Medical Device Courses | ljw3 | Activity https://medicaldevicecourses.com/members/ljw3/activity/ Activity feed for ljw3. Fri, 24 Apr 2026 21:58:15 -0400 https://buddypress.org/?v= en-US 30 hourly 2 073896c350d802637359d3c5c2d8e9ae ljw3 replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/11419/ Wed, 15 May 2019 16:44:48 -0400 I’d like to add that criteria for giving and receiving gifts often applies to both sides in a lot of company policies. Specifically, my company’s policy is that I am not allowed to receive gifts of any kind, no matter…   Read more»

]]> f111e44cfea20cfca5d82aeb5e824dc9 ljw3 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11417/ Wed, 15 May 2019 16:44:47 -0400 When I enrolled as this class (which I did as an elective course), I was expecting to learn more about the technical details of the development of different types of devices themselves. I was pleasantly surprised to learn that this…   Read more»

]]> edae7633bcf1d40da92d7d2736f817e2 ljw3 replied to the topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/11413/ Wed, 15 May 2019 16:44:45 -0400 As Juan mentioned, it was pretty easy to dig up an example of a kickback allegation that occured within the pharmaceutical/medical/device industries. Check out this example: http://www.nytimes.com/2013/04/28/opinion/sunday/another-alleged-drug-kickback-scheme.html In this example, Novartis Pharmaceuticals enticed doctors to prescribe their…[Read more]

]]> ebae68397937bb00d1b32ace2c60a3ac ljw3 replied to the topic "Organizational Behavior Management" - https://medicaldevicecourses.com/activity/p/11312/ Wed, 15 May 2019 16:43:50 -0400 I 100% agree that there should be a good balance of comfort & structure in an organization. I’ve worked in departments on both ends of that spectrum. In a structured department, team members are so uptight and overly professional that…   Read more»

]]> 51a80e88d121d1c9df7d9e8d047455eb ljw3 replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11310/ Wed, 15 May 2019 16:43:49 -0400 I work in a matrix organization and I definitely think I prefer working in that environment. At my company, there are distinct departments within the product development portion of R&D. These include synthetic chemists, analytical chemists, chemical engineers and formulators,…   Read more»

]]> 716ca91b08e0c872fa68f4265a425cf9 ljw3 replied to the topic "Forming a Project Team" - https://medicaldevicecourses.com/activity/p/11306/ Wed, 15 May 2019 16:43:47 -0400 I agree with what many others have mentioned so far, that most likely managers do not directly pick their project teams. In that case, as you mentioned, having strategies to deal with conflicts is ideal. I’d like to add that…   Read more»

]]> 11d89aaf3b6a3322af855f4b4ecb9faa ljw3 replied to the topic "Combination Product Phase I clinical Studies" - https://medicaldevicecourses.com/activity/p/11030/ Wed, 15 May 2019 16:39:13 -0400 As a few others have mentioned, technical transfer activities are not completed until a company has fully developed the medical device/drug/combination product and its manufacturing process. This often doesn’t occur until during or after Ph3 clinical trials (and often the…   Read more»

]]> d99d641554f7c68d50c2d6e3c289086d ljw3 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/11029/ Wed, 15 May 2019 16:39:12 -0400 As Murad and others have mentioned, meeting minutes are crucial for capturing meetings and holding meeting attendees responsible for decisions and actions. In my opinion, the concept of using meeting minutes is beneficial in every single industry, not just the…   Read more»

]]> 016c4ebecb8b84d331d49a225d84184a ljw3 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/11026/ Wed, 15 May 2019 16:39:11 -0400 I think that even though Gantt charts are meant to document all of the related activities for a project, I think overall flexibility is key to delivering a project. Sort of related: A common thing that happens at my job…   Read more»

]]> bf760dea3196b51efd97dc4b6fe2f621 ljw3 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/10914/ Wed, 15 May 2019 16:37:53 -0400 I think the DHF mindset of continuously documenting the “whole story” is more beneficial than the EU approach, where the design is evaluated at a single point in time. I think that documenting the entire development process and rationale for…   Read more»

]]> 8d154be0241cebdb5f69a34c0ec288a3 ljw3 replied to the topic "Design Controls for Legacy Combination Products" - https://medicaldevicecourses.com/activity/p/10912/ Wed, 15 May 2019 16:37:52 -0400 I agree with you, John. As others have mentioned, companies that have developed legacy products must have some level of documentation on the design and manufacturing processes at minimum. I think that it may be worthwhile to compare their level…   Read more»

]]> 413335adc2bf206e808b105c447c50b2 ljw3 replied to the topic "Consequences Of Insufficient Design Controls" - https://medicaldevicecourses.com/activity/p/10910/ Wed, 15 May 2019 16:37:49 -0400 Poor planning can definitely lead to a lack of proper design controls and therefore a medical device lacking in quality, as others have mentioned. As you mentioned in your example, when the people responsible for development & documentation of the…   Read more»

]]> ff0c08dbe13929f6c14eede169217cd4 ljw3 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/920/ Mon, 05 Dec 2016 02:47:34 -0500 I’d like to add that criteria for giving and receiving gifts often applies to both sides in a lot of company policies. Specifically, my company’s policy is that I am not allowed to receive gifts of any kind, no matter how small. For example, if a vendor sends me flowers to wish me well after an illness for example, I am not allowed to accept…[Read more]

]]> 0 5dd4fd09cff8e9aba52c7f8824cbad0f ljw3 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/918/ Mon, 05 Dec 2016 02:36:20 -0500 When I enrolled as this class (which I did as an elective course), I was expecting to learn more about the technical details of the development of different types of devices themselves. I was pleasantly surprised to learn that this course was a more “big picture” lesson in what types of professions are necessary to produce a device. While I…[Read more]

]]> 0 e7f2ffb2c6ed6d07efc4121260c851e1 ljw3 replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/914/ Mon, 05 Dec 2016 02:27:54 -0500 As Juan mentioned, it was pretty easy to dig up an example of a kickback allegation that occured within the pharmaceutical/medical/device industries.

Check out this example: http://www.nytimes.com/2013/04/28/opinion/sunday/another-alleged-drug-kickback-scheme.html

In this example, Novartis Pharmaceuticals enticed doctors to prescribe their…[Read more]

]]> 0 27f59f1bb20eef7896d62865abdb7e1a ljw3 replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/786/ Mon, 28 Nov 2016 03:37:35 -0500 I 100% agree that there should be a good balance of comfort & structure in an organization. I’ve worked in departments on both ends of that spectrum.

In a structured department, team members are so uptight and overly professional that open discussion in general wasn’t encouraged. This can be detrimental because it is crucial in my opinion to…[Read more]

]]> 0 ab242fdcf4f777de8ed6df6acf4db055 ljw3 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/784/ Mon, 28 Nov 2016 03:27:13 -0500 I work in a matrix organization and I definitely think I prefer working in that environment. At my company, there are distinct departments within the product development portion of R&D. These include synthetic chemists, analytical chemists, chemical engineers and formulators, for example. Usually a couple people from each of the functional…[Read more]

]]> 0 f03d6bbd99eec5d274765e61dbc74080 ljw3 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/783/ Mon, 28 Nov 2016 03:27:13 -0500 I work in a matrix organization and I definitely think I prefer working in that environment. At my company, there are distinct departments within the product development portion of R&D. These include synthetic chemists, analytical chemists, chemical engineers and formulators, for example. Usually a couple people from each of the functional…[Read more]

]]> 0 6d1413fcfb1cff83e2fd261f7c40d34b ljw3 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/779/ Mon, 28 Nov 2016 03:15:36 -0500 I agree with what many others have mentioned so far, that most likely managers do not directly pick their project teams. In that case, as you mentioned, having strategies to deal with conflicts is ideal. I’d like to add that one tip that was given to me by a senior project leader was even though you may not like or agree with every team member,…[Read more]

]]> 0 c6fc8923ec519afc66a7094c8d2213e2 ljw3 replied to the topic Combination Product Phase I clinical Studies in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/431/ Mon, 14 Nov 2016 02:54:21 -0500 As a few others have mentioned, technical transfer activities are not completed until a company has fully developed the medical device/drug/combination product and its manufacturing process. This often doesn’t occur until during or after Ph3 clinical trials (and often the timeline depends on how risk averse the company is, i.e. some companies…[Read more]

]]> 0 07e140f01cb4dbe43814d4622c6fd49c ljw3 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/430/ Mon, 14 Nov 2016 02:49:10 -0500 As Murad and others have mentioned, meeting minutes are crucial for capturing meetings and holding meeting attendees responsible for decisions and actions. In my opinion, the concept of using meeting minutes is beneficial in every single industry, not just the medical device or pharmaceutical industries. In my experience, meeting minutes are very…[Read more]

]]> 0 a644126872ffc5d822c9e7a39ed747a7 ljw3 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/426/ Mon, 14 Nov 2016 02:41:53 -0500 I think that even though Gantt charts are meant to document all of the related activities for a project, I think overall flexibility is key to delivering a project.

Sort of related: A common thing that happens at my job is that project teams know their drug file date a few years in advance. While that is helpful, sometimes it causes the…[Read more]

]]> 0 af1fe055221ccb2443f97bcb8668a70b ljw3 replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/271/ Mon, 07 Nov 2016 03:49:39 -0500 I think the DHF mindset of continuously documenting the “whole story” is more beneficial than the EU approach, where the design is evaluated at a single point in time. I think that documenting the entire development process and rationale for key decisions (which is done in the DHF) is advantageous when issues arise in the manufacturing of the…[Read more]

]]> 0 386bcf9448a844d48d7ca39af3431b49 ljw3 replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/269/ Mon, 07 Nov 2016 03:40:13 -0500 I agree with you, John. As others have mentioned, companies that have developed legacy products must have some level of documentation on the design and manufacturing processes at minimum. I think that it may be worthwhile to compare their level of documentation with a DHF to identify gaps, but I think if the gaps are small and the history of the…[Read more]

]]> 0 5d0163a08af13306c7b36bf9197dc791 ljw3 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/265/ Mon, 07 Nov 2016 03:27:37 -0500 Poor planning can definitely lead to a lack of proper design controls and therefore a medical device lacking in quality, as others have mentioned. As you mentioned in your example, when the people responsible for development & documentation of the device are not on the same page as the clinical team, it could cause misalignment and the necessary…[Read more]

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