https://medicaldevicecourses.com/members/jaf22/activity/ Activity feed for jaf22. Fri, 24 Apr 2026 18:41:04 -0400 https://buddypress.org/?v= en-US 30 hourly 2 f21b94c8d161d065ed21f8a25370f210 https://medicaldevicecourses.com/activity/p/24061/ Mon, 22 Nov 2021 22:50:32 -0500 Consultants in my company or my previous company have been useful in bringing expertise where our group lacks or needs a third party view. For instance, my company had a large acquisition that needed some smoothing of culture and understanding…   Read more»

]]> 4290ab8af1ed1e9eec84d3a138eb84fd https://medicaldevicecourses.com/activity/p/24060/ Mon, 22 Nov 2021 22:47:31 -0500 Honestly, this is one of the best courses offered at NJIT for younger professionals who aren’t sure of what career paths may have in store for them. This definitely provides the foundation of design controls and roles within a medical…   Read more»

]]> c5169062c01d30be48e73eea8415ef39 https://medicaldevicecourses.com/activity/p/24059/ Mon, 22 Nov 2021 22:44:28 -0500 It is important to understand the full implications of an NDA before signing. Some may sign them for their job multiple times on different patients and such. Others, like myself, will have an NDA that bares them from working on…   Read more»

]]> 700f0c14be06a3957218d0b36a49cbc2 https://medicaldevicecourses.com/activity/p/24019/ Tue, 16 Nov 2021 04:14:11 -0500 Do you ever get lost in the matrix due to having too many responsibilities with multiple project teams that it can be confusing on who you work with at the end of the day? I know large organizations can have…   Read more»

]]> fd8c29aa6d3e8bc100cf667753e33fb1 https://medicaldevicecourses.com/activity/p/24018/ Tue, 16 Nov 2021 04:11:29 -0500 In terms of enlightening the manager to the importance in QC and regulatory roles, there would need to be a reason why a project is being impacted significantly due to a loss in those pipelines. There are times that one…   Read more»

]]> e0145d003f3c2edcb660e831ca47d9a9 https://medicaldevicecourses.com/activity/p/24017/ Tue, 16 Nov 2021 04:06:31 -0500 Organizational structures, in addition to more effective communication and autonomy in a project, provide the handoff of the project from development to post launch as well as lead the culture of the company. Projects that have a matrix based team…   Read more»

]]> 2af3c5f64cd4386f1ff7634cf39454b1 https://medicaldevicecourses.com/activity/p/23965/ Tue, 09 Nov 2021 00:49:35 -0500 In the world of medical devices, there is no such thing as a waste of money for risk assessment. When a device deals with aiding in human function with direct contact to user, then there is a need for risk…   Read more»

]]> 1e804c65d5f0c2c6d7917b420e3dbdd7 https://medicaldevicecourses.com/activity/p/23964/ Tue, 09 Nov 2021 00:47:56 -0500 Another internal risk can be seen where the transfer from prototype to process equivalent part may not be as easy due to a poor CQA list or difficulty of manufacturing of the parts. This can set a project back months…   Read more»

]]> fdb4238ae09686b790df1f36fe92d01a https://medicaldevicecourses.com/activity/p/23963/ Tue, 09 Nov 2021 00:45:20 -0500 Another form of risk control during design is knowing the intended misuse scenarios and how they can be mitigated during design. Lets say they know a scalpel can cut easily and is sharp on all sides. The design can force…   Read more»

]]> fbf3e2a4a5d2c17a7878363b0eba750f https://medicaldevicecourses.com/activity/p/23915/ Mon, 01 Nov 2021 23:08:11 -0400 The company I currently work for does not let any sort of failures go through. Since I work at a medical device company, the product affects patient care and health which in turn, if product fails, can be a big…   Read more»

]]> 532992c3d00b3d86c8191f182ed79e18 https://medicaldevicecourses.com/activity/p/23914/ Mon, 01 Nov 2021 23:02:02 -0400 Statistical sampling can be pretty dependent on what you are working towards. There are guidelines to follow an ANOVA for a process to validate their systems which can be very different from medical device validation. Medical device validation can often…   Read more»

]]> 70eb709a3f51adce19c4e04c60538207 https://medicaldevicecourses.com/activity/p/23913/ Mon, 01 Nov 2021 22:56:52 -0400 As said by mcf29, there are many different qualifications that the manufacturer goes through to validate their processes. They usually need to also go through different steps on how they validate their systems whether that is an MSA (variable or…   Read more»

]]> 807d2e67aa0d7b457c6c9e145d0e85ed https://medicaldevicecourses.com/activity/p/23862/ Thu, 28 Oct 2021 01:52:17 -0400 Just going back to TMV, its less specific for low variation, but rather determining whether that variation is consistent for different users. There is always going to be tests that have a large bias and TMV covers the aspect that…   Read more»

]]> 9d732a88b66e9faca8427c13cefe607a https://medicaldevicecourses.com/activity/p/23861/ Thu, 28 Oct 2021 01:47:31 -0400 Not all design inputs are necessarily related to some performance output. For some requirements such as color or force, there is an output that can be related to manufacturing or test related value. For some inputs such as ones based…   Read more»

]]> 5cf1a7014468ce6a0d70b07a346ebcca https://medicaldevicecourses.com/activity/p/23860/ Thu, 28 Oct 2021 01:40:38 -0400 I actually have a large amount of experience with test method validation as I recently completed my labs validation for our non-compendial testing. Test method validation is not needed for standardized testing, but is needed for all testing that is…   Read more»

]]> 302864f325d15baaa82e166358aa72e7 https://medicaldevicecourses.com/activity/p/23787/ Tue, 19 Oct 2021 02:40:48 -0400 One of my previous coworkers went from working in an engineering research lab to a clinical research associate position. He was only a year or two into his career so the transition to the next job was a big step…   Read more»

]]> 8579ee433de6463d4576781519a4b409 https://medicaldevicecourses.com/activity/p/23786/ Tue, 19 Oct 2021 02:35:26 -0400 I agree with the prior authors of the statements saying that there currently is no way to prove on why a vaccine may be more effective. You could compare it to different generations of people living in a specific area,…   Read more»

]]> de1731689259d1430d408d6b621a39a9 https://medicaldevicecourses.com/activity/p/23785/ Tue, 19 Oct 2021 02:29:15 -0400 Usually a phase 2 trial will have a more statistical sample size with the medication with the most favorable outcome from phase 1. This extended time is used to start to derive the efficacy of the drug as well as…   Read more»

]]> d4c1dde08c8340fda7be05e0860b4e82 https://medicaldevicecourses.com/activity/p/23712/ Wed, 13 Oct 2021 23:56:11 -0400 There are many times within my company that someone from engineering will go into marketing or sales as they believe in a career path change that will benefit their growth (it doesn’t usually go the opposite way as the requirements…   Read more»

]]> f7530ee56b6b8d2bb483ed674f58fe71 https://medicaldevicecourses.com/activity/p/23711/ Wed, 13 Oct 2021 23:49:24 -0400 There are probably more specifics that would need to be involved as the previous commenters suggest. If the items are single use or limited use items, this would go to retail or the physicians. These items aren’t made to last…   Read more»

]]> cafdade4ae6251bb9513ba31eff400df https://medicaldevicecourses.com/activity/p/23710/ Wed, 13 Oct 2021 23:45:44 -0400 I believe one way the internet has changed marketing is the competitiveness of a product’s launch and the benefits a product has to remain novel and interesting. Prior to a more digital age, sales would most likely need to find…   Read more»

]]> 41207675a93aeca03e2137417d85fb8b https://medicaldevicecourses.com/activity/p/23607/ Tue, 05 Oct 2021 04:29:01 -0400 There are multiple posts that compare the public and private sector and types of corporations to work for. What are your top requirements for a company to work for in terms of private/public and corporation type and how does it…   Read more»

]]> 38852d4f26fc2eaf228691f785bb5ce3 https://medicaldevicecourses.com/activity/p/23606/ Tue, 05 Oct 2021 04:16:21 -0400 Public traded companies have a pro on, if successful, their financial growth year after year that provides momentum to their customer basis. On the other side of the coin, if a company is doing poorly, investors may become wary about…   Read more»

]]> 25a7c1716f63182af31068d8d77154e3 https://medicaldevicecourses.com/activity/p/23605/ Tue, 05 Oct 2021 04:07:00 -0400 One aspect about this that I would factor in is that a private company can be tumultuous if the owners are thinking of selling their business. My one friend was working at a private company that was sold which led…   Read more»

]]> 936bbda96acadc25142fd60f08d47807 https://medicaldevicecourses.com/activity/p/23519/ Wed, 29 Sep 2021 03:35:45 -0400 Quality assurance engineers are rock stars of many project teams in their way of adding rails to a project and know when to tell engineers when to hit the breaks. They are the literal phrase of dotting your I(s) and…   Read more»

]]> db4f2588bb3e1ab749306d47b3ed82d9 https://medicaldevicecourses.com/activity/p/23518/ Wed, 29 Sep 2021 03:28:01 -0400 I personally can’t see myself within a QA/QC role, no matter where that may be. QA and QC need to be able to take a fine tooth comb when reading through documentation and have a keen sense on when things…   Read more»

]]> 5f7ba84d106f23c6026463c653511ce7 https://medicaldevicecourses.com/activity/p/23517/ Wed, 29 Sep 2021 03:25:03 -0400 I’m personally not in QA/QC, but I work heavily with QA on a lot of my projects and know them very well. There are many roles in QA and QC that revolve in resolving QMS issues, CAPA/NC(s), product development, and…   Read more»

]]> 5a39a937d3d97294972065f4cf534930 https://medicaldevicecourses.com/activity/p/23416/ Tue, 21 Sep 2021 01:19:48 -0400 I have worked on a few different projects that I have worked with my regulatory counterpart to aid with submissions. This one project had myself and my coworked work with ANVISA to have a product already approved in the US…   Read more»

]]> c4372a6f7640da62ab39ba0ede5c74e9 https://medicaldevicecourses.com/activity/p/23414/ Tue, 21 Sep 2021 01:14:49 -0400 I don’t think there is a way to speed up the medical device approval process. There are many reasons why there is a bottle neck during medical device development that is not always the fault of the FDA. There are…   Read more»

]]> f118fc4a53ffabec648bdd5e7f610478 https://medicaldevicecourses.com/activity/p/23413/ Tue, 21 Sep 2021 01:06:20 -0400 Posted by: @cb447  There has been attempts to harmonize regulations worldwide, but it has not been successfully implemented yet. I am wondering, do you think regulations should be harmonized worldwide or should it be up to each country to enforce…   Read more»

]]> d6b30d83d154d278c3dfb78b23263155 https://medicaldevicecourses.com/activity/p/23331/ Tue, 14 Sep 2021 03:16:09 -0400 Posted by: @mejefferson Posted by: @tulikadasp When it comes to animal research there are various constraints we need to keep in mind. One of them is animal rights. A lot of animal rights group are against this. Recently there are…   Read more»

]]> 3634a3b3244284654a6acd362cf3a1a1 https://medicaldevicecourses.com/activity/p/23330/ Tue, 14 Sep 2021 03:04:03 -0400 I currently work within the research department within my company for medical devices and I would say I would stay within industry. Although I do have a passion for learning more about the unknown advancements within my field, I enjoy…   Read more»

]]> 91696d4908753dbca4dd477df26e1466 https://medicaldevicecourses.com/activity/p/23329/ Tue, 14 Sep 2021 02:57:02 -0400 I believe the guideline: “The principle of proportionality: responsibility for considering and balancing suffering and benefit” is the most important aspect in biomedical research in terms of wellbeing. This is the moral saying that the end justifies the means where…   Read more»

]]> 4dcc41e3f61c82b5890bcc4ace3dae2d https://medicaldevicecourses.com/activity/p/23210/ Tue, 07 Sep 2021 04:04:38 -0400 A project management challenge for a combination product, as many of previous replies mentioned, are the regulations and requirements to have the product accepted and approved by the regulatory body. An additional aspect not yet touched upon is the verification…   Read more»

]]> 0189ab49b3c858e83902e03874f8072e https://medicaldevicecourses.com/activity/p/23209/ Tue, 07 Sep 2021 03:58:36 -0400 A feasibility study would boil down to:  – Economic gain vs expense of the medical device (Business case). I would have field data on what completive devices would sell for and how much profit this type of device will bring…   Read more»

]]> 3d51ac2a5e42f203c670c1ced502ff8f https://medicaldevicecourses.com/activity/p/23208/ Tue, 07 Sep 2021 03:47:31 -0400 I agree with many of those whose sentiment is that many who manage projects are experienced in their field before project management. There are many times that those who are very organized and understand the deliverables of the project are…   Read more»

]]> 956f1e7ce72e438dceb41461e76bea3b https://medicaldevicecourses.com/activity/p/23207/ Tue, 07 Sep 2021 03:33:14 -0400 I disagree with having a student take a coding course as a requirement for the biomedical degree as the program is already broad with its class type and may not give enough working knowledge for the student to find a…   Read more»

]]> d72995f22000f3775e85ac82c831598e https://medicaldevicecourses.com/activity/p/23206/ Tue, 07 Sep 2021 03:28:15 -0400 I would agree with those who have said that their practical vs academic ratio should be higher for the academic area of interest. I actually believe that the ratio should be closer to 70% practical courses and 30% academic for…   Read more»

]]> c7197d24f8667087481481eecb046a63 https://medicaldevicecourses.com/activity/p/23205/ Tue, 07 Sep 2021 03:22:01 -0400 I would agree with sseal98 as the the broad curricula and job variety for a biomedical engineering student can be applicable to many different engineering disciplines. There are many times an employer is looking for specific areas of knowledge and…   Read more»

]]> bdbd4dbc1904e065cddd4287edafef4d https://medicaldevicecourses.com/activity/p/22325/ Tue, 27 Apr 2021 01:30:34 -0400 @abhishek-roy  For the path after college, the GET or EIT depending on where you are may be specific for that role. Other places will have different levels of engineering that you can start in and you can keep moving up…   Read more»

]]> d7a594d72c9f598ddd791fdb9d7aa4f7 https://medicaldevicecourses.com/activity/p/22323/ Tue, 27 Apr 2021 01:22:48 -0400 I have been industry for a few years so this class was beneficial for me to understand different areas of project management. Everyone learns these on the job and they are different for each company, but I think this class…   Read more»

]]> 4eb85b9676f28f321cddfe0e6113ad30 https://medicaldevicecourses.com/activity/p/22322/ Tue, 27 Apr 2021 01:16:01 -0400 Posted by: @talha-chaudhry Exciting and Challenging Work: 48%Career growth and development: 43%Working with great people: 42%Fair pay: 32%Supportive Manager/Boss: 25%Be Recognized/valued & respected: 23%Benefits: 22%Meaningful Work/Make a difference: 17% I’m not surprised by the statistics on this as it does…   Read more»

]]> 7c5a1bad42d6287d756774d7f4618e4c https://medicaldevicecourses.com/activity/p/22222/ Tue, 20 Apr 2021 17:50:07 -0400 Tunnel vision can occur due to stress that one needs to figure out a solution. There can be such a focus on finishing the task that you may believe that there is only one route that may be correct and…   Read more»

]]> c73c7a23e1aeb7b07f5a34ec2eacc7e9 https://medicaldevicecourses.com/activity/p/22221/ Tue, 20 Apr 2021 17:44:37 -0400 I would agree with many of the sentiments in this thread. People leave work due to multiple factors that can also include a transition from one area of a business to another. I’ve seen some people transition from engineering to…   Read more»

]]> e4e351f24482a67b6770e0973d1adc22 https://medicaldevicecourses.com/activity/p/22220/ Tue, 20 Apr 2021 17:31:06 -0400 My biggest motivators in my career are centered in both the challenges at work (that are exciting to work on) as well as the development of my career my manager is able to provide. I love the challenges at work…   Read more»

]]> d48f97ef14307759d0c2deda002acaff https://medicaldevicecourses.com/activity/p/22107/ Tue, 13 Apr 2021 20:47:44 -0400 Posted by: @tn58 My question to everyone who works in industry is, was there ever a case where a major team player was placed on another project and removed from your team? If yes, how did that change the project…   Read more»

]]> ccb0fd8cb1bdfcf7b7391f43013c592d https://medicaldevicecourses.com/activity/p/22106/ Tue, 13 Apr 2021 20:38:02 -0400 Recently, there was a project I was on that had two instruments removed from scope earlier on in the project as this project was worked on by different divisions of the company. The two instruments were removed from scope for…   Read more»

]]> 501309230ed295bf9143a159f922c7b4 https://medicaldevicecourses.com/activity/p/22105/ Tue, 13 Apr 2021 20:29:52 -0400 I agree with many who have posted that this does occur more frequently than not on projects. People shift positions or leave a company within the project timeline (especially if the timeline is expanded past two years). From experience in…   Read more»

]]> 31943e139419d729f117b476303006d3 https://medicaldevicecourses.com/activity/p/22013/ Wed, 07 Apr 2021 03:13:13 -0400 A project should be initiated once a team has produced a feasible design of a product that can be realistically manufactured and be brought to market with a large return on investment. Sometimes, the discovery phase can last for years…   Read more»

]]> 2e269f1f2cd6a71e4a0070a6e992ff6e https://medicaldevicecourses.com/activity/p/22012/ Wed, 07 Apr 2021 03:03:29 -0400 Risk is a negative term for many, but it does lead to better innovation for product. There is always a risk assessment completed for a projects I work with that is completed by quality to ensure product is safe for…   Read more»

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