https://medicaldevicecourses.com/members/jal58/activity/ Activity feed for jal58. Fri, 24 Apr 2026 15:43:24 -0400 https://buddypress.org/?v= en-US 30 hourly 2 49df51a9f266748884ef74a3048f3cdd https://medicaldevicecourses.com/activity/p/25850/ Mon, 25 Apr 2022 00:25:52 -0400 The preference between engineer and manager is certainly a personal opinion. The engineering field does often call for the manager to have more technical background. Manager positions are found in pretty much every industry. However, an engineering manager is expected…   Read more»

]]> 1f9c2f6d44b68cca010f68be0a01d2f3 https://medicaldevicecourses.com/activity/p/25849/ Mon, 25 Apr 2022 00:20:46 -0400 It is absolutely possible for a project to have multiple priorities. Priorities should always be tasks that might affect the timeline of the project. Sometimes multiples things may be affecting the timeline. It is important to focus on each of…   Read more»

]]> 5a23f843247497af40e748fcf5538432 https://medicaldevicecourses.com/activity/p/25848/ Mon, 25 Apr 2022 00:15:55 -0400 I think many people choose the medical device industry, as it often entails exciting and challenging work. Being able to work with products that improve people’s quality of life is an extremely motivating factor. I found this week’s lecture interesting,…   Read more»

]]> d9bf7392d2cb5b04f2fa18ba17aa8cf5 https://medicaldevicecourses.com/activity/p/25548/ Mon, 11 Apr 2022 03:17:50 -0400 It is important to identify the problems first. There needs to be a clear definition of the problem to determine how it will be dealt with. Is it a design problem, process problem, or resource problem? Whatever the problem may…   Read more»

]]> 2236fe6673d4df5cd5fa73a18b8c168c https://medicaldevicecourses.com/activity/p/25546/ Mon, 11 Apr 2022 03:08:06 -0400 The most common method to fill project team spots is to pull from other internal teams within the company. Most companies will have teams dedicated to certain functions. These resources can be pulled into the project to support.  Sometimes there…   Read more»

]]> aef6a7ab6101ae85bbd5606e00007121 https://medicaldevicecourses.com/activity/p/25544/ Mon, 11 Apr 2022 02:54:55 -0400 I don’t believe this week’s simulation was an example of un-ethically rushing a product to market. The license agreement was a business agreement between the vendor and the client. The agreement gives a royalty to the vendor every time the…   Read more»

]]> 99836d609ea4e10121830d687dd10a39 https://medicaldevicecourses.com/activity/p/25225/ Sun, 27 Mar 2022 23:05:52 -0400 The scaling of the size of teams is crucial to project performance. In simple terms, you need to have enough people to complete the tasks. As you mentioned, some bigger companies may have dedicated teams assigned to a certain task…   Read more»

]]> a31f3aa3ccf54fcf24f5d711c70d4237 https://medicaldevicecourses.com/activity/p/25224/ Sun, 27 Mar 2022 22:44:12 -0400 Hi All,   Unlike most in this course, I am actually a ME Master’s student at NJIT. As part of my curriculum, I am allowed to take 3 courses from any discipline. I chose this course because I work for…   Read more»

]]> eb545420bf5066f861d6abdd6e33649f https://medicaldevicecourses.com/activity/p/25223/ Sun, 27 Mar 2022 22:25:44 -0400 I would define a successful project as one that has all its tasks completed. In the medical device industry, this can often be releasing a product to market. The project itself is always set up to complete a certain goal….   Read more»

]]> ed2cdfecb18102a61083f339222c0bd0 https://medicaldevicecourses.com/activity/p/24989/ Mon, 14 Mar 2022 00:51:53 -0400 Gantt charts are fantastic for laying out the project timeline. The best tool I’ve seen for creating Gantt charts is Microsoft Project. There are also several free versions, but Microsoft’s version has many great features and Office integration. The issue…   Read more»

]]> 5856957a5bc62b22f6895af80d78164e https://medicaldevicecourses.com/activity/p/24988/ Mon, 14 Mar 2022 00:35:24 -0400 You should not set out to design a verification test that cannot fail. The engineer should strive to design a test that can accurately verify that the specifications of the product are met. This heavily depends on what type of…   Read more»

]]> d270f02bd8e585fb1164bcbbc5126c14 https://medicaldevicecourses.com/activity/p/24987/ Mon, 14 Mar 2022 00:27:06 -0400 Working from home definitely has some advantages and some drawbacks. The benefits of this workflow will vary on a case-to-case basis. It obviously depends on what kind of position it is and what industry. For certain positions, working from home…   Read more»

]]> e55c35f5e01732df350d9a9c29345bd9 https://medicaldevicecourses.com/activity/p/24847/ Mon, 07 Mar 2022 03:00:40 -0500 Accounting for the duration of tasks is sometimes more difficult than it sounds. The only real way to know the duration of a task is to just measure it. This can be captured in various types of process studies. Knowledge…   Read more»

]]> 5869330d1b37d7ef4fcf9e940a5130e3 https://medicaldevicecourses.com/activity/p/24846/ Mon, 07 Mar 2022 02:54:15 -0500 Sometimes the success of the new project manager can heavily rely on how diligent the previous project manager was. It will take the new PM some time to learn about the project, and gain an idea of the current status….   Read more»

]]> dac7c4a74e0af9781c9297827548edf5 https://medicaldevicecourses.com/activity/p/24841/ Mon, 07 Mar 2022 02:25:19 -0500 An important factor in the medical device supply chain is quality. Like any other industry, medical device companies want to optimize costs and increase profits. What makes them different is that their suppliers have to maintain a high level of…   Read more»

]]> c42cfeb5fa9bfa911123e26b3e4ae73d https://medicaldevicecourses.com/activity/p/24546/ Mon, 21 Feb 2022 02:57:56 -0500 I believe the development phase is the most important. By this time most of the groundwork for the project is complete. The planning and design phases are complete, and major project deliverables are beginning. The project team begins to finalize…   Read more»

]]> 838126c53184bca9e1bc087766973096 https://medicaldevicecourses.com/activity/p/24545/ Mon, 21 Feb 2022 02:49:04 -0500 As many others have suggested, it is a good start to look at similar products. Even if a true predicate device does not exist, risk strategies can be adopted from other products. The risk analysis process should also be standardized…   Read more»

]]> f33c9b4cbedfe839f51d9147dc7360bf https://medicaldevicecourses.com/activity/p/24542/ Mon, 21 Feb 2022 01:57:28 -0500 There would have to be something fundamentally wrong with the project in order to go back to a previous phase. The design review process is set up to guide the project forward. Certain requirements must be met to move on…   Read more»

]]> 8fa1863384dff8f115298c63dec66f71 https://medicaldevicecourses.com/activity/p/24478/ Mon, 14 Feb 2022 03:00:45 -0500 I do not believe that additional approval would be required for a medical device that has already had a PMA. However, all medical device manufacturers are subject to audit from the FDA. Audits can be conducted at certain intervals depending…   Read more»

]]> b3fbc528009983ab2af636ed6bd959e9 https://medicaldevicecourses.com/activity/p/24477/ Mon, 14 Feb 2022 02:51:34 -0500 It is important to understand how you would define underperforming. Is the team member failing to meet deadlines? Are they continuously making mistakes? Are they showing up late often? As a team leader or manager, it is necessary to clearly…   Read more»

]]> 0f4c90a4c816d65537564c3d9fa605f3 https://medicaldevicecourses.com/activity/p/24476/ Mon, 14 Feb 2022 02:42:31 -0500 I do not necessarily have a preference for a larger or smaller project team. The size of the project team should be determined by the workload needed to complete the project. It is one of the project manager’s duties to…   Read more»

]]> eba355acc9a154595c94bf7fd325cfca https://medicaldevicecourses.com/activity/p/24326/ Mon, 31 Jan 2022 03:18:55 -0500 As a new engineer, I sometimes have trouble assessing priorities for a project I’m not familiar with. Upon becoming familiar with the project, the major milestones needed to complete the project become more clear. Determining how long these milestones take…   Read more»

]]> 5539ce20cfd2b2f0ddb8c86812ead7e4 https://medicaldevicecourses.com/activity/p/24319/ Mon, 31 Jan 2022 01:21:24 -0500 I have spent my career so far as an engineer only. However, I often think of what attributes my project managers are looking for in me. There are many things that contribute to being a good team member: determination, knowledge,…   Read more»

]]> ecd9eb8570f385bc072d538266a9a66b https://medicaldevicecourses.com/activity/p/24318/ Mon, 31 Jan 2022 01:13:51 -0500 As an engineer, I would prefer a regulatory role in the product development phase. During the development, regulatory must give the engineering team guidance to ensure their activity meets FDA requirements.  In this role they can outline the requirements to…   Read more»

]]> 87ee41a5b1094442f7392ecbd4d96cec https://medicaldevicecourses.com/activity/p/21087/ Thu, 10 Dec 2020 01:00:36 -0500 I have used FMEA extensively and consider it to be extremely productive. Specifically, a design FMEA allows the device or part to be analyzed on a feature by feature basis. Each feature is evaluated and assigned a risk value. This…   Read more»

]]> 40deaf4c2d0679715226acb955006768 https://medicaldevicecourses.com/activity/p/21086/ Thu, 10 Dec 2020 00:56:45 -0500 The fact that the risk management file is a living document is one of the most important aspects of this area. Risk management is a constant cycle of analysis, evaluation, management, and measurement. This process continues far beyond the release…   Read more»

]]> 8e40338a4504d5da4eaa4ba758cb4f41 https://medicaldevicecourses.com/activity/p/21085/ Thu, 10 Dec 2020 00:52:46 -0500 I think one of the most interesting risk factors is the probability of a harmful event. The FDA factors the proportion of the intended population that would experience that event and how many times it would occur. It is important…   Read more»

]]> 3140279afa5d44ae3f7941f42c66f38b https://medicaldevicecourses.com/activity/p/21084/ Thu, 10 Dec 2020 00:41:47 -0500 I believe that upper management should have a better idea of the overall function of the company. They should be knowledgeable about the goals and future of the company. It is also important to have some experience in middle management…   Read more»

]]> 0b1f36891f10258ce83ed7143cd718fb https://medicaldevicecourses.com/activity/p/21083/ Thu, 10 Dec 2020 00:38:53 -0500 FOrming a project team can prove to be difficult but I will share some of my observations. It is sometimes good to form a team which with you have a good relationship. You are aware of the extent of their…   Read more»

]]> f7a75a5659e5a5171552c722b1060a27 https://medicaldevicecourses.com/activity/p/21082/ Thu, 10 Dec 2020 00:34:56 -0500 Hello. I am writing this discussion late so I have the benefit of having completed the Medical Device Development Project. I had the role of regulatory and was in charge of completing the regulatory rationale. I think one of the…   Read more»

]]> 9e4aa9cfa1f14704936946af1e383964 https://medicaldevicecourses.com/activity/p/21081/ Thu, 10 Dec 2020 00:27:38 -0500 Interesting topic. I was not aware of such restrictions on physicians. I think the idea of these restrictions is to maintain a sense of integrity and professionalism in the medical field. Physicians are often directly responsible for the health and…   Read more»

]]> 892cff23a3ca7a67f0af19a320925884 https://medicaldevicecourses.com/activity/p/21080/ Thu, 10 Dec 2020 00:14:24 -0500 Consultants can be extremely beneficial if a company requires advice in a specific field or niche area. I believe the main benefit of hiring a consultant is the lack of need to train this person in said field. In most…   Read more»

]]> 4c987747af16d1a39e691a3d686c4699 https://medicaldevicecourses.com/activity/p/21079/ Thu, 10 Dec 2020 00:10:48 -0500 The main thing to consider before signing is the contents of the NDA. Specifically, what restrictions does the NDA impose on you. NDAs are an agreement between the employer and employee to protect trade secrets and confidential information. The company…   Read more»

]]> b8a4fff6ea882e3b39131b4e11cb51c2 https://medicaldevicecourses.com/activity/p/20778/ Sun, 01 Nov 2020 22:59:15 -0500 The DID and DSD tie in very nicely when developing Verification and Validation procedures. The Design Input Document should be used for Validation, where the resultant function of the product is assured to meet consumer needs. The Design Specification Document…   Read more»

]]> d907da6de4270441c997ef76756b8ab7 https://medicaldevicecourses.com/activity/p/20777/ Sun, 01 Nov 2020 22:52:20 -0500 Outsourcing manufacturing is often cost-effective for companies. Cheaper materials and optimized manufacturing processes can lead to cheaper products and faster production. However, outsourcing can also lead to sub-optimal quality inspection. Outsourcing manufacturing will require a more extensive Design Transfer Process….   Read more»

]]> e39ab0493f81f5746e546f15bfc1f7e9 https://medicaldevicecourses.com/activity/p/20776/ Sun, 01 Nov 2020 22:33:17 -0500 One of the most important factors of the engineering design process is ” If it is not documented, then it never happened”. This applies to meetings too. Someone should be keeping track of the meeting conversation in some sort of…   Read more»

]]> a80e8a3251302c65c17dac922696e654 https://medicaldevicecourses.com/activity/p/20775/ Sun, 01 Nov 2020 22:25:59 -0500 I think any ethical issues related to the Right to Try Act can be mitigated by clear communication between the physicians and the patients. The RTA specifies that the patient must be diagnosed with a terminal illness. I think participation…   Read more»

]]> 6ec182405f099851249b663eb04fe08f https://medicaldevicecourses.com/activity/p/20774/ Sun, 01 Nov 2020 21:51:41 -0500 Posted by: @amd29 No one has ever claimed that their disease was cured by some pharmaceutical drug; in other words, pharmaceutical drugs have never actually improved the direction of human wellbeing. I think this statement is just false. I guess…   Read more»

]]> 1de20939bb7ebf67fb4206dd5215635e https://medicaldevicecourses.com/activity/p/20773/ Sun, 01 Nov 2020 21:34:33 -0500 I disagree with your statement that “placebo treatment is better than no treatment at all”. In fact, I think that is the biggest ethical dilemma in utilizing PCTs. Medical professionals have the responsibility to provide optimal medical care to the…   Read more»

]]> fa60276660ee63279bcce2ae2e542a6e https://medicaldevicecourses.com/activity/p/20665/ Sun, 18 Oct 2020 23:55:01 -0400 I think manipulation is a harsh term compared to other similar terms such as “persuasion”. Yes, I think in the most general sense, marketing can be considered manipulation. It’s the marketing team’s job to get as many people as they…   Read more»

]]> eac7ef055f212e42b7f11d4bf9c6c514 https://medicaldevicecourses.com/activity/p/20664/ Sun, 18 Oct 2020 23:44:53 -0400 Emotional Intelligence is a combination of self-awareness, self-regulation, motivation, empathy, and social skills. Employees with great emotional intelligence are generally more personable and have great interpersonal skills. EI is extremely beneficial and important to marketing employees. The ability to know…   Read more»

]]> 4931bd330278b777b51db58cecec3efc https://medicaldevicecourses.com/activity/p/20661/ Sun, 18 Oct 2020 23:37:11 -0400 Brand coloring is one of the simplest facets of marketing. The integration of color in marketing material is often a subconscious, psychological factor that affects the viewer. The most common colors that I see are blue and white. These colors…   Read more»

]]> d26be79105e92fe55f1eb866b91b3e66 https://medicaldevicecourses.com/activity/p/20622/ Fri, 16 Oct 2020 01:44:49 -0400 Choosing the correct partner is certainly a great risk when starting a company. Having a partner instead of a sole proprietorship can reduce liability, but divides the ownership between the partners. I would definitely consider doing a partnership in the…   Read more»

]]> 11878f62b30277de4a51c7e7fca98aec https://medicaldevicecourses.com/activity/p/20621/ Fri, 16 Oct 2020 01:16:58 -0400 Yes. Someone should absolutely consider the type of business when accepting a job. The type of company could have a huge effect on, work-environment, stock options, retirement plans, job opportunities, networking opportunities, and much more. However, I don’t think someone…   Read more»

]]> 74b6e12d05063feaa8991bb69e12138b https://medicaldevicecourses.com/activity/p/20620/ Fri, 16 Oct 2020 00:52:27 -0400 The ownership of a sole proprietor business cannot be directly passed on. The sons would have to start a new business, either with sole proprietorship (one of them owns and runs it), or a Limited Liability Partnership (both of them…   Read more»

]]> df5e9c964aef6599df1714eb13d0ef4e https://medicaldevicecourses.com/activity/p/20537/ Mon, 05 Oct 2020 00:19:36 -0400 I have experienced a solution to this quality and r&d integration problem. A separate department called “Advanced Operations” assists the R&D team to formulate manufacturing & testing plans that minimize the risks associated with quality. This provides a clear plan…   Read more»

]]> 1f2e4b8706305a6751a3e900ea8ede35 https://medicaldevicecourses.com/activity/p/20535/ Mon, 05 Oct 2020 00:13:13 -0400 Technology such as AI can be helpful in developing semi or fully automated quality inspections processes. I think it’s important to note that these new technologies also have to get validated themselves. Any new technology added to improve quality control…   Read more»

]]> b77f322748d9762ffaf2e87d9ea3aa73 https://medicaldevicecourses.com/activity/p/20534/ Mon, 05 Oct 2020 00:05:23 -0400 Quality Assurance is the methods used to ensure a product is suitable for the market. The methods include all of the systems, structures, reviews and evaluations used to meet product requirements. Quality Control is more focused on if the product…   Read more»

]]> 9ae5c4b44c61cdb61729fe183930ba78 https://medicaldevicecourses.com/activity/p/20437/ Sat, 26 Sep 2020 01:25:46 -0400 I agree that many new medical devices have no business being compared to 40-year-old devices. One of the primary benefits of a 510k is to bypass long and expensive clinical trials. So truly “new” developmental technology has no business being…   Read more»

]]> 1e807078ad3d906b49d07a620e765628 https://medicaldevicecourses.com/activity/p/20436/ Sat, 26 Sep 2020 00:56:44 -0400 A physician would likely have a hard time developing their own medical device. The design, development, verification, and validation phases can prove to be very expensive. Depending on the completixity of the device, extra personnel would likely have to be…   Read more»

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