To understand the importance of an input source leading to the design of a medical device, it only suffices to recall Dr. Simon’s lecture Marketing – week 7. This lecture examines the volume of sales from the conception phase to obsolescence. It will be seen that the curve describing the sales trend is not a straight line. At one point -…[Read more]

Truth is: I have never worked in industry to participate in Design Review Meetings. However, if such a meetings is to produce any useful results for the company it must be aimed at ensuring that a project is moving forward and if it has anything to do with a project then it must be designed to cover a phase of the project.

This is a project. It…[Read more]

Hi Fady: let’s, for a second, suppose that the auscultation, acoustic medical device, the stethoscope – known to be in use since 1816 – just got introduced to FDA for approval, what classification would anyone expect to be assigned the device; say, in comparison with the stent, of high invasivity during usage?

Measurements taken by both have to…[Read more]

Hello Folks:

Simply put, haven’t had much experience dealing with Gantt charts; but after studying Gantt charts, the take of each individual on this topic conjured a few ideas into my mind; I just had to share them with you; hope you don’t mind.

I do agree with most of what has been written so far.

Hetal, the initiator of the topic, attempts…[Read more]

Heh Folks:

You’ve all provided quite some reading; I was tempted to just get by; but Gantt charts are a little more tempting than the don’t give a damn attitude.

Simply put, haven’t had much experience dealing with Gantt charts; but what they are conjures quite a few ideas in my mind that I am willing to shared. I do agree with most that has…[Read more]

Hey folks:
The initiator of this topic, hg93, defines DDP as including certain named elements in an attempt to draw our attention to the fact that certain aspects used to determine the inclination of a project may be more important than others as we strive to achieve the project’s ‘aim’ or ‘objective’.

How do we measure success of a project?…[Read more]

Let us suppose, for the heck of it, that at one time or another you went for the purchase or were delegated with the responsibility to make a purchase of a dress or shirt for a loved one; you would also love to see this relative in a smashingly hot dress.

There is all kinds of us: the massif, skinny and others still wearing a size somewhere…[Read more]

Whether it be about freedom of choice or some other ethical issue, I can understand when conducting clinical trial on a medical device. From what I know of the engineers trend of thought, the idea is always to bring about improvement to the health of the human being; it is always to determine the efficacy of the device when used on the human…[Read more]

Folks allow me the opportunity to chip in somewhat.

The field is not an easy spot: lots of trials, even benefits. You’ll meet people looking at you this way or that way and making weird conclusions about you. Face it, we are going to be dealing with people of different backgrounds, upbringings, and education. But however you look at it, it will…[Read more]

It might be surprising to observe that your wonderings in relation to “how much of marketing is about manipulation” was well placed considering that marketing or sales is not even based on manipulation. Blair Kidwell et al in their study “Emotional Intelligence in Marketing Exchange” try to narrow marketing to be based on some emotion. I…[Read more]

“Emotional Intelligence” is like some magical tool within some people; especially as it is made to sound in “Emotional Intelligence in Marketing Exchanges” by Blair Kidwell et al. To my understanding, this is just another one of those drives by the psychologist to understand man. Sorry to say, I experienced no satisfaction in all the efforts made…[Read more]

Wanting to own a company is not like trying to land a job; yet both have that intuitive drive toward something; and agreed, in both cases you wind up with something that takes you into the future only via very different pathways. The quest for a job is for yourself – you have no supportive walls to prevent you from falling into a ditch. For…[Read more]

This may be interesting: I wouldn’t really advise an LLC Medical Device midsize, 50 person, $10 million revenue company operating as an LLC to revert to the status of a public company. Considering the advantages and disadvantages of both a private vs a public company, we notice that the Medical device company operating as an LLC has assumed a…[Read more]

It’s a beautiful thing that we can now be able to analyze a company simply by looking at such aspects as:
Current Ratio which is: Current assets/Current Liabilities
to see how far above/below unity, ‘1’, this component may be as we attempt to pick into the debt status of the company;
Debt Ratio; namely, total liabilities/total assets…[Read more]

An item in your posting has caught my attention: “Understanding Barriers To Medical Device Quality” This document has been extremely forthcoming as it regards the effort the Biomedical Engineer is making to improve medical devices with the intent to improve medical service rendered to patients by those in the medical arena. By the disclosure of…[Read more]

Agreed, a smooth coordination among the parties involved in the manufacture of a product will enhance product quality; but we may not forget that quality of a product is actually determined by the user. How a product does in sales matters; it reflects on the nature of the company; and above all, it impacts how the company is doing. In an earlier…[Read more]

Trump is one of the wealthiest individual in the US; i.e., besides being elected to the highest executive office in the country. Actually, his only reason for seeking access to this thrown is to solidify the security of the wealthy. What FDA handles can very easily impact the security of the wealthy. And you ask for my concerns? It will,…[Read more]