Medical Device Courses | Agnieszka | Activity https://medicaldevicecourses.com/members/ama59/activity/ Activity feed for Agnieszka. Fri, 24 Apr 2026 18:20:46 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7d38eef7cae5ca043997d00eede823be Agnieszka replied to the topic "Why do people leave work?" - https://medicaldevicecourses.com/activity/p/12614/ Wed, 15 May 2019 16:57:35 -0400 People leave work because of “limited recognition and praise” but they stay for “exciting, challenging work.” If the work is interesting but there is no recognition, will people leave? If the work is uninteresting but they are receiving praise, will…   Read more»

]]> efb38aecf24b19b98be03aff74a4924b Agnieszka replied to the topic "Why do people work?" - https://medicaldevicecourses.com/activity/p/12610/ Wed, 15 May 2019 16:57:33 -0400 This was a nice and revealing question. I enjoyed reading everyone’s posts. I would stay and work for a company if the work interested me. I want a fulfilling career and life, I do not want to be stuck working…   Read more»

]]> 056823c10d340c7f5343176f343aa364 Agnieszka replied to the topic "Disconnect in rewarding motivation" - https://medicaldevicecourses.com/activity/p/12606/ Wed, 15 May 2019 16:57:31 -0400 I feel as engineers we can take one of two career paths, administrative or research based. If you want to follow an administrative path, partiality is definitely an obstacle that will be faced. Partiality in the form of favoritism, talked…   Read more»

]]> ba613b4e6e9863f7c1ca1084306a20fc Agnieszka replied to the topic "Discussion Topic: Risk Analysis methods" - https://medicaldevicecourses.com/activity/p/12423/ Wed, 15 May 2019 16:55:52 -0400 A collection of some drawbacks experienced by most risk analysis methods: 1. Slight variations between similar projects/medical devices. Difficulty estimating variations and their magnitude and impact. 2. Synergistic effects of several, combined risks. 1 + 1 = 3. 3. Information…   Read more»

]]> 04d9398024154fb322902b7310df2ffd Agnieszka replied to the topic "Discussion Topic: Scope creep....when your project changes" - https://medicaldevicecourses.com/activity/p/12422/ Wed, 15 May 2019 16:55:51 -0400 I am definitely feeling the pressures of scope creep as I near closer to my Master’s defense. I made the mistake of waiting until the last month to run my most important and intricate experiment, not giving myself enough time…   Read more»

]]> e69654ef41dbb766fe2df2ed7335c702 Agnieszka replied to the topic "Discussion Topic: Costs and managing your investment" - https://medicaldevicecourses.com/activity/p/12418/ Wed, 15 May 2019 16:55:49 -0400 Simply, the rate of return is profit, it could be a dollar amount or percentage of how much was invested. It is impossible to know exactly what the rate of return is just as it is impossible to predict the…   Read more»

]]> e2fc3c37a902abe6eee559b6ddafcae3 Agnieszka replied to the topic "Design Review Meeting Culture" - https://medicaldevicecourses.com/activity/p/12329/ Wed, 15 May 2019 16:54:55 -0400 I don’t have any med-tech industry experience but I imagine the design review experience being tense for the product developing team. Passing a design review means completing a major milestone in the project development process and shows that the product…   Read more»

]]> ff094a64368632c5b52ba7c8086b0708 Agnieszka replied to the topic "Risk Management" - https://medicaldevicecourses.com/activity/p/12313/ Wed, 15 May 2019 16:54:46 -0400 A product risk can be a faulty release mechanism on a drug delivering device. Under FMEA this would be a Concept Design / Hardware risk where we could monitor its probability of failure throughout its development process. Specifically, risk can…   Read more»

]]> 991eadf13304bbab10b351f5acfcbf22 Agnieszka replied to the topic "FDA Recall...Now What?" - https://medicaldevicecourses.com/activity/p/12298/ Wed, 15 May 2019 16:54:39 -0400 Recalls are a very interesting topic, nice post. Recalls are done, not by the company that designs and develops the product, but by the manufacturer or distributor. When these parties find that the medical device violates an FDA law (e.g….   Read more»

]]> cb1e8d48fba0e2fe5637f4cb56156965 Agnieszka replied to the topic "Engineering change order" - https://medicaldevicecourses.com/activity/p/12221/ Wed, 15 May 2019 16:53:57 -0400 ECOs admit that no design is ever completely perfect, infallible. They are neither a positive or negative event, ECOs are an eventuality. The cause could be: a design error evident only during the testing phases of the product; change in…   Read more»

]]> 09f29b210fd1d19bd2484ee7c3f1cae2 Agnieszka replied to the topic "Cost Analysis of Project" - https://medicaldevicecourses.com/activity/p/12212/ Wed, 15 May 2019 16:53:50 -0400 I was lucky enough to choose a Capstone project where we did not have to pay for anything, all of our parts were given to us from previous attempts at the project. However we later found out that the sensors…   Read more»

]]> c8363e69657ebb8837579bbc1eebf1ee Agnieszka replied to the topic "Work Logs and FDA Audits" - https://medicaldevicecourses.com/activity/p/12209/ Wed, 15 May 2019 16:53:48 -0400 There are many reasons why tracking time is an important practice for any company or organization. Some include: 1) Following the progress of the project, how much time is needed to complete a certain task, is this time spent wisely,…   Read more»

]]> 40e09f4a20bd7b6e435ada98646c3b9f Agnieszka replied to the topic "PM: Handling Team Issues" - https://medicaldevicecourses.com/activity/p/12137/ Wed, 15 May 2019 16:53:11 -0400 A lot has already been said in this post, but teamwork and a PM’s handling of team management is a very important prevalent topic. I think the best approach is to set the rules right from the start. Explain what…   Read more»

]]> d12ee370acfe8a51ce068f2d7b5357ea Agnieszka replied to the topic "Source Selection in Executing Process" - https://medicaldevicecourses.com/activity/p/12133/ Wed, 15 May 2019 16:53:09 -0400 I agree here. The suppliers you want to be dealing with are well-established and are known for their high quality materials. In fact build a relationship with these suppliers and do not burden the planning phase. Additionally, a good relationship…   Read more»

]]> 9ba69e02577b192fb8bbd5854a9ab0b5 Agnieszka replied to the topic "PM: Quality Assurance Process" - https://medicaldevicecourses.com/activity/p/12132/ Wed, 15 May 2019 16:53:09 -0400 Some tools/techniques that can be used to assess quality assurance include: Fishbone Diagram. In this cause-and-effect type diagram factors causing a defect are listed as inputs and their combined efforts may output the possible defect. For example, inputs such as…   Read more»

]]> 3a1bd68d77e1245a5944262a5db60438 Agnieszka replied to the topic "In the Shoes of a Project Manager" - https://medicaldevicecourses.com/activity/p/12031/ Wed, 15 May 2019 16:52:09 -0400 When creating my group’s Gantt Chart I would organize our tasks considering the following (in order of importance): 1. What tasks must be completed before this task can begin? 2. What is an ideal time to complete this task? A…   Read more»

]]> a69ffb729680613af570e9cd62586ff1 Agnieszka replied to the topic "Benefits of this course" - https://medicaldevicecourses.com/activity/p/12027/ Wed, 15 May 2019 16:52:06 -0400 The most impactful lesson I have learned from this class so far is how applied research/basic science (that is, what we learn in our core classes) is just a small percentage of research and development and R&D is just a…   Read more»

]]> ad2161f99f288a3c2560ccd037503f01 Agnieszka replied to the topic "Discussion Topic: What are the PM elements in your company?" - https://medicaldevicecourses.com/activity/p/11945/ Wed, 15 May 2019 16:51:21 -0400 Some enterprise environmental factors might include a sudden market niche for a particular product or a governmental decrease in sales tax for a particular resource. I would then argue that the proposed project should be initiated because there is a…   Read more»

]]> f8d1fe0146bfbd51eda9ec1e74e0227a Agnieszka replied to the topic "Experience Breaking Down A Project" - https://medicaldevicecourses.com/activity/p/11944/ Wed, 15 May 2019 16:51:20 -0400 My capstone project involved programming a 3-DOF admittance control hand exoskeleton for robotically facilitated training of the hemiparetic hand and an interactive, virtual 3D environment for its platform. We broke the project down by task and order of completion because…   Read more»

]]> 5d8e216a7c34097eecbca71cf47b2e3a Agnieszka replied to the topic "Revising a Gantt Chart" - https://medicaldevicecourses.com/activity/p/11943/ Wed, 15 May 2019 16:51:20 -0400 Missing a milestone might be the worst thing that can happen to a project. A milestone defines the completion of an important step in a project’s development process and task times are often dictated by it. If a milestone is…   Read more»

]]> a3efe86d70dbdeab6b7cf3817d0af880 Agnieszka replied to the topic "Discussion Topic: The critical path" - https://medicaldevicecourses.com/activity/p/11862/ Wed, 15 May 2019 16:50:28 -0400 Absolutely! One of the aspects of my thesis project was to develop an in vitro blood-brain barrier; primary cortical neuronal cells would be attached to the bottom of a well while endothelial cells and astrocytes would be suspended on either…   Read more»

]]> a3b627e3ac0448ac587289b7c4c5aae0 Agnieszka replied to the topic "Discussion Topic: The proper time for Project Initiation" - https://medicaldevicecourses.com/activity/p/11861/ Wed, 15 May 2019 16:50:27 -0400 To answer how much information is needed to begin a formal project it is important to outline what information is needed. You sort of answered this in your question, enough preliminary details to plan or propose. These preliminary details (most…   Read more»

]]> 0e5e204e6965fc67cbefdd8b91c2f1ea Agnieszka replied to the topic "Discussion Topic: Design and Process Verification" - https://medicaldevicecourses.com/activity/p/11860/ Wed, 15 May 2019 16:50:27 -0400 Verification tasks can be designed during the Planning process of project management. For example, if the project will need clinical trials for design verification then anticipating and formulating them in the Planning process would ease the remainder of the development…   Read more»

]]> b2364eb9229928587cb91d3283c59467 Agnieszka replied to the topic "Simulations" - https://medicaldevicecourses.com/activity/p/11818/ Wed, 15 May 2019 16:50:01 -0400 If I were to interact face-to-face I might take more initiative. For this simulation I mostly waited until a group member made a suggestion then either agreed or offered an alternative. Face-to-face interactions are, to me, much more motivating and…   Read more»

]]> 73e59d26d81765b39731d868733a0ed7 Agnieszka replied to the topic "Ideal project team" - https://medicaldevicecourses.com/activity/p/11782/ Wed, 15 May 2019 16:49:42 -0400 My dream team would be selected based on personal traits and drives under the notion that technical skills are less important because they can be learned while personal skills need time and nurturing to be developed. These would be the…   Read more»

]]> 49d075c2b1b9a5ad8c6d7ba5d1220165 Agnieszka replied to the topic "Fitbit: A Medical-Grade Device?" - https://medicaldevicecourses.com/activity/p/11780/ Wed, 15 May 2019 16:49:41 -0400 The FDA is currently drafting a guidance to regulate certain “general wellness devices.” These include ones that help “log, track, or trend exercise activity” for the maintenance of a healthy lifestyle, exactly what the Fitbit does. Although, with the coercion…   Read more»

]]> 2e5b6624327b8e869809546c0af7e841 Agnieszka replied to the topic "Validation vs. Verification" - https://medicaldevicecourses.com/activity/p/11729/ Wed, 15 May 2019 16:49:06 -0400 Most of the example above described some variation of testing as their chief form of design verification. But verification is more than this, it is making sure that the design of the device is right, i.e. it meets its required…   Read more»

]]> cea680ca51b62d64babf06810400254b Agnieszka replied to the topic "Potential FDA Changes under Trump" - https://medicaldevicecourses.com/activity/p/11713/ Wed, 15 May 2019 16:48:57 -0400 This is a really great topic because it is relevant and controversial. My thoughts are these: Trump has the right intent, there are problems within the regulatory practices/policies of the FDA and we need a concrete, forthright solution. However, his…   Read more»

]]> 821b01f2019bbd4ca1825a3a2db5a7d9 Agnieszka replied to the topic "Product Life Cycle" - https://medicaldevicecourses.com/activity/p/11689/ Wed, 15 May 2019 16:48:45 -0400 I disagree with the argument that some products do not seem to enter the Decline phase of their life cycle. Instead, the actual need does not decline while the product can get replaced with one that is more technologically advanced,…   Read more»

]]> 33c756afcbcb54edcd8e155a21a07fa1 Agnieszka replied to the topic "Thalidomide's Impact on Regulation and the FDA" - https://medicaldevicecourses.com/activity/p/11606/ Wed, 15 May 2019 16:48:02 -0400 What the Thalidomide disaster did to the FDA was not only demonstrate the importance of drug trials, as Chris’s post pointed out, but, even more importantly, tightened surveillance on how these trials were conducted, their results, and the efficacy of…   Read more»

]]> 8e05c26248c765d3289268a987a95486 Agnieszka replied to the topic "Mobile Medical Applications" - https://medicaldevicecourses.com/activity/p/11600/ Wed, 15 May 2019 16:48:00 -0400 I disagree and feel your application is more than a simple mobile medical app, I would consider it a rehabilitation device (conveniently packaged as an app on your phone, ipad, etc.). (I am expanding on Hiren’s post). In retraining auditory…   Read more»

]]> f461fce33652ee1316fbd6eed271409f Agnieszka replied to the topic "Human Factors study in combination products" - https://medicaldevicecourses.com/activity/p/11599/ Wed, 15 May 2019 16:47:59 -0400 Combination product development alone is very tricky because of the FDA’s rudimentary policies on combination products. Manufacturers are often left scratching their heads as to which regulatory pathway to follow for their combination product even before it is complete; they…   Read more»

]]> 0a1b3e43d56fd692fc2742feca4b9c57 Agnieszka replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/11537/ Wed, 15 May 2019 16:47:27 -0400 I think I might enjoy working in a classical functional organization. I like working in research/engineering and would prefer not to be bothered with the marketing, manufacturing, or accounting aspects of the project; in a functional organization each department works…   Read more»

]]> 14635527183149a13b84dd00de273a7f Agnieszka replied to the topic "Discussion Topic: Projects of all types" - https://medicaldevicecourses.com/activity/p/11530/ Wed, 15 May 2019 16:45:44 -0400 For a Project Manager, the difficulty in hopping from fundamentally different projects would be in executing project planning. The inventory of necessary materials, equipment, and specialists, time management, and overall project execution for skyscraper construction are completely different from those…   Read more»

]]> a0cb3db75929589aa626787a3948d302 Agnieszka replied to the topic "Discussion Topic: To trial or not to trial" - https://medicaldevicecourses.com/activity/p/11518/ Wed, 15 May 2019 16:45:37 -0400 Design Validation means exactly that, verifying that the right device was designed. For example, if a user wanted an ointment to heal burn scars but the final product only caused hair to grow on the scar instead then this product…   Read more»

]]> 4bb533f98d8c6f8bfe6c4b61a6ee8b6f Agnieszka posted a new topic "PM Internationally" - https://medicaldevicecourses.com/activity/p/10474/ Wed, 15 May 2019 16:33:51 -0400 So far we have learned about project management as it pertains to the US. What if your company becomes so large and successful you feel it is time to expand globally? How would project management standards and methodologies be different…   Read more»

]]> 150d76d9569bc5c74f3de8017ba171d1 Agnieszka replied to the topic Why do people leave work? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2559/ Mon, 01 May 2017 01:07:43 -0400 People leave work because of “limited recognition and praise” but they stay for “exciting, challenging work.” If the work is interesting but there is no recognition, will people leave? If the work is uninteresting but they are receiving praise, will they stay? I think both answers depend on the money being made, i.e. the relationship between these…[Read more]

]]> 0 80f7a685779b4675de8911714bc850da Agnieszka replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2555/ Mon, 01 May 2017 00:14:18 -0400 This was a nice and revealing question. I enjoyed reading everyone’s posts. I would stay and work for a company if the work interested me. I want a fulfilling career and life, I do not want to be stuck working for money. Surviving also means doing something that does not drain your life. An interesting job would be one where I can learn something…[Read more]

]]> 0 b774d4db72b91f723975da9add8aac44 Agnieszka replied to the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/2551/ Sun, 30 Apr 2017 22:58:37 -0400 I feel as engineers we can take one of two career paths, administrative or research based. If you want to follow an administrative path, partiality is definitely an obstacle that will be faced. Partiality in the form of favoritism, talked about in the posts above (management’s policies are followed and respected), but there is also nepotism,…[Read more]

]]> 0 f60f058cab207c1ede1105cca6eb5ec3 Agnieszka replied to the topic Discussion Topic: Risk Analysis methods in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2291/ Mon, 17 Apr 2017 01:45:32 -0400 A collection of some drawbacks experienced by most risk analysis methods:

1. Slight variations between similar projects/medical devices. Difficulty estimating variations and their magnitude and impact.
2. Synergistic effects of several, combined risks. 1 + 1 = 3.
3. Information gaps. Many of these methods were developed decades ago.
4. Telling…[Read more]

]]> 0 2da28c6a05729ff9f996776bc6b10a85 Agnieszka replied to the topic Discussion Topic: Scope creep....when your project changes in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2290/ Mon, 17 Apr 2017 01:29:03 -0400 I am definitely feeling the pressures of scope creep as I near closer to my Master’s defense. I made the mistake of waiting until the last month to run my most important and intricate experiment, not giving myself enough time to repeat it if something were to go wrong. Also, best case became finishing the experiment, collecting and analyzing data…[Read more]

]]> 0 1df68be8f765d8e7094945b0e1f5db0a Agnieszka replied to the topic Discussion Topic: Costs and managing your investment in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/2286/ Mon, 17 Apr 2017 00:14:57 -0400 Simply, the rate of return is profit, it could be a dollar amount or percentage of how much was invested. It is impossible to know exactly what the rate of return is just as it is impossible to predict the future; the best that can be done is to make an educated guess. Factors that can influence this guess and subsequently the rate of return are:…[Read more]

]]> 0 c4cc10eba2f8468d4e2fb835e55fd1ad Agnieszka replied to the topic Design Review Meeting Culture in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2180/ Sun, 09 Apr 2017 23:37:59 -0400 I don’t have any med-tech industry experience but I imagine the design review experience being tense for the product developing team. Passing a design review means completing a major milestone in the project development process and shows that the product is ready to be launched therefore it can be distressful for any engineer/developer. The…[Read more]

]]> 0 3efc2e4b2ca1fa0ede061b5047e6a61b Agnieszka replied to the topic Risk Management in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2162/ Sun, 09 Apr 2017 15:47:56 -0400 A product risk can be a faulty release mechanism on a drug delivering device. Under FMEA this would be a Concept Design / Hardware risk where we could monitor its probability of failure throughout its development process. Specifically, risk can be monitored with modeling software; designs would be imputed into the software then the software can…[Read more]

]]> 0 984aaa987dcf62c49ba348eaa5143896 Agnieszka replied to the topic FDA Recall...Now What? in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2147/ Sat, 08 Apr 2017 22:44:16 -0400 Recalls are a very interesting topic, nice post. Recalls are done, not by the company that designs and develops the product, but by the manufacturer or distributor. When these parties find that the medical device violates an FDA law (e.g. efficacy or failure to perform what it was designed for) they initiate a recall. How did this device slip…[Read more]

]]> 0 7d607bb0152d6bda13b19e9873d3cafb Agnieszka replied to the topic Engineering change order in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2030/ Mon, 27 Mar 2017 01:30:43 -0400 ECOs admit that no design is ever completely perfect, infallible. They are neither a positive or negative event, ECOs are an eventuality. The cause could be: a design error evident only during the testing phases of the product; change in customer needs, market demands, and/or governmental regulations or policies; manufacturer problems such as not…[Read more]

]]> 0 0cab5d3891edd735f10cf723556f8fda Agnieszka replied to the topic Cost Analysis of Project in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2021/ Mon, 27 Mar 2017 00:54:11 -0400 I was lucky enough to choose a Capstone project where we did not have to pay for anything, all of our parts were given to us from previous attempts at the project. However we later found out that the sensors we got were faulty and we had to buy new ones ourselves. This was a major set back to the project, we kept modifying our code thinking we…[Read more]

]]> 0 6e6394095ecdffad9c8cd7bdf73edd45 Agnieszka replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/2018/ Mon, 27 Mar 2017 00:26:51 -0400 There are many reasons why tracking time is an important practice for any company or organization. Some include: 1) Following the progress of the project, how much time is needed to complete a certain task, is this time spent wisely, any unnecessary time wasted, can time management be improved? 2) Determining cost of the project, how much should…[Read more]

]]> 0 8d8ae591b2738956121004aca87e9d0f Agnieszka replied to the topic PM: Handling Team Issues in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/1920/ Mon, 13 Mar 2017 01:41:37 -0400 A lot has already been said in this post, but teamwork and a PM’s handling of team management is a very important prevalent topic. I think the best approach is to set the rules right from the start. Explain what is expected from the employee, how those expectations are to be met, what constitutes deviation from these expectations, what is the…[Read more]

]]> 0 33342cfa5fdec5241c6e5d1b9dc1430e Agnieszka replied to the topic Source Selection in Executing Process in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/1916/ Mon, 13 Mar 2017 01:13:12 -0400 I agree here. The suppliers you want to be dealing with are well-established and are known for their high quality materials. In fact build a relationship with these suppliers and do not burden the planning phase. Additionally, a good relationship might help you get your materials faster and at better prices and latest qualities. A good…[Read more]

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