From my experiences determining the duration of each task is highly important. Through past projects within industry, I have found that project managers are sometimes over optimistic about how long a task takes. Finally, when that task exceeds the amount…   Read more»

I fully agree with this. There are various test that can be done to physically test a device. Instron testing to test mechanical properties, environmental testing to test how a product reacts in certain temperature conditions and for shelf life,…   Read more»

To have an adequate Design Control System – one that will pass audits at the minimum, you must have Design Inputs, Design Outputs, Verification, Validation, Design Transfers, Risk Analysis, the DHF. For Design Input this includes physical appearance of the…   Read more»

I recently went through an internal audit in which we reviewed the DHF of one of our product lines. There was heavy debate on information within the Design Specification Document (DID). The DID contains specific specifications and tolerances for drawings…   Read more»

I don’t believe it is completely necessary to have a clinical background to work in this field. To say you need have a clinical background for a role is highly limiting the talent pool that would potentially be interested in…   Read more»

From a Big Pharma standpoint in terms of clinical research, it is very money driven and results driven. For example, for a double blind test, the intent is to remove as much bias from the test subject and investigator as…   Read more»

SWOT Analysis for Boston Scientific – Boston Scientific is a global developer of interventional medical devices that target cardiac rhythm management, cardiac and vascular surgery, electrophysiology, tumor reduction, cancer treatments, hearing reduction; and pain management Strengths: Broad Product Portfolio in…   Read more»

I feel this video clearly depicts that there tends to be disconnect from the customer and the supplier. I believe most of this can either be attributed to lack of communication – the customer doesn’t clearly communicate what they desire…   Read more»

In China, the country offers Wholly Foreign Owned Enterprises. This is the most popular form of incorporation of foreign companies in China. WFOE allows an LLC company that is owned by foreign to open their company in China, usually for…   Read more»

Depends. If you are looking to work in medical devices and it is a well established company such as a conglomerate like Johnson and Johnson, then you don’t need to worry about their stability or financial history since it is…   Read more»

As many have mentioned, it highly depends on what type of business you are trying to conduct. If I was creating a tech start up I would most likely go the route of an LLC. With an LLC it will…   Read more»

What if your favorite company pertains to a cryptocurrency? Can I discuss my evaluation on that?

Interesting that you say “some auditors have the mindset that they must issue an observation or a finding before leaving a plant.” I believe ALL auditors have this mindset no matter how good your quality system is. From what I…   Read more»

I agree with this. As an engineer that is outside the quality department, looking for continuous ways to improve processes is key for a company to continually increase efficiency and productivity. A lot of Green Belt Six Sigma/Lean projects are…   Read more»

With more and more companies wanting to adapt a lean culture to reduce downtime, increase efficiency, and reduce waste improving Quality and Manufacturing practices is key. I believe one of the first aspects in improving Quality in general is getting…   Read more»

I believe it comes off as a burden because Quality are the people who tend to reject or question every detail of a report or analysis. You want to get product that moves out the door in a timely matter….   Read more»

Going on a tangent as well – I understand the idea of simplicity that technology adds. But to turn an app into a medical device that is used by doctors to make decisions seems foolish. I’m for the idea of…   Read more»

The Tylenol Recall in 1982 was what started the idea of recalling products off shelves. Johnson and Johnson had to deal with this issue and James Burke, the CEO at the time, was commended for the way he handled the…   Read more»

After the brain is frozen and transported, I assume to a customer, would the customer try to use the brain, realize it doesn’t work, and then go back to you? I assume after that you do an investigation to see…   Read more»

I would like to know the answer to this as well.