https://medicaldevicecourses.com/members/jo277/activity/ Activity feed for jo277@njit.edu (Julian Ong). Sat, 25 Apr 2026 01:24:17 -0400 https://buddypress.org/?v= en-US 30 hourly 2 cb187b1eb3f956f2cb16da3a6fd348ad https://medicaldevicecourses.com/activity/p/29303/ Sun, 14 Apr 2024 02:40:52 -0400 I can speak about vendors and how vendor choices are made. I currently work at a multinational pharmaceutical company, and usually they are have a primary vendor that they solely work for to purchase materials from. As part of the…   Read more»

]]> 4a839dd8a2bcd7fabaa22503987ada34 https://medicaldevicecourses.com/activity/p/29302/ Sun, 14 Apr 2024 02:34:27 -0400 I absolutely believe that it is important for people to understand the work and style of their team members and the project goal as a whole, reason being it helps them understand the big picture as to how their part…   Read more»

]]> 000c1ae663470d76504245ce4af7b84c https://medicaldevicecourses.com/activity/p/29301/ Sun, 14 Apr 2024 02:30:48 -0400 I think that it is totally possible to have an exciting and fruitful team development process that can be equally rewarding on a low or lower budget. Oftentimes, throwing money towards the development of team chemistry or individuals is not…   Read more»

]]> 46ef474524d63cbee677c424e8ba9cf6 https://medicaldevicecourses.com/activity/p/29233/ Fri, 05 Apr 2024 21:15:48 -0400 Project managers should absolutely be flexible when a personal situation comes up for one of their members. I think it is important to emphasize work life balance in the sense that personal life matters should always take precedence over work,…   Read more»

]]> 63f8fdd10c37ea30dfd1ae6e09cb5d89 https://medicaldevicecourses.com/activity/p/29232/ Fri, 05 Apr 2024 21:11:04 -0400 When working on a project, you are bound to encounter personalities among a wide variety and range that can be polar opposites or alike. As a project manager, your role would not to necessarily contain these personalities, but rather to…   Read more»

]]> e59607449c8ab907be03997deee41f50 https://medicaldevicecourses.com/activity/p/29231/ Fri, 05 Apr 2024 21:06:25 -0400 Project slack time is important because it allows some flexibility for issues that may arise during the project’s life cycle without having to worry about being late or creating unforeseen consequences and hardship later on. It is important to note…   Read more»

]]> bc1cc5ca28e166ce4157555479c87e6d https://medicaldevicecourses.com/activity/p/29184/ Sat, 23 Mar 2024 15:37:27 -0400 In my opinion, the best compromises are those where no party involved in the conflict can comfortably exclaim that they took the majority win of decisions. Often times, when the solution offered by the different parties involved is not sufficient,…   Read more»

]]> f46044592780ac4cd03557106a69d53c https://medicaldevicecourses.com/activity/p/29183/ Sat, 23 Mar 2024 15:18:13 -0400 Once a product reaches the end of its developmental life cycle, where all associated documents and paperwork are formalized and finalized, I would assume that two things would happen. First, the original core team that was instrumental in the product…   Read more»

]]> 56bbc224a0f1a990c0fd16d5d1860120 https://medicaldevicecourses.com/activity/p/29182/ Sat, 23 Mar 2024 15:08:55 -0400 Hi all! I’m Julian and I would love to connect with everyone. Please find my linkedin below!
 
https://www.linkedin.com/in/julian-ong-/

]]> 71e85c6cd713ea96720ca1386d432630 https://medicaldevicecourses.com/activity/p/29117/ Fri, 08 Mar 2024 19:19:01 -0500 There are many technical challenges that play hand in hand in attributing to a medical device’s success, each one creating domino effects that cascades one weak point into complete failure if not remedied. It can be argued about what the…   Read more»

]]> 9d274e7e4f6e87f74faa9fb0d4210c00 https://medicaldevicecourses.com/activity/p/29116/ Fri, 08 Mar 2024 19:10:20 -0500 In my perspective, the best general resolutions of conflict include parts of both opposing parties ideas. Being able to incorporate the best of both solutions would indicate two things; first it would show that teamwork and different perspectives of thinkings…   Read more»

]]> aa4f12c0fa69440db8fa22df1eeb0143 https://medicaldevicecourses.com/activity/p/29115/ Fri, 08 Mar 2024 19:04:38 -0500 Like any good team, some type of established chemistry and repertoire should already exist between the PMs and team members, or atleast have some familiarity with their roles and responsibilities. Being able to come into a  team with an previous…   Read more»

]]> 6630102fd0f5ee155392b3d2754c1f6d https://medicaldevicecourses.com/activity/p/29045/ Tue, 27 Feb 2024 00:13:30 -0500 Like many of those mentioned above, I share their overall sentiment that poor planning takes a significant toll on both project success and overall chemistry of the team. Team composition and chemistry is important when running a project because the…   Read more»

]]> 8d23b3af7ebc85e46eea57d5502e03fe https://medicaldevicecourses.com/activity/p/29044/ Tue, 27 Feb 2024 00:02:33 -0500 Realistically, a project Manager may not be able to meet all of the needs and wants of their team BUT can prioritize them in a way that the most impactful needs get met prior to the QoL ones. It is…   Read more»

]]> 73d41942694003c2b53c5d9339f8d9c0 https://medicaldevicecourses.com/activity/p/29043/ Mon, 26 Feb 2024 23:53:20 -0500 Like what the previous responders have mentioned, stakeholders are not just the board of directors and those with a financial stake in the company. It can be defined as almost anyone who is employed by the company, as well as…   Read more»

]]> 4500ef6c147de392c1bd810856c858e6 https://medicaldevicecourses.com/activity/p/29006/ Fri, 23 Feb 2024 21:22:01 -0500 In my opinion, stakeholders have tremendous power in directing the course of a project, since it is their money/investment that is used to fund the company’s ambitions and projects. If a majority of stakeholders are looking to throw a project…   Read more»

]]> 09412e013ba32db1d5bcaeb7d1b4de59 https://medicaldevicecourses.com/activity/p/29005/ Fri, 23 Feb 2024 21:13:56 -0500 Echoing many of the sentiments shared above, working with a limited scope of the budget overall would “force” creativity and innovation on the “limited” resources that may be available. Often times, an overly expanded budget would just result in misuse…   Read more»

]]> 330977bb19d388e22dbdd5c193d34989 https://medicaldevicecourses.com/activity/p/29003/ Fri, 23 Feb 2024 21:08:30 -0500 What a great and insightful question! I can tell you from experience, that the forecasting and management of costs spent is an extremely important aspect of any company, let alone a medical company. In a medical or big pharma company,…   Read more»

]]> c9dba443d3a453fdcc3ded7b0b07c829 https://medicaldevicecourses.com/activity/p/28944/ Sun, 18 Feb 2024 03:45:01 -0500 Working in QA, I understand the complex, almost difficult degree of flow of change between the BOM, SOP, and the master data, but it is difficult to gauge another validated process to initiate, verify, and complete changes to an already…   Read more»

]]> d2d1b2fe3b6b16ff97e974bcac8e6774 https://medicaldevicecourses.com/activity/p/28943/ Sun, 18 Feb 2024 03:39:04 -0500 Like mentioned above, the effectiveness of the leadership style is really dependent on the type of project and how everything needs to be organized. I personally have experienced multiple types of leaderships styles, being able to work at startups, mid-sized…   Read more»

]]> aa31cc4611dffe87e2aff48cb022845e https://medicaldevicecourses.com/activity/p/28942/ Sun, 18 Feb 2024 03:28:12 -0500 As a project manager, I would prefer a cast of members that have a broad range of skills that all gets tied together through an underlying skill that would be prioritized as the most essential and foundational skill for the…   Read more»

]]> 0f3b3231b177fde8ee8625d14c8ad40f https://medicaldevicecourses.com/activity/p/28893/ Sun, 11 Feb 2024 19:17:54 -0500 In the company that I work at, we used project management software to track different timelines and projects all at once. It is organized through various parent and child tabs, with each parent tab being a major part of the…   Read more»

]]> 971353e6a7f6b9d5ccef976f10af3b1d https://medicaldevicecourses.com/activity/p/28892/ Sun, 11 Feb 2024 19:10:21 -0500 I think that these review meetings need to be adequately prepared beforehand, both in terms of document organization and the relevant document trail that might be associated with it, in order to be considered effective and useful. If the meeting…   Read more»

]]> 22a1f4cc02bc1553abec8977488b0fc1 https://medicaldevicecourses.com/activity/p/28890/ Sun, 11 Feb 2024 17:51:12 -0500 In my opinion, project managers with diverse backgrounds offer unique strengths that can greatly benefit project teams. Those with academic-focused backgrounds can bring strong analytical skills from their rigorous research and critical thinking methodologies which would help in risk assessment…   Read more»

]]> 16fe285c17512420c93487615daa15f1 https://medicaldevicecourses.com/activity/p/28823/ Sun, 04 Feb 2024 22:02:56 -0500 1. Drug has chemical reaction and medical device do not have chemical reaction.  any other differences ?   Well, there are alot of differences between a drug and a medical device, both in application and definition. By definition, a medicinal…   Read more»

]]> fc2b3500b2522282384f366685acfc25 https://medicaldevicecourses.com/activity/p/28821/ Sun, 04 Feb 2024 21:55:39 -0500 Personally, I think company culture is a major aspect of any company, but especially a medical device company, to fuel talent retention and attraction. It is important for any company to make their talent feel welcomed, productive, useful, and rewarded…   Read more»

]]> 25edc951ddd51fbb72b28ad490372620 https://medicaldevicecourses.com/activity/p/28820/ Sun, 04 Feb 2024 21:48:49 -0500 If there is an idea that has the potential to be an extremely profitable or life-changing device, then money should never be a concern. One reason is that there are many routes, as a business, for you to be able…   Read more»

]]> 745047614b9be38a4df559ffe5f1d18f https://medicaldevicecourses.com/activity/p/28685/ Mon, 22 Jan 2024 23:45:31 -0500 In a general sense, a good project team should include a couple different types of individuals, including subject matter experts (SMEs) that may handle a more specialized technical role like advanced programming or mechanics-related issues, as well as more versatile…   Read more»

]]> b43476bbd2c58bcc954e215b74d60531 https://medicaldevicecourses.com/activity/p/28684/ Mon, 22 Jan 2024 23:38:18 -0500 Personally, I think that the team makeup should be dependent on the project type and objective. In terms of a multi-perspective project like the development or invention of a new product, working with teams that are filled with individuals with…   Read more»

]]> ec2ee54b5ec5efcb2d391fb2a6e424ab https://medicaldevicecourses.com/activity/p/28683/ Mon, 22 Jan 2024 23:25:27 -0500 Like many of the commentators here, emotional intelligence, or atleast the acknowledgment of some degree of emotional understanding, has some link to a personality type. Some personality types may be more inclined to reach out and communicate when things are…   Read more»

]]> 51ac5357fe1aa0ae83962830bb2332cb https://medicaldevicecourses.com/activity/p/28563/ Thu, 30 Nov 2023 21:41:12 -0500 Kickbacks are a truly frightening example of corruption and illegal preference because it blurs the line of authenticity and faithfulness of a free making decision that is for the best rather than being under the influence. My first exposure to…   Read more»

]]> d9ea154cda56afc3c037f0bf6c447d98 https://medicaldevicecourses.com/activity/p/28562/ Thu, 30 Nov 2023 21:33:33 -0500 My dad had gone through this issue during the 2008 financial crisis, so I am familiar with this experience. In his case, him and his coworkers had exceptional leverage with his company to negotiate the severance package which includes pay,…   Read more»

]]> 700c3f08c6d6ebe38f3262f6bfbde5eb https://medicaldevicecourses.com/activity/p/28561/ Thu, 30 Nov 2023 21:12:33 -0500 Non-compete agreements typically barr you from working with a competitor on a similar product that you had previously worked on. In my experience, it was not an umbrella restriction that prevented you from moving into a job that was in…   Read more»

]]> 949de83bce5a4e06e65fcb6813b035bf https://medicaldevicecourses.com/activity/p/28516/ Tue, 21 Nov 2023 22:37:47 -0500 I prefer the hierarchal organizational structure because it provides clear and coherent structure of what the leadership and continuity of reporting is. My opinion is based on my own experiences, having worked in only hierarchal-structure organized companies and it was…   Read more»

]]> 9d546b51835a617d52450e67ed1aa8ef https://medicaldevicecourses.com/activity/p/28515/ Tue, 21 Nov 2023 22:28:07 -0500 There are a wide variety of organizational structures, each serving its own benefits and cons that suits their own respective business goals and objectives. Therefore in my opinion, there is no “best organizational structure” that every corporation should follow.  …   Read more»

]]> 25a355f89134d49f66d4612b2f4de69e https://medicaldevicecourses.com/activity/p/28514/ Tue, 21 Nov 2023 22:16:31 -0500 Speaking from Nov. 2023, the specifications for Prof. Simon’s final project have remained relatively the same. Currently, my team is still in the drafting phase, working to find resources and develop our own individual department assignments based on our team’s…   Read more»

]]> 8ad84dec6b7c8ab24fa17910b5b06f1d https://medicaldevicecourses.com/activity/p/28467/ Thu, 16 Nov 2023 21:47:31 -0500 I think the term is meant to signify the balance between reducing risks as much as cost effectively possible for that medical device. The transition from ALARP to AFAP suggests that there is more emphasis on reducing risk as much…   Read more»

]]> df1944fa241b9282b3709361c1699656 https://medicaldevicecourses.com/activity/p/28466/ Thu, 16 Nov 2023 21:33:02 -0500 In the medical device industry, risk management is critical to ensuring patient’s safety and regulatory compliancy of both federal and international governments. Throughout the device’s life cycle, possible risks must be identified, analyzed, and evaluated as part of a systematic…   Read more»

]]> 27280f4745b5f70d2ac3a6c1c78ca46e https://medicaldevicecourses.com/activity/p/28465/ Thu, 16 Nov 2023 21:13:27 -0500 Going based off the forum post title question, I think that it is absolutely essential for the medical devices to have risk assessments. Firstly, medical devices and alike are often the frontline treatment for many medical and health issues, which…   Read more»

]]> 30f9eadb2cd4739e6b4c7f2c8b13a30e https://medicaldevicecourses.com/activity/p/28424/ Sun, 12 Nov 2023 18:44:22 -0500 Whether or not a company has good ethical responsibility to put out a good, safe product, they are upmost certainly minded with some sort of fiscal responsibility to make a profit. So they certainly have a motivation to put out…   Read more»

]]> 43d1bb5163fdc42af509e523521f91dc https://medicaldevicecourses.com/activity/p/28422/ Sun, 12 Nov 2023 18:09:28 -0500 My senior year’s capstone or design project was the development of a computational pipeline to help sort and categorize different cell types into its biological classifications. Our market research involved defining a target market, which in this case would be…   Read more»

]]> 8e5fe6b3c158c86b6fd907459e457714 https://medicaldevicecourses.com/activity/p/28421/ Sun, 12 Nov 2023 17:53:18 -0500 I think that the team should first have a strong basis of understanding for what is being examined and needed to be defined. Preferentially, the decision should come down to a cross-functional project team that can have multiple perspective/inputs to…   Read more»

]]> ca9deb8f8e07eae67e0c0f7d70fc8342 https://medicaldevicecourses.com/activity/p/28359/ Thu, 02 Nov 2023 18:19:27 -0400 Having worked at a medical device company as a QA intern, I worked on ensuring compliancy with CAPA records, some of which that were opened because of design controls issues. I think largely, CAPA reports require a heavy dosage of…   Read more»

]]> b8542b4735cd7dfbc1d2576a0b8513a0 https://medicaldevicecourses.com/activity/p/28358/ Thu, 02 Nov 2023 18:11:57 -0400 Design controls are important for any manufacturing or R&D role because it allows it would ideally provide limitations of what is safe enough to be used or allowed in specifications, which is typically discovered during experimentation/research, or mistakes found/recalls made…   Read more»

]]> a909d2ee67dc3c6110e415f479cd6612 https://medicaldevicecourses.com/activity/p/28357/ Thu, 02 Nov 2023 18:07:47 -0400 I think to revise design controls for a medical device, it starts with understanding why the controls are there in the first place, including the history or events that may have lead to the controls being implemented in the first…   Read more»

]]> 301522022d739337edea1376c930cbe9 https://medicaldevicecourses.com/activity/p/28301/ Sat, 28 Oct 2023 04:37:57 -0400 There is a whole sea of CROs and medical/pharmaceutical groups that are looking for all types of participants to participate in one of their clinical trial. Each study having its own inclusion/exclusion criteria makes it easy to find a wide…   Read more»

]]> b5bc833aac0740f497dd16d656c359aa https://medicaldevicecourses.com/activity/p/28300/ Sat, 28 Oct 2023 04:31:00 -0400 Given my background in research, medical devices, and clinical trials, I feel that I would be able to take on any role comfortably after the typical training and learning curve procedures. However, in terms of personal preference and overall skills,…   Read more»

]]> 35926dac45355ab83864c47f6408d53a https://medicaldevicecourses.com/activity/p/28299/ Sat, 28 Oct 2023 04:27:07 -0400 From my internship at a CRO, I was able to observe the workings of phase 1 and 2 clinical trials that were happening. For the study in its second phase, I was able to witness a developed drug undergo its…   Read more»

]]> f386924ad67e0c8e20efd26988aa53fe https://medicaldevicecourses.com/activity/p/28247/ Thu, 19 Oct 2023 19:54:50 -0400 I think this is an interesting question to pose for those with or without entrepreneurship ambitions. I think most biopharama or medical device companies share a similar mission objective in the sense that it generally follow the guidelines of collaboration,…   Read more»

]]> f29f6bc6e2e45ba0f29f18bd8b43ddf6 https://medicaldevicecourses.com/activity/p/28246/ Thu, 19 Oct 2023 19:47:58 -0400 Like many of the posters above, I would also like to reiterate the importance of the sales and marketing team behind any product’s development and marketability. It is important for any product to be: a.) known by its consumer base…   Read more»

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