https://medicaldevicecourses.com/members/ih37/activity/ Activity feed for ih37. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 8a9351a1d68738a418da00cfbf1f7e52 https://medicaldevicecourses.com/activity/p/18331/ Wed, 15 May 2019 21:47:22 -0400 A non-conforming material report (NCMR) is something that must get taken up with the current vendor to prevent the incorporation of defective equipment into a medical device project. An NCMR is generated by either the quality department or during a…   Read more»

]]> 8a4172f6dfce13a62628cc889ac6ca27 https://medicaldevicecourses.com/activity/p/18330/ Wed, 15 May 2019 21:47:21 -0400 One of the main reasons people leave work is poor management. This can occur when a manager is not competent enough to keep track of all members on a team which leads to an imbalanced assignment of tasks where qualified…   Read more»

]]> b1119072319fd9c57f4721c8078c03ac https://medicaldevicecourses.com/activity/p/18328/ Wed, 15 May 2019 21:47:20 -0400 This course has definitely given me a better understanding of how contract research organizations (CRO) are managed, which is of particular interest to me since I have been working in a CRO for almost a year now. Knowledge of a…   Read more»

]]> ad7958cfb349853e60e79b5fdb3c2d37 https://medicaldevicecourses.com/activity/p/18267/ Wed, 15 May 2019 21:46:49 -0400 Tunnel vision is generally defined as the tendency to focus on a single goal with a limited point of view. The definition itself indicates that it is not an ideal element for project management, especially that of a Class III…   Read more»

]]> bc7f132b17b998cb2dafdeb91376fff4 https://medicaldevicecourses.com/activity/p/18266/ Wed, 15 May 2019 21:46:49 -0400 One motivation for working on designing a medical device project is to finally get a chance to apply all that you learned in the years of being an undergraduate and going through grad school. It is also known that a…   Read more»

]]> 4e68b863f16a10e8d34a3b6a82a803c7 https://medicaldevicecourses.com/activity/p/18265/ Wed, 15 May 2019 21:46:48 -0400 I currently work in a project-based organization, which as we learned in lecture is run by project managers who govern project teams consisting of members from all vital departments (production, quality control, quality assurance, etc). One of the most imperative…   Read more»

]]> 34bdcc3197fb506c7f795cdbaea666c2 https://medicaldevicecourses.com/activity/p/18196/ Wed, 15 May 2019 21:46:11 -0400 Procurement management is a process carried out by a project manager that requires them to collaborate with the purchasing department to determine the most optimal vendor for any particular provision. A few essential requirements for project procurement is to have…   Read more»

]]> af64c18aec042c0a1cc09af84ed84d4a https://medicaldevicecourses.com/activity/p/18188/ Wed, 15 May 2019 21:46:07 -0400 It goes without say that communication management is an essential aspect of a company’s environment as it ensures a consistent flow of information to each entity in a company in order for them to fulfill their respective duties. As we…   Read more»

]]> c414b38d15db29b6fafaf0a2b2f453eb https://medicaldevicecourses.com/activity/p/18187/ Wed, 15 May 2019 21:46:07 -0400 The primary difference between quality control (QC) and quality assurance (QA) is that QA correlates the industry’s standards to the project at hand, whereas QC ensures that the standards are being met as a project proceeds. From an industry perspective,…   Read more»

]]> 11e7f7cd73f5264f782d092cd8803631 https://medicaldevicecourses.com/activity/p/18123/ Wed, 15 May 2019 21:45:35 -0400 As learned in lecture, stakeholders can be a wide variety of individuals ranging from patients to the financial investors that support the project. This goes to state that risk can come in many forms and can actually become more prominent…   Read more»

]]> 2511194403d0fdc90fec3df83bf73bd7 https://medicaldevicecourses.com/activity/p/18122/ Wed, 15 May 2019 21:45:35 -0400 Planned value (PV) and actual cost (AC) are values that are implemented during the monitoring and controlling phase to give the project manager an idea of their progress in terms of time and budget. The degree of progress made is…   Read more»

]]> 2a64b102769c78b05649a93f8e230225 https://medicaldevicecourses.com/activity/p/18121/ Wed, 15 May 2019 21:45:34 -0400 The diagram explaining the relationship between PM processes and design controls (from the Initiating and Planning lecture) indicates that design controls can easily exist in more than one PM process. Design input, output, and planning for example, are shown to…   Read more»

]]> 09146573920e214c515e20e1603d663c https://medicaldevicecourses.com/activity/p/18052/ Wed, 15 May 2019 21:44:59 -0400 One of the changes that occurs in my company is the managing of the bill of materials (BoM). Whenever a general change control is carried out, it must include a justification as to why the change is being implemented as…   Read more»

]]> a4bbcf99c18fb8448dfc1f2fe1e709fd https://medicaldevicecourses.com/activity/p/18043/ Wed, 15 May 2019 21:44:55 -0400 I currently work at a project-based clinical research company where I process and manufacture cell-based infusion products for the treatment of conditions that are not easily treatable (myelomas, melanoma, renal carcinomas, etc). We hold daily meetings at the start of…   Read more»

]]> 513701403a5624a4299e78425a279f88 https://medicaldevicecourses.com/activity/p/18042/ Wed, 15 May 2019 21:44:54 -0400 It seems that the difference between planned value (PV) and earned value (EV) is a project’s way to determine whether or not it is on track on a financial level. If a project is budgeted at $5 million with a…   Read more»

]]> 1f080924474c6a68c4d8599b4d2e95b0 https://medicaldevicecourses.com/activity/p/17985/ Wed, 15 May 2019 21:44:24 -0400 If a vendor is providing a medical device project with defective equipment/packaging, then they need to be made aware of it immediately so that they can either address it, or at least prevent it from happening to other clients. Whether…   Read more»

]]> 7ad5824b06a3e4e97ad92681b45ddd0d https://medicaldevicecourses.com/activity/p/17984/ Wed, 15 May 2019 21:44:23 -0400 Based on what we have learned so far, one could say that the execution process is rather one of the more simpler phases of the design cycle (assuming one has a competent project team). This is the phase where all…   Read more»

]]> 8b80b28078693f635825ed7c1ed9701e https://medicaldevicecourses.com/activity/p/17983/ Wed, 15 May 2019 21:44:22 -0400 As we learned earlier in the course, emotional intelligence determines approximately 70% of success, which without a doubt applied to the MiniSim. The only real way to fail the first part of the MiniSim was to take a condescending approach…   Read more»

]]> 7df6021d923845aff602724607aaac37 https://medicaldevicecourses.com/activity/p/17922/ Wed, 15 May 2019 21:43:52 -0400 As a PM for BoneFix working on the Fset1 growth factor product, I would constitute organizational diagrams such as a Gantt chart, a design matrix, and a Pareto chart so that the project can be carried out fluently. A Gantt…   Read more»

]]> c7071a584960416b43fe031f56eda96b https://medicaldevicecourses.com/activity/p/17921/ Wed, 15 May 2019 21:43:52 -0400 One of the major driving factors of a project is determining the project’s cost and budget, which without a doubt becomes more complicated the longer a project’s duration is. The PMBOK guidebook dedicates an entire chapter towards project cost management…   Read more»

]]> f102ad939ad31d97e15e6c79ca15265f https://medicaldevicecourses.com/activity/p/17907/ Wed, 15 May 2019 21:43:45 -0400 I currently work in industry at a clinical research project-based company where I manufacture cell-based transfusion products intended for treating patients diagnosed with a variety of cancer. From what we learned in this course regarding corporation types, I would say…   Read more»

]]> e6631b67f50b107064ffa8c670a82023 https://medicaldevicecourses.com/activity/p/17809/ Wed, 15 May 2019 21:42:49 -0400 The first factor in understanding Gantt charts is being able to associate tasks to one another in terms of their dependencies. These relationships are known as Finish to Start (FS), Start to Finish (SF), Finish to Finish (FF), and Start…   Read more»

]]> ccd1e4db422fda27e9d58d6a8c07c918 https://medicaldevicecourses.com/activity/p/17808/ Wed, 15 May 2019 21:42:49 -0400 The advantage to having a risk management team internally associated with a project team is the absence of “information silos”, in which departments withhold knowledge and information from one another as a norm. By having a risk management team within…   Read more»

]]> 3244fc488b9b6a2716f0c9227e30c7ec https://medicaldevicecourses.com/activity/p/17806/ Wed, 15 May 2019 21:42:47 -0400 The concept of a risk/benefit ratio is to acknowledge that the most promising rewards come at a price. Immunotherapy for example, extracts, amplifies, and expands a patient’s own white blood cells (WBCs) so that they can be infused back into…   Read more»

]]> 45ed3ad522d8c23cfd3ca7b192a586e8 https://medicaldevicecourses.com/activity/p/17769/ Wed, 15 May 2019 21:42:30 -0400 Formulating a Design Input Document (DID) can require participation from every department involved on any given project. As mentioned in lecture, while marketing has a strong influence over a product’s design, it is also imperative to include a member from…   Read more»

]]> 8a0703f8acc36b59392b8852e57f6533 https://medicaldevicecourses.com/activity/p/17756/ Wed, 15 May 2019 21:42:23 -0400 The most effective way of addressing scope creep is to determine its origin/source in a way that not only resolves its conflicts, but also prevents them from resurfacing. One main cause of scope creep is a lack of communication between…   Read more»

]]> c6b648d7aef747d15c98e359e72113ba https://medicaldevicecourses.com/activity/p/17755/ Wed, 15 May 2019 21:42:22 -0400 When it comes time for a medical device company to select a supply vendor, many factors must be taken into consideration. Medical devices are not the simplest products as they are expected to carry a lot more risk in their…   Read more»

]]> c3592b1db2b29b61d1b464068db2116a https://medicaldevicecourses.com/activity/p/17684/ Wed, 15 May 2019 21:41:44 -0400 If a company does not have funding for a project, then it can reach out to other entities for additional support, such as a federal organizations like the National Science Foundation (NSF), the National Institutes of Health (NIH), the Veteran’s…   Read more»

]]> d85d3abd0f3fe3826c0c574d2306d05a https://medicaldevicecourses.com/activity/p/17669/ Wed, 15 May 2019 21:41:36 -0400 Selecting a project team can undeniably determine not just the success of a project, but also the potential for new contingent projects that expand on the work that was done. Any online source that regards selecting a project team will…   Read more»

]]> 0c2e61cd86f6e697f65568a489e4acbe https://medicaldevicecourses.com/activity/p/17668/ Wed, 15 May 2019 21:41:36 -0400 The company I work at went through a similar situation in which we were performing two separate projects for two different clients, but only had enough supplies to fulfill one project. The materials we work with are highly expensive viral…   Read more»

]]> dd22f5f79bb80bdc8f3d640d29ecb575 https://medicaldevicecourses.com/activity/p/17617/ Wed, 15 May 2019 21:41:06 -0400 The most appropriate time to conduct design verification is once all of the design inputs have been specified within the document known as the verification protocol. This requires one to know their product’s shape, function, dimensions, specifications and FDA/governmental regulations…   Read more»

]]> 2a712725461f5934b8ad50500a00343f https://medicaldevicecourses.com/activity/p/17614/ Wed, 15 May 2019 21:41:04 -0400 I currently work in manufacturing/production at a cell-research company where I process autologous cell-therapy products that is in its clinical phase with the hopes of becoming marketed. The most imperative design control I’ve had the chance to be a part…   Read more»

]]> e4b8a2eb0e2964ba28c6f7017ae17e16 https://medicaldevicecourses.com/activity/p/17597/ Wed, 15 May 2019 21:40:56 -0400 As we learned in lecture, all projects have a life cycle that dictates how smoothly the design process is going to flow, which in turn determines the overall success of the product upon entering the market. The initiation phase can…   Read more»

]]> 3309b38d40e66412e32d8cd75ef3f19e https://medicaldevicecourses.com/activity/p/17505/ Wed, 15 May 2019 21:40:05 -0400 The Ellipta inhaler is considered to be a combination product in the same sense that a pre-filled syringe is. The Ellipta inhaler contains a drug that is combined with a device to facilitate the drug’s delivery, regardless of whether the…   Read more»

]]> 6932e7c6ed13f80af79ee379f770efcc https://medicaldevicecourses.com/activity/p/17503/ Wed, 15 May 2019 21:40:04 -0400 A straightforward way to classify a medical device is to go on the FDA website under their device classification panels page. This web-page allows one to locate their classification regulations by selecting which field their device falls under (i.e. cardiology,…   Read more»

]]> a064949a97727cc6007c39e2a9b1ccb9 https://medicaldevicecourses.com/activity/p/17502/ Wed, 15 May 2019 21:40:04 -0400 A quality management plan is defined in our PMBOK guidebook as “a component of the project or program management plan that describes how an organization’s quality policies will be implemented”. This is especially important in the biotech field in which…   Read more»

]]> a8e8e2543613d8df0b81c97e00c4b11e https://medicaldevicecourses.com/activity/p/17473/ Wed, 15 May 2019 21:39:49 -0400 A general online look at job openings for project managers (PM) lists a variety of skills ranging from interpersonal leadership skills to math-based analytical skills such as time and budgeting, or any skill that will yield a progressive workflow. Leadership…   Read more»

]]> 5ce959ce164d20fb26796bfe5e95e21b https://medicaldevicecourses.com/activity/p/17437/ Wed, 15 May 2019 21:39:31 -0400 I believe that in a perfect world, the ratio of success between interpersonal skills and technical knowledge should favor technical knowledge, especially in the science/medical field. One reason as to why the success equation regarding emotional intelligence (EI) is perceived…   Read more»

]]> 498f855a5eb21901e6b924d23adc89f1 https://medicaldevicecourses.com/activity/p/17436/ Wed, 15 May 2019 21:39:30 -0400 The company that I currently work at would be considered a project-based organization in that we conduct research on cell therapy-based products and processes. For example our projects focus mainly on optimizing the processing and transplantation of stem cells, bone…   Read more»

]]> 523fa272b484f422ff1a8dfc892cd13b https://medicaldevicecourses.com/activity/p/17358/ Wed, 15 May 2019 21:38:49 -0400 I think it’s quite clear that it is always more important to have an agreement transcribed into writing rather than have it established verbally, especially when occurring between two aspiring companies. A verbal agreement in this case can result in…   Read more»

]]> 11eb3341d4b79713c2eaa3ad90f7173a https://medicaldevicecourses.com/activity/p/17354/ Wed, 15 May 2019 21:38:47 -0400 I work at a clinical research company that is involved with recent breakthroughs in immunotherapy. This includes treating conditions such as cancer, HIV, hepatitis, or pro-inflammatory diseases by processesing cell-based products that are intended for patients in Europe (EU) and…   Read more»

]]> 844f7fad773958edfc58f13514c0b00c https://medicaldevicecourses.com/activity/p/17352/ Wed, 15 May 2019 21:38:46 -0400 As a master’s student approaching my last semester, I can say that this course is unlike any other course I have taken in that it provides an alternative and even a more practical perspective on the medical device field. We…   Read more»

]]> 2e14e1f5d86117be4be4b4544ef4e4fc https://medicaldevicecourses.com/activity/p/17241/ Wed, 15 May 2019 21:37:53 -0400 The role and responsibilities of a project manager easily varies depending on which organizational type they are placed in along with their preferred working environment. In terms of which organization is more challenging for a project manager, a project-based organization…   Read more»

]]> 1dc88fa5c87539906716a7d2ef747229 https://medicaldevicecourses.com/activity/p/17237/ Wed, 15 May 2019 21:37:51 -0400 According to lecture, information silos are most prominent in functional organizations, meaning that the departments and project teams within the organization keep to themselves to the point that they establish their own exclusive culture. Initially, the formation of silos may…   Read more»

]]> d2dfd10b4e21bca49dd934225e160269 https://medicaldevicecourses.com/activity/p/17224/ Wed, 15 May 2019 21:37:43 -0400 The company that I currently work at would be considered a project-based organization considering that we conduct research on cell therapy-based products and techniques. For example the projects that we conduct focus on the processing and transplantation of stem cells,…   Read more»

]]> e4ad0647c58d6601e7230cc76fdea702 https://medicaldevicecourses.com/activity/p/17144/ Wed, 15 May 2019 21:37:01 -0400 My company manufactures a blood-based infusion product that is currently undergoing its clinical phase in trials, so it is common for errors to occur along the process which are then handled under a risk-based approach. One such approach in which…   Read more»

]]> 78da8d237df16e42ed578ce98963493f https://medicaldevicecourses.com/activity/p/17128/ Wed, 15 May 2019 21:36:52 -0400 The first part of risk management, as mentioned, is to assess all the potential threats of a device by formulating a list of risks associated with its use. Each risk is then individually analyzed so that all potential hazards can…   Read more»

]]> 929e0c6997db8e267c6c5e6a41df05a8 https://medicaldevicecourses.com/activity/p/17124/ Wed, 15 May 2019 21:36:51 -0400 The major ISO for risk management is ISO 14971, which is enforced onto medical device companies as a means of preventing or mitigating the hazards associated with the devices. As mentioned in lecture, risk management occurs within multiple areas of…   Read more»

]]> c0b614f0522fad71a52bb67471faa8c2 https://medicaldevicecourses.com/activity/p/17036/ Wed, 15 May 2019 21:36:08 -0400 A proper validation process should revolve around the patient by ensuring that the medical device under development meets the user’s needs. An important aspect of design validation, as mentioned in lecture, is the application of clinical human studies in order…   Read more»

]]> 128d86a0ccd2d2027c8e4b792e1e8cb9 https://medicaldevicecourses.com/activity/p/17035/ Wed, 15 May 2019 21:36:08 -0400 The clinical research company I work for carries out cell therapy in that T-cells are taken from a patient’s blood, which are then amplified via additives (viral vectors), and then expanded/proliferated until they reach the specified quantity stated in the…   Read more»

]]>