I think the required documentation for design control is most important. Revised design control documentation serves as a valuable source of truth for the project.  Recording everything in one document helps you to organize your thoughts, makes it easier to…   Read more»

Risk control should form part of the company`s broader health and safety plan providing a method to identify, control, and reduce the risks present in the workplace. The control of workplace risk is a practical, evidence-driven process; employers assess the…   Read more»

One factor is the likelihood that the patient will receive one or more benefits — using the information supplied, it is occasionally feasible to forecast which patients would benefit. It’s also feasible that various patient subgroups will get different results,…   Read more»

Internal risk includes personnel management concerns such as labor shortages or low morale, as well as technology difficulties such as outdated software. External risks include economic slowdowns, which result in lower revenue, as well as political dangers from trade wars,…   Read more»

If I were to create a medical device firm, I believe I would do so as a project-based company at first. PBOs are more concerned with project outcomes than with organizational structure. In compared to other organizations, I feel this…   Read more»

  In a functional organization, projects that exist within a single functional division generate no organizational issues. But projects that extend across functional divisions are demanding to manage. This is because the project manager has no direct functional authority and…   Read more»

I work for Coca-Cola which is now operating in more than 200 countries and producing nearly 500 brands. From a legal and management standpoint, the Coca-Cola company is not a single organization, and the Company does not own or control…   Read more»

Generating interest for a product before it is released is difficult to do if you are a medical device company, with respect to the consumer side. Attracting the attention of investors, and perhaps B2B sales is some that may generate…   Read more»

Personally, for me I am just starting out and would prefer to gain more time as an engineer before switching positions later in my career path. I believe that someone who has had a few years as an engineer developing…   Read more»

In this hypothetical company, for the sake of clarity we will name it BioStents. BioStents is a privately owned company based in the US, and is primarily focused in R&D, in which they are developing new materials and innovative structures…   Read more»

In my opinion, one of the biggest improvements that needs to be made to most quality departments, especially at my company, is the communication between quality and manufacturing. A lot of times, quality thinks they have the final say on…   Read more»

At my company I have worked with R&D on many issues which Quality was also involved. As stated by @dbonanno1, R&D and Quality had very different opinions on how to handle most situations, R&D coming from a view of practicality…   Read more»

Like @bb254, I also work for a company that has a document control system that wastes a large amount of time and resources. While I understand the need for a quality management system and the need for quality to review…   Read more»

Human differences can be very beneficial to producing medical devices, but they can also have their drawbacks. When it comes to engineering itself, differences in thoughts, perspective and experiences can be a huge benefit looking at development from different angles….   Read more»

There are many drugs and medical devices that are manufactured and sold in other countries that are currently banned in the US or not allowed to be manufactured in the US. The main reason for this is because the FDA…   Read more»

In academia, research is much more based on the love of knowledge and advancement then it is on how much the research can increase profit or productivity. As Professor Simon suggested in the lecture, most members of academia generally research…   Read more»

I would not choose marketing or sales because I much prefer to be actively engaged in the engineering aspect of products. Being completely honest, marketing and sales do not interest me, and they seem to be quite repetitive. As @jaf22…   Read more»

As I sat here and tried to recall many company logos, there is one color not prominent: purple. After doing a general google search of logos, most consist of red, yellow, and blue. Purple is present in Taco Bell, Yahoo!,…   Read more»