https://medicaldevicecourses.com/members/ryanrattazzi/activity/ Activity feed for RyanRattazzi2. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 21f71ed2284babdac5d7b7c04fa26de1 https://medicaldevicecourses.com/activity/p/19193/ Tue, 26 Nov 2019 16:23:08 -0500 Currently, my team is in the middle stages of our product development project. We have all submitted first drafts of our documents to each other for review, so that we can make required editations before we advance. I am in…   Read more»

]]> 63567cdc15161b731bc53fafd14a40c7 https://medicaldevicecourses.com/activity/p/19192/ Tue, 26 Nov 2019 16:15:17 -0500 In starting my own company, I think the functional matrix organization structure makes then most sense. Having departments structured and separated by function would allow every aspect of the development process to be completed efficiently. Additionally, there will be cross-talk…   Read more»

]]> 7dde324ffdc94c1c383e01af680d8cd6 https://medicaldevicecourses.com/activity/p/19191/ Tue, 26 Nov 2019 16:10:07 -0500 I don’t have an abundance of experience operating in different organization types, however I do feel that the most effective in my opinion would be a rigidly organized structure. While the “everyone does a little bit of everything” sounds good…   Read more»

]]> c0df099d6b6688cf115dbb12abddc75a https://medicaldevicecourses.com/activity/p/19137/ Wed, 20 Nov 2019 16:18:47 -0500 Much of what we have learned about risk management uses terms like “minimize” and “as much as possible” due to the nature of risk. Risk is something that can never completely go away. Some amount of risk will be present…   Read more»

]]> 7eab18286dd7ffd5b68798e1f9167cbe https://medicaldevicecourses.com/activity/p/19136/ Wed, 20 Nov 2019 16:07:33 -0500 Post-Market surveillance is important for medical devices of all classifications, and additionally all products in general. This goes back to the statement that risk management does not have a specific timeline, because it should be performed in conjunction with every…   Read more»

]]> e0472ff0aff6b88c21b17ba9f6070f9a https://medicaldevicecourses.com/activity/p/19135/ Wed, 20 Nov 2019 16:00:52 -0500 Quantifying risk in product development is incredibly important for the project to stay on track successfully. This is not always an easy task, which is why there are methods like the SWOT analysis method. This takes an in depth look…   Read more»

]]> 2c2f09afe9c00de50ca993a4eac928a8 https://medicaldevicecourses.com/activity/p/19068/ Wed, 13 Nov 2019 00:52:08 -0500 You have encompassed just about all of what goes into risk assessment with the two categories of “how often the failure occurs” and “severity of the failure.” However, both of these could be expanded upon to get a better idea…   Read more»

]]> 120e200a0fe27f92f8bfd554e907ca56 https://medicaldevicecourses.com/activity/p/19067/ Wed, 13 Nov 2019 00:43:12 -0500 As a project manager, the main this I would be looking for in a risk assessment meeting is input and feedback from everyone. Obviously as the project manager, I would have a good idea of the risk assumed by each…   Read more»

]]> f9649f5b98e690d2e269cdbe74c067cf https://medicaldevicecourses.com/activity/p/19066/ Wed, 13 Nov 2019 00:33:42 -0500 Determining the sample size for validation protocols seems to be a somewhat neglected, but very important task. The biggest reason this task proves to be difficult is the ability to properly analyze risk and quantify how many employees are required….   Read more»

]]> 33f23d9df012ebc5055bff5748979f04 https://medicaldevicecourses.com/activity/p/19027/ Sat, 09 Nov 2019 03:17:00 -0500 From my experience working on a Gantt Chart, the most important thing to consider is the relationship between tasks. Many tasks depend on other tasks completion before they can be finished, or even started. This is a crucial aspect of…   Read more»

]]> 3930a811177c6df65377111448870e2c https://medicaldevicecourses.com/activity/p/19026/ Sat, 09 Nov 2019 03:10:07 -0500 Design verification and validation are very similar, and I struggled to grasp why they needed to be separated into two distinct phases as well, when they seem be almost the same thing. What I have learned is that verification checks…   Read more»

]]> b73e8f38eb2c74782f9f68694b587eba https://medicaldevicecourses.com/activity/p/19025/ Sat, 09 Nov 2019 03:03:37 -0500 Design Controls organize everything about a product, and the product development stages. The importance of proper design controls stems back to the importance of communication. Design controls play a major role in every aspect of product development because it is…   Read more»

]]> 16f8d9dfd1b104eb5a605b36e58ec25a https://medicaldevicecourses.com/activity/p/18959/ Wed, 30 Oct 2019 00:20:40 -0400 Obviously, I think all parts of the DDP are essential. If they were not, by now they would likely be obsolete. However, out of all of them, I agree, the Communication management is the most essential aspect. Communication is key…   Read more»

]]> 373fa9b82d14a9415087f1290d290bfb https://medicaldevicecourses.com/activity/p/18958/ Wed, 30 Oct 2019 00:08:58 -0400 Design Controls are important for any product development project. However, just any Design Controls thrown together haphazardly and insufficiently will not suffice. Design Controls are the blueprints and building blocks fro everything else in the product development process.  Design controls…   Read more»

]]> 0c20b1617265f32f9eec742f59b42ae6 https://medicaldevicecourses.com/activity/p/18955/ Tue, 29 Oct 2019 23:44:05 -0400 The Design Input Document is the foundation of any product development project. It contains the basic functionality requirements and details of the product. Because of the amount of information that needs to be in the Design Input Document, there are…   Read more»

]]> a538ba753fcfd897f48724eb64b8afab https://medicaldevicecourses.com/activity/p/18897/ Tue, 22 Oct 2019 21:33:55 -0400 Placebo Controlled Trials are incredibly important to the validity of research done in clinical settings. To answer your question of why they are necessary, many subjects in a study would be greatly influenced by the group of the study they…   Read more»

]]> 8892e386f3f756c59f27f68e28761b12 https://medicaldevicecourses.com/activity/p/18896/ Tue, 22 Oct 2019 21:18:13 -0400 Informed consent is crucial in clinical trials and medical research. Like stated in the question, this could end up being a disservice to the larger scientific field in the instance that a person such as Henrietta Lacks were to check…   Read more»

]]> a364a37bfa1c9ba2372062a7f6b8865b https://medicaldevicecourses.com/activity/p/18895/ Tue, 22 Oct 2019 20:57:24 -0400 For most cases, single blind studies suffice for removing bias from the study. As the main reason for skewed data would stem from if subjects knew whether or not they had been given a placebo. However, in many cases, researchers…   Read more»

]]> 058a04e7947e8ef087f419f428b87780 https://medicaldevicecourses.com/activity/p/18822/ Mon, 14 Oct 2019 20:46:04 -0400 Marketing is absolutely all about manipulation. Product development works tirelessly to create something that is new, useful, innovative, etc, but if there is no marketing plan to get the target audience to know about and want to buy this product,…   Read more»

]]> 08346d5abc32816495d6428534ab3440 https://medicaldevicecourses.com/activity/p/18821/ Mon, 14 Oct 2019 20:29:55 -0400 Marketing in today’s digital age seems to have become more effective than ever. A large percentage of the population has a smartphone at our immediate disposal in which we look at somewhere around 40 times per day. With social media…   Read more»

]]> cec9fc2695849f03165ff69eeea84305 https://medicaldevicecourses.com/activity/p/18820/ Mon, 14 Oct 2019 20:17:15 -0400 So much thought goes into marketing surrounding the psychology of colors and the effects it has on consumers. A common example, as used in the post of this question is McDonald’s. They heavily utilize the colors red and yellow, as…   Read more»

]]> 47614c59673306239eab4128bcc073a1 https://medicaldevicecourses.com/activity/p/18776/ Thu, 10 Oct 2019 21:18:06 -0400 Which kind of company I would want to own directly depends upon what exactly the company is/does. But for most cases, I think the most beneficial company would be a LLC. This is due to the fact that it implies…   Read more»

]]> 80cb67f416bbf3ebd5fbc2d980f0e4e4 https://medicaldevicecourses.com/activity/p/18775/ Thu, 10 Oct 2019 21:01:35 -0400 Like many of you said before me, it is not seen as a horrible things or a sign to be worried when a large company suffers from a bad quarter or a bad year. This is because due to the…   Read more»

]]> 8e35947396dbe945ed7aa6e54ab58a9b https://medicaldevicecourses.com/activity/p/18774/ Thu, 10 Oct 2019 20:52:20 -0400 One of the biggest differences between private and public companies is that while private companies are owned by only a few individuals are do not have stocks that are traded publicly, public companies can have many millions of shareholders. Additionally,…   Read more»

]]> 12b87ba2f2ff5962464a862295ed3141 https://medicaldevicecourses.com/activity/p/18701/ Tue, 01 Oct 2019 16:21:30 -0400 The job of the FDA is “protecting the public health by assuring the safety, efficacy, and security of drugs, products, etc.” Noticeably, this mission statement does not mention “quality.” The term quality generally goes hand in hand with the duties…   Read more»

]]> a431fdc6e77fc94197a61f13ec2d0454 https://medicaldevicecourses.com/activity/p/18700/ Tue, 01 Oct 2019 16:10:29 -0400 This question goes back to the first and maybe most important thing we learned about in this class. Communication is key. Proper communication between R&D and QA/QC can allow both sides to understand what the other wants from them, and…   Read more»

]]> fbf52571904fc1ec59208e7aed832b01 https://medicaldevicecourses.com/activity/p/18699/ Tue, 01 Oct 2019 15:58:09 -0400 We learned last week about the negative consequences that can face a company when they are forced to recall a product. Many times the blame is put on the FDA for allowing this product to reach commercial markets anyway with…   Read more»

]]> 5fe7ffb0b78d861df6c5efa11dab34e3 https://medicaldevicecourses.com/activity/p/18638/ Wed, 25 Sep 2019 15:57:43 -0400 I have watched that documentary “The Bleeding Edge.” It was very informative and also made me question some of the things you are asking as well. The FDA is seen as such a strict overseer in the medical device product…   Read more»

]]> d9eec48cf822fa5eb532ad649e98277d https://medicaldevicecourses.com/activity/p/18637/ Wed, 25 Sep 2019 15:41:06 -0400 Precision and Accuracy are similar in context, but very different in definition, and equally important in the medical device field. Having one without the other is essentially useless, and will either cause harm to the consumer, cause the product to…   Read more»

]]> effd0c68cd7d5abd55c6ea500450a53b https://medicaldevicecourses.com/activity/p/18636/ Wed, 25 Sep 2019 15:29:57 -0400 Many medical devices and medical products get recalled every year. This could be due to a variety of different issues with the item, mostly revolving around a possible harm to the consumer. For example, a company called DePuy Synthes had…   Read more»

]]> e88f7cf2f46d2b105301eaae7683436e https://medicaldevicecourses.com/activity/p/18579/ Tue, 17 Sep 2019 15:52:13 -0400 I have also never been a part of a team doing pre-clinical or clinical research, however I do know that there are many things that can have detrimental effects on this stage of development. For example,  a simple equipment failure…   Read more»

]]> 27d5e3d67e10ba7c4d3642eebc191601 https://medicaldevicecourses.com/activity/p/18577/ Tue, 17 Sep 2019 15:20:32 -0400 Working in Academia, it is true, you do get to work on the cool stuff. Currently working as a researcher at NJIT, some of the robotics projects I am working on are the coolest things I have ever seen and…   Read more»

]]> e29d22ac09e1269beecf2667b29a731b https://medicaldevicecourses.com/activity/p/18576/ Tue, 17 Sep 2019 15:10:38 -0400 There is a difference between the expected timeline for the work being done in academia vs industry to create real results. Much of the work done in academia, because it is late-breaking research, and always on the cutting edge, takes…   Read more»

]]> c183d7961c9db3da15af47944442bfcf https://medicaldevicecourses.com/activity/p/18541/ Sun, 15 Sep 2019 19:28:31 -0400 I have never worked on a project with multiple project managers. However, based off my experience working on projects with one, I think it could definitely have some benefits to have multiple. For example, often it is beneficial to have…   Read more»

]]> 9ad95ee7a509a3d1ac1525ba1c32664f https://medicaldevicecourses.com/activity/p/18540/ Sun, 15 Sep 2019 19:24:17 -0400 I believe missed milestones are a failure. Nobody goes into a project saying, “ideally we will miss this deadline.” That doesn’t make sense. However, through a proper planning phase, there is a sufficient amount of time built into the schedule…   Read more»

]]> 99540267f4f99324abd4e592b27b3db3 https://medicaldevicecourses.com/activity/p/18539/ Sun, 15 Sep 2019 19:19:48 -0400 The obvious answer for which phase of a project’s life cycle is the most important would be theexecuting phase. Because, if the executing phase doesn’t happen, then nothing happens in thedevelopment of the project. But additionally, if the planning phase…   Read more»

]]> cdd99eaff68d29f8ea1f171911db66a0 https://medicaldevicecourses.com/activity/p/18432/ Fri, 06 Sep 2019 13:47:12 -0400 Currently, I work in the research field while I am pursuing my Master’s degree at NJIT. And as much as I like my job currently, I would like to get experience in industry at some point. As far as I…   Read more»

]]> 68f3aea699cf5b04eac511181dfd0b45 https://medicaldevicecourses.com/activity/p/18431/ Fri, 06 Sep 2019 13:39:25 -0400 Biomedical Degree is definitely a “Jack-of-all-Trades” degree with broad knowledge in Mechanical Engineering, Chemical Engineering, and Biology. From what I have found out through, interviews, work experience, and hearing from others, the stigma that BME covers too many disciplines to…   Read more»

]]> 391de13dbc7a74d0c26ee2526c3ea57d https://medicaldevicecourses.com/activity/p/18430/ Fri, 06 Sep 2019 13:28:00 -0400 I have been wondering this question for a while as well, of what the benefits and holdbacks are between a BS, MS, and PhD in Biomedical Engineering are. I graduated from NJIT with a BS in biomedical Engineering, and have…   Read more»

]]> 79589cb7ec062b37d2d6c8e5595d6fc9 https://medicaldevicecourses.com/activity/p/18319/ Wed, 15 May 2019 21:47:15 -0400 These two reasons for motivation at work and for leaving work, in “exciting & challenging work” and “limited recognition & praise” do seem unrelated. Personally, exciting and challenging work is a very large motivation factor for me in a job….   Read more»

]]> d5fd034e3d2896d5e8dc918a18fef4d3 https://medicaldevicecourses.com/activity/p/18318/ Wed, 15 May 2019 21:47:15 -0400 As compared to the rest of the world, Americans do on average work more, and this overworking could definitely been seen as detrimental for motivation, happiness, and overall production. From my point of view, the reason for this overworking is…   Read more»

]]> 4a95b414e68cb76dda0fbf64593d9976 https://medicaldevicecourses.com/activity/p/18317/ Wed, 15 May 2019 21:47:14 -0400 Motivation of project managers have a direct correlation on the overall productiveness of the team. For team members to stay engaged and productive, they generally need proper motivation. This is just another incredibly important aspect of the project managers job….   Read more»

]]> b7b2a48447044bb3aa0604fa6a5183ad https://medicaldevicecourses.com/activity/p/18224/ Wed, 15 May 2019 21:46:29 -0400 Project managers are required to be a sort of jack-of-all-trades. Meaning, as you said, project managers must have strong qualities of communication, interpersonal skills, organization, crisis management, along with others. Managers are tasked with managing a project by managing the…   Read more»

]]> ccc6af5928383e2702b48e89c719d9ef https://medicaldevicecourses.com/activity/p/18223/ Wed, 15 May 2019 21:46:25 -0400 Personally, I don’t find this list of motivations to work particularly surprising. Most people enjoy challenging and exciting work to keep them engaged in their job. And generally this will go hand and hand with the career growth and development…   Read more»

]]> 77ad7bae4f72c15956efb16dd55dd67b https://medicaldevicecourses.com/activity/p/18222/ Wed, 15 May 2019 21:46:24 -0400 One of the most important aspects of project management I learned in this course is just how crucial proper communication is. In almost every lecture, and every aspect of project management from planning to execution, communication is key. Communication between…   Read more»

]]> 0d6d053c51789fbd6f4022ae7d911de2 https://medicaldevicecourses.com/activity/p/18191/ Wed, 15 May 2019 21:46:09 -0400 The WBS lays out all the small tasks required to be done for the completion of the overall project. In order to have a plan set for all aspects working together, which is necessary for product development, the WBS is…   Read more»

]]> b83bcb529e3fbc66958c514ea0877d3f https://medicaldevicecourses.com/activity/p/18190/ Wed, 15 May 2019 21:46:08 -0400 In my experience with procurement management, it is necessary to have a very clear idea of the plan of the project and the specs of the materials needed. This is where procurement management becomes important. There are a lot of…   Read more»

]]> 339084e576cfa1fb4e5d710eeac8586c https://medicaldevicecourses.com/activity/p/18189/ Wed, 15 May 2019 21:46:08 -0400 Communication should be present between all people in every branch of product development. Communication is the key for success in the development of a project and if even one part of a team is slacking in communication it can have…   Read more»

]]> 48d9c92289f5c3a65084e6c9b6826f30 https://medicaldevicecourses.com/activity/p/18104/ Wed, 15 May 2019 21:45:26 -0400 Planned value and actual costs, relating to the overall budget is one of the most important factors, if not the most important, in product development. While it would be nice to say money doesn’t matter, and the goal is only…   Read more»

]]> 90a39366ccf7da02f8c51c585d9fefdd https://medicaldevicecourses.com/activity/p/18103/ Wed, 15 May 2019 21:45:26 -0400 It is a common theme that different phases of product development can flow into one another. This is the same case with design verification. However,due to the nature of design verification being to check that inputs=outputs, this does not mean…   Read more»

]]>