Medical Device Courses | Adrian | Activity https://medicaldevicecourses.com/members/aowalker/activity/ Activity feed for Adrian. Fri, 24 Apr 2026 20:47:02 -0400 https://buddypress.org/?v= en-US 30 hourly 2 12b762a45b84c7d0633dacbcc0e8a543 Adrian replied to the topic "Recent Examples of Kickback Allegations" - https://medicaldevicecourses.com/activity/p/11404/ Wed, 15 May 2019 16:44:38 -0400 I know a lot of folks in the medical field, and unfortunately the medical industry is riddle with kick backs. Just about all company’s are guilty of this in one form or another. As you will find, some companies are…   Read more»

]]> b1e969fd99764e557cf0b8e928898898 Adrian replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11400/ Wed, 15 May 2019 16:44:36 -0400 It’s not so easy to come up with a name due what the class covers. With that said, I would say something along the lines of “Medical device development process” or “Product development for medical devices”, would provide a little…   Read more»

]]> d6799cb3afe0204b2fd1de2883dbccaf Adrian replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11333/ Wed, 15 May 2019 16:44:00 -0400 I thought this course did a good job of covering the key areas of the medical device industry, in additional to how people work within the industry. There are certainly areas within the fields that I now know is definitely…   Read more»

]]> 334217a9b49d611d15577ba7296acb02 Adrian replied to the topic "Organizational Behavior Management" - https://medicaldevicecourses.com/activity/p/11316/ Wed, 15 May 2019 16:43:52 -0400 Based on my experience, I disagree with those that say corporate culture can change in the blink of an eye. This is usually the hardest to change, and what some mistake for culture change is simply a change in moral….   Read more»

]]> 0667192ac98f69b3e4538523f7d636f3 Adrian replied to the topic "Collaboration projects" - https://medicaldevicecourses.com/activity/p/11308/ Wed, 15 May 2019 16:43:48 -0400 I have worked on several projects like this before with some good and bad outcomes. From an engineering point of view, this can be a pain if the work culture and engineering processes are different in both companies. Also, if…   Read more»

]]> a7838f8406fae2be5e36ab6dd28b992f Adrian replied to the topic "Discussion Topic: Your organizational type" - https://medicaldevicecourses.com/activity/p/11219/ Wed, 15 May 2019 16:43:02 -0400 Hi, In one my past job, I worked in a “Self directed cross functional team”, which I enjoyed and saw as having many advantages.This included creativity, such as each member offering an alternative perspective to the problem and potential solution…   Read more»

]]> 0a86943efe9f85ac8f60c41e8fdd4f7a Adrian replied to the topic "Sample Size Based on Risk Analysis" - https://medicaldevicecourses.com/activity/p/11149/ Wed, 15 May 2019 16:40:19 -0400 I agree that sample size is critical to any project. I don’t have any industry experience with sample size related to risk analysis, however, I was able to find an article that talks able sample size estimation which was a…   Read more»

]]> d557a715b8c6aeddabfecf09c66656df Adrian replied to the topic "Risk management methods" - https://medicaldevicecourses.com/activity/p/11080/ Wed, 15 May 2019 16:39:43 -0400 Another method: Event Tree Analysis (ETA) It is an inductive failure analysis performed to determine the consequences of a single failure for the overall system risk or reliability. Event Tree Analysis uses similar logic and mathematics as Fault Tree Analysis,…   Read more»

]]> 37d2b3322216921850f2544de59979bf Adrian replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11077/ Wed, 15 May 2019 16:39:42 -0400 I had the experience of sitting in on a couple of risk analysis meeting, and this is early in the process when the team are trying to determine if the project is a go or no go. This prevent the…   Read more»

]]> a2e57ea0c7f74098b1ad9fb959ca228f Adrian replied to the topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/10985/ Wed, 15 May 2019 16:38:34 -0400 There are always pros and cons with outsourcing, however, this is not really dependent on the size of a company, but more so to do with time, cost or if you have the expertize and setup to do the job…   Read more»

]]> def4f691e3ce0272840a1d13391ec443 Adrian replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/10979/ Wed, 15 May 2019 16:38:30 -0400 Meeting minutes are an extremely important part of any project, without this your project will easily failure. The bigger the project to the more important the meeting minutes are. Based on experience and as several you of you have already…   Read more»

]]> ab3c3f34a28b017a595f40054650bacf Adrian replied to the topic "Making up tests for design verification and validation" - https://medicaldevicecourses.com/activity/p/10977/ Wed, 15 May 2019 16:38:29 -0400 I agree with most of that the FDA doesn’t demand specific test and to me this would be too much of an overhead and additional unwanted burden for them. I have some experience outside of BME with verification and validation,…   Read more»

]]> ce79b7261b42584f5263fc5bf3bd8213 Adrian replied to the topic "Design input sources" - https://medicaldevicecourses.com/activity/p/10882/ Wed, 15 May 2019 16:37:31 -0400 Design inputs can and will come from various sources. Depending of the type of design, input can come from the customer, market research, feasibility study, medical standards, past projects, FDA, ISO, etc. Also, design input can change based on needs…   Read more»

]]> 349d8aff049dd2d1cc6262a4d1e34ffd Adrian replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10851/ Wed, 15 May 2019 16:37:10 -0400 I agree that all the parts are very important, however, I have to disagree with you on this point, that the communication management plan is the most important part of the DDP. Not that there is more important part, but…   Read more»

]]> 2cc77874d280e0357af9eafcf53a3f15 Adrian replied to the topic "Design Controls for Legacy Combination Products" - https://medicaldevicecourses.com/activity/p/10847/ Wed, 15 May 2019 16:37:08 -0400 Fady, This is a very interesting and also important subject matter. To answer your question, even products that were designed and built pre 21 CFR, has to have some sort of design and technical documentation somewhere, and especially so if…   Read more»

]]> a7192a82a117a03db41892c0c51cdc94 Adrian replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/904/ Mon, 05 Dec 2016 01:12:23 -0500 I know a lot of folks in the medical field, and unfortunately the medical industry is riddle with kick backs. Just about all company’s are guilty of this in one form or another. As you will find, some companies are just more clever than others at covering how the kickback scheme works.

]]> 0 8845e6301ea31b85da3769030a420c41 Adrian replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/900/ Mon, 05 Dec 2016 00:30:59 -0500 It’s not so easy to come up with a name due what the class covers. With that said, I would say something along the lines of “Medical device development process” or “Product development for medical devices”, would provide a little more clarity.
As for the Verbiage, something like, “Medical device development cycle follows a well-established path,…[Read more]

]]> 0 22b281414c155cd649ca3ef28ef5a62a Adrian replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/812/ Wed, 30 Nov 2016 15:04:12 -0500 I thought this course did a good job of covering the key areas of the medical device industry, in additional to how people work within the industry. There are certainly areas within the fields that I now know is definitely not a fit for myself, such as pre-clinical and clinical. This course was just what I was needed, however, as someone else…[Read more]

]]> 0 60b77d32b9112ea9b7db751c74880ac9 Adrian replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/811/ Wed, 30 Nov 2016 15:04:12 -0500 I thought this course did a good job of covering the key areas of the medical device industry, in additional to how people work within the industry. There are certainly areas within the fields that I now know is definitely not a fit for myself, such as pre-clinical and clinical. This course was just what I was needed, however, as someone else…[Read more]

]]> 0 a981e761b0dd68eedeb2b8e0295ef35a Adrian replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/791/ Mon, 28 Nov 2016 04:07:32 -0500 Based on my experience, I disagree with those that say corporate culture can change in the blink of an eye. This is usually the hardest to change, and what some mistake for culture change is simply a change in moral. Moral can easily increase or decrease with some changes such as, hiring or firing of management or employees, stock price increasing…[Read more]

]]> 0 02fcfe24da507d6d0aa6c4d22aa077b4 Adrian replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/790/ Mon, 28 Nov 2016 04:07:32 -0500 Based on my experience, I disagree with those that say corporate culture can change in the blink of an eye. This is usually the hardest to change, and what some mistake for culture change is simply a change in moral. Moral can easily increase or decrease with some changes such as, hiring or firing of management or employees, stock price increasing…[Read more]

]]> 0 c7d2f81cab544e0d7d95204f60425d50 Adrian replied to the topic Collaboration projects in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/781/ Mon, 28 Nov 2016 03:26:05 -0500 I have worked on several projects like this before with some good and bad outcomes. From an engineering point of view, this can be a pain if the work culture and engineering processes are different in both companies. Also, if there are intellectual properties that one or more companies are trying to protect during this collaboration, this can make…[Read more]

]]> 0 f31e8b04d5c9ec4f09bd91ee40368e6c Adrian replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/677/ Wed, 23 Nov 2016 18:08:53 -0500 Hi,
In one my past job, I worked in a “Self directed cross functional team”, which I enjoyed and saw as having many advantages.This included creativity, such as each member offering an alternative perspective to the problem and potential solution to the task. However, without a good coach or leader, these team can easily fail if consensus is not…[Read more]

]]> 0 3e03bae5ea8a74df77df730521fd1b73 Adrian replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/676/ Wed, 23 Nov 2016 18:08:53 -0500 Hi,
In one my past job, I worked in a “Self directed cross functional team”, which I enjoyed see has many advantages and creativity, such as each member offering an alternative perspective to the problem and potential solution to the task. However, without a good coach or leader, these team can easily fail if consensus is not reached on any…[Read more]

]]> 0 d4fa13eaa4ccd62710ca96f1c0f698d7 Adrian replied to the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/594/ Sun, 20 Nov 2016 23:01:14 -0500 I agree that sample size is critical to any project. I don’t have any industry experience with sample size related to risk analysis, however, I was able to find an article that talks able sample size estimation which was a good read.

http://www.sciencedirect.com/science/article/pii/S1532046414000501

]]> 0 8a9aa891b26eddb9095856056a3c0962 Adrian replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/493/ Tue, 15 Nov 2016 21:08:33 -0500 Another method: Event Tree Analysis (ETA)
It is an inductive failure analysis performed to determine the consequences of a single failure for the overall system risk or reliability. Event Tree Analysis uses similar logic and mathematics as Fault Tree Analysis, but the approach is different – FTA uses deductive approach (from a system failure to…[Read more]

]]> 0 f737044e28c53a666263580eb7fca537 Adrian replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/487/ Tue, 15 Nov 2016 20:11:15 -0500 I had the experience of sitting in on a couple of risk analysis meeting, and this is early in the process when the team are trying to determine if the project is a go or no go. This prevent the company from spending too much time and money on a device or project to then deem it too dangerous or risky. As some of you have mentioned, these meetings…[Read more]

]]> 0 3f221bffd5dfc18fcd613635c3ac31fc Adrian replied to the topic Design Transfer in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/373/ Sat, 12 Nov 2016 20:55:51 -0500 There are always pros and cons with outsourcing, however, this is not really dependent on the size of a company, but more so to do with time, cost or if you have the expertize and setup to do the job in-house. Additional when company decides that it’s going to outsource a product in development, a lot of time the manufacturer are involved in the…[Read more]

]]> 0 b534f64187cbebb0e789c4ef61ce8bbc Adrian replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/361/ Sat, 12 Nov 2016 17:14:41 -0500 Meeting minutes are an extremely important part of any project, without this your project will easily failure. The bigger the project to the more important the meeting minutes are. Based on experience and as several you of you have already mentioned, most time test are quickly glanced over when sent out in emails. The issue here is, often time…[Read more]

]]> 0 eda8f083774376f471fe88d4847eead1 Adrian replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/359/ Sat, 12 Nov 2016 16:43:11 -0500 I agree with most of that the FDA doesn’t demand specific test and to me this would be too much of an overhead and additional unwanted burden for them. I have some experience outside of BME with verification and validation, however, there is not much difference here. For each input requirement a test has to be created, and how to create the test…[Read more]

]]> 0 2e968b3fcb43534a5ab5c241caeffcb7 Adrian replied to the topic Design input sources in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/229/ Mon, 07 Nov 2016 01:33:34 -0500 Design inputs can and will come from various sources. Depending of the type of design, input can come from the customer, market research, feasibility study, medical standards, past projects, FDA, ISO, etc. Also, design input can change based on needs of the end user, schedule or any of the above source.

]]> 0 f8536b69760e946c997822a02d4d595e Adrian replied to the topic Important Part of DDP in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/177/ Sat, 05 Nov 2016 19:49:49 -0400 I agree that all the parts are very important, however, I have to disagree with you on this point, that the communication management plan is the most important part of the DDP. Not that there is more important part, but my reasoning is that without any of the other parts, the project will fail, and I can’t see the communication being more…[Read more]

]]> 0 438b2735365a7cb9ef41e421e09d1898 Adrian replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/173/ Sat, 05 Nov 2016 19:17:39 -0400 Fady,
This is a very interesting and also important subject matter. To answer your question, even products that were designed and built pre 21 CFR, has to have some sort of design and technical documentation somewhere, and especially so if these products were patented. They won’t be as completes as the DHF, however, we now have a starting point.…[Read more]

]]> 0 d21b2d51d4423bb001c9908cfaa093b0 Adrian became a registered member https://medicaldevicecourses.com/activity/p/167/ Sat, 05 Nov 2016 18:54:54 -0400 0