https://medicaldevicecourses.com/members/gaberuiz13/activity/ Activity feed for gaberuiz13. Sat, 16 May 2026 06:09:01 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e7492a6721aba632e4e6c494958bf070 https://medicaldevicecourses.com/activity/p/14256/ Wed, 15 May 2019 18:54:29 -0400 I agree with the notion that an organizational structure leads to certain cultures within the work place that may make or break a potential project. In a functional organization, each department is divided and controlled by different functional managers. This…   Read more»

]]> 868a6685cf274d66ff2419b158d08b13 https://medicaldevicecourses.com/activity/p/14255/ Wed, 15 May 2019 18:54:28 -0400 I feel as though each organizational structure has its own strengths and weaknesses; however, depending on the size or needs of the company one structure may be more advantageous than the others. For example, a functional organization may prove adequate…   Read more»

]]> 869c61aa557524375adb3eed34b76139 https://medicaldevicecourses.com/activity/p/14231/ Wed, 15 May 2019 18:54:16 -0400 I have never worked as part as one of these teams; however, with that being said, I am torn between wanting to work with either a project-based organization or matrix organization. In project-based organization, there is no “silos of departmental…   Read more»

]]> 9dbb515fc90a51076706f035c891fcab https://medicaldevicecourses.com/activity/p/14127/ Wed, 15 May 2019 18:52:15 -0400 I feel as though all the mistakes you mentioned highlights the fault in companies when it comes to understanding how to handle risk management. I agree that risk management and design control are separate things and that risk management should…   Read more»

]]> 62e0e013fa742c06509119ab9f07b2b2 https://medicaldevicecourses.com/activity/p/14105/ Wed, 15 May 2019 18:51:57 -0400 The major ISO regulation governing Risk Management for medical device companies is ISO14971. According to the link, the major requirements for a medical device company has to follow is to construct a Failure Mode and Effect Analysis (FMEA) and a…   Read more»

]]> 6df267c57452a3d4def8235f6d2ae348 https://medicaldevicecourses.com/activity/p/14041/ Wed, 15 May 2019 18:51:21 -0400 In Capstone, we had to formulate test plans in order verify our design. Should one of our tests fail, we were taught to reassess our design and change the specifications and tolerance in our document in order to assure that…   Read more»

]]> 96d54f00d98148dbcc4d1e30d605d2e9 https://medicaldevicecourses.com/activity/p/13983/ Wed, 15 May 2019 17:10:09 -0400 I personally don’t have any experience in industry; however, we’ve had design reviews for our capstone project at NJIT. The way these meetings go is that each team has their requirement documents or test plan reviewed in front of all…   Read more»

]]> f6d95f5998ef1ef7082daa506c7720c0 https://medicaldevicecourses.com/activity/p/13956/ Wed, 15 May 2019 17:09:51 -0400 It is true that the engineer is supposed to “make up a test”; however, the test needs to reflect the section of the design requirements that the test will be verifying. In the Capstone class in NJIT, when we were…   Read more»

]]> 1c8a5873701310bbc1fbd9dc42537757 https://medicaldevicecourses.com/activity/p/13886/ Wed, 15 May 2019 17:09:07 -0400 Although it may hinder the product a bit in a business sense, I feel as though a medical device meant to work with humans should require validation even if it already passed the verification phase. This is due to the…   Read more»

]]> fdedb48ecb50c983cf3027841d9a8458 https://medicaldevicecourses.com/activity/p/13872/ Wed, 15 May 2019 17:08:59 -0400 I don’t have an work experience; however, for Capstone my senior year we had to develop a project schedule that was essentially a Gantt Chart. As such, you can think of a Gantt Chart as a detailed project schedule with…   Read more»

]]> 80c76cb1302c5ffc77e76595c6d69df6 https://medicaldevicecourses.com/activity/p/13828/ Wed, 15 May 2019 17:08:35 -0400 From the deliverables Dr. Simon requested for this class I noticed a lot of similarities between them and the deliverables we had to submit for the undergraduate capstone project. In capstone, we were required to submit a lengthy and extremely…   Read more»

]]> 41132981349fa8e9f52765e52451d35d https://medicaldevicecourses.com/activity/p/13712/ Wed, 15 May 2019 17:07:28 -0400 In the past, consent was not used since medical regulation was still young and not widely enforced. In the case of Henrietta Lacks, the doctor did not give her the option to use her valuable cells for research, but as…   Read more»

]]> 958d3bd2c8ba8c924e663431d0a6b6ce https://medicaldevicecourses.com/activity/p/13710/ Wed, 15 May 2019 17:07:27 -0400 In a single blind study, only the investigator knows what is to be used on the subject, this has its advantages since the investigator in this case has complete control over what is given; however, this can also induce some…   Read more»

]]> 4f32d6187fdb26a4adcf5855402ec4fd https://medicaldevicecourses.com/activity/p/13697/ Wed, 15 May 2019 17:07:20 -0400 I personally feel as though placebos are necessary for studies and clinical trials. When doing statistical analysis, you’ll have a controlled-group that’ll receive the drug or device in question for actual treatment and perhaps another group that’ll receive a type…   Read more»

]]> 5faf918c9e32ffa2fa83cfb402422f83 https://medicaldevicecourses.com/activity/p/13574/ Wed, 15 May 2019 17:06:11 -0400 EI can easily turn into manipulation as the sales pitch has to be tailored to certain demographics. Dr. Simon mentions in his lecture that people may not even know they want something until they heard of it, but I think…   Read more»

]]> 9bb8e3611215b0d9e1b3d141f641b08b https://medicaldevicecourses.com/activity/p/13573/ Wed, 15 May 2019 17:06:11 -0400 Participation has become the fifth “P” of marketing since consumers these days have the ability to block unwanted ads and such unlike before where ads on TV or the radio couldn’t really be avoided. With this, companies had to focus…   Read more»

]]> c6fed4c081d5a62dc6a4f9c8236436f5 https://medicaldevicecourses.com/activity/p/13569/ Wed, 15 May 2019 17:06:08 -0400 Emotional Intelligence (EI) is the ability for an individual to identify and utilize emotional factors when it comes to either themselves or other people. Essentially, an emotional intelligent person will be able to tell how another person is feeling simply…   Read more»

]]> ba683caed53c4db7182d65007f684dd2 https://medicaldevicecourses.com/activity/p/13438/ Wed, 15 May 2019 17:04:53 -0400 I may the pessimist here, but I don’t believe I personally would turn down a job simply based on the type of company it labels itself as. In this day and age, especially for people fresh out of college, landing…   Read more»

]]> 7ff24cce331ecf2ce035eb12bc8cd843 https://medicaldevicecourses.com/activity/p/13432/ Wed, 15 May 2019 17:04:50 -0400 There a few things to consider when deciding to make a business either an LLC (limited liability company) or an incorporated company (S-corp or C-corp). With an LLC, business owners are personally protected from the risks that involve a lawsuit…   Read more»

]]> 8f1cbb11b6b7bebdeb9cee0ab9bfe2f2 https://medicaldevicecourses.com/activity/p/13417/ Wed, 15 May 2019 17:04:43 -0400 The reason a business owner may choose to form a corporation or limited liability company (LLC) is so that should the company find itself unable to pay its debts to its creditors, the owners, shareholders, etc. won’t have to be…   Read more»

]]> ad893c8177eba913ca1ba05fd51327b7 https://medicaldevicecourses.com/activity/p/13292/ Wed, 15 May 2019 17:03:39 -0400 Document control of a QA department is meant to assure that all documentation for a project is in order so when the FDA or some other organization comes for an audit, for example, the company team is prepared to show…   Read more»

]]> ebbc6807c04eadfd50d6776a3a67711c https://medicaldevicecourses.com/activity/p/13280/ Wed, 15 May 2019 17:03:34 -0400 I feel as though both sides have valid concerns in how a project should proceed. On the R&D hand, you have legitimate data and statistic to prove that the project is good to continue. Quality on the other hand have…   Read more»

]]> 91389c8bc8fb5e9c058a13b86db4bcb0 https://medicaldevicecourses.com/activity/p/13255/ Wed, 15 May 2019 17:03:19 -0400 To those who say quality is a burden I can see where they’re coming from. With QA/QC in place, a lot of money has to thrown into a process that hinders the launch of a product, but it is a…   Read more»

]]> b2877a35355a3d2f7150206d7489d07c https://medicaldevicecourses.com/activity/p/13222/ Wed, 15 May 2019 17:03:02 -0400 I personally feel the FDA is in the right for being as strict as they are. In fact, they may not be strict enough as the products that get released into the market often get recalled after further investigation. I’d…   Read more»

]]> d0ac171e5a51c25240d8106b0a558f7e https://medicaldevicecourses.com/activity/p/13172/ Wed, 15 May 2019 17:02:35 -0400 Precision and accuracy play critical roles in medical device development as it is these factors that determine the validity of what a device claims to do. The FDA has guidelines that refer to calibration measures for instruments and such. In…   Read more»

]]> efd8203366c7c4151c88d24548521d1c https://medicaldevicecourses.com/activity/p/13101/ Wed, 15 May 2019 17:01:57 -0400 Any medical device of any type can experience a recall for numerous different reasons. One prevailing issue that effects device such as sensor systems is the accuracy and precision of said medical device. Often times the FDA will shut down…   Read more»

]]> 0660cb19147cc582ae8a1ecfe5974c3a https://medicaldevicecourses.com/activity/p/12995/ Wed, 15 May 2019 17:01:05 -0400 As the other before me have said, the biomedical device will have to comply with ISO 10993. This means that the medical device in question cannot harm a subject depending on the application. This can be viewed in the toxicity…   Read more»

]]> 2546eb70db27913288f6d1f315caeb23 https://medicaldevicecourses.com/activity/p/12972/ Wed, 15 May 2019 17:00:54 -0400 Research in academia is generally approached in the following manner: “I am curious about this subject and I want to delve deeper into it.” Research in academia generally stems from the thrill of discovery and requires a kind of passion…   Read more»

]]> a916808574914e2add7a5c0e7ee7ae5b https://medicaldevicecourses.com/activity/p/12963/ Wed, 15 May 2019 17:00:47 -0400 I personally would prefer to do research that can be utilized as soon as possible. There is that sense of instant gratification where you can see what you have created and see it be applied in the ‘real world’. I…   Read more»

]]> 2b746c19ec26b9861dd432a689ca546b https://medicaldevicecourses.com/activity/p/12815/ Wed, 15 May 2019 16:59:22 -0400 I would say that the planning process is among the most important phases followed by the execution process. This is because the planning process is the time where a project’s execution is discussed and where all things leading up to…   Read more»

]]> ffceb8c0bf2729c69046c79249c2f36b https://medicaldevicecourses.com/activity/p/12790/ Wed, 15 May 2019 16:59:10 -0400 I never worked in industry, but for the Capstone class here in NJIT we used Microsoft Project in order to create an in depth schedule for our project. You’re able to use this in several views such as a Gantt…   Read more»

]]> 930b332cda2b32086aefe1b8b74d1d78 https://medicaldevicecourses.com/activity/p/12768/ Wed, 15 May 2019 16:58:59 -0400 One of the biggest challenges of doing project management for a medical device as opposed to building a building is having to assure that the device in question is meeting vigorous FDA regulations and that all other documents such as…   Read more»

]]> 428f4f3bc2dde0a97a3e7d4c7bd47b2d https://medicaldevicecourses.com/activity/p/12665/ Wed, 15 May 2019 16:58:02 -0400 I personally never worked in the field, but I can share the advise other upperclassmen and advisors gave me. In my experience, landing an internship is not easy and from what I hear in some other fields may not be…   Read more»

]]> 3cdc768fc93e00c12babcaa14aefcb33 https://medicaldevicecourses.com/activity/p/12664/ Wed, 15 May 2019 16:58:01 -0400 If someone wanted to work in academia I would say academia is very research oriented and allows for great opportunities to discover new things and maybe even travel the world to share your knowledge. At the same time for academia,…   Read more»

]]> 2c0aab8ff940a1c7e70ef482f20aa519 https://medicaldevicecourses.com/activity/p/12661/ Wed, 15 May 2019 16:58:00 -0400 The 3:7 ratio of practical classes to academic classes feels as though it is a missed opportunity; however, it could be worse. I’ll start by saying that I feel as though this ratio should be 1:1 or at least 4:6…   Read more»

]]> a01ff7081062acc0e2e65e237b3e061e https://medicaldevicecourses.com/activity/p/5295/ Sun, 26 Nov 2017 16:30:07 -0500 I agree with the notion that an organizational structure leads to certain cultures within the work place that may make or break a potential project. In a functional organization, each department is divided and controlled by different functional managers. This type of organization can lead to information silos and it can prove difficult to…[Read more]

]]> 0 4af25028cfa2e5148ba31f51ff65f571 https://medicaldevicecourses.com/activity/p/5294/ Sun, 26 Nov 2017 16:16:35 -0500 I feel as though each organizational structure has its own strengths and weaknesses; however, depending on the size or needs of the company one structure may be more advantageous than the others. For example, a functional organization may prove adequate for a small company who doesn’t have many employees and therefore, it can use this organization…[Read more]

]]> 0 8977b477c35623f24a11fc8e6962d6cd https://medicaldevicecourses.com/activity/p/5267/ Fri, 24 Nov 2017 18:11:39 -0500 I have never worked as part as one of these teams; however, with that being said, I am torn between wanting to work with either a project-based organization or matrix organization. In project-based organization, there is no “silos of departmental information” in the sense that all the information for a project is shared transparently between…[Read more]

]]> 0 a51115891e9211ac29c709bfe937689e https://medicaldevicecourses.com/activity/p/5161/ Sun, 19 Nov 2017 16:22:15 -0500 I feel as though all the mistakes you mentioned highlights the fault in companies when it comes to understanding how to handle risk management. I agree that risk management and design control are separate things and that risk management should be treated like a checkbox activity that can be used to improve the design as its being designed as…[Read more]

]]> 0 1d1aecf960191cd6389e694cedf52c3b https://medicaldevicecourses.com/activity/p/5139/ Sat, 18 Nov 2017 17:52:43 -0500 The major ISO regulation governing Risk Management for medical device companies is ISO14971. According to the link, the major requirements for a medical device company has to follow is to construct a Failure Mode and Effect Analysis (FMEA) and a Fault-Tree Analysis (FTA). With these documents, the aim is to have the company provide a risk…[Read more]

]]> 0 23eed01d6062339fd0bc40e4e46a5a48 https://medicaldevicecourses.com/activity/p/5064/ Mon, 13 Nov 2017 03:30:20 -0500 In Capstone, we had to formulate test plans in order verify our design. Should one of our tests fail, we were taught to reassess our design and change the specifications and tolerance in our document in order to assure that the product will pass the test the next time it is tested. Based on the other’s responses, this is also the case in industry…[Read more]

]]> 0 f69cb60ef0c2a6adc4444a3248324cb2 https://medicaldevicecourses.com/activity/p/5002/ Sat, 11 Nov 2017 22:29:26 -0500 I personally don’t have any experience in industry; however, we’ve had design reviews for our capstone project at NJIT. The way these meetings go is that each team has their requirement documents or test plan reviewed in front of all the other teams and every other team has to pick apart nuances in the document for the purpose of helping the…[Read more]

]]> 0 eeb50866e5756dd35a1e7702a6a509a2 https://medicaldevicecourses.com/activity/p/4973/ Fri, 10 Nov 2017 16:25:56 -0500 It is true that the engineer is supposed to “make up a test”; however, the test needs to reflect the section of the design requirements that the test will be verifying. In the Capstone class in NJIT, when we were designing our test plan, we had to specify which requirements in our requirements document the test was aiming to satisfy. Numerous…[Read more]

]]> 0 7e5b7213da820626c56677f70b43f66b https://medicaldevicecourses.com/activity/p/4893/ Sun, 05 Nov 2017 23:23:33 -0500 Although it may hinder the product a bit in a business sense, I feel as though a medical device meant to work with humans should require validation even if it already passed the verification phase. This is due to the fact that it may not behave consistently across a vast amount of human subjects and these tests need to be in place in order to…[Read more]

]]> 0 4446a586ac46a797dc5a0753d767d363 https://medicaldevicecourses.com/activity/p/4878/ Sun, 05 Nov 2017 17:05:05 -0500 I don’t have an work experience; however, for Capstone my senior year we had to develop a project schedule that was essentially a Gantt Chart. As such, you can think of a Gantt Chart as a detailed project schedule with clearly outlined goals/ milestones and tasks that need to be performed to achieve these project goals. For this, you should…[Read more]

]]> 0 d1a3983bb17111e95e37551d9745a8d1 https://medicaldevicecourses.com/activity/p/4834/ Sat, 04 Nov 2017 15:41:16 -0400 From the deliverables Dr. Simon requested for this class I noticed a lot of similarities between them and the deliverables we had to submit for the undergraduate capstone project. In capstone, we were required to submit a lengthy and extremely detailed requirements document and a test plan. My professor for capstone described that the requirements…[Read more]

]]> 0 4a6ace12bee810d65b487f857d63830a https://medicaldevicecourses.com/activity/p/4572/ Sun, 29 Oct 2017 13:57:27 -0400 In the past, consent was not used since medical regulation was still young and not widely enforced. In the case of Henrietta Lacks, the doctor did not give her the option to use her valuable cells for research, but as you said, that cell culture lead to mass scientific advancements in cancer research. Had Lacks checked “no” on a consent form when…[Read more]

]]> 0 c2740bc264fd8d601632df2f5d1f7407 https://medicaldevicecourses.com/activity/p/4567/ Sun, 29 Oct 2017 02:49:54 -0400 In a single blind study, only the investigator knows what is to be used on the subject, this has its advantages since the investigator in this case has complete control over what is given; however, this can also induce some bias from either the investigator him/herself or the subject should the investigator do a poor job in hiding the contents of…[Read more]

]]> 0 6d15c2997af8ee044d83ffa14a0da55f https://medicaldevicecourses.com/activity/p/4547/ Sat, 28 Oct 2017 16:15:29 -0400 I personally feel as though placebos are necessary for studies and clinical trials. When doing statistical analysis, you’ll have a controlled-group that’ll receive the drug or device in question for actual treatment and perhaps another group that’ll receive a type of “sugar pill” or something else that won’t treat the illness or condition, but the…[Read more]

]]> 0 c5c6f21197b0ee6fd9e4e51e0ee12386 https://medicaldevicecourses.com/activity/p/4292/ Sun, 22 Oct 2017 17:30:16 -0400 EI can easily turn into manipulation as the sales pitch has to be tailored to certain demographics. Dr. Simon mentions in his lecture that people may not even know they want something until they heard of it, but I think its also important to consider how the consumer hears about the product since this can affect their investment into product. This…[Read more]

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