Medical Device Courses | asn99 | Activity

asn9 replied to the topic "Types of Clinical Studies" -

Wed, 15 May 2019 16:57:31 -0400

Hi mjf34, That is a really interesting example. I have always wondered what the negative outcome would be of attempting to complete a double blind study. However your example of the group becoming bias based on the experimental group and… Read more»

asn9 replied to the topic "AMDD" -

Wed, 15 May 2019 16:57:30 -0400

Hi All, I would agree that both MDD and AMDD are very useful and practical classes. Working in the pharmaceutical industry, I even saw the great benefit. I believe that these courses, or similar ones, should be a mandate for… Read more»

asn9 replied to the topic "Simulation Experience" -

Wed, 15 May 2019 16:57:29 -0400

Hi All, The thoughts above were great, and I would have to agree that I have learned much from the simulations. One of the main things was simply how to better work with a team in solving problems. While I… Read more»

asn9 replied to the topic "Significant risk vs Non-significant Risk" -

Wed, 15 May 2019 16:56:31 -0400

Hi All, I would agree with the examples and the points given above. I believe that SR vs. NSR is really determined by a combination of the classification of the device and the application of the device. As was mentioned… Read more»

asn9 replied to the topic "Consent and predicted outcome" -

Wed, 15 May 2019 16:56:12 -0400

Hi All, I found that interesting as well. I believe the partial answer to your question is that there are unexpected results sometimes, even if extensive animal trials have been done. There can be cases where we would expect certain… Read more»

asn9 replied to the topic "CROs" -

Wed, 15 May 2019 16:56:11 -0400

Hi All, This is a very good question. I actually work with a company that helps Pharmaceutical companies to connect with CROs and I found it quite surprising how much they are willing to outsource through these companies. Many of… Read more»

asn9 replied to the topic "CAPA" -

Wed, 15 May 2019 16:55:23 -0400

Hi All, I would agree with the many point above made about CAPA. Since first learning about I can truly see why it is needed in companies to repair non-conforming products. It is really a system designed to prevent and… Read more»

asn9 replied to the topic "Audits" -

Wed, 15 May 2019 16:55:23 -0400

Hi All, I would agree with the points made above and believe that they highlight the main pros and cons. I would also agree that it is largely up to the company to decide how they would like to conduct… Read more»

asn9 replied to the topic "Improving GMPs" -

Wed, 15 May 2019 16:55:16 -0400

Hi All, Thank you very much for your input on this question. I would agree that when a company’s technologies are updated the GMPs must then be kept up to date. When these updates in technology occur, they can drastically… Read more»

asn9 replied to the topic "Discussion Topic: When Quality Systems change in the middle of a project" -

Wed, 15 May 2019 16:54:36 -0400

Hi All, I think the best way to make this change is to grandfather in some projects, but making a specific completion percentage for the projects. For example if a DHF is complete and Design Transfer is complete then the… Read more»

asn9 replied to the topic "No GMPs" -

Wed, 15 May 2019 16:54:26 -0400

Hi All, This is a very interesting question about the GMP process. I believe that if all companies had the choice between GMP and no GMP, there would be those that choose no GMP. These companies would be able to… Read more»

asn9 replied to the topic "Discussion Topic: Vagueness of GMP's" -

Wed, 15 May 2019 16:54:24 -0400

Hi All, Yes, I believe that the ambiguity of GMP’s make it difficult for start-up companies that do not have pre-existing GMPs; however I do not believe it simply sets them up for failure. The ambiguity of the GMPs allow… Read more»

asn9 replied to the topic "Product Life Cycle Curve" -

Wed, 15 May 2019 16:54:12 -0400

Hi All, I would agree that in many products the R&D/Development can be very expensive. However I would say with many products that the introduction phase can be just as costly. If a product needs a lot of marketing to… Read more»

asn9 replied to the topic "Interpersonal Skills" -

Wed, 15 May 2019 16:54:12 -0400

Hi All, Thank you for the question as well as the comments so far. I believe that, as stated above, both interpersonal skills and business skills are needed to close a deal. To give an example, I currently have a… Read more»

asn9 replied to the topic "Product Failure" -

Wed, 15 May 2019 16:54:11 -0400

Hi All, I have not had personal experience with a product recall; however one I remember quite well is the Toyota recall of many of its cars. The pedals had the tendency to stick, causing many accidents. Over 4.1 million… Read more»

asn9 replied to the topic "product manager role" -

Wed, 15 May 2019 16:53:42 -0400

Hi All, I would agree with the comments above that each role is important and it is difficult to say which would be most important. However, one that I believe is often overlooked, but still extremely important is the creating… Read more»

asn9 replied to the topic "Go or Kill" -

Wed, 15 May 2019 16:53:26 -0400

Hi All, Thank you very much for your interesting question, I had not thought about this instance in the past. However I believe that it would make the most sense for a company to kill a project if it will… Read more»

asn9 replied to the topic "Discussion Topic: Managing the Product Life Cycle" -

Wed, 15 May 2019 16:53:21 -0400

Hi All, I was thinking about the Planning and Development phase of the Product Life Cycle. One of the most important aspect in this phase is the market and the evaluation of the market. Ensuring that the market is a… Read more»

asn9 replied to the topic "Validation Expiration" -

Wed, 15 May 2019 16:52:26 -0400

Hi All, This is a very interesting question that I had not thought about before. As was mentioned above if any changes, upgrades, or repairs occur on a machine it would need to be re-validated. However if no changes were… Read more»

asn9 replied to the topic "Comparing Knowledge of FDA, EU, etc before and after this course" -

Wed, 15 May 2019 16:52:25 -0400

Hi All, Thank you for the great question. I feel these classes have greatly benefited me as well. I work mainly in the pharmaceutical side of the industry, with very little done in medical devices. However taking these courses, I… Read more»

asn9 replied to the topic "Simulation" -

Wed, 15 May 2019 16:52:01 -0400

Hi All, I would agree that this simulation really shows the importance of having multiple vendors. It will limit delays like this and allows you to always have a backup plan. When only one vendor has been selected, you are… Read more»

asn9 replied to the topic "Process Revalidation" -

Wed, 15 May 2019 16:51:24 -0400

Hi All, I do not have personal experience in this area however I could see why the quality team would argue that when equipment is moved all processes had to be revalidated. Most likely they were concerned that when equipment… Read more»

asn9 replied to the topic "Discussion Topic: Differences between ISO and FDA" -

Wed, 15 May 2019 16:51:15 -0400

Hi All, I believe that both require full verification of the process, but at different times. The FDA definition seems to be requiring full verification of the process by inspection and test, or 100% testing of a process. However taking:… Read more»

asn9 replied to the topic "Discussion Topic: Playing with IQ, OQ, PQ" -

Wed, 15 May 2019 16:51:04 -0400

Hi All, After viewing the lecture for this week, I have thought about the IQ, OQ, and PQ for the Syringe Filling Process – filling syringes with an injectible bone void filler. IQ – meets specs including the amount of… Read more»

asn9 replied to the topic "SOP: how much detail before too much detail?" -

Wed, 15 May 2019 16:50:17 -0400

Hi All, I would agree with those that stated the SOPs should contain as much information as possible. As soon as something is left up for interpretation, issues can occur. When issues occur and the individual followed the SOP to… Read more»

asn9 replied to the topic "Standard Operating Procedures (SOP's)" -

Wed, 15 May 2019 16:50:16 -0400

Hi All, I would agree with those that stated SOPs should be required during the research phase. Working for a start-up we did not have many SOPs in place. As more were hired we learned the hard way that without… Read more»

asn9 replied to the topic "DHF vs. DHR" -

Wed, 15 May 2019 16:49:40 -0400

Hi All, My best understanding is that the Design History File (DHF) contains all information about the development of the the product, as the design is created. It contains all inputs, outputs, and protocols. The Device History Record (DHR) is… Read more»

asn9 replied to the topic "Discussion Topic: Post-market surveillance" -

Wed, 15 May 2019 16:49:25 -0400

Hi All, Post Market Surveillance is simply the process of monitoring a device after it is part of the market. It includes many aspects of a medical device, like device failure. There are even requirements for some Class II and… Read more»

asn9 replied to the topic "Discussion Topic: ECO's" -

Wed, 15 May 2019 16:49:24 -0400

Hi All, Thank you very much for this interesting topic. I have not worked too much with ECOs; however I do have a bit of experience. I have needed an ECO in the past for a change of an SOP…. Read more»

asn9 replied to the topic "Discussion Topic: Verification vs. Validation" -

Wed, 15 May 2019 16:48:30 -0400

Hi All, Verification and validation of a process includes making sure that process and all aspects of it are meeting the correct specifications. As was stated above this would involve ensuring that equipment used during testing is giving accurate results…. Read more»

asn9 replied to the topic "Discussion Topic: Is the DHF a living document?" -

Wed, 15 May 2019 16:48:30 -0400

Hi All, I would say that the school of thought that appeals to me most is that the DHF is not a living document. As small processes change over time they can be inserted into the DMR, but not change… Read more»

asn9 replied to the topic "Discussion Topic: Easier regulatory in EU?" -

Wed, 15 May 2019 16:48:08 -0400

Hi All, I was thinking of one way that getting a medical device approved in the EU may be more difficult than in the USA and only thought of one: It may be difficult for a small, US based company… Read more»

asn9 replied to the topic "Discussion Topic: Easier regulatory in EU?" -

Wed, 15 May 2019 16:47:54 -0400

Hi All, I would agree that devices would be easier to get approved in the EU for a number of reasons. The main reason being that the classification is purely based on a checklist and risk. This allows a device… Read more»

asn9 replied to the topic "Multi-Center Clinical Studies" -

Wed, 15 May 2019 16:45:36 -0400

Hi Fady and Luisa, I would agree that it is a difficult measurement to simply say that every time a certain number. However I would agree with Luisa that a study needs to be clearly defined and there needs to… Read more»

asn9 replied to the topic "Discussion Topic: Your Field or Profession" -

Wed, 15 May 2019 16:45:12 -0400

Hi All, I currently work in the pharmaceutical industry assisting pharmaceutical companies to outsource their pre-clinical research. I have also looked into medical device research outsourcing as well. One of the main trends I can see is the outsourcing pre-clinical… Read more»

asn9 replied to the topic "Restrictions for physician's gifts" -

Wed, 15 May 2019 16:44:15 -0400

Hi All, Thank you very much for the very interesting topic. I would agree that the restrictions in theory seem to be very strict. However I would agree with the level that they are set at. This is due to… Read more»

asn9 replied to the topic "Written Agreement v/s Verbal Agreement" -

Wed, 15 May 2019 16:44:05 -0400

Hi All, As the previous posted mentioned a written contract is greatly needed if any piece of the matter needs to be protected from a legal point of view. Oral contracts are extremely difficult to defend in court as it… Read more»

asn9 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Wed, 15 May 2019 16:43:59 -0400

Hi All, I believe that this was a very interesting course. As others previously mentioned, I believed that it would be a course that would involve more about theory of medical devices. I found this course very useful, as I… Read more»

asn9 replied to the topic "Project Management Preferences" -

Wed, 15 May 2019 16:43:12 -0400

Hi All, I would agree that all who posted that stated a Matrix organization would be ideal. This is due to the fact that a project based organization puts much responsibility on the project manager and their team. In an… Read more»

asn9 replied to the topic "Organization types of medical devices?" -

Wed, 15 May 2019 16:41:00 -0400

Hi All, I would say that the best type of organization would depend on the specific company, but I would consider starting as a matrix organization. As a matrix organization, everyone would know each other, and knowledge would transfer well…. Read more»

asn9 replied to the topic "Discussion Topic: Your organizational type" -

Wed, 15 May 2019 16:40:59 -0400

Hi All, Currently I work for a Matrix Organization. While I work currently as a Functional Manager because we are a start-up we work on many other side projects. This allows for many of the functional managers to become project… Read more»

asn9 replied to the topic "Risk Identification" -

Wed, 15 May 2019 16:39:51 -0400

Hi All, At my company we have a similar setup as was mentioned previously: 1- Documentation Reviews 2- Information Gathering Techniques like Brainstorming, Delphi Technique, Interviewing, Root cause analysis 3- Checklist analysis – previous similar project, lowest level RBS 4-… Read more»

asn9 replied to the topic "Risk management and Labels" -

Wed, 15 May 2019 16:39:45 -0400

I would agree with Dr. Simon that it makes sense why labeling would not be considered a strong way to mitigate risk. While warning and instruction labels are important, it is also up to the company to ensure that the… Read more»

asn9 replied to the topic "Risk analysis in real company" -

Wed, 15 May 2019 16:39:33 -0400

Thank you very much for the interesting question. I would agree with Tarek that determining the risk associated with a project is a team effort. Each member of the team may be able to evaluate different risks with the device…. Read more»

asn9 replied to the topic "Making up tests for design verification and validation" -

Wed, 15 May 2019 16:38:13 -0400

Hi Roberto, After doing some research, I was able to find that the FDA does not demand specific tests, but establishes guidelines for developing design controls, design validation, and design verification. Looking through the site briefly it seems that much… Read more»

asn9 replied to the topic "Minutes for meetings" -

Wed, 15 May 2019 16:38:12 -0400

Hi Roberto, Thank you very much for your question. I would agree with Dr. Simon that meeting minutes are extremely important. I have been in meetings may times where tasks have been assigned and deadlines have been established. Oftentimes if… Read more»

asn9 replied to the topic "Design Transfer and Challenges" -

Wed, 15 May 2019 16:38:04 -0400

Hi All, I wanted to elaborate a little on a point that was made about the difficulty of the purchasing department not not having enough time to identify and approve new vendors, as this can be a major difficultly in… Read more»

asn9 replied to the topic "Consequences Of Insufficient Design Controls" -

Wed, 15 May 2019 16:36:55 -0400

Hi Lamiaa, Thank you for your questions and the examples provided by the others. I believe that one main issue that would occur is that the project would be extremely disorganized and would be greatly delayed. The different areas of… Read more»

asn9 replied to the topic "Important Part of DDP" -

Wed, 15 May 2019 16:36:49 -0400

Thank you very much for your interesting question. I would agree with Tarek that it is difficult to choose which area of the DDP is most important, but the Gantt Chart is extremely useful. As Tarek mentioned, it really outlines… Read more»

asn9 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" -

Wed, 15 May 2019 16:36:45 -0400

Yes, Design Controls would be needed for a medical device in the EU. While there would be no DHF needed in the EU, most of the parts of design controls would still be needed, such as the: PDF, DDP, DID,… Read more»