Medical Device Courses | jtl27 | Activity https://medicaldevicecourses.com/members/jtl27/activity/ Activity feed for jtl27. Fri, 24 Apr 2026 23:46:26 -0400 https://buddypress.org/?v= en-US 30 hourly 2 a101b687ddd8091a6d6b8788c7358158 jtl27 replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/11410/ Wed, 15 May 2019 16:44:44 -0400 The fact of the matter is that whether its done by the books or not, bribery can be done very easily. Paying for a spouse’s dinner? That’s the least that a company can bribe someone if they wanted to. Besides,…   Read more»

]]> 4ebc0f08aca49af1f968c9293cde447b jtl27 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/11403/ Wed, 15 May 2019 16:44:37 -0400 I disagree with most of what people are saying. Oral contracts are not difficult to prove as long as there is just one witness. Oral contracts are just as binding as written contracts. Although there is no disputing a written…   Read more»

]]> 3f251fee58b24f745d026a5c1867fd4b jtl27 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11395/ Wed, 15 May 2019 16:44:33 -0400 This class has helped me realize that my initial desire to work in RD is still what I want to do with my career. This course does not go into any actual research of new devices, and why would it….   Read more»

]]> c54ffb71a116e2c628e5dddc0fcf03e7 jtl27 replied to the topic "Organization Type vs. Effectiveness" - https://medicaldevicecourses.com/activity/p/11297/ Wed, 15 May 2019 16:43:42 -0400 I think that the functional org structure is the most effective structure. This way, you can hire experts in their respect fields who don’t need to know too much about other parts of the company. Granted, it’s important to understand…   Read more»

]]> 57ae04af7266565e12917bed18122cbc jtl27 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11280/ Wed, 15 May 2019 16:43:34 -0400 I think it depends at what stage of the company you are in. For example, an RD team doesn’t necessarily need to have that great of a relationship or have an immense amount of trust between them. Their job is…   Read more»

]]> 4a9cda0e454cf8a4121af7ef2f519331 jtl27 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/11272/ Wed, 15 May 2019 16:43:31 -0400 I think if I were to start up a company, I would try to go with a structure similar to the divisional market based org structure. As stated in the article, this is structured for a specific niche of market,…   Read more»

]]> 8638c503cadace739c1c0d71da896475 jtl27 replied to the topic "how far is "As Far As Possible"" - https://medicaldevicecourses.com/activity/p/11167/ Wed, 15 May 2019 16:40:28 -0400 I think what it comes down to is essentially the honor system. It may sound quite counterproductive because, of course if you give companies an inch, they’ll take a mile. However, if something during the production of an medical device…   Read more»

]]> 480c9c1794604aed8e8a719f6d4c68ab jtl27 replied to the topic "Discussion Topic: Risk Management, Risk Analysis" - https://medicaldevicecourses.com/activity/p/11109/ Wed, 15 May 2019 16:39:59 -0400 As I understand it, dealing with risk is split up into three different categories: Risk Analysis: Risk analysis is simply a definition of risk. Basically, if we do x, y and z may occur. Risk Assessment: If y and z…   Read more»

]]> ac3f1530942ce92623b46fe098b62b81 jtl27 replied to the topic "Risk Identification" - https://medicaldevicecourses.com/activity/p/11107/ Wed, 15 May 2019 16:39:58 -0400 Yes I was going to mention the SWOT analysis. Preliminary risk assessments are hard to quantify sometimes, so there are many times when the best way to assess each risk is to go back and evaluate what the company has…   Read more»

]]> 19a0ba0d0a8f12d2d3f3b6b33d2a099f jtl27 replied to the topic "Making up tests for design verification and validation" - https://medicaldevicecourses.com/activity/p/11052/ Wed, 15 May 2019 16:39:27 -0400 One really important test is a fatigue tests and heat test. A the fatigue test is essentially a device that will put a certain amount of cyclic loading to the device and will determine how many of those cycles it…   Read more»

]]> 453345aa4b53ade7feb8aa6e470dd7e3 jtl27 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/11034/ Wed, 15 May 2019 16:39:15 -0400 When I was the president of a club during my NJIT undergrad tenure, the secretary of the club introduced the concept of minutes during our weekly e-board meetings. I didn’t really understand the concept of minutes other than just notes…   Read more»

]]> c9ec4519833c8df9372f65682d94ec9f jtl27 replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/10917/ Wed, 15 May 2019 16:37:55 -0400 The verification refers to the process that deals with evaluating the customer needs and “verifying” that what the scope is focused in on is based on the customer needs. Validation refers to the process of complying with regulations and specifications…   Read more»

]]> 3501e4d699ad20160ad2a33abd16bbde jtl27 replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10895/ Wed, 15 May 2019 16:37:40 -0400 Thanks for this post. I think the scope management is the most important, not to say the others are unimportant, but understanding what needs to be done in the amount of time given is the best way to complete an…   Read more»

]]> a46d3e1dd748ab9c646b0a8ab2aa3956 jtl27 replied to the topic "Design Controls for Legacy Combination Products" - https://medicaldevicecourses.com/activity/p/10886/ Wed, 15 May 2019 16:37:33 -0400 Personally, I think that this topic should be considered with the famous motto “If it ain’t broke, don’t fix it” . Obviously, these documents and the protocol to make all these devices safe and effective are necessary. However, if these…   Read more»

]]> dc52567f49a6ec333c60b9afb7a0eac8 jtl27 posted a new topic "Customer Needs, Business Requirements, Test Plan" - https://medicaldevicecourses.com/activity/p/10397/ Wed, 15 May 2019 16:33:13 -0400 This week’s discussion reminds me a lot of what we had to learn in our capstone design class senior year. The three biggest deliverables for that class other than our powerpoint presentations were the two documents that we had to…   Read more»

]]> 152f4a775eae59d4e265a524db0e882d jtl27 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/911/ Mon, 05 Dec 2016 02:02:02 -0500 The fact of the matter is that whether its done by the books or not, bribery can be done very easily. Paying for a spouse’s dinner? That’s the least that a company can bribe someone if they wanted to. Besides, this is just a part of business that frankly doesn’t even bother to be investigated. People bring clients to baseball games, dinners, etc.…[Read more]

]]> 0 d04bb665711e98074da46189ec93fbc6 jtl27 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/903/ Mon, 05 Dec 2016 00:40:47 -0500 I disagree with most of what people are saying. Oral contracts are not difficult to prove as long as there is just one witness. Oral contracts are just as binding as written contracts. Although there is no disputing a written contract in a court of law, something as unprotected as a piece of paper is probably just as difficult to protect as a…[Read more]

]]> 0 53c79b6da95cd4269dbf186b0243cfae jtl27 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/895/ Sun, 04 Dec 2016 23:45:27 -0500 This class has helped me realize that my initial desire to work in RD is still what I want to do with my career. This course does not go into any actual research of new devices, and why would it. That’s just a design course. In many of my other classes, I get the freedom to create new designs. I really enjoy working on those and wish I had more…[Read more]

]]> 0 db9e1fd30e20e262420fd60881d8057a jtl27 replied to the topic Organization Type vs. Effectiveness in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/769/ Mon, 28 Nov 2016 02:26:25 -0500 I think that the functional org structure is the most effective structure. This way, you can hire experts in their respect fields who don’t need to know too much about other parts of the company. Granted, it’s important to understand certain basics, but in other forms of structures, each different person has to have a really good understanding of…[Read more]

]]> 0 418555744000fc77e4c8ff1797460218 jtl27 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/751/ Mon, 28 Nov 2016 00:15:40 -0500 I think it depends at what stage of the company you are in. For example, an RD team doesn’t necessarily need to have that great of a relationship or have an immense amount of trust between them. Their job is to use their knowledge and their skills to collaborate on which ideas would work for a new product. I think where the trust between…[Read more]

]]> 0 0073506ad8993575c2ac6bc1afcff08b jtl27 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/743/ Sun, 27 Nov 2016 22:59:17 -0500 I think if I were to start up a company, I would try to go with a structure similar to the divisional market based org structure. As stated in the article, this is structured for a specific niche of market, such as a medical device. Medical devices do not reach out to much of the general market, but for the sake fo the medical market, it would be…[Read more]

]]> 0 679901795d6fc9194858109536f5fdad jtl27 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/612/ Mon, 21 Nov 2016 02:50:50 -0500 I think what it comes down to is essentially the honor system. It may sound quite counterproductive because, of course if you give companies an inch, they’ll take a mile. However, if something during the production of an medical device goes wrong, and the company becomes scrutinized, they are going to be cross examined to see if they truly did go…[Read more]

]]> 0 bc4d28c3c2995bd8a09963e313bc3877 jtl27 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/539/ Fri, 18 Nov 2016 20:42:07 -0500 As I understand it, dealing with risk is split up into three different categories:

Risk Analysis: Risk analysis is simply a definition of risk. Basically, if we do x, y and z may occur.
Risk Assessment: If y and z do occur, what security do we have in place to make sure y and z are taken care of in an efficient manner.
Risk Management: Risk…[Read more]

]]> 0 c9885bfa1e9054ec4bc74f234a946bd1 jtl27 replied to the topic Risk Identification in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/533/ Fri, 18 Nov 2016 15:28:35 -0500 Yes I was going to mention the SWOT analysis. Preliminary risk assessments are hard to quantify sometimes, so there are many times when the best way to assess each risk is to go back and evaluate what the company has done previously and analyze the risks associated with that project. In a SWOT analysis, the company sits down and reviews something…[Read more]

]]> 0 23f2cf5b4478438e81cc989ecbe7e856 jtl27 replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/456/ Mon, 14 Nov 2016 04:59:28 -0500 One really important test is a fatigue tests and heat test. A the fatigue test is essentially a device that will put a certain amount of cyclic loading to the device and will determine how many of those cycles it takes to fatigue. That number is documented and a safety factor is created. Another common test is a heat test which is supposed to…[Read more]

]]> 0 6953246d53da26e98b61dfdab9ea1780 jtl27 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/436/ Mon, 14 Nov 2016 03:35:29 -0500 When I was the president of a club during my NJIT undergrad tenure, the secretary of the club introduced the concept of minutes during our weekly e-board meetings. I didn’t really understand the concept of minutes other than just notes being taken. However, she was in a couple of other clubs in which she was responsible for taking minutes. She…[Read more]

]]> 0 0cc75039ff55fb2cdb707c94444d5f5d jtl27 started the topic Customer Needs, Business Requirements, Test Plan in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/432/ Mon, 14 Nov 2016 03:15:20 -0500 This week’s discussion reminds me a lot of what we had to learn in our capstone design class senior year. The three biggest deliverables for that class other than our powerpoint presentations were the two documents that we had to turn in: business requirements document and the test plan document. The business requirements document was a direct…[Read more]

]]> 0 446c2cee2121997cb976327d063cc5ed jtl27 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/274/ Mon, 07 Nov 2016 04:12:20 -0500 The verification refers to the process that deals with evaluating the customer needs and “verifying” that what the scope is focused in on is based on the customer needs. Validation refers to the process of complying with regulations and specifications based on the process of verification. It seems that the verification precedes the validation…[Read more]

]]> 0 b4408cf82de1b520aaff76f7cfc73a64 jtl27 replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/246/ Mon, 07 Nov 2016 02:18:35 -0500 Thanks for this post. I think the scope management is the most important, not to say the others are unimportant, but understanding what needs to be done in the amount of time given is the best way to complete an efficient project. There’s nothing worse than having a project with a deadline, getting distracted and working on something out of the…[Read more]

]]> 0 b0d69882bfc8b9b92d7fed6622ee7bb7 jtl27 replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/233/ Mon, 07 Nov 2016 02:00:38 -0500 Personally, I think that this topic should be considered with the famous motto “If it ain’t broke, don’t fix it” . Obviously, these documents and the protocol to make all these devices safe and effective are necessary. However, if these legacy products have been used in hospitals, doctors offices, and over the counter for years already, and there…[Read more]

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