https://medicaldevicecourses.com/members/dmf2/activity/ Activity feed for dmf2. Fri, 24 Apr 2026 22:39:12 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b953cf97f0c65012957a4e00cd2f4dd5 https://medicaldevicecourses.com/activity/p/30301/ Wed, 27 Nov 2024 22:32:10 -0500 When finalizing a consulting agreement, several key elements must be meticulously addressed to ensure clarity, safeguard the company’s interests, and establish mutual expectations. Defining the scope of work is essential, as it outlines the specific tasks, deliverables, and timelines the…   Read more»

]]> 693d6bd6e00108465204ac687944e316 https://medicaldevicecourses.com/activity/p/30300/ Wed, 27 Nov 2024 22:12:24 -0500 While I don’t have personal experience with consulting, I believe it’s a strong option for recent graduates, especially in industries where full-time positions are highly competitive and difficult to secure. It’s interesting to note that consulting isn’t particularly common among…   Read more»

]]> 32f4bc9e640d975d95eff887d9e0641a https://medicaldevicecourses.com/activity/p/30289/ Tue, 26 Nov 2024 22:46:04 -0500 The discussion on verbal contracts is indeed fascinating, especially in the medical device industry, where precise documentation and regulatory compliance are critical for success. While written contracts are generally preferred for their clarity and enforceability, verbal agreements can be valuable…   Read more»

]]> eaabcd10772efe2f08b1bf5b51964512 https://medicaldevicecourses.com/activity/p/30228/ Thu, 21 Nov 2024 19:31:57 -0500 Given the structure that was presented to us during class, I would say that my group originally started off as a functional organization. As organized by Dr. Simon, each student was grouped into an area of expertise of their choosing,…   Read more»

]]> 91ad62d5cf0f6ad8d0a71fbf3079e11f https://medicaldevicecourses.com/activity/p/30227/ Thu, 21 Nov 2024 18:55:50 -0500 A functional organization is hierarchal structure in which employees are grouped in departments based on their specialized functions or area of expertise. In this type of organization, authority and decision making are centralized within the functional department. For medical device…   Read more»

]]> d3aa8f74f1f3ba354dc91ac0591676c6 https://medicaldevicecourses.com/activity/p/30226/ Thu, 21 Nov 2024 18:23:18 -0500 When it comes to the appropriateness of a matrix type (strong, weak, or balanced) for a medical device project team, it is important to consider several factors, including the complexity and regulatory requirements of the project. To start with a…   Read more»

]]> 72cd306b0eddaeda0bf92e45d23136a5 https://medicaldevicecourses.com/activity/p/30161/ Thu, 14 Nov 2024 20:16:38 -0500 As someone who lacks industry experience it is very interesting to see everyone’s experience with risk management and which circumstances they encountered with each method (risk avoidance, mitigation, and acceptance). While each method has similarities to each other, they can…   Read more»

]]> 92f1ab3b2ab99f2e70bf751cbbadb415 https://medicaldevicecourses.com/activity/p/30159/ Thu, 14 Nov 2024 19:07:25 -0500 Just as many have said above, it is clear that risk management is a crucial process conducted throughout each stage and area of the project, but I would argue that the product design stage requires the most attention and awareness….   Read more»

]]> 7015775e7232f4e1fc2e1f21675d4afc https://medicaldevicecourses.com/activity/p/30158/ Thu, 14 Nov 2024 18:38:58 -0500 Risk acceptance is a risk management strategy in which an organization consciously decides to accept a risk without taking proactive steps to avoid or mitigate it. Therefore, to answer the question above, risk acceptance can technically lead to a higher…   Read more»

]]> 311381f01b8f8219dea36fba5d682eeb https://medicaldevicecourses.com/activity/p/30073/ Thu, 07 Nov 2024 20:45:33 -0500 The responses seen above do a great job in explaining and describing the steps/process a team must take to define success criteria, but it is also important to highlight the disadvantages that come with moving target success criteria. To start,…   Read more»

]]> e63c48b69a629f4dd3f9d9dea18220f1 https://medicaldevicecourses.com/activity/p/30072/ Thu, 07 Nov 2024 19:37:35 -0500 This an interesting topic because there are so many medical devices that the 3 categories of design input requirements can be very different. The device that I will be mentioning is a pacemaker, which is a small, battery-powered device that’s…   Read more»

]]> 01a8bf331d8c54d2462e7da099e2ba4f https://medicaldevicecourses.com/activity/p/30071/ Thu, 07 Nov 2024 18:57:55 -0500 As many of the previous responses have stated, a project proposal is crucial because it establishes the foundation and direction of the project within a company. Not only does a project proposal clearly identify a business need and present a…   Read more»

]]> ba4c64984d9ce91d19a3d78f312c32ea https://medicaldevicecourses.com/activity/p/29990/ Wed, 30 Oct 2024 01:49:38 -0400 When it comes to medical device companies and “corporate responsibility”, they tend to the take the matter very serious due to ethical obligations and regulatory requirements. To start with regulatory accountability, medical device companies need to follow the stringent safety…   Read more»

]]> 408b5692537bef7fb72fb8139a2299ef https://medicaldevicecourses.com/activity/p/29989/ Tue, 29 Oct 2024 22:29:01 -0400 While it is certainly worth arguing that a Design Matrix with the four columns listed above (inputs, specifications, validation, and verification) can provide enough critical information to complete a matrix, I believe that adding additional columns could enhance the matrix’s…   Read more»

]]> b156dc6c7aced0f840c60b07d1f400c4 https://medicaldevicecourses.com/activity/p/29988/ Tue, 29 Oct 2024 20:53:30 -0400 For my capstone project, my team and I designed and developed a mechano-myography (MMG) armband that was able to track the mechanical vibrations of the upper arm while also measuring the changes in circumference during a muscle contraction. The armband…   Read more»

]]> dbe9e5de6d4f13d777fece797e6e166f https://medicaldevicecourses.com/activity/p/29938/ Fri, 25 Oct 2024 23:29:35 -0400 This is a very interesting topic because controlling the placebo effect in clinical research is critical to the success and accuracy of a trial, especially in studies in which the patient’s perception of pain can heavily influence the results. While…   Read more»

]]> f5bab505689f6b80093dd48302a9ab79 https://medicaldevicecourses.com/activity/p/29937/ Thu, 24 Oct 2024 21:58:01 -0400 People decide to participate in clinical trials for a variety of personal and medical reasons. To start from a medical perspective, one of the main reasons individuals volunteer in clinical trials is because it gives them early access to new,…   Read more»

]]> 02e8bb526cfe679cb0aa5e5c83f8886b https://medicaldevicecourses.com/activity/p/29936/ Thu, 24 Oct 2024 20:00:52 -0400 As a graduate student-athlete who is pursing their Master’s in Biomedical Engineering at NJIT, I definitely think that students would greatly benefit from spending time in a clinical setting. Throughout my past four years at NJIT, I have found it…   Read more»

]]> b292742362d7368ff95912f91c7a93f7 https://medicaldevicecourses.com/activity/p/29853/ Tue, 15 Oct 2024 20:34:20 -0400 Although currently, with my aspirations and desires, I do not really see myself transitioning into either marketing or sales after completing my biomedical engineering degree, if it truly came down to it and I were to transition into one of…   Read more»

]]> a4b46698783dbc1b2404fa0304ca2d4b https://medicaldevicecourses.com/activity/p/29852/ Tue, 15 Oct 2024 19:24:50 -0400 In today’s world, social media has certainly proven its effectiveness in reaching vast and diverse audiences. With various different social media platforms like TikTok, Instagram, Twitter, Facebook, and YouTube it is practically inevitable to come across an advertisement that will…   Read more»

]]> 6765b3a495fd46f494f8b257b77b2ced https://medicaldevicecourses.com/activity/p/29851/ Tue, 15 Oct 2024 18:36:43 -0400 As technology and engineering continue to play a pivotal role in the development of medical devices, it is clear that marketing strategies need to adapt by emphasizing the integration of technical benefits with patient outcomes. This requires a combination of…   Read more»

]]> cb9a3c0863022bee71ca845122c414e3 https://medicaldevicecourses.com/activity/p/29777/ Wed, 09 Oct 2024 00:52:05 -0400 As a graduate student pursuing their Master’s in Biomedical Engineering at NJIT, I feel as though I am someone who knows very little about the business side of the industry. Therefore, I certainly believe that requiring engineering students to take…   Read more»

]]> fa0b4df123ce3f5df604d84f38122537 https://medicaldevicecourses.com/activity/p/29776/ Wed, 09 Oct 2024 00:19:25 -0400 In general, yes, the size and maturity of a company unquestionably has a large influence on the relative importance of financial ratios within the company. As stated above, the main reason being is that large, established companies often have diverse…   Read more»

]]> 78ed8f0a1ad76fb34d3f9eb4bc1acd6d https://medicaldevicecourses.com/activity/p/29775/ Tue, 08 Oct 2024 19:47:05 -0400 The idea that a corporation can be considered a legal entity and, thus, bear moral responsibility instead of the individuals running it is has been a complex debate in law and philosophy for many years now. This framework, known as…   Read more»

]]> 4f5700623f20425e61a9fc48063c84c7 https://medicaldevicecourses.com/activity/p/29717/ Thu, 03 Oct 2024 22:19:30 -0400 When looking at the rapid advancement of technology and evolving standards seen in the world today, it can be increasingly complex to ensure the safety and efficacy of medical devices through quality control and quality assurance. In the context of…   Read more»

]]> fbb05e2845a20ef17f7c5ff51b494988 https://medicaldevicecourses.com/activity/p/29716/ Thu, 03 Oct 2024 21:34:27 -0400 Preventing mistakes and ensuring safety in manufacturing environments is critical for maintaining quality, regulatory compliance, and worker safety. One important way to ensure manufacturing safety is through conducting comprehensive training programs for employees. Employee training is critical to manufacturing safety…   Read more»

]]> 0f7b6eb5f8dbc6f53f8707f385887e92 https://medicaldevicecourses.com/activity/p/29634/ Tue, 24 Sep 2024 21:26:09 -0400 In this scenario I do not believe that one is necessarily working better or more in detail than the other, it is more-so a matter of a difference in priorities and regulatory philosophies between the two agencies. When looking at…   Read more»

]]> cc5bffe499060c3bfdef57919ce6ef46 https://medicaldevicecourses.com/activity/p/29633/ Tue, 24 Sep 2024 20:34:36 -0400 In the scenario of a damaged label on a product at a store, I believe that the responsibility for addressing the issue should involve both the store and the product’s manufacturer. The main reason the store should be held responsible…   Read more»

]]> 994cb771d7d6944da080082c83aaa1fd https://medicaldevicecourses.com/activity/p/29632/ Tue, 24 Sep 2024 19:55:28 -0400 Today in the US, the FDA classifies medical devices based on their overall risk. Devices that are classified as Class II generally have moderate-risk, including devices like syringes or blood pressure cuffs. These are items in which general control is…   Read more»

]]> 15cc0148d43c9c5f46f68baa96f1a784 https://medicaldevicecourses.com/activity/p/29565/ Tue, 17 Sep 2024 03:15:41 -0400 Project Management (PM) plays a vital role in both pre-clinical and clinical studies by providing structure, organization, and oversight to ensure that these complex and highly regulated processes are completed efficiently and effectively. PM helps structure and organize the entire…   Read more»

]]> 9f4b1a4f4b0ad4eff219d9f0510f30aa https://medicaldevicecourses.com/activity/p/29564/ Tue, 17 Sep 2024 02:14:04 -0400 This is a very interesting question that I think would certainly be worth analyzing for all colleges that contain professors that conduct research in academia. In my experience at NJIT there has certainly been instances of both cases. When looking…   Read more»

]]> 8e41e9d98ef9752c1eb6df4b78f3e91c https://medicaldevicecourses.com/activity/p/29563/ Tue, 17 Sep 2024 01:00:20 -0400 When weighing out the pros and cons of conducting academia research versus industry research, I would be lying if I said that academia research does not seem like it would be more enjoyable than industry research. Having the ability to…   Read more»

]]> be29eb80887b5c03194048d9ab69b76e https://medicaldevicecourses.com/activity/p/29506/ Thu, 12 Sep 2024 22:04:23 -0400 I agree with the perspective that being a “people person” is certainly beneficial when it comes to project management, but I do not believe that it is essential in becoming a successful one. As stated above, it is clear that…   Read more»

]]> 899a341927d3cf4bb05c01e85ef58565 https://medicaldevicecourses.com/activity/p/29505/ Thu, 12 Sep 2024 21:23:48 -0400 I think that it makes sense to raise concerns about the feasibility of a project during the initial planning and scoping phases, especially when the project’s feasibility study or risk assessment is being conducted. By this point in the project…   Read more»

]]> d5b30d63d1f571053b8cf49105da4385 https://medicaldevicecourses.com/activity/p/29504/ Thu, 12 Sep 2024 20:09:45 -0400 When using a Gantt Chart to assist in planning and scheduling my capstone project last year, one thing I learned was that when dealing with an issue that has potential to delay the project’s timeline, it is crucial to continuously…   Read more»

]]> d859ca0f0583756c37adef363ddd339e https://medicaldevicecourses.com/activity/p/29423/ Thu, 05 Sep 2024 21:09:53 -0400 In recent years, Biomedical Engineering (BME) has been a rapidly evolving field that continues to discover and develop various clinically relevant applications within the medical world. However, with such a rapid evolution comes many pressing issues in the field. One…   Read more»

]]> e2a5d729d83516f91c066930ff217027 https://medicaldevicecourses.com/activity/p/29413/ Wed, 04 Sep 2024 23:29:19 -0400 I believe that the graduate program here at NJIT should contain a better ratio of practical to informal courses than what is given. As stated by Dr. Simon, the ratio between the two types of courses currently sits at about…   Read more»

]]> e6ced5ea3281827dd92b7b8cffa9b432 https://medicaldevicecourses.com/activity/p/29407/ Wed, 04 Sep 2024 16:54:47 -0400 Academically speaking, I believe that it is more beneficial to be overqualified for a position rather than meeting the bare minimum qualification. However, I am also of the opinion that the decision between the two depends on one’s career goals…   Read more»

]]> 594420a8390fee332714ad786ef960b0 https://medicaldevicecourses.com/activity/p/29337/ Tue, 16 Apr 2024 01:55:08 -0400 When considering placing a mass order for a product, price is just one of several crucial factors to weigh. In my opinion, the number one factor other than price would be quality. It is paramount that the product is able…   Read more»

]]> e442a53f424165ae1af8b15008d3fbb8 https://medicaldevicecourses.com/activity/p/29333/ Tue, 16 Apr 2024 00:49:19 -0400 When looking at factors that drive motivation and productivity within the workplace, financial compensation is undoubtedly an essential factor because it provides a means to meet basic needs and achieve financial security. However, many non-monetary factors like job satisfaction and…   Read more»

]]> 5c3bebc15ee098a1fb8511789991dab9 https://medicaldevicecourses.com/activity/p/29332/ Tue, 16 Apr 2024 00:31:15 -0400 As stated above, failure within a project presents a pivotal opportunity for the team to gain valuable insights that can be beneficial for future endeavors. Firstly, the team can thoroughly inspect the planning phase of the project. This may include…   Read more»

]]> 944c13408d7cf22fb23756d8b28a400c https://medicaldevicecourses.com/activity/p/29290/ Thu, 11 Apr 2024 02:13:28 -0400 When a team member who is responsible for a critical task on a project changes positions or leaves the team, there’s no doubt that the project’s timeline will be affected. However, there are still many strategies that can be implemented…   Read more»

]]> a6d7ec2039ccc31ad0d560aaf28709d9 https://medicaldevicecourses.com/activity/p/29288/ Thu, 11 Apr 2024 01:03:08 -0400 While it may seem like a time-consuming step that could potentially delay the project deadline, ensuring that everyone on a project team has a working understanding of what each part of the team does is crucial for effective project management….   Read more»

]]> ee503b3593ae07f7b379949e3fa1652c https://medicaldevicecourses.com/activity/p/29285/ Wed, 10 Apr 2024 23:55:37 -0400 As for long term benefits, it would not be a smart idea for a company to prioritize cost savings over supplier diversity in their procurement strategies. The reason being is the opportunities that supplier diversity can bring. Diverse suppliers are…   Read more»

]]> 7a90671e9f118b23409b3b1be26718d3 https://medicaldevicecourses.com/activity/p/29217/ Mon, 01 Apr 2024 23:57:16 -0400 Change control is a critical aspect of quality management in a medical device company because it ensures that the changes are being implemented in a controlled manner to maintain product quality, safety, and regulatory compliance. By following established procedures, involving…   Read more»

]]> 4ed786c3eb7c7d1e262fa6acccf0a15a https://medicaldevicecourses.com/activity/p/29216/ Mon, 01 Apr 2024 16:57:11 -0400 Overall, the ratio of positive and negative aspects in personnel evaluation will depend on the specific contributions and actions of each individual throughout the project. When looking at positive aspects, several factors can be taken into consideration including the quality…   Read more»

]]> 40260248c46681554c1fde3692848107 https://medicaldevicecourses.com/activity/p/29215/ Mon, 01 Apr 2024 16:27:56 -0400 Just as many have stated, the first step in counteracting negative schedule variance is to identify the root cause behind the schedule variance. In the medical device industry, common causes could include poor planning, scope changes, resource constraints, and unexpected…   Read more»

]]> d9c54d563200a4ed53cb88a5f221b18d https://medicaldevicecourses.com/activity/p/29158/ Mon, 18 Mar 2024 23:29:46 -0400 While it is easy to constitute a project’s success based on if it is completed on schedule, within budget, and whether it adhered to the established scope, there are still many other ways to justify whether a project was successful…   Read more»

]]> bf70fad2932089d3a42a9b7f3f929be0 https://medicaldevicecourses.com/activity/p/29157/ Mon, 18 Mar 2024 22:22:38 -0400 While the approach to handling project delays or exceeding allotted expenses can vary depending on the circumstances, organizational culture, and the severity of the situation, I personally believe that punishment will achieve nothing but resentment. When working on a project,…   Read more»

]]> 911c8489895dc1b14f1ffab3542b6123 https://medicaldevicecourses.com/activity/p/29156/ Mon, 18 Mar 2024 22:08:54 -0400 When dealing with an imbalance of power, using compromise as a solution is a key strategy for resolving conflicts effectively. The three most common challenges in a compromise is to overcome assumptions, one-sided conclusions, and selective data. In order to…   Read more»

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