https://medicaldevicecourses.com/members/atk27njit-edu/activity/ Activity feed for atk27@njit.edu. Fri, 24 Apr 2026 21:48:21 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8bf1d537e7c9885d8395657af00d5df2 https://medicaldevicecourses.com/activity/p/29354/ Sat, 27 Apr 2024 14:50:59 -0400 Outsourcing could provide the expertise and experiences needed for a company to conduct their clinical trial but it does not eliminate conflict of interest. They may have financial incentives to the success of the trial and the approval of that…   Read more»

]]> 278b3dc9b85978836e774ba81653d44e https://medicaldevicecourses.com/activity/p/29353/ Sat, 27 Apr 2024 14:20:31 -0400 Providing regular feedback and recognition for employees’ contributions to the company is essential for fostering a sense of appreciation for them.  Implementing a feedback system where performance evaluations and informal recognition programs are done can go a long way in…   Read more»

]]> 58a85bb6c54b4a44dadd96af4b9b0a57 https://medicaldevicecourses.com/activity/p/29352/ Sat, 27 Apr 2024 14:15:27 -0400 @jh597 I would also like to add that workplace flexibility has become more of a factor within the recent years. After covid, most teams have become remote and/or hybrid so the flexibility is another crucial factor in the retention of…   Read more»

]]> e98640e294026d8a7173b1bfc903b84c https://medicaldevicecourses.com/activity/p/29351/ Sat, 27 Apr 2024 14:04:55 -0400 Consider a situation in which a company needs to explore the feasibility of launching a new product line within a short timeframe. A detailed task identification and bottom-up estimation may not be feasible due to time constraints and the need…   Read more»

]]> e9575048176e91b471ea76a5f31d872f https://medicaldevicecourses.com/activity/p/29350/ Sat, 27 Apr 2024 13:58:50 -0400 This is an issue that has arised with my specific department. A lot of the engineers in the design department would create their models, order them, and it would be used in productions. However, any changes made to that fixture…   Read more»

]]> 80761a7ecf784e32a310f63ff24730d5 https://medicaldevicecourses.com/activity/p/29197/ Mon, 25 Mar 2024 01:14:09 -0400 Yes, ensuring the safety and efficacy of medical devices is important, and change control plays a critical role in achieving that goal. The final approval authority typically rests with a Change Control Board (CCB) comprised of senior representatives from various departments…   Read more»

]]> b457987453c277ee679d84f6aeefea1a https://medicaldevicecourses.com/activity/p/29196/ Mon, 25 Mar 2024 01:11:18 -0400 Project managers can reclaim their inbox with a strategic approach. Schedule specific times to check emails and ruthlessly prioritize them. They can leverage tools like filters, labels, and canned responses to automate organization and save time.Choosing between emails and Teams…   Read more»

]]> 00b88f70ca4855555cd315efa0537029 https://medicaldevicecourses.com/activity/p/29029/ Mon, 26 Feb 2024 01:42:52 -0500 Employees can also be stakeholders in various contexts. Beyond their roles as workers, employees are stakeholders in their organizations. They have a vested interest in job security, workplace culture, opportunities for advancement, and fair compensation. Their engagement and satisfaction directly…   Read more»

]]> 5c507f633e2870daacd028527b00ba21 https://medicaldevicecourses.com/activity/p/29024/ Mon, 26 Feb 2024 01:07:37 -0500 I have had experiences where projects have been dropped because of improper funding or lack of resources especially after a lot of work have been put into it. This hurts the company a lot in the short-term because all the…   Read more»

]]> 1ed0b2aa2506acba5f358e32e6b28418 https://medicaldevicecourses.com/activity/p/28964/ Mon, 19 Feb 2024 01:26:42 -0500 @torikul Yes, the strategic and business management skills are very important for project managers since they enable effective decision-making, value creation, and project success. While technical and project management skills are essential, the level of importance attached to strategic and…   Read more»

]]> 78cb09e11ab024b70eeb67b1c1b18c6b https://medicaldevicecourses.com/activity/p/28962/ Mon, 19 Feb 2024 01:20:45 -0500 The pre-feasibility/feasibility data and the business case(BAM) are interdependent with each other. The feasibility data provides the fundamental information that is necessary for the development of the business case for that project. For instance, the feasibility data might suggest market…   Read more»

]]> ee694eb528b17653d61a99ba223f7271 https://medicaldevicecourses.com/activity/p/28908/ Mon, 12 Feb 2024 02:55:48 -0500 Microsoft Teams is a widely-used tool among project managers for facilitating team meetings, collaboration, and communication. Its integration with other Microsoft Office applications ease of use and features make it an excellent choice for project teams, especially in remote or…   Read more»

]]> 117c364fbfc8049dadb03de08640b9f2 https://medicaldevicecourses.com/activity/p/28907/ Mon, 12 Feb 2024 02:51:41 -0500 I feel like a PM has to work on-site to be a good PM. Working under a project manager who communicates primarily in-person can foster stronger interpersonal connections and facilitate more immediate feedback and problem-solving. In-person interactions also enables clearer…   Read more»

]]> 3a578e6b4adc9d3d782206d5ae2053ee https://medicaldevicecourses.com/activity/p/28906/ Mon, 12 Feb 2024 02:49:23 -0500 It is important to understand that project management can be beneficial even if one does not plan on pursuing it as a career. Project management principles and techniques are applicable across various domains and can enhance efficiency, collaboration, and overall…   Read more»

]]> f1a61bbe7c2e013aef67daee087f90fa https://medicaldevicecourses.com/activity/p/28830/ Sun, 04 Feb 2024 23:28:35 -0500 The approval process for design meetings are usually what causes a lot of delay within a project. There are so many things that managers need to track that causes them to put it off causing unnecessary delays and projects going…   Read more»

]]> e61008999e8c9f719c3a6ff85f81cb7f https://medicaldevicecourses.com/activity/p/28828/ Sun, 04 Feb 2024 23:21:49 -0500 There are different leadership styles that a PM can implement but it all comes down to whether they want to be loved or feared as a leader. Every good leader will inspire and set clear expectations for their team but…   Read more»

]]> 608128cf6b088d75ad8bfc2c58d36dd5 https://medicaldevicecourses.com/activity/p/28827/ Sun, 04 Feb 2024 23:10:16 -0500 A detailed plan is always going to include sub-plans that require planning with different areas within the project. There are many different components and plans that goes into a medical device so it requires sub-planning on specific teams required for…   Read more»

]]> c745cab21302c56738f63817d533ea7e https://medicaldevicecourses.com/activity/p/28768/ Mon, 29 Jan 2024 04:49:58 -0500 @nm523njit-edu The key requirement for this is to establish clear communication channels between project managers, regulatory affairs, and upper management. Regular updates on regulatory progress, potential challenges, and milestone achievements can help them manage their expectations and allow for efficiency…   Read more»

]]> f476b7f9003f84e854fcbcf070116aa0 https://medicaldevicecourses.com/activity/p/28766/ Mon, 29 Jan 2024 04:42:36 -0500 First, the adequate predicate of that device needs to be found which will be the first starting point to figure out the product code and regulation number for the medical device. For this, utilize the FDA database and search up…   Read more»

]]> 137cbbad01d138353659104edd91a476 https://medicaldevicecourses.com/activity/p/28765/ Mon, 29 Jan 2024 04:38:24 -0500 The main solution to this would be either getting outside help using consultations or educating yourself on the topic. It is crucial to learn the biologics and drugs side of any medical component to ensure the overall success of the…   Read more»

]]> c9aa96aff369c6b51ed7c032ac99bcd7 https://medicaldevicecourses.com/activity/p/28668/ Mon, 22 Jan 2024 01:32:50 -0500 Another topic that is unique to medical devices include a robust quality management system or ISO 13485:2016 standards. This standard requires that a quality management system is implemented to meet the standards for safety and effectiveness of medical devices. Every…   Read more»

]]> 06bafe3408fa1901a6238e941cb705c8 https://medicaldevicecourses.com/activity/p/28660/ Sun, 21 Jan 2024 22:46:22 -0500 The PDCA cycle varies with different specialties and the companies but the overall principle provides the framework for how problems should be addressed and mitigated. In manufacturing engineering, the Plan phase is usually carried out by process and design engineers…   Read more»

]]> c14c2b271582a99d8a804a3363f5a178 https://medicaldevicecourses.com/activity/p/28659/ Sun, 21 Jan 2024 22:38:17 -0500 From a business standpoint, having a smaller and more experienced team is better than having a larger team where there is not enough work to go out to everyone. At least where I have worked, there were would be one…   Read more»

]]> 61c76ee873b4ff751e14463e80556120 https://medicaldevicecourses.com/activity/p/28589/ Sun, 03 Dec 2023 23:29:19 -0500 Events held in anything considered non-professional, especially in the context of medical industry, can be considered an unreasonable location. Events held in resort locations, exotic destinations, or business’ where the primary context is not known for business should be considered…   Read more»

]]> 927e0ad13e0fde4bce89cf70ffb7a734 https://medicaldevicecourses.com/activity/p/28588/ Sun, 03 Dec 2023 23:23:34 -0500 Verbal contracts are still legally binding if they have elements of validity. The problem with verbal contracts though is that people misunderstand each other causing disputes and other legal problems. I’d say verbal agreements in general are always insufficient and…   Read more»

]]> 3074fcf58051cc846aa091511a147a7b https://medicaldevicecourses.com/activity/p/28587/ Sun, 03 Dec 2023 23:18:10 -0500 There are also some restrictions where patients can not give gifts to their physicians to. It carries a risk of subtle biasing to the care of that patient. According to the AMA, doctors are supposed to decline any cash and…   Read more»

]]> 72ca96f1801e2ba249b40684fe8dab5f https://medicaldevicecourses.com/activity/p/28554/ Mon, 27 Nov 2023 21:01:25 -0500 The matrix completely depends on the organizational culture, project, and preference of the company overall. Where I currently work, most of the PMs do not have the power to make major decisions on a project without consulting the technical lead…   Read more»

]]> c100155395a0e498de08cc3b108a8893 https://medicaldevicecourses.com/activity/p/28553/ Mon, 27 Nov 2023 20:54:45 -0500 I’d say middle management, which includes any type of manager or director, because they have to maintain the operations of their team. More than that, they have to innovate to improve performance of their organization which can be very challenging…   Read more»

]]> 8293af060efd9c7d5c4c7f6441255922 https://medicaldevicecourses.com/activity/p/28519/ Thu, 23 Nov 2023 17:29:57 -0500 I currently work in a matrix organization as well and the program managers would recruit people from different departments for their program. This organization works really well because there is no need to pay for more than what is necessary…   Read more»

]]> 08c466a7c745347c1bbd58ae5df0dea6 https://medicaldevicecourses.com/activity/p/28496/ Mon, 20 Nov 2023 01:12:17 -0500 The thing is some risks are relatively minor and have a very low probability of occurring. However, high probability risks need to considered and approaches should be taken to minimize the damage it may cause. So, within the acceptance phase,…   Read more»

]]> 6b5db21c1fa65a796748c7e9224a6b4d https://medicaldevicecourses.com/activity/p/28487/ Sun, 19 Nov 2023 21:34:02 -0500 I’ve seen PFMEA used by process engineers for machines. PFMEA us used to identify the different failure modes for the machine and ways to fix this issue. For instance, some of these issues could include sensor malfunctioning, programming error, or…   Read more»

]]> 1e2523478e37b64a5b57880a6c4efeaf https://medicaldevicecourses.com/activity/p/28486/ Sun, 19 Nov 2023 21:20:54 -0500 A type of risk management seen in manufacturing is a concept called “Poka-yoke.” It’s a Japanese term that translates to “mistake-proofing” and was developed by Japanese engineers at Toyota to avoid errors during mass production. Poka-yoke involves implementing mechanisms or…   Read more»

]]> 9fc01c53c4bfea4866a726572c7423cd https://medicaldevicecourses.com/activity/p/28454/ Mon, 13 Nov 2023 18:22:00 -0500 The validation process ensures that all the customer needs are met so that a successful, good quality, and reliable product is made. Thus, it requires rigorous, well-planned, and well-thought-out tests to test the reliability of the product so that all…   Read more»

]]> 88b844f9852174229596a60d894913ad https://medicaldevicecourses.com/activity/p/28453/ Mon, 13 Nov 2023 13:32:15 -0500 Initiating document releases and revisions are a crucial part of an effective quality management of any device. In fact, there is a cycle that every document goes through which includes its creation, review, release approval, distribute training, use, and if…   Read more»

]]> 296480ce7a375e73627196d830004572 https://medicaldevicecourses.com/activity/p/28452/ Mon, 13 Nov 2023 13:15:52 -0500 Design Matrix with columns for inputs, specifications, validation, and verification is a good starting point but each device has to adapt to its own design process system and all the requirements included for that device. For example, the design matrix…   Read more»

]]> 66b0bbe2d69e5537da79ba2b66265e45 https://medicaldevicecourses.com/activity/p/28381/ Mon, 06 Nov 2023 01:43:42 -0500 This is usually written out within the companies mission/vision statement. They really care about the quality of their products, especially in the medical field, so they will take every effort to do each of the steps according to the standards….   Read more»

]]> 5b735999704faff2a6cccc9a0b3cba60 https://medicaldevicecourses.com/activity/p/28355/ Wed, 01 Nov 2023 14:55:23 -0400 Some of the design verification plans that is done for companies that manufacture medical devices are to see if that devices meet their design specifications and intended purpose. So this will be tests such as QC measuring using CMMs, optical…   Read more»

]]> 8ad5fec4729bbf5bae3542c5282cf7ac https://medicaldevicecourses.com/activity/p/28354/ Wed, 01 Nov 2023 14:35:00 -0400 That is true. We did follow the design control process for capstone where we first wrote up the customer requirements, design requirements, test plans, and evaluation of the test plans. These are basically the Project Proposal, Design Development Plan(DDP), Design…   Read more»

]]> 66f1f1c9f0fe5b5d4d58289ae713ed1d https://medicaldevicecourses.com/activity/p/28344/ Mon, 30 Oct 2023 03:08:58 -0400 Compensating participants is a necessary part of any trial but there are ethical concerns that arise under coercion and exploitation. In third-world countries, people who come from a poorer background would be incentivized to take on something just because of…   Read more»

]]> a276d75971a8051b6c1808086b02cfb0 https://medicaldevicecourses.com/activity/p/28342/ Mon, 30 Oct 2023 02:53:40 -0400 Another main concern that nobody has brought up yet is informed consent. The individuals in the trial should make their own decision about whether they want to participate or continue participating or not. Researchers usually have to write up what…   Read more»

]]> 6316a2a7dc5b760251ffb618c54da70f https://medicaldevicecourses.com/activity/p/28341/ Mon, 30 Oct 2023 02:42:04 -0400 Placebo pills work because the person taking its expects that pill to work and it works(sometimes) because of the power of the mind. For instance, stress has been shown to increase blood pressure which can lead to a risk factor…   Read more»

]]> 673dfc51d403487184521a741f709291 https://medicaldevicecourses.com/activity/p/28267/ Sun, 22 Oct 2023 22:51:33 -0400 I am wondering, does people think that it is worth working as a sales/marketing engineer role in a company. I feel like there isn’t much engineers, in the first place, that would be more interested in the sales/marketing side of…   Read more»

]]> 3bb907cb5fee9face787a3f797552edd https://medicaldevicecourses.com/activity/p/28266/ Sun, 22 Oct 2023 22:42:12 -0400 To be in any position that requires marketing as an engineer, you have to be able to help service both the customer and the business. I feel like this job is for people that possess the ability to initiate, establish,…   Read more»

]]> 44c40f4a538dda4f8a8b36932d8e747c https://medicaldevicecourses.com/activity/p/28264/ Sun, 22 Oct 2023 22:29:12 -0400 If you really want to go into management type position(such as project manager or technical specialists), I would definity do an MBA since you have to be very business focused for this type of job. These type of people are…   Read more»

]]> 93a4ab6e8372005dcc113d58cb2a4b66 https://medicaldevicecourses.com/activity/p/28231/ Mon, 16 Oct 2023 00:49:54 -0400 Something that I have learned working as an intern is an MSA, or more specifically a Gage R&R study, in which a measurement system, in which our case was a tool used for pull force testing our product, is analyzed…   Read more»

]]> db3051d4804661b28693b9a9c5c404fd https://medicaldevicecourses.com/activity/p/28230/ Mon, 16 Oct 2023 00:49:53 -0400 Something that I have learned working as an intern is an MSA, or more specifically a Gage R&R study, in which a measurement system, in which our case was a tool used for pull force testing our product, is analyzed…   Read more»

]]> 032d1cd72f09fd9fb8bb94d6cad84f8f https://medicaldevicecourses.com/activity/p/28222/ Mon, 16 Oct 2023 00:12:09 -0400 I work in a medical device company that manufactures surgical products and one of the main problems we have is when we scrap more material that we need to because the whole process that was fully optimized. Since this was…   Read more»

]]> e70c1b70f67251abbc59f102411de805 https://medicaldevicecourses.com/activity/p/28221/ Sun, 15 Oct 2023 23:57:04 -0400 The quality of the medical device needs to be ensured to protect the patient’s health which is why there is a difficult regulatory landscape for this. And this is made harder because during an phase of manufacturing or translating concepts…   Read more»

]]> 3b195fb8cd81da7167bd989c61a2cc63 https://medicaldevicecourses.com/activity/p/28163/ Mon, 09 Oct 2023 01:19:37 -0400 We learned from this week that corporation can be considered as a moral entity so it receives the blame/praise instead of the people running the corporation. Should this be allowed?  Currently, since corporations are considered as a legal entity, they…   Read more»

]]> 87a7532472be36fdad5259f2da40b437 https://medicaldevicecourses.com/activity/p/28162/ Mon, 09 Oct 2023 00:14:53 -0400 All of the profit margin depends on the type of product that a company is selling. If the device is something that is fairly conventional, these products are treated like commodities so their profit margin is going to be low…   Read more»

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