Activity | amd29 | Medical Device Courses

amd29 replied to the topic "Discussion Topic: Inc. vs. LLC in the US" – 6 years ago

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… Read more»
amd29 replied to the topic "Accepting job based on company." – 6 years ago

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… Read more»
amd29 replied to the topic "Regulations with quality" – 6 years ago

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… Read more»
amd29 replied to the topic "Your Ideas about Improving Quality Control" – 6 years ago

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… Read more»
amd29 replied to the topic "Changes in FDA under Trump's Administration" – 6 years ago

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…. Read more»
amd29 replied to the topic "Drugs banned in US but not in other countries" – 6 years ago

That drugs are banned in the US but not in other countries does not necessarily make drugs in the US safe. They, in fact, could be downright dangerous. Take the statin drug, for instance, an MIT research scientist has shown… Read more»
amd29 posted a new topic "Your Organizational prference; but why?" – 6 years ago

Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird. Personally, after experiencing with the Functional Organizational type in the past,… Read more»
amd29 posted a new topic "WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?" – 6 years ago

When a medical device is clinically tested it is to evaluate the safety of such a device on the human and whether or not the desired result will be obtained from doing the clinical testing of the device. In the… Read more»
amd29 posted a new topic "WHAT IS MARKETING TO YOU?" – 6 years ago

Prof. Simon has made it simple; he seems to define i) Marketing: — as being able to have the customer believe that what you – the marketing agent – are offering is what they truly need ii) Sales: —- as… Read more»
amd29 posted a new topic "A VICIOUS GAME PLAYED BY PHYSICIANS AND DRUG DESIGNERS MUST BE STOPPED." – 6 years ago

Both our plans are to graduate and become the very best Biomedical Engineers possible; engineers that will come up with ideal medical devices, high quality devices that meet all requirements to help fight and eliminate human ailments. All this is… Read more»
amd29 posted a new topic "The people we shall encounter in the field" – 6 years ago

In the field we will be dealing with people of different backgrounds, accents, looks and drives. What do these human differences mean to you as it relates to your function in directing their operation in the creation of new medical… Read more»
amd29 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 6 years, 6 months ago

It should all depend on what the agreement is being made about. I hope we are not talking about an agreement that involves a medical device creation. If this has to do with a medical device I will strongly suggest the contract be written in that medical devices often involve the human. The format of other types of contract agreements can be…[Read more]
amd29 replied to the topic Factors to consider when executing the NDA in the forum Consultants and Legal Basics 6 years, 6 months ago

First, I make sure we spell out what is to be held confidential; we must agree to how long this information will be held confidential. We must also agree to the consequences of violating the terms of the agreement. The must be a witness to see us both sign the NDA document. The witness will also sign to the form in the appropriate place as witness…[Read more]
amd29 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics 6 years, 6 months ago

Prof. Simon:
perhaps it will make more sense to say if I had not taken this course, I would unknowingly have passed up on a great learning experience as a Biomedical Engineer. It was critical to learn what the engagements of a Biomedical Engineer out in the field are while still a student. This knowledge is irreplaceable.
In this course, a…[Read more]
amd29 started the topic Your Organizational prference; but why? in the forum Organizational Development in Device Companies 6 years, 6 months ago

Quite recently Dr. Simon organized us into project teams. And strangely, I became a part of one before I knew it. The approach of forming the team was weird.
Personally, after experiencing with the Functional Organizational type in the past, learning of the Project-based type and now having an experience with the Matrix type organization, I seem…[Read more]
amd29 replied to the topic Matrix Organization- Conflict in the forum Organizational Development in Device Companies 6 years, 6 months ago

Folks, if there is any problem in a “Matrix Organizational Structure” it won’t be because of the structure. I have almost grown up in a functional type organizational structure where there is always a supreme leader who almost always seem to knows it all. From what I have seen, the only thing that can create problems in a Matrix Organizational set…[Read more]
amd29 replied to the topic Medical Device Project in the forum Organizational Development in Device Companies 6 years, 6 months ago

Hello 9275: Our Medical Device Development class brings to reality things I never knew before, the Matrix Organizational Structure, for instance. It’s quite exciting; I hope you’ll agree. In my opinion, every Biomedical Engineer should go through this course, because they wouldn’t know what they would be missing if they didn’t; it’s the least a…[Read more]
amd29 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices 6 years, 6 months ago

Hello Viraj: I see you are interested in the identification of risk and its prioritization; me, too. Never had experience dealing with medical device risk analysis. And you are right “Managing risk early is the best way to avoid issues later”.

Discussion on this topic so far has been quite enlightening; for example,jtl27 posting code 1377…[Read more]
amd29 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices 6 years, 6 months ago

I shall assume that by value you are referring to the impact you assign a risk. If using a matrix to measure the value of a risk is not sufficient I shall wonder what value you are concerned about.

Imagine your being in school is funded from a family resource – from your parents’ savings. You have, may be, two siblings who could be using the…[Read more]
amd29 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 6 months ago

Somehow this topic interests me. Especially when participant nk229, posting coded 1461 seeks to express the dilemma of attempting to assess pharmaceutical drug risks as a major concern. That it is a concern, is actually an understatement. It is possible to work with risks associated with a medical device; but not with pharmaceutical items put out…[Read more]
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