Medical Device Courses | zmh4 | Activity https://medicaldevicecourses.com/members/zmh4/activity/ Activity feed for zmh4. Sat, 18 Apr 2026 03:11:29 -0400 https://buddypress.org/?v= en-US 30 hourly 2 3760cdc8f71f2e717682f2038b30c533 zmh4 replied to the topic "Consultants NDAs and CDAs" - https://medicaldevicecourses.com/activity/p/11361/ Wed, 15 May 2019 16:44:13 -0400 I believe that the consultant was in violation of an NDA or CDA, especially if this was not agreed upon by the other company he used to work with. I think this is also why it is necessary for companies…   Read more»

]]> 5776468c68b490610631f03b47323045 zmh4 replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/11359/ Wed, 15 May 2019 16:44:12 -0400 Hey Roberto, Good question. I think although it is too restricted, it is necessary. In my opinion, if two people are out to discuss business, then only the individuals involved should be there. There is no reason to invite a…   Read more»

]]> 877220e82ea8bad62a1f6e65d577bd2c zmh4 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11358/ Wed, 15 May 2019 16:44:11 -0400 Hello Dr. Simon, I really enjoyed this course. In fact, it was probably the most useful course I have taken at NJIT, only because it is the only course explaining what the different career options are for BME students and…   Read more»

]]> ff575124fc43d8296c3701eee74d7f9a zmh4 replied to the topic "Project Management Preferences" - https://medicaldevicecourses.com/activity/p/11291/ Wed, 15 May 2019 16:43:39 -0400 Hi kdg4, You brought up a really good point. I agree that one of the hardest parts for a project manager is choosing individuals for their team in a matrix-based organization. However, I also see that as a benefit. Assuming…   Read more»

]]> 6aadec7ff70dbb7c3ae6bab8e54c9742 zmh4 replied to the topic "Organization types of medical devices?" - https://medicaldevicecourses.com/activity/p/11289/ Wed, 15 May 2019 16:43:38 -0400 In my opinion, it depends on the goal of the company, as well as the size. A small company may function best as a functional organization. That way, every employee has their own department focus. A smaller company may not…   Read more»

]]> eb2bb633b50c7bd90e8b4db1ec11591a zmh4 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11281/ Wed, 15 May 2019 16:43:35 -0400 In my opinion, it is always best to work with someone who is most knowledgeable about the task they will work on. While maintaining good relations with people in the workplace, you do not always need to “like” someone necessarily…   Read more»

]]> 52cf7ad60741d73fdf4c9530c4a13c90 zmh4 replied to the topic "Expense of Regulations" - https://medicaldevicecourses.com/activity/p/11180/ Wed, 15 May 2019 16:40:35 -0400 I would have to disagree with most people on here. These regulations should not cost any money. There should be a standard set of rules that all companies should follow, similar to the way the FDA has guidelines for medical…   Read more»

]]> 8d678e64b56c648c7f04e55081f085bc zmh4 replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/11173/ Wed, 15 May 2019 16:40:31 -0400 Hello, This is an interesting article. While I do agree that yes, companies can make these common mistakes, it still does not hurt to follow a process. The article mentioned that risk management is looked at as a “checkbox” activity….   Read more»

]]> 50d958649793e3cad3906fbf859e6728 zmh4 replied to the topic "Factors Contributing to Risk Values" - https://medicaldevicecourses.com/activity/p/11115/ Wed, 15 May 2019 16:40:02 -0400 Other factors would also be the probability of the occurrence; degree of harm caused by the failure; number of individuals affected and how exactly the failure affects them. Also, I wanted to add that it really all comes down to…   Read more»

]]> f29b60ef84a3b4358d8e901f74483033 zmh4 replied to the topic "When is validation is not required?" - https://medicaldevicecourses.com/activity/p/11038/ Wed, 15 May 2019 16:39:17 -0400 Human factors/usability engineering focuses on the interactions between people and devices. For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and…   Read more»

]]> 6e8dd526d1be5ce81ceb37a6dbd5c47a zmh4 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/11036/ Wed, 15 May 2019 16:39:16 -0400 Meeting minutes are important because specific points can be made in a meeting that are important in moving the project forward. If we overlook those points or tasks, it could cost the team the quality and deadline on finishing the…   Read more»

]]> d4b82d7d1f3ab86da1265fb140bd2704 zmh4 replied to the topic "Making up tests for design verification and validation" - https://medicaldevicecourses.com/activity/p/11031/ Wed, 15 May 2019 16:39:14 -0400 Hey Roberto, I agree with what everyone on this thread has said so far. However, I would also like to add that when “making up tests” it is often beneficial to read up on publications that have done similar clinical…   Read more»

]]> 92cd49a6f6af51d894ff60fc64755b76 zmh4 replied to the topic "Design Controls for Legacy Combination Products" - https://medicaldevicecourses.com/activity/p/10913/ Wed, 15 May 2019 16:37:53 -0400 These products, although no longer under development, as you mentioned, are still being manufactured. If this is the case, then there exist documentation in order to create the product. I do not think it will be too difficult to use…   Read more»

]]> c6c0b27184ef186f25241c6765f46faa zmh4 replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10909/ Wed, 15 May 2019 16:37:48 -0400 In my opinion, if you were to write a document on how to make a device, and give that document to someone else, they should be able to build an exact replica without coming back to you for questions. This…   Read more»

]]> 9ff7a300960c1a0a1b80b293530bb4dc zmh4 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10905/ Wed, 15 May 2019 16:37:46 -0400 Hey Lamiaa, Good discussion question. I agree with all of the points on here. I just wanted to add also, that for a medical device, not following design controls can result in severe safety issues. It can cause numerous medical…   Read more»

]]> 25bcee7f83a8ff2a8381db0bf4079875 zmh4 replied to the topic Consultants NDAs and CDAs in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/851/ Sat, 03 Dec 2016 01:28:34 -0500 I believe that the consultant was in violation of an NDA or CDA, especially if this was not agreed upon by the other company he used to work with. I think this is also why it is necessary for companies to work directly with attorneys in such matters to protect the company from any legal actions that can occur or to file legal actions against…[Read more]

]]> 0 5a2c9494b7c1bc9f68fe7c4eb5175bc1 zmh4 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/849/ Sat, 03 Dec 2016 01:14:07 -0500 Hey Roberto,

Good question. I think although it is too restricted, it is necessary. In my opinion, if two people are out to discuss business, then only the individuals involved should be there. There is no reason to invite a spouse or family member in such meetings, as they are work related and not social events. I think the point of these…[Read more]

]]> 0 ecf6c18be3fbc1df0827374cebbe57c6 zmh4 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/847/ Sat, 03 Dec 2016 00:34:11 -0500 Hello Dr. Simon,

I really enjoyed this course. In fact, it was probably the most useful course I have taken at NJIT, only because it is the only course explaining what the different career options are for BME students and helps them explore those options to get a feel of what they like and don’t like. Because of this course, I now have a better…[Read more]

]]> 0 d012c01fb15933c71109e6f6e36bd4f8 zmh4 replied to the topic Project Management Preferences in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/762/ Mon, 28 Nov 2016 01:31:30 -0500 Hi kdg4,
You brought up a really good point. I agree that one of the hardest parts for a project manager is choosing individuals for their team in a matrix-based organization. However, I also see that as a benefit. Assuming the project manager is able to gather the team members, they get to choose from a variety of different people, all with…[Read more]

]]> 0 728960869cebcb38d63c2ccf57ec2822 zmh4 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/760/ Mon, 28 Nov 2016 00:54:10 -0500 In my opinion, it depends on the goal of the company, as well as the size. A small company may function best as a functional organization. That way, every employee has their own department focus. A smaller company may not have many projects going on at once. Therefore, a functional organization may be most suitable in this case. As the company…[Read more]

]]> 0 09d53d697d6fd3733b20a3bb959193ee zmh4 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/752/ Mon, 28 Nov 2016 00:18:12 -0500 In my opinion, it is always best to work with someone who is most knowledgeable about the task they will work on. While maintaining good relations with people in the workplace, you do not always need to “like” someone necessarily to be able to do your job. From my experience, work and friendships do not go hand in hand. That does not mean however,…[Read more]

]]> 0 865a46b2e57b85f3d32dfc10a14d523f zmh4 replied to the topic Expense of Regulations in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/625/ Mon, 21 Nov 2016 03:34:27 -0500 I would have to disagree with most people on here. These regulations should not cost any money. There should be a standard set of rules that all companies should follow, similar to the way the FDA has guidelines for medical devices and holds certain standards for them before they are put in the market. These rules are important for safety, and…[Read more]

]]> 0 d1861de4abc1b3087b0411fce4afaff8 zmh4 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/618/ Mon, 21 Nov 2016 03:15:13 -0500 Hello,

This is an interesting article. While I do agree that yes, companies can make these common mistakes, it still does not hurt to follow a process. The article mentioned that risk management is looked at as a “checkbox” activity. The checkbox is there to guide the company on brainstorming the potential risks and figuring out how to prevent or…[Read more]

]]> 0 bfe9d5030baec579131cd1b354b93593 zmh4 replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/547/ Sat, 19 Nov 2016 04:02:15 -0500 Other factors would also be the probability of the occurrence; degree of harm caused by the failure; number of individuals affected and how exactly the failure affects them. Also, I wanted to add that it really all comes down to objective judgement. Often, you can tell how severe a failure is just by looking at the nature of the harm it brings and…[Read more]

]]> 0 52cc3bcf619ce0ead58ae7cd31653a97 zmh4 replied to the topic When is validation is not required? in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/440/ Mon, 14 Nov 2016 03:55:46 -0500 Human factors/usability engineering focuses on the interactions between people and devices. For medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful and users can use the device safely and effectively.

In my…[Read more]

]]> 0 d2c262bffa727ed6a09122a61bd57718 zmh4 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/438/ Mon, 14 Nov 2016 03:46:47 -0500 Meeting minutes are important because specific points can be made in a meeting that are important in moving the project forward. If we overlook those points or tasks, it could cost the team the quality and deadline on finishing the project. It can be really easy to forget what was stated and therefore, having meeting minutes is a very useful tool…[Read more]

]]> 0 0dcbfed849c8d6f0eec9df1f231c6563 zmh4 replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/433/ Mon, 14 Nov 2016 03:22:25 -0500 Hey Roberto,

I agree with what everyone on this thread has said so far. However, I would also like to add that when “making up tests” it is often beneficial to read up on publications that have done similar clinical or preclinical testing. Although the product being tested might be novel, there is always a good chance you may be able to find…[Read more]

]]> 0 64dd2143d2a8f2386ca4ad3cd3508f50 zmh4 replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/270/ Mon, 07 Nov 2016 03:40:33 -0500 These products, although no longer under development, as you mentioned, are still being manufactured. If this is the case, then there exist documentation in order to create the product. I do not think it will be too difficult to use these documentation in order to create a DHF. At the end of the day, a DHF is a document that entails a list of…[Read more]

]]> 0 2148231ddc84b813687e552e3d8b831c zmh4 replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/264/ Mon, 07 Nov 2016 03:24:00 -0500 In my opinion, if you were to write a document on how to make a device, and give that document to someone else, they should be able to build an exact replica without coming back to you for questions. This is the basis of a design input or requirement. Each requirement would describe a component inside the device. It would list things such as the…[Read more]

]]> 0 67d657c061fa4b5406807cc731efd6e2 zmh4 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/258/ Mon, 07 Nov 2016 03:09:20 -0500 Hey Lamiaa,

Good discussion question. I agree with all of the points on here. I just wanted to add also, that for a medical device, not following design controls can result in severe safety issues. It can cause numerous medical problems in patients as well as death in some cases. The reason that we have stringent design controls is to minimize…[Read more]

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