https://medicaldevicecourses.com/members/bjv9/activity/ Activity feed for BijinV. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 0aea7d8cdb50bc156eae7b1a97672fbe https://medicaldevicecourses.com/activity/p/14486/ Wed, 15 May 2019 18:57:22 -0400 At the previous company for which I worked, I was required to sign a non-compete agreement. While I generally believe that very restrictive non-compete agreements are very unfair to employees, especially recent graduates, I did understand it from the perspective…   Read more»

]]> 63903c3ceac6dddf066b2d0300e521a5 https://medicaldevicecourses.com/activity/p/14483/ Wed, 15 May 2019 18:57:20 -0400 As has been mentioned in previous posts, there needs to be a clear line between work and family. But I do not believe that is the primary issue. The primary issue is a matter of ethics and conflicts of interest….   Read more»

]]> 2feabd017772af03e311b27ad599365f https://medicaldevicecourses.com/activity/p/14482/ Wed, 15 May 2019 18:57:20 -0400 This is my second course with you, Dr. Simon. I previously took your Project Management for Medical Devices course. This course was good, but I felt the project management course was superior in content, delivery, and structure. While there is…   Read more»

]]> c229a530f41299c5440db130cc25734b https://medicaldevicecourses.com/activity/p/14320/ Wed, 15 May 2019 18:55:06 -0400 I believe that when forming a project team, one must always start with subject matter experts. Technical knowledge is critical in the early phases of a project. Even if the knowledge is not complete, at least knowing where to look…   Read more»

]]> 1bd2e5d5251f4ff8dd4876ae78555261 https://medicaldevicecourses.com/activity/p/14319/ Wed, 15 May 2019 18:55:05 -0400 I believe that I am better suited for a role in middle management with my current skill set. I have a fair amount of technical expertise which would allow me to think about logistics much more naturally. I believe that…   Read more»

]]> f26a4bc27d9c2e58dfdd350d6d533318 https://medicaldevicecourses.com/activity/p/14317/ Wed, 15 May 2019 18:55:04 -0400 I work for a company that follows a functional organization. Functional heads operate with a large degree of power governing day to day operations as well as project development. Groups are also organized around projects with little cross talk between…   Read more»

]]> 3e4269aade5f5ba141d6ac9a4896f171 https://medicaldevicecourses.com/activity/p/14180/ Wed, 15 May 2019 18:52:47 -0400 I believe the concept of as far as possible is meant to be vague. It isn’t defined as a certain level of safety or risk mitigation. Because by defining the point at which risk is “adequately” mitigated would lead to…   Read more»

]]> 1ba30d4deccdb57758210ac2a7080324 https://medicaldevicecourses.com/activity/p/14177/ Wed, 15 May 2019 18:52:45 -0400 Risk mitigation begins with end user training and education, in my opinion. After a company has done all it can to make a safe and efficacious device or product, it is up to them to educate the end user population…   Read more»

]]> 35c9f984c0becb57d12155532f938e78 https://medicaldevicecourses.com/activity/p/14175/ Wed, 15 May 2019 18:52:44 -0400 The companies that I have worked for that operate under any sort of regulation either purchase the standards or opt to use a subscription service. There are many regulations, and as has been mentioned, they are very expensive to purchase….   Read more»

]]> 0364d0e6f2fe5e99b9acc1cd42b6d59f https://medicaldevicecourses.com/activity/p/13914/ Wed, 15 May 2019 17:09:22 -0400 In our senior design capstone project for BME, the design inputs were developed from two sources: market research and customer needs. In order to develop design inputs, market research was conducted in order to understand what products and devices exist…   Read more»

]]> 7238d11ec59d6e1433bae205560417f9 https://medicaldevicecourses.com/activity/p/13910/ Wed, 15 May 2019 17:09:19 -0400 Gantt charts provide two critical functions: timing and dependence. The overall view of the Gantt chart allows all the tasks and deadlines of a project to be looked at. These timelines can be further detailed with macro and micro tasks….   Read more»

]]> 5b51c3089d6c145af10f578328f752ef https://medicaldevicecourses.com/activity/p/13908/ Wed, 15 May 2019 17:09:18 -0400 Meeting minutes, we can all agree, are useful in retracing and revisiting topics covered during meetings. As has been mentioned above, meeting minutes can help track some of the thought processes and logic that lead to decisions. Acting as a…   Read more»

]]> 009a2f57fbbff97708cfb30a4248d82c https://medicaldevicecourses.com/activity/p/13752/ Wed, 15 May 2019 17:07:54 -0400 I believe that every individual has the right to know what is going to be done to them in any sort of clinical setting. I believe that the passage of knowledge to a patient and their understanding is absolutely critical…   Read more»

]]> 1c54cf10f3a18caea03cfa4fea463b68 https://medicaldevicecourses.com/activity/p/13750/ Wed, 15 May 2019 17:07:53 -0400 Placebo-controlled trials are very important in establishing efficacy and statistical significance during the development of a medical device or drug. It should also be noted that a placebo doesn’t necessarily mean that no treatment is given to an individual in…   Read more»

]]> c8fa46f8513eb1b76d7b63e89e011415 https://medicaldevicecourses.com/activity/p/13748/ Wed, 15 May 2019 17:07:52 -0400 A clinical background is a very valuable trait when considering the field of clinical research. While engineers and technical experts are capable of working in this field, and successfully so, having a greater depth of knowledge in the intricacies of…   Read more»

]]> 5583eccf02733b4b4c91cea87819ff0f https://medicaldevicecourses.com/activity/p/13479/ Wed, 15 May 2019 17:05:14 -0400 When starting a small business, an LLC is a great model to set up the business. As has been mentioned above, it provides liability protection and more control over the business and its operations. However, as the business grows, corporate…   Read more»

]]> e987ac9e87f1ae90709bc4b5d1f48f91 https://medicaldevicecourses.com/activity/p/13476/ Wed, 15 May 2019 17:05:12 -0400 When deciding which company to work for, either the company has to be a reputable/well-known one, or the position/work has to be in line with the goals/desires of the individual. Ideally, you have a job that meets both of these….   Read more»

]]> 00fefe00012c4a59d390379ff7cfb3b5 https://medicaldevicecourses.com/activity/p/13475/ Wed, 15 May 2019 17:05:12 -0400 I did some research on Pfizer. Here are my findings: Current Stock Price: $36.37 Market Cap: $216.13 Billion Revenue per employee: $542.46k (I would like to see a larger fraction of this) Total Asset Turnover: 0.31 Net Margin: 13.63 Current…   Read more»

]]> 5b36454c7eb24bfc4235aa7480804991 https://medicaldevicecourses.com/activity/p/13354/ Wed, 15 May 2019 17:04:13 -0400 The company I currently work for has a good relationship with its QA/QC departments. The reason for this is integration. All projects that are proposed and piloted are done so while consulting with the QA department. Before a project can…   Read more»

]]> b791aed2f96dce6f04747d222c62e20e https://medicaldevicecourses.com/activity/p/13351/ Wed, 15 May 2019 17:04:12 -0400 Quality departments are often seen as standing in the way of innovation or creativity. However, their primary directive is protection. Protecting the company from FDA/NGO intervention. Protecting the company from releasing bad products. Protecting the business in general. But as…   Read more»

]]> 61cb6d2ae1c7ef81da6edd03320e1356 https://medicaldevicecourses.com/activity/p/13349/ Wed, 15 May 2019 17:04:11 -0400 Ultimately the difference between quality and R&D comes down to who each group answers to. Quality is responsible to the FDA, whereas R&D is responsible to the business. R&D strives to find innovation and solutions for products, services, and devices….   Read more»

]]> 260212dad509de83d7b49570ffd89ac1 https://medicaldevicecourses.com/activity/p/13193/ Wed, 15 May 2019 17:02:47 -0400 The importance of accuracy and precision when it comes to the FDA stems from concerns over safety. If a device or drug is not accurate or precise, there is no way the FDA can allow that level of variability and…   Read more»

]]> 40a522f9529395d0a6ade11850c5604c https://medicaldevicecourses.com/activity/p/13192/ Wed, 15 May 2019 17:02:46 -0400 In addition to the list above, it should be noted, that not only is there differing regulations on pharmaceuticals, there are also differing regulations on medical devices. And it is interesting, but there are other parts of the world that…   Read more»

]]> 0adb0fa64234d006cb97069de548e25f https://medicaldevicecourses.com/activity/p/13190/ Wed, 15 May 2019 17:02:45 -0400 The FDA is strict largely for the protection of the general public. Without these measures in place, there is a greater ability for dangerous products to make it out into the market. I believe the crux of the issue lies…   Read more»

]]> 393387605540a64909b0887a30e612a2 https://medicaldevicecourses.com/activity/p/13024/ Wed, 15 May 2019 17:01:19 -0400 In order to determine what biocompatibility testing a device needs, ISO 10993 can be referenced. There are various tests and requirements that need to be evaluated for each medical device based on its intended use and duration of use and…   Read more»

]]> 45d715f4743fb0bd3da250d24b7dad9d https://medicaldevicecourses.com/activity/p/13018/ Wed, 15 May 2019 17:01:16 -0400 Where I work currently, there was such a failure during the early phase 2 clinical trial period for an investigational drug. The drug had performed remarkably well during animal testing trials. However, when it was used on the intended patient…   Read more»

]]> c6fa49a5d8bc35912edd85ab86cc28d4 https://medicaldevicecourses.com/activity/p/13013/ Wed, 15 May 2019 17:01:14 -0400 Animal models are critical to the advancement of science. They are employed in the development of drugs, vaccines, and even medical devices. They have been used for hundreds of years and will be used for hundreds of years to come….   Read more»

]]> 38401662278cca9b8e1598d69018b67c https://medicaldevicecourses.com/activity/p/12880/ Wed, 15 May 2019 16:59:56 -0400 In a perfect world, managers would have all the technical knowledge that all the engineers under him/her have. This is not realistic or feasible. However, a good manager makes the effort to be involved in all the projects their employees…   Read more»

]]> ce57fdf53e168d0625ce505d1a762832 https://medicaldevicecourses.com/activity/p/12878/ Wed, 15 May 2019 16:59:55 -0400 I do not see any scenario in which missing a milestone can be considered a success. I understand that a milestone not being met because “something came up” with respect to safety may seem like a blessing in disguise. But…   Read more»

]]> 828f9bef9bcab230f193121514bcb736 https://medicaldevicecourses.com/activity/p/12877/ Wed, 15 May 2019 16:59:54 -0400 The primary difference between project management for medical devices and other non-medical companies is the adherence to regulations set forth by the FDA. Due to the fact that medical devices are ultimately intended for human use, there are much tighter…   Read more»

]]> 37ad4e7e5bc8d7a1021480f7bdb2fd12 https://medicaldevicecourses.com/activity/p/12706/ Wed, 15 May 2019 16:58:24 -0400 I believe that the 70:30 ratio is a little lopsided. The ideal ratio of informative to practical courses should be 50% informative and 50% practical. Among the most useful informative course taught at NJIT, the ones that feature labs are…   Read more»

]]> 572759c0d199e047592577ac1961fcd2 https://medicaldevicecourses.com/activity/p/12704/ Wed, 15 May 2019 16:58:23 -0400 My advice to current biomedical engineering students would be to find any form of work in engineering, or any STEM field in general. While the work may not directly use your skill set, getting experience in the field is more…   Read more»

]]> 7729778d799e306b39fc65d3af47a290 https://medicaldevicecourses.com/activity/p/12703/ Wed, 15 May 2019 16:58:23 -0400 The primary difference between academia and industry is the route to success and the degree to which work is structured. When it comes to the route to success, industry typically defines it as bring a product to market that is…   Read more»

]]> 804e6fabf9e5d9a4ba0768f924191ead https://medicaldevicecourses.com/activity/p/12604/ Wed, 15 May 2019 16:57:30 -0400 I personally have zero desire to be a manager. It could be a function of the experiences that I have had with managers that I have worked for currently and in the past. While there is a large salary increase…   Read more»

]]> 30ea8c60d939b5543a864879813582b1 https://medicaldevicecourses.com/activity/p/12602/ Wed, 15 May 2019 16:57:29 -0400 Much of what Chris mentioned in this post is something that resonates with me at my current position. While not always manifested in the form or a promotion, I do see accolades and preferential treatment being heaped on the same…   Read more»

]]> 4691f32eccc3954bfd2ff8ecccaad958 https://medicaldevicecourses.com/activity/p/12588/ Wed, 15 May 2019 16:57:22 -0400 I would liken an employee’s feeling about a job to the product life cycle. It is phasic, moving from introduction, through growth, maturity, and ultimately decline. In much the same way, there is excitement and positive feelings during the introduction…   Read more»

]]> 092bdfbefee63fb3e229f7cd0175f97e https://medicaldevicecourses.com/activity/p/12510/ Wed, 15 May 2019 16:56:38 -0400 I tend to agree with the overall results of the study. The top four reasons for working at a specific company are very much the same reasons I have for working somewhere (not necessarily in that order). Most people work…   Read more»

]]> 7f21a0473f06d23637d6bd91789cdb1a https://medicaldevicecourses.com/activity/p/12508/ Wed, 15 May 2019 16:56:37 -0400 Many of the things that motivate others are similar to what motivates me. In addition, one of the biggest things that motivates me is the simple acquisition of knowledge. Through school, through work, through experiences, I hope to learn and…   Read more»

]]> 34c61e6dbef8a62121fed683373a7a99 https://medicaldevicecourses.com/activity/p/12506/ Wed, 15 May 2019 16:56:37 -0400 A project manager’s motivation level will of course affect the team he/she manages. Lazy project managers beget lazy project teams, aggressive/motivated project managers beget aggressive/motivated project teams. Of course, individual personality has a great deal of influence beyond just the…   Read more»

]]> d4eb4383a56d922865d21caf39d8246c https://medicaldevicecourses.com/activity/p/12339/ Wed, 15 May 2019 16:55:07 -0400 As had been mentioned above, an engineering change order (ECO) will be required since the device design controls portion of the process has already been completed. Since the device now requires a recall, the design review process will likely need…   Read more»

]]> 206565159d235eb0fa3d2175bbf2e4d7 https://medicaldevicecourses.com/activity/p/12336/ Wed, 15 May 2019 16:55:05 -0400 Another example of a combination product is a drug-eluting stent. This product can fall under CDER or CDRH guidelines. But a request for designation by the FDA would likely place this under CDRH jurisdiction since its primary mode of action…   Read more»

]]> 4fe83c8e08488911c634b99e9ea6cf93 https://medicaldevicecourses.com/activity/p/12335/ Wed, 15 May 2019 16:55:04 -0400 At the company I work for, we are constantly developing prototypes and special products for customers based on existing devices that we have filed for. In order for us to determine the approval pathway, the regulatory department uses a flowchart/decision…   Read more»

]]> 84c53026782a532be175af170533e0fc https://medicaldevicecourses.com/activity/p/12224/ Wed, 15 May 2019 16:53:58 -0400 Engineering change orders are a critical aspect of design and process improvements. The description of the ECO has been echoed by many of the previous posts. ECOs are often critical controlled documents that enable changes to designs or processes to…   Read more»

]]> 014112ec3de4bef47d9aa230113542d5 https://medicaldevicecourses.com/activity/p/12223/ Wed, 15 May 2019 16:53:58 -0400 At my current job, logging and lack thereof, has proven to be far more critical than anticipated. As I work primarily in R&D and am responsible for much of the new product development, logging my work in a registered laboratory…   Read more»

]]> 070812ea29ef27ed3c42e9d5ef774885 https://medicaldevicecourses.com/activity/p/12145/ Wed, 15 May 2019 16:53:16 -0400 One interesting aspect of a project manager’s responsibility is meeting customer expectations. I bring this up because this is something that I see my project manager deal with on a regular basis. Customer’s will often come to my manager with…   Read more»

]]> 58b767ce6e5c8cfb8e115e34ff3f042a https://medicaldevicecourses.com/activity/p/12142/ Wed, 15 May 2019 16:53:14 -0400 As has been mentioned above, communication is the key when handling the majority of issues when it comes to team members and personnel. Transparency and communication when it comes to leaves of absence and vacation is immensely helpful. By knowing…   Read more»

]]> 5fde68a745120fb733f1112cbfbb1b5f https://medicaldevicecourses.com/activity/p/12138/ Wed, 15 May 2019 16:53:12 -0400 As has been mentioned above, the general selection of a vendor for a given supply is probably considered in the planning phases of a project, but not finalized until the execution phase. However, no matter who the vendor is, they…   Read more»

]]> f40b80b0c7b51fcd0fdab8f6b4399862 https://medicaldevicecourses.com/activity/p/12080/ Wed, 15 May 2019 16:52:37 -0400 This course has echoes many of the things I experience on a daily basis at the company I work for. As a small medical device company, each team member has expanded roles and responsibilities. Although I primarily work in R&D…   Read more»

]]> 4b7866fcdaa0ba17b44e0b63f8d87fc1 https://medicaldevicecourses.com/activity/p/12079/ Wed, 15 May 2019 16:52:36 -0400 One of the largest considerations when taking a company global is meeting various international regulations. As an employee of a medical device company that has reach in Europe and Asia, much of our regulatory teams responsibility is deciphering and meeting…   Read more»

]]> ca0dc745d1b764f22b6a630ca5f6c884 https://medicaldevicecourses.com/activity/p/12078/ Wed, 15 May 2019 16:52:36 -0400 During project planning, consulting with the members of the various teams would help to develop more accurate project timing forecasts. This is something that I experience at my company rather frequently. As projects move into the planning phase, critical members…   Read more»

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