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»

Two well-known medical device companies are Medtronic and Stryker. Medtronic’s market cap is $168.59 billion and Stryker’s is $99.43 billion. Therefore, both are massive companies in the space and each dominate their niche, respectively. In the case of Medtronic, they…   Read more»

Hi Hodafattel, I believe you have a point here in that life saving technology are being milked for their maximum value. From a business perspective, the company is doing exactly what they are supposed to and to that extent, they…   Read more»

Due to the advantages and disadvantages of s-corporations and c-corporations there are suitable for different types companies depending upon their case. For instance, should someone create a corporation which is relatively small and simply does not have the capital to…   Read more»

Many have mentioned above the implementation of new technologies such as AI will help measure dimensions and automate processes. This in turn will help and rapidly increase production, since a computer can process data much faster than a human. Another…   Read more»

Quality assurance and quality control are two sides of the same coin. The focus revolves around quality of the product, and for medical devices, this can be vital. Having a defect occur in a product can be costly, and may…   Read more»

@jwashin3  Your post here is very insightful as I did not know there was a MASSIVE change regarding what is a 510(k) in recent years. For others who want read the exact details on the amendment, the new process is…   Read more»

I think one interesting point that this thread has not mentioned is how the pandemic has worsened the backlog of device awaiting approval due to the delays in inspection. According to medtechdive, the FDA still has 3,229 device inspections which…   Read more»

ISO 9001:2000 and the FDA’s 21 CFR Part 820 draw many parallels. Both of these two regulations deal with the quality of product’s and how they are produced. The FDA;s regulation is part of CGMP (Current Good Manufacturing Process), this…   Read more»

Posted by: @yroberts Preclinical research trials are know to be performed on a single lab creature such as rodent, pig, fruit fly, or monkey. Most recent research appears that having an animal model and conditional differences in the studies can…   Read more»

This is a topic which crosses the boundaries between what is ethical and what is not. Several individuals will usually have a different take on the topic and the line drawn for testing varies between person to person. I believe…   Read more»

Posted by: @orleron Up until now we have talked about two big topics:  project management and pre-clinical research.  There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk…   Read more»

Personally, I believe the best manager is someone who had previously done the work, or job, of the people which they is managing. Having that experience makes him/her not only knowledgeable on the subject matter, but it also makes that…   Read more»

One interesting way to view a portfolio is in the same manner as a venture capitalist, this may be, a collection of stocks of companies which you own within certain industries. Therefore when someone describes another portfolio as being quite…   Read more»

@kmbell Although this question is not directed at me, I will answer. From what I understand, it appears as though you are asking if a sales associate from one company would be “short-ending” himself by moving to a sales position…   Read more»

As I begin my second year into my MS degree, I am also taking my last elective which will satisfy my degree requirements. This accounts for 30% of courses which I have taken in the mechanical engineering program. I think…   Read more»

Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»