Medical Device Courses | amd29 | Activity https://medicaldevicecourses.com/members/amd29/activity/ Activity feed for amd29. Fri, 24 Apr 2026 17:34:39 -0400 https://buddypress.org/?v= en-US 30 hourly 2 88b23a68f3dca2299f461ab9ea00ca29 amd29 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/17346/ Wed, 15 May 2019 21:38:43 -0400 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…   Read more»

]]> f81b19bb4ab0d086d5dfc1760a74b51e amd29 replied to the topic "Factors to consider when executing the NDA" - https://medicaldevicecourses.com/activity/p/17345/ Wed, 15 May 2019 21:38:43 -0400 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…   Read more»

]]> 7f9b39863815d09074998c89dffb3f46 amd29 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/17341/ Wed, 15 May 2019 21:38:41 -0400 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…   Read more»

]]> 10572147f24bbf5a3015a663d001a4fd amd29 replied to the topic "Matrix Organization- Conflict" - https://medicaldevicecourses.com/activity/p/17244/ Wed, 15 May 2019 21:37:54 -0400 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…   Read more»

]]> a2ac8b1d11346bc46834588f27d9c9d8 amd29 replied to the topic "Medical Device Project" - https://medicaldevicecourses.com/activity/p/17243/ Wed, 15 May 2019 21:37:53 -0400 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…   Read more»

]]> 2602fb16d4f87e885abda68dd2f36191 amd29 replied to the topic "Risk Identification" - https://medicaldevicecourses.com/activity/p/17157/ Wed, 15 May 2019 21:37:07 -0400 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…   Read more»

]]> 432a98a24726a5ba03cc64d2894c236a amd29 replied to the topic "Factors Contributing to Risk Values" - https://medicaldevicecourses.com/activity/p/17147/ Wed, 15 May 2019 21:37:03 -0400 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…   Read more»

]]> 202d24e065142025eb44f1bdeff66576 amd29 replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/17146/ Wed, 15 May 2019 21:37:02 -0400 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…   Read more»

]]> e46ba5c295ba7cab413f284004251fcf amd29 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/17064/ Wed, 15 May 2019 21:36:21 -0400 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…   Read more»

]]> 3a859fecfa9bda2876f50d2a18f011ed amd29 replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/17063/ Wed, 15 May 2019 21:36:21 -0400 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…   Read more»

]]> 9c3c0d13d69b367a2d3c3f0b8468a48f amd29 replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/17039/ Wed, 15 May 2019 21:36:10 -0400 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…   Read more»

]]> fe7e57de18adfb17142e2aa8e6d17f1b amd29 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/16957/ Wed, 15 May 2019 21:35:27 -0400 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;…   Read more»

]]> 7c0b7906b12ca59adb6bd23952a0d000 amd29 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/16953/ Wed, 15 May 2019 21:35:25 -0400 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;…   Read more»

]]> c4be19762149873eac978dcc2494fff2 amd29 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/16933/ Wed, 15 May 2019 21:35:14 -0400 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…   Read more»

]]> 51d387fa5edebd4a16d9f521c5a7ac44 amd29 replied to the topic "Customer Needs and Design Input" - https://medicaldevicecourses.com/activity/p/16932/ Wed, 15 May 2019 21:35:13 -0400 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…   Read more»

]]> 3184dc5a8160aea17329ad8adf7523f8 amd29 replied to the topic "Ethical Issues with Clinical Trials" - https://medicaldevicecourses.com/activity/p/16848/ Wed, 15 May 2019 21:34:30 -0400 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…   Read more»

]]> 80e67f7c6e906c4b2b8f08e67592d3b0 amd29 replied to the topic "Discussion Topic: Having a "clinical background"" - https://medicaldevicecourses.com/activity/p/16847/ Wed, 15 May 2019 21:34:29 -0400 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,…   Read more»

]]> 3ad8958bb11f9c4484b2da30a43286db amd29 replied to the topic "Manipulation or no?" - https://medicaldevicecourses.com/activity/p/16732/ Wed, 15 May 2019 19:42:04 -0400 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…   Read more»

]]> c207d03be844c9eb2bb6289064a1032b amd29 replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" - https://medicaldevicecourses.com/activity/p/16722/ Wed, 15 May 2019 19:41:58 -0400 “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…   Read more»

]]> 6ec78d01d742c19078f9954f62c7c6b7 amd29 replied to the topic "Types of Corporations" - https://medicaldevicecourses.com/activity/p/16694/ Wed, 15 May 2019 19:41:41 -0400 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…   Read more»

]]> 474645cf320549754865d953bad8ae9c amd29 replied to the topic "Discussion Topic: Inc. vs. LLC in the US" - https://medicaldevicecourses.com/activity/p/16665/ Wed, 15 May 2019 19:41:24 -0400 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»

]]> 7940cde8197bf88a417cc25748296eb9 amd29 replied to the topic "Accepting job based on company." - https://medicaldevicecourses.com/activity/p/16637/ Wed, 15 May 2019 19:41:09 -0400 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»

]]> 9c43aac0b7550bee26cfd99da911ebd9 amd29 replied to the topic "Regulations with quality" - https://medicaldevicecourses.com/activity/p/16573/ Wed, 15 May 2019 19:40:28 -0400 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»

]]> 616f63f1e9d5ec817c5ccb97e50f9ee3 amd29 replied to the topic "Your Ideas about Improving Quality Control" - https://medicaldevicecourses.com/activity/p/16528/ Wed, 15 May 2019 19:40:02 -0400 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»

]]> 83f5791c551db07e99b13b822dd68eb5 amd29 replied to the topic "Changes in FDA under Trump's Administration" - https://medicaldevicecourses.com/activity/p/16464/ Wed, 15 May 2019 19:39:31 -0400 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»

]]> d819b6a45ae45603f4a352c4435e9523 amd29 replied to the topic "Drugs banned in US but not in other countries" - https://medicaldevicecourses.com/activity/p/16457/ Wed, 15 May 2019 19:39:28 -0400 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»

]]> 21308454cb083b0d60359d839e142dca amd29 posted a new topic "Your Organizational prference; but why?" - https://medicaldevicecourses.com/activity/p/10769/ Wed, 15 May 2019 16:36:22 -0400 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»

]]> 324cf9ab888bc5bf98cf890097f39b80 amd29 posted a new topic "WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?" - https://medicaldevicecourses.com/activity/p/10760/ Wed, 15 May 2019 16:36:18 -0400 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»

]]> e56d2ab49a5050591f4889c6a41710eb amd29 posted a new topic "WHAT IS MARKETING TO YOU?" - https://medicaldevicecourses.com/activity/p/10756/ Wed, 15 May 2019 16:36:16 -0400 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»

]]> e23c4dd51917c27e748e87c2e661da60 amd29 posted a new topic "A VICIOUS GAME PLAYED BY PHYSICIANS AND DRUG DESIGNERS MUST BE STOPPED." - https://medicaldevicecourses.com/activity/p/10748/ Wed, 15 May 2019 16:36:12 -0400 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»

]]> fa77cafebefaa55b8ab7d86c4af41569 amd29 posted a new topic "The people we shall encounter in the field" - https://medicaldevicecourses.com/activity/p/10743/ Wed, 15 May 2019 16:36:10 -0400 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»

]]> 3775428c591186c238a12ab13be2010b amd29 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/9182/ Fri, 30 Nov 2018 07:54:26 -0500 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]

]]> 0 5e1b5c42a092ed6dfd45dcc05159a70f amd29 replied to the topic Factors to consider when executing the NDA in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/9181/ Fri, 30 Nov 2018 07:26:41 -0500 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]

]]> 0 249930ebd785a00e8570d9cab06af57a amd29 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/9177/ Fri, 30 Nov 2018 01:07:12 -0500 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]

]]> 0 b4b0c8920bc64ef3d529a9c12849f0a5 amd29 started the topic Your Organizational prference; but why? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/9073/ Fri, 23 Nov 2018 19:04:22 -0500 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]

]]> 0 e49f4ff66756460b4969a25c5439c79f amd29 replied to the topic Matrix Organization- Conflict in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/9070/ Fri, 23 Nov 2018 15:37:42 -0500 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]

]]> 0 d430c656e9c1fe8d1d58c3af3da4ae2e amd29 replied to the topic Medical Device Project in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/9069/ Fri, 23 Nov 2018 14:56:49 -0500 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]

]]> 0 fb9f22a11213df48256ec69ba51e4515 amd29 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/8976/ Sun, 18 Nov 2018 08:06:02 -0500 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]

]]> 0 5bea06d3741113e7d490c45a9a00dd32 amd29 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/8966/ Sat, 17 Nov 2018 07:00:45 -0500 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]

]]> 0 8d374505947ef1fea3c2958feb65866e amd29 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/8965/ Sat, 17 Nov 2018 05:49:14 -0500 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]

]]> 0 371161aaf9447d866a92a2c37ef187d5 amd29 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8877/ Sun, 11 Nov 2018 07:22:53 -0500 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]

]]> 0 f05358317f3107c9a19ab562d40ff921 amd29 replied to the topic Design Review Meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8876/ Sun, 11 Nov 2018 06:23:04 -0500 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]

]]> 0 4e8471c078c036b20de988a2a20515a0 amd29 replied to the topic When is validation is not required? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8852/ Thu, 08 Nov 2018 14:19:08 -0500 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]

]]> 0 ccced3817030618b526ac4d84f7de53a amd29 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8766/ Sat, 03 Nov 2018 21:28:13 -0400 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]

]]> 0 bc96743648d93c2687c8abc85fc6516d amd29 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8761/ Sat, 03 Nov 2018 08:33:41 -0400 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]

]]> 0 429adf687ad0d21aef5d59a89e2864bd amd29 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8739/ Thu, 01 Nov 2018 15:29:55 -0400 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]

]]> 0 bda47f62ff06248736b034c6ede65098 amd29 replied to the topic Customer Needs and Design Input in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8738/ Thu, 01 Nov 2018 05:51:19 -0400 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]

]]> 0 b8e940314b216958ef476ea58d4dc46b amd29 started the topic WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS? in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/8651/ Fri, 26 Oct 2018 09:07:31 -0400 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 case of medical devices, the results have always been known to improve human wellbeing.

In the case of pharmaceutical drugs, however,…[Read more]

]]> 0 6708ce20edc7bb05b0cfeb2af68dbf8d amd29 replied to the topic Ethical Issues with Clinical Trials in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/8650/ Fri, 26 Oct 2018 07:39:59 -0400 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]

]]> 0 738fc5b6b65e4cfdbde83762d16124e7 amd29 replied to the topic Discussion Topic: Having a "clinical background" in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/8649/ Fri, 26 Oct 2018 06:23:35 -0400 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]

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