sense and I agree. People want to see the fruits of their labor. One of the reasons…   Read more»

In addition to competition against similar products, there is also a challenge of continuous improvement of the device itself. Medical Device companies almost always want smaller products with “cutting edge technology” and that means increased complexity and increased sophistication of…   Read more»

I am currently working on a project that I inherited from a former coworker about a month ago. Very high level, it is a software driven update to some manufacturing equipment. It seems like the people who controlled this project…   Read more»

I don’t know if you can remove the undergrad stress over academics because you need that GPA for scholarships, internships and to make yourself more competitive as an applicant. I agree that you shouldn’t sacrifice an opportunity for co-op, research,…   Read more»

I currently work in the industry as a manufacturing engineer and I am primarily focused on Design Control. Before starting this job, I had very little understanding of the industry. When I first started, my coworkers and management tossed around…   Read more»