Medical Device Courses | mjf34 | Activity https://medicaldevicecourses.com/members/mjf34/activity/ Activity feed for mjf34. Fri, 24 Apr 2026 20:02:28 -0400 https://buddypress.org/?v= en-US 30 hourly 2 fcb2ad9f337fcd908f4afa26c363100c mjf34 replied to the topic "Types of Clinical Studies" - https://medicaldevicecourses.com/activity/p/12533/ Wed, 15 May 2019 16:56:55 -0400 I’ve been involved in double blind and randomized studies. In the randomized study, we actually ran into an issue where the trial was cancelled. For this study, active ingredient material was administered to some patients and placebo to others. The…   Read more»

]]> 68a6137abefc69dff799915271e27942 mjf34 replied to the topic "Unexpected Clinical Study Results" - https://medicaldevicecourses.com/activity/p/12532/ Wed, 15 May 2019 16:56:54 -0400 One example of what could shut down a clinical study is an adverse side effect, such as an allergic reaction. I’ve seen one clinical trial put on pause because one participant had a severe allergic reaction to the material being…   Read more»

]]> 62a652cab33e1910e459e86d296f6a67 mjf34 replied to the topic "career path" - https://medicaldevicecourses.com/activity/p/12531/ Wed, 15 May 2019 16:56:49 -0400 I’m not sure if clinical research would be the path for me either. I have some experience in creating clinical trial material and I did not enjoy it. It was very tedious and the amount of paperwork involved was enough…   Read more»

]]> 61be56b22dbcce4a5ba45dbc0f00626a mjf34 replied to the topic "Clinical Study Location/cost vs. results" - https://medicaldevicecourses.com/activity/p/12487/ Wed, 15 May 2019 16:56:27 -0400 I’m not sure if cost would be the leading purpose for conducting a clinical study in a developing country but regulations and target audience would probably be. For example, a researcher interested in conducting a study focused around the ZIKA…   Read more»

]]> e8bed39451ee74791367d2fa6dccaed1 mjf34 replied to the topic "Consent and predicted outcome" - https://medicaldevicecourses.com/activity/p/12447/ Wed, 15 May 2019 16:56:08 -0400 One example of this that I have heard about has been thalidomide. Thalidomide was used to treat nausea and morning sickness in pregnant women in the 1950’s. Previous studies in mice showed that thalidomide was not a risk in mice,…   Read more»

]]> a984216ed1f221209f88ae66db5dd036 mjf34 replied to the topic "CROs" - https://medicaldevicecourses.com/activity/p/12446/ Wed, 15 May 2019 16:56:08 -0400 Great question- I would have to say that if I were a sponsor, I would not want to transfer the responsibilities of: selecting monitors & investigators and overall managing/checking investigators. The reason why I selected these was because most of…   Read more»

]]> aa1697a5995b90317efd11634ff778c6 mjf34 replied to the topic "Improving GMPs" - https://medicaldevicecourses.com/activity/p/12377/ Wed, 15 May 2019 16:55:27 -0400 From experience, I have seen GMP documents get updated fairly often and the reason for them being updated is usually because the previous instructions were unclear and created confusion. I have also seen GMP standards updated for technology updates, or…   Read more»

]]> 2947b7ce47b4258d333a0e0dddcbbc2b mjf34 replied to the topic "Audits" - https://medicaldevicecourses.com/activity/p/12376/ Wed, 15 May 2019 16:55:26 -0400 Great question, neb2. I’ve been a part of an internal audit once before and the main advantage that I saw as a result was that it introduced to everyone what an external audit would be like and it trained multiple…   Read more»

]]> 2e3fcd932fcb6d35b8e68ebfe1ee9b1f mjf34 replied to the topic "CAPA" - https://medicaldevicecourses.com/activity/p/12375/ Wed, 15 May 2019 16:55:26 -0400 I think that the previous answers work to describe the idea of CAPA well. It’s basically saying that you will not make the same mistake twice. If you know something is not functioning correctly or well and you continue to…   Read more»

]]> 94f4f128dc3f05953f724ec2b3373eb8 mjf34 replied to the topic "No GMPs" - https://medicaldevicecourses.com/activity/p/12281/ Wed, 15 May 2019 16:54:28 -0400 That’s an interesting question. I think that companies everywhere would be extremely happy to save the money, time, and hassle of going through GMP processes but ultimately, I think that something else would take its place that would not be…   Read more»

]]> 09b1323ac1878449e914c6533cf7f5fa mjf34 replied to the topic "Discussion Topic: When Quality Systems change in the middle of a project" - https://medicaldevicecourses.com/activity/p/12280/ Wed, 15 May 2019 16:54:27 -0400 To me, it would make sense to grandfather old documentation into the new system, as it is. In my previous experience when Quality Systems were changed, it was required that all previous, in-process projects be updated to fit the new…   Read more»

]]> f9403244554d42493582042106d95a10 mjf34 replied to the topic "Discussion Topic: Vagueness of GMP's" - https://medicaldevicecourses.com/activity/p/12279/ Wed, 15 May 2019 16:54:27 -0400 From experience, I’ve found that GMP creates more arguments than anything else within a company and that is because of the ambiguity. The ambiguity lends itself to debate and people tend to get carried away with minor details. Discussions can…   Read more»

]]> 94f83c2ef911f7939a49fef8d7d96da4 mjf34 replied to the topic "Product Life Cycle Curve" - https://medicaldevicecourses.com/activity/p/12239/ Wed, 15 May 2019 16:54:06 -0400 I agree with the above responses- R&D/Development phase seems to be the most expensive stage. The reason being that although one product may make it to the market and produce a great deal of profit for the company, there were…   Read more»

]]> 55a94a44eabe2ec106150812e5b06c93 mjf34 replied to the topic "Interpersonal Skills" - https://medicaldevicecourses.com/activity/p/12238/ Wed, 15 May 2019 16:54:05 -0400 That’s a great question- I agree with your answer and thoughts on it. A big part of selling any item is the feel and confidence that you get when purchasing it but also the factual performance of the product or…   Read more»

]]> 4f59132c710388ebc8089d6df8c68832 mjf34 replied to the topic "product manager role" - https://medicaldevicecourses.com/activity/p/12235/ Wed, 15 May 2019 16:54:04 -0400 Hello, While all are extremely important, I have found that the most important thing for a product manager to know would be to stay informed about the industry and market data. The reason why I say this is because it…   Read more»

]]> 3bc7d625f050bed331bc27103e09b4a3 mjf34 replied to the topic "Discussion Topic: Managing the Product Life Cycle" - https://medicaldevicecourses.com/activity/p/12168/ Wed, 15 May 2019 16:53:27 -0400 One key feature of post-launch product management is having a fully trained, knowledgeable, and enthusiastic sales force. It is important to keep a sale and advertising team up to date but also well-informed on the product because if a sales…   Read more»

]]> 62227edf32c6096bb303092ef52d321e mjf34 replied to the topic "Go or Kill" - https://medicaldevicecourses.com/activity/p/12167/ Wed, 15 May 2019 16:53:26 -0400 That raises a great question. From experience, I was on a project team where we were developing a cough and cold product for the market. At the start of concept, the previous year’s data completely warranted entering the cough and…   Read more»

]]> d6cf3312b8b6371c69077227e5fc3929 mjf34 replied to the topic "Maintenance & validation" - https://medicaldevicecourses.com/activity/p/12089/ Wed, 15 May 2019 16:52:42 -0400 The above posts seem to discuss this well. It is very similar to this week’s simulation: assuming that a machine failed due to machine failure (or nearby machine malfunction), it would most likely not require a new IQ, OQ, PQ…   Read more»

]]> ce12a17f8c57d96b70a467e5b59fd485 mjf34 replied to the topic "Technical Writing Skills" - https://medicaldevicecourses.com/activity/p/12088/ Wed, 15 May 2019 16:52:41 -0400 This brings up a great point- typically, engineers have limited exposure to technical writing. Personally, as an undergraduate, I was not required to take a technical writing course but it was integrated into many courses in the curriculum. However, even…   Read more»

]]> 845dba8573d3cc851d1fe4d711c413e4 mjf34 replied to the topic "Simulation" - https://medicaldevicecourses.com/activity/p/12086/ Wed, 15 May 2019 16:52:40 -0400 I would say that an alternative option to dual sourcing would be to also keep a “cushion” stock or back stock of both the final product and each component. This is often done at times in the industry. To ensure…   Read more»

]]> 8168ee0a3e5e34cea0d15b780fdfe736 mjf34 replied to the topic "Discussion Topic: Post-market surveillance" - https://medicaldevicecourses.com/activity/p/12084/ Wed, 15 May 2019 16:52:39 -0400 It seems like one of the simplest and most cost effective ways to conduct post-market surveillance would be to request feedback from the patients using the device. For example, if the device is a knee replacement, it would be in…   Read more»

]]> 9f73c43bc94b2dd90ef038db927ba18b mjf34 replied to the topic "Standard Operating Procedures (SOP's)" - https://medicaldevicecourses.com/activity/p/12083/ Wed, 15 May 2019 16:52:38 -0400 Great question, Luisa. From previous experience, I, myself, have been responsible while working in the research phase to create SOP’s. This is important even for research and development because SOP’s are needed for operating small scale equipment and testing equipment,…   Read more»

]]> 456a1eaa404580c800a694d0e788e074 mjf34 replied to the topic "SOP: how much detail before too much detail?" - https://medicaldevicecourses.com/activity/p/12082/ Wed, 15 May 2019 16:52:38 -0400 Great question, Chris. I had a similar problem at a previous job when I was responsible for writing and updating SOP’s as well. One problem that I often came across was including troubleshooting instructions in an SOP. As I am…   Read more»

]]> 138680056945481bf438a608cdc9dbf4 mjf34 replied to the topic "Holistic Qualification" - https://medicaldevicecourses.com/activity/p/11971/ Wed, 15 May 2019 16:51:33 -0400 I have heard of holistic qualification before and from my understanding, it is the approach of qualifying a process by qualifying its individual parts. For example if you wanted to qualify a production line of some tablets in a bottle,…   Read more»

]]> 0af04ffc473557742d6464ad4a17797a mjf34 replied to the topic "Process Revalidation" - https://medicaldevicecourses.com/activity/p/11970/ Wed, 15 May 2019 16:51:33 -0400 I have actually run into this at a previous job. We had a similar situation where we would move a piece of equipment from a production area to an R&D area. When needed for production, it would be used there…   Read more»

]]> a778b4f0a1d3fb36443153adaebb1b4b mjf34 replied to the topic "Discussion Topic: Playing with IQ, OQ, PQ" - https://medicaldevicecourses.com/activity/p/11969/ Wed, 15 May 2019 16:51:32 -0400 Syringe Filling Process IQ- Filling machine has working parts, SOP’s, WI’s, calibration schedule, maintenance schedule, meets OSHA standards, has qualified personnel trained on it OQ- Syringes are filled with bone void filler to the same level and amount within a…   Read more»

]]> dc54ab6ff6de46cc4e6e7ad5b07b1772 mjf34 replied to the topic "DHF vs. DHR" - https://medicaldevicecourses.com/activity/p/11779/ Wed, 15 May 2019 16:49:40 -0400 From my experience, your product will almost always require both a DHR and a DHF. The reason being is that one is for the design phase (DHF) and one is for the production phase (DHR). A DHR shows how to…   Read more»

]]> 2c1d85468a4dda12540331c7784f34b3 mjf34 replied to the topic "Discussion Topic: Post-market surveillance" - https://medicaldevicecourses.com/activity/p/11777/ Wed, 15 May 2019 16:49:39 -0400 From my experience, the most post-market surveillance we would receive is from the end user, or the patient. People will often call the company’s main hotline if they have any major complaints. Additionally, doctors, responsible for administering the device, also…   Read more»

]]> fc12456e916edb1c88e2fb2132539367 mjf34 replied to the topic "Discussion Topic: Verification vs. Validation" - https://medicaldevicecourses.com/activity/p/11677/ Wed, 15 May 2019 16:48:39 -0400 Verification is making sure that the product/ device is functional and performs as it should. It entails testing, inspections, and analysis. Validation is making sure that the product/device is useful and meets the needs of a consumer. It ensures that…   Read more»

]]> 2d57cc34442c44620282b1fef3daf722 mjf34 replied to the topic "DHF vs. Tech File/Design Dossier" - https://medicaldevicecourses.com/activity/p/11671/ Wed, 15 May 2019 16:48:36 -0400 In my opinion, the tech file/dossier is more useful. The reason being is that it gives an overview to the entire product and design and is most useful to someone that was not heavily involved in the device’s development. This…   Read more»

]]> 7149f1e359b788a023a60d234a67556d mjf34 replied to the topic "Discussion Topic: Is the DHF a living document?" - https://medicaldevicecourses.com/activity/p/11670/ Wed, 15 May 2019 16:48:35 -0400 I think that the DHF should be a live document. The reason being that from experience, the original idea of the device is rarely ever the outcome. While it may be useful to have a document of the thought process,…   Read more»

]]> 06e900e2df19a2466a0befd73c6f9cf8 mjf34 replied to the topic "Discussion Topic: Easier regulatory in EU?" - https://medicaldevicecourses.com/activity/p/11633/ Wed, 15 May 2019 16:48:16 -0400 I would tend to say that device approval is easier in the EU because it is faster. And it is faster because it is simpler and is based on a checklist that leaves little room for gray area and saves…   Read more»

]]> cd79722298c94469d9376ca68ad49e74 mjf34 replied to the topic "Guidance Documents" - https://medicaldevicecourses.com/activity/p/11615/ Wed, 15 May 2019 16:48:06 -0400 I would say that NB-MED guidance documents are the most useful to follow. The notified bodies have the power to inspect devices and can lead to a suspension or halted sale of the product. This can cost a company a…   Read more»

]]> 65a14e1a0aecdb2a593a680272547a53 mjf34 replied to the topic "Combination Products in EU" - https://medicaldevicecourses.com/activity/p/11613/ Wed, 15 May 2019 16:48:05 -0400 Great question, Fady! I have some experience with filing combination drug product in the EU. One instance, in particular, that comes to mind is a topical gel for scarring that was accompanied by a massaging applicator. The purpose of the…   Read more»

]]> 4d940802b87d9aecfdfbb9c97151c4da mjf34 replied to the topic "Primary Mode of Action (PMOA)" - https://medicaldevicecourses.com/activity/p/11520/ Wed, 15 May 2019 16:45:38 -0400 Hello Fady, I have a small amount of experience in working with PMOA’s for combination products. In my experience, I have worked with drug/device PMOA’s and the separation of two drugs until consumer use (for example: two active vitamins are…   Read more»

]]> 6efa6c89703c35d86d463b25bc8a29c4 mjf34 replied to the topic "Discussion Topic: Your Field or Profession" - https://medicaldevicecourses.com/activity/p/11519/ Wed, 15 May 2019 16:45:37 -0400 Hello, Previously, I worked in the OTC pharmaceutical field but since becoming a full time graduate student, I have a stemmed interest in medical devices for women’s health and have recently become involved in a project focusing on intrauterine devices…   Read more»

]]> c501fe3789fa2c91cfbeed82b652e158 mjf34 replied to the topic "Legal Contracts" - https://medicaldevicecourses.com/activity/p/11513/ Wed, 15 May 2019 16:45:34 -0400 Hello Andrew When I worked in industry and had trouble getting contracts signed and have input on everything, I would often request a meeting. It usually wasn’t in person, and that wasn’t necessary anyway. Typically, I would gather a lawyer…   Read more»

]]> 9b67ec788cc6c9c850cea84cda3fe406 mjf34 posted a new topic "Product Failure" - https://medicaldevicecourses.com/activity/p/10490/ Wed, 15 May 2019 16:33:57 -0400 In this week’s lecture, Dr. Simon discusses some reasons as to why a product can fail on the market. Can you describe an experience that you have had with a product failure? (Either from a development standpoint, before it reached…   Read more»

]]> 42524dcf36e093a834e371fd28bc6901 mjf34 posted a new topic "Discussion Topic: ECO's" - https://medicaldevicecourses.com/activity/p/10447/ Wed, 15 May 2019 16:33:38 -0400 Hi Everyone, This week, Dr. Simon talked about ECO’s (Engineering Change Orders) and how they are used to change something about the medical device after the design controls are finished. This can be a result of a few things, whether…   Read more»

]]> 95da6a576078c2ec58979504ee67c121 mjf34 replied to the topic Types of Clinical Studies in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2444/ Tue, 25 Apr 2017 18:12:18 -0400 I’ve been involved in double blind and randomized studies. In the randomized study, we actually ran into an issue where the trial was cancelled. For this study, active ingredient material was administered to some patients and placebo to others. The problem was that the placebo had a very minor difference to the active material and when patients c…[Read more]

]]> 0 8f1730889da574ff0f484d27d819341e mjf34 replied to the topic Unexpected Clinical Study Results in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2441/ Tue, 25 Apr 2017 18:06:57 -0400 One example of what could shut down a clinical study is an adverse side effect, such as an allergic reaction. I’ve seen one clinical trial put on pause because one participant had a severe allergic reaction to the material being administered and it was thought that the whole group was at high risk but it ended up just being this one particular p…[Read more]

]]> 0 d11d4339f04d5d83732e3d0d4628398c mjf34 replied to the topic career path in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2440/ Tue, 25 Apr 2017 18:01:43 -0400 I’m not sure if clinical research would be the path for me either. I have some experience in creating clinical trial material and I did not enjoy it. It was very tedious and the amount of paperwork involved was enough to make your head spin. The other thing to take into account is the huge liability involved with a clinical trial, which puts a l…[Read more]

]]> 0 8ded9103d60b7d6bfc30f76f1c43f396 mjf34 replied to the topic Clinical Study Location/cost vs. results in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2383/ Sun, 23 Apr 2017 12:56:17 -0400 I’m not sure if cost would be the leading purpose for conducting a clinical study in a developing country but regulations and target audience would probably be. For example, a researcher interested in conducting a study focused around the ZIKA virus would be much better off in a South American country like Brazil, where the disease is much more p…[Read more]

]]> 0 2c4dbb0ce7db881c67801900fa5a5cb8 mjf34 replied to the topic Consent and predicted outcome in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2324/ Tue, 18 Apr 2017 15:02:54 -0400 One example of this that I have heard about has been thalidomide. Thalidomide was used to treat nausea and morning sickness in pregnant women in the 1950’s. Previous studies in mice showed that thalidomide was not a risk in mice, but it is in humans. It caused limb deformities/absence and phocomelia in the unborn babies and was withdrawn from t…[Read more]

]]> 0 5b2d2e422d8620737182222ab3a61e2b mjf34 replied to the topic CROs in the forum Clinical Trials for Medical Devices https://medicaldevicecourses.com/activity/p/2323/ Tue, 18 Apr 2017 14:52:29 -0400 Great question- I would have to say that if I were a sponsor, I would not want to transfer the responsibilities of: selecting monitors & investigators and overall managing/checking investigators. The reason why I selected these was because most of the other work that a sponsor is responsible for can usually be learned very quickly, such as record…[Read more]

]]> 0 e2f3273c4fa6165f19f5cf6457b46dbf mjf34 replied to the topic Improving GMPs in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2240/ Fri, 14 Apr 2017 17:52:25 -0400 From experience, I have seen GMP documents get updated fairly often and the reason for them being updated is usually because the previous instructions were unclear and created confusion. I have also seen GMP standards updated for technology updates, or building updates, such as a wash room being moved, and as a result, different tools were needed…[Read more]

]]> 0 51c3eed7b94bf7a6cc8394e2e1aa4bf9 mjf34 replied to the topic Audits in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2239/ Fri, 14 Apr 2017 16:12:32 -0400 Great question, neb2.

I’ve been a part of an internal audit once before and the main advantage that I saw as a result was that it introduced to everyone what an external audit would be like and it trained multiple employees on how to handle audit questions and answers. As Dr. Simon said in the lecture, external audits can carry on for quite s…[Read more]

]]> 0 7d7ae800907307691af769a2b5ef1084 mjf34 replied to the topic CAPA in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2238/ Fri, 14 Apr 2017 15:15:20 -0400 I think that the previous answers work to describe the idea of CAPA well. It’s basically saying that you will not make the same mistake twice. If you know something is not functioning correctly or well and you continue to do it wrong, it would make sense the FDA (or governmental figure) would not be willing to overlook. In a way, it is a p…[Read more]

]]> 0 715ab0384ae986173b1b34a1bfd142ba mjf34 replied to the topic No GMPs in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2121/ Fri, 07 Apr 2017 01:47:25 -0400 That’s an interesting question. I think that companies everywhere would be extremely happy to save the money, time, and hassle of going through GMP processes but ultimately, I think that something else would take its place that would not be required but make a company more competitive to have those standards. For example, similar to how the CE m…[Read more]

]]> 0 b27f503191c231fe81a2e6f713c8e91b mjf34 replied to the topic Discussion Topic: When Quality Systems change in the middle of a project in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/2120/ Fri, 07 Apr 2017 01:39:28 -0400 To me, it would make sense to grandfather old documentation into the new system, as it is. In my previous experience when Quality Systems were changed, it was required that all previous, in-process projects be updated to fit the new system. In hindsight, this seemed like the direction to go since it would save time later, but ultimately it did…[Read more]

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