https://medicaldevicecourses.com/members/julienneviuya/activity/ Activity feed for julienneviuya. Fri, 24 Apr 2026 21:58:15 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ba45a888f5519437fed1c64e8fdcfeda https://medicaldevicecourses.com/activity/p/16017/ Wed, 15 May 2019 19:16:11 -0400 I believe that MDD and AMDD have been essential to my coursework here at NJIT. I am currently working in manufacturing engineering at a medical device company. In the manufacturing department of a medical device company, it is all about…   Read more»

]]> 9f479852acec89479c65629722d6ae03 https://medicaldevicecourses.com/activity/p/16014/ Wed, 15 May 2019 19:16:10 -0400 I appreciated going through the simulations each week. It was a more hands-on experience of everything that the course has been teaching through lectures. Using my current industry experience, I have been able to suggest logical solutions. In the opposite…   Read more»

]]> 71108987a921140ae4fb34fef9276ac1 https://medicaldevicecourses.com/activity/p/15876/ Wed, 15 May 2019 19:14:51 -0400 I am not personally involved in the clinical aspect of medical device development. However, in the future I would like to at one point be part of this process as it seems to be very interesting. In the previous course,…   Read more»

]]> d307e62c4988449dc290bd9a91741b51 https://medicaldevicecourses.com/activity/p/15875/ Wed, 15 May 2019 19:14:51 -0400 Executing a clinical trial can take large budgets to complete. To compete with this, companies tend to use developing countries as their regulations are less strict or even non-existent. The location of these trials makes a difference, however. For example,…   Read more»

]]> 406232f811b9f9bc2038a5ecb8f1ef07 https://medicaldevicecourses.com/activity/p/15874/ Wed, 15 May 2019 19:14:50 -0400 If the subject were to undergo unexpected outcomes and no longer wants to take part in the trial, it is up to their discretion to continue or to end their treatment. Informed consent includes consent throughout the entirety of the…   Read more»

]]> 73c6181059ad20d846a9034cfe2073dd https://medicaldevicecourses.com/activity/p/15732/ Wed, 15 May 2019 19:13:22 -0400 With management, it is important to be open to communication while still maintaining a high level of respect. It is possible that since management is so far removed from the lower levels of the chain, they are blind to the…   Read more»

]]> 669d3b835191c580d6d9df0923ce043a https://medicaldevicecourses.com/activity/p/15731/ Wed, 15 May 2019 19:13:22 -0400 Non-conformance can occur at any point in the production process, and this does not always indicate the need for a CAPA. A non-conformance for a singular unit of the device can just indicate a minor human error from an operator….   Read more»

]]> e353d7ab31d208ed9348ddc40b00fbc6 https://medicaldevicecourses.com/activity/p/15730/ Wed, 15 May 2019 19:13:21 -0400 In my experience, a correction can also be called a rework in which the product is fixed for a nonconformity. In the medical device industry, this would mean fixing the medical device before it even leaves the production floor. For…   Read more»

]]> 5e868dc6b2f9786f0e89de8307dbe8aa https://medicaldevicecourses.com/activity/p/15675/ Wed, 15 May 2019 19:12:47 -0400 Depending on how established the company is, GMPs may be constantly under appraisal in order to refine them. The changes can range from a minor difference in recording something to entirely modifying the system in place for the company’s QSR….   Read more»

]]> 56a475f6ad71b5b6944e415ab85f9252 https://medicaldevicecourses.com/activity/p/15674/ Wed, 15 May 2019 19:12:46 -0400 The purpose of CAPAs is to ensure that the product is up to the highest consumer standards. The preventative actions are required to foresee every possible negative outcome. These preventative actions are used to anticipate what can go wrong and…   Read more»

]]> ea8dbe72c04507683532fbec06dcee53 https://medicaldevicecourses.com/activity/p/15673/ Wed, 15 May 2019 19:12:45 -0400 Internal audits are essential to medical device companies because this creates a controlled environment in which the company can comprehensively evaluate how they are doing in terms of their Quality System. Internal audits are less variable than one from a…   Read more»

]]> f059eb8f767198c29781597b35ac507f https://medicaldevicecourses.com/activity/p/15594/ Wed, 15 May 2019 19:08:02 -0400 During the maturity phase of the product life cycle, it is important to be FDA and EU compliant. This product is now on the market and is used for real people. These FDA and EU guidelines are in place to…   Read more»

]]> 9161524851e2b4de6505a2d57a1fb9eb https://medicaldevicecourses.com/activity/p/15593/ Wed, 15 May 2019 19:08:01 -0400 Since the development phase of production is one of the most expensive parts of production, I think a company, depending on their resources and priorities, should consider killing the project. This can vary from company to company, for example a…   Read more»

]]> bad3ee4b9962a079c9edaed2dd4c35f5 https://medicaldevicecourses.com/activity/p/15592/ Wed, 15 May 2019 19:08:01 -0400 It is essential to have both accurate business knowledge as well as good interpersonal skills. This comes from any point of sales in any aspect, everything from clothing retail to medical device sales. In order to first develop a bond…   Read more»

]]> 3f5ba5f6221af78bac5c034ceb8b0f17 https://medicaldevicecourses.com/activity/p/15552/ Wed, 15 May 2019 19:07:34 -0400 I find that the development phase can be the more expensive phase as not every investment made during this phase will ultimately have a pay off or even lead down the path that the company wants to go down. This…   Read more»

]]> f91e76738f1bf193ce6e540ce9f85f9e https://medicaldevicecourses.com/activity/p/15496/ Wed, 15 May 2019 19:07:00 -0400 There is always a push and pull between keeping companies as is, and moving forward towards innovation. In my experience, there has always been individuals that have been in place for so long that they lack the motivation to change….   Read more»

]]> ab267507245d742008a78ba4181890b2 https://medicaldevicecourses.com/activity/p/15495/ Wed, 15 May 2019 19:06:59 -0400 I have had experience with obsoleting product in my company that had been cumbersome to carry as a product. These were product that had not been making the amount of money that was worth the cost of production. The undertaking…   Read more»

]]> 2d27a2795be82016bca2508b6d655e94 https://medicaldevicecourses.com/activity/p/15357/ Wed, 15 May 2019 19:05:32 -0400 It would vary with each company, but even if the equipment does not go through the entire validation process again, it does have to keep up with calibration expiration as well as preventive maintenance at scheduled intervals. With these routine…   Read more»

]]> d7af244187cb1892b497fe56fd43d87c https://medicaldevicecourses.com/activity/p/15356/ Wed, 15 May 2019 19:05:31 -0400 It is important to have preventative action in medical devices because once a negative effect happens, it has already been out on the market if it was not prevented and this could cost lives. Reactive action is important but it…   Read more»

]]> d502fef68aa9949028267115826601f4 https://medicaldevicecourses.com/activity/p/15160/ Wed, 15 May 2019 19:03:34 -0400 I have come across this issue with a certain gauge that was applicable to several parts of the production process. The manufacturing department argued that it can just be specified that this gauge has several locations but still performs the…   Read more»

]]> ba5eed45f2ab3e8d3fdbb64fe2ac67de https://medicaldevicecourses.com/activity/p/15159/ Wed, 15 May 2019 19:03:34 -0400 I agree with the posts above, depending on the degree of failure and the complexity of the machine, it may need to undergo IQ OQ PQ again to ensure safety and efficacy. However, if it is just undergoing routine maintenance…   Read more»

]]> ff97b03c4bbca0ca7d79611819dc7904 https://medicaldevicecourses.com/activity/p/15158/ Wed, 15 May 2019 19:03:33 -0400 In my undergraduate experience, I took Capstone which was a two-semester long simulation of what industry is like. This class exposed me to technical writing in order to make clear and concise documentations. My professor would use the term “idiot-proof”…   Read more»

]]> 00976e2f460ddc9af79a35190eb16540 https://medicaldevicecourses.com/activity/p/14936/ Wed, 15 May 2019 19:01:31 -0400 There is a vast difference between the Design History File (DHF) and the Device History Record (DHR). Once the timeline during which these are created is understood, the difference is apparent. The Design History File is created during the product…   Read more»

]]> dfc39bd983424d2d5c2ccc09fe655984 https://medicaldevicecourses.com/activity/p/14935/ Wed, 15 May 2019 19:01:31 -0400 Our company uses ECOs and refers to them as Change Notices, as these can be originated by non-engineering as well. These CNs serve to make revisions to any document in the Quality Management System, including but not limited to SOPs,…   Read more»

]]> 8b226e19f70f51c877405275de1b187f https://medicaldevicecourses.com/activity/p/14809/ Wed, 15 May 2019 19:00:17 -0400 Regarding verification and validation themselves, the difference lies in what is being confirmed. Verification is the confirmation that the design output meets the design input requirements. Verification is showing that what the project defined as their requirements of the design…   Read more»

]]> 7a1f4069813912bb278a8ed7a044c2ef https://medicaldevicecourses.com/activity/p/14808/ Wed, 15 May 2019 19:00:16 -0400 I agree with the above points that this debate would have to be on a case by case basis. If there is a failure in V&V testing, it is primarily important to make sure that your testing method itself is…   Read more»

]]> cd64a2c38d44d971e93d109787e759a1 https://medicaldevicecourses.com/activity/p/14807/ Wed, 15 May 2019 19:00:16 -0400 It is most sensible for the DHF to be a living document, as updates are made and the design revised, it must be permanently logged. Even post design transfer, it is important to update the origin of these designs so…   Read more»

]]> f636912b69edd5a748c8dc04087c21f9 https://medicaldevicecourses.com/activity/p/14689/ Wed, 15 May 2019 18:59:13 -0400 I would consider the NB-MED guidance document to be the most useful and most powerful. This is based on the governing power that writes said document. The NB-MED guidance documents are written by the Notified Bodies, which have more central…   Read more»

]]> f160101bd4a2422bdf2cf5453a118861 https://medicaldevicecourses.com/activity/p/14682/ Wed, 15 May 2019 18:59:09 -0400 It is apparent that it is easier to have a medical device approved in the EU versus in the US, possibly due to the simplified yet still effective method of approval. Where the FDA takes into consideration devices being safe…   Read more»

]]> b2d0171d06b6a324a6ab5e60e1fff79a https://medicaldevicecourses.com/activity/p/14381/ Wed, 15 May 2019 18:55:37 -0400 I have not personally had this experience as it is early on in my career. However, I do have a colleague who interned at Zimmer Biomet, and as a result, the non-compete agreement had barred him from applying and working…   Read more»

]]> e046acb29233fad7ecc2205e5531bffa https://medicaldevicecourses.com/activity/p/14379/ Wed, 15 May 2019 18:55:36 -0400 From my understanding, you would need to first have a patent to protect your ideas. An NDA protects you from other people that get involved in the project. You may need to have both to fully protect your ideas, especially…   Read more»

]]> 0739b3278f879b2895d711993e778eec https://medicaldevicecourses.com/activity/p/14378/ Wed, 15 May 2019 18:55:35 -0400 The restriction of physician’s gifts is a guideline for companies to follow to avoid being accused of bribery or influencing their decision to be involved with a project. While it is a bit strict and some may find it unnecessary,…   Read more»

]]> b6f0a6e332006e6f22fbc08daec5d33a https://medicaldevicecourses.com/activity/p/14271/ Wed, 15 May 2019 18:54:38 -0400 I believe from the point of view of a project manager, it can be the most challenging to work in a matrix organization. This comes from the conflict of everyone having at least two distinctly separate bosses. The project manager…   Read more»

]]> 691d86d544494e5e25ef011a9d2064c1 https://medicaldevicecourses.com/activity/p/14270/ Wed, 15 May 2019 18:54:37 -0400 I currently work in a functional organization, which to my understanding is the most traditional form of business organization. There are functional managers of each department, such as Manufacturing, Quality, Purchasing, and R&D. Within these, there are individual staff members…   Read more»

]]> c39b0d5ff93468fa3521cc6eb89681b4 https://medicaldevicecourses.com/activity/p/14268/ Wed, 15 May 2019 18:54:36 -0400 When forming a project team, it is important to consider someone’s skill as well as their personable skills. It is important to get along well with everyone on the team. It is not always ideal to choose close friends as…   Read more»

]]> cbf49fd73ee0d7873a7019763bb28244 https://medicaldevicecourses.com/activity/p/14135/ Wed, 15 May 2019 18:52:21 -0400 I think in the context of any other field, As Far As Possible is daunting and almost unattainable. However, in medical devices and anything else regulated by the FDA, it is necessary. The goal of the FDA is to have…   Read more»

]]> 4baef06785e0dd102725b7ef27d79ac2 https://medicaldevicecourses.com/activity/p/14133/ Wed, 15 May 2019 18:52:19 -0400 It seems like a fair trade-off, especially for more established companies that know what their goals and needs are. However, for new companies like start ups, it would make sense to have some way to rent the material before purchasing…   Read more»

]]> 80a96618287d7bf95deb0c4d81b6adb8 https://medicaldevicecourses.com/activity/p/14109/ Wed, 15 May 2019 18:52:00 -0400 Our company uses FMEA, which only differs from the acronym for FMECA by the one word “criticality”. In an FMEA, the Failure Mode Effects Analysis addresses potential risks of the product, whether in production or distribution. There is an extensive…   Read more»

]]> a33a12ee393aff47fb2d9a2def65e1e7 https://medicaldevicecourses.com/activity/p/14016/ Wed, 15 May 2019 17:10:27 -0400 The ultimate goal of the FDA is to ensure that products are safe and effective. These are the two most crucial factors of a medical device. For design control systems, the FDA is making sure that every phase in the…   Read more»

]]> bc813194044a9662b43c0e5373b2f118 https://medicaldevicecourses.com/activity/p/14014/ Wed, 15 May 2019 17:10:26 -0400 I am currently in Capstone I, and we have completed the phase of customer needs and business requirements. This phase is very similar to the process in industry, as we are learning in the course. Through gathering customer needs, we…   Read more»

]]> 5a3132e44a8d170bbf41bd928fb22993 https://medicaldevicecourses.com/activity/p/14012/ Wed, 15 May 2019 17:10:24 -0400 I support @bb254‘s description of the process of design review meetings. While I am not yet an engineer, as a co-op I am often tasked with preparing the data and materials before an engineer’s design review meeting. For example I…   Read more»

]]> 46c9bbdc3619cfa2e8126fc4a0d2077a https://medicaldevicecourses.com/activity/p/13926/ Wed, 15 May 2019 17:09:28 -0400 As mentioned above, design review meetings happen at various points during a project, usually towards the end. In my experience in production engineering, however, design review meetings are conducted once a week and attended to by every engineer and upper…   Read more»

]]> e50e0454b03c0d3a30e86b304e974f98 https://medicaldevicecourses.com/activity/p/13921/ Wed, 15 May 2019 17:09:25 -0400 Currently in capstone this semester, I see the importance of the business requirements. We have yet to create test plans for our device. Through the detailed business requirements, someone not familiar with your product should have the ability to recreate…   Read more»

]]> eefe2205e2382d59960ad45b120c30d0 https://medicaldevicecourses.com/activity/p/13896/ Wed, 15 May 2019 17:09:11 -0400 In my experience with minutes, it is important to keep them handy and organized, especially in anything involving a group and a long term project. For our capstone group, our advisor encourages or even requires us to take copious meeting…   Read more»

]]> 9985bd7b240caf7120098196f9670991 https://medicaldevicecourses.com/activity/p/13729/ Wed, 15 May 2019 17:07:37 -0400 Every individual has the right to his or her own body, along with whatever may come from a study of it. In the case of Henrietta Lacks, she should have of course been given the right to refuse, as well…   Read more»

]]> 2f2a5dce7a81a412cf97326c59ada422 https://medicaldevicecourses.com/activity/p/13726/ Wed, 15 May 2019 17:07:35 -0400 A double-blind study is necessary in cases where the investigator may become biased if they had knowledge of which is the effective drug. For the example presented in the question, with a drug to treat Alzheimer’s the investigator may selectively…   Read more»

]]> d8bc807680cfcb98f135b71fb6a06a68 https://medicaldevicecourses.com/activity/p/13722/ Wed, 15 May 2019 17:07:32 -0400 Placebo-controlled trials are necessary to the effectiveness of certain studies. In order to be sure that the drug or device is the factor that is in actuality changing the condition of the patient or just a change of mentality. There…   Read more»

]]> 149ab8a786bab2938462f0d6d17b5796 https://medicaldevicecourses.com/activity/p/13591/ Wed, 15 May 2019 17:06:20 -0400 A product that does well without the use of television or other mainstream forms of advertisement is Krispy Kreme doughnuts. These have such a strong following of enthusiasts that search specifically for the coveted glazed doughnut that it does not…   Read more»

]]> 92187b837c19eeeb86dce933a33a1d64 https://medicaldevicecourses.com/activity/p/13589/ Wed, 15 May 2019 17:06:19 -0400 A vision statement, as discussed in the lecture, states the goal of the company, along with what they value and why they do what they do. A mission statement states how the company carries out these goals and what the…   Read more»

]]> 5935cc526213a23493048c4fa93438ef https://medicaldevicecourses.com/activity/p/13538/ Wed, 15 May 2019 17:05:52 -0400 In highly populated places like New York City, it is becoming popular to have interactive and immersive advertising tools. These can be in the form of exhibits or distributing samples of the product, or making it an “instagrammable” ad. For…   Read more»

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