https://medicaldevicecourses.com/members/hzy2/activity/ Activity feed for hzy2. Sat, 16 May 2026 05:36:09 -0400 https://buddypress.org/?v= en-US 30 hourly 2 5fcbfdb6316b3a75d2ab8183acb4cbd2 https://medicaldevicecourses.com/activity/p/17368/ Wed, 15 May 2019 21:38:54 -0400 I think it makes perfect sense that there are rules and laws that prevent these things from continuing to happen. As Dr. Simon mentioned in this week’s lecture, there are products out there that could give better results for patients…   Read more»

]]> 3107c384cbd63ed81c7749aa91548db2 https://medicaldevicecourses.com/activity/p/17367/ Wed, 15 May 2019 21:38:53 -0400 NDA is not a substitute for a patent. Patents give you a solid proof of ownership of an idea or a product itself whereas an NDA is just a contract that is signed by two people who promise to keep…   Read more»

]]> 16b300021a4e94cd5e238708c3af6007 https://medicaldevicecourses.com/activity/p/17366/ Wed, 15 May 2019 21:38:53 -0400 This course was definitely beneficial in giving us an idea of what to expect when we go out into the real world. Dr. Simon did a good job in keeping us all engaged throughout the semester by asking us to…   Read more»

]]> 888d45dc12524f94493ef0d2a0cfb79f https://medicaldevicecourses.com/activity/p/17268/ Wed, 15 May 2019 21:38:05 -0400 I agree with @jr377 that in order to move up to the upper level positions, you would have to be promoted from a middle level position. Similarly, in order to move up to the middle level position, you would need…   Read more»

]]> c64e1e169d9c007a85387000a6631a0c https://medicaldevicecourses.com/activity/p/17267/ Wed, 15 May 2019 21:38:05 -0400 There are advantages to each type so it’s good to go over those first before you make a decision to be part of one. From a project manager’s standpoint, functional structure gives you the least power. This structure is good…   Read more»

]]> 92641f8273014c3a1fd727db97472b14 https://medicaldevicecourses.com/activity/p/17266/ Wed, 15 May 2019 21:38:04 -0400 We are planning on having weekly meetings to make sure everyone is on track. So far, we have completed the DID and DDP. Our project manager created a document where we wrote down the date we expect to finish our…   Read more»

]]> 36bc6ae2a8ba13fe69ef4449dab103d1 https://medicaldevicecourses.com/activity/p/17160/ Wed, 15 May 2019 21:37:09 -0400 When developing a new product or device, there is always a risk that things might go wrong. In order to effectively deal with and overcome these risks, companies need to come up with risk management plans. Dr. Simon mentioned in…   Read more»

]]> 21a8e52ac95aa7f69f1183349012a268 https://medicaldevicecourses.com/activity/p/17159/ Wed, 15 May 2019 21:37:08 -0400 Risk-benefit assessment is the foundation for FDA’s decision making process in terms of its medical device regulations. This assessment helps to determine whether the advantages a medical device brings to the public outweighs the risks that it might have associated…   Read more»

]]> 15c5869366cd59f3ba49a088b4f6f79a https://medicaldevicecourses.com/activity/p/17158/ Wed, 15 May 2019 21:37:08 -0400 Medical device companies are required to have an established risk management process in compliance with ISO14971. This process includes identifying hazardous situations that may come up with the medical device being developed, evaluation of these hazardous situations, ways in which…   Read more»

]]> 0540c10bd0922f9e70ab334af14f4ada https://medicaldevicecourses.com/activity/p/17057/ Wed, 15 May 2019 21:36:18 -0400 All of the design meetings held throughout the design and development stages were to ensure that the product design inputs met the product design outputs. This means that your final product functions in the way that it was intended to…   Read more»

]]> 0d79c85f3950a83a8c310f56dbcdb309 https://medicaldevicecourses.com/activity/p/17054/ Wed, 15 May 2019 21:36:16 -0400 I’m so glad that we have capstone as a required class. I think it would be really nice if we got to do a capstone project for each year that we are in college. That way we would have the…   Read more»

]]> 8d57981a578facf3fc4c03659d235e88 https://medicaldevicecourses.com/activity/p/17053/ Wed, 15 May 2019 21:36:16 -0400 Design reviews are technical meetings held by a group of people who are working on the same project where the design for that particular project or product is evaluated against all of its requirements. These meetings help to identify and…   Read more»

]]> 4b803eb64174767b5660ea39b8d16f39 https://medicaldevicecourses.com/activity/p/16980/ Wed, 15 May 2019 21:35:38 -0400 Establishing solid design inputs are essential to the success of a project. Each and every single requirement to a product needs to be clearly stated and understood by everyone working on that project so that it can be developed correctly….   Read more»

]]> 62770cf04d829fe568e2369178c09aba https://medicaldevicecourses.com/activity/p/16976/ Wed, 15 May 2019 21:35:36 -0400 Gantt chart allows you to create an outline of the tasks involved in a project and the time period in which those tasks need to be completed in order to finish the project on time. It gives you a visual…   Read more»

]]> 4c8686fb345f27e29ea2335370354d96 https://medicaldevicecourses.com/activity/p/16975/ Wed, 15 May 2019 21:35:35 -0400 Design controls are necessary documentations required by the FDA to ensure that a product is in compliance with regulations, is safe and meets customer needs. In 1984, FDA identified lack of design controls as one of the major causes of…   Read more»

]]> e8b83938a7796c0c88b37a1f0248baa7 https://medicaldevicecourses.com/activity/p/16864/ Wed, 15 May 2019 21:34:38 -0400 I think I would want to work for the sponsor company as the person putting the clinical protocols together. It seems like it would be an interesting position where not only would I get to prepare procedures for people to…   Read more»

]]> 677e23a0c70089935f5a84f303bddacf https://medicaldevicecourses.com/activity/p/16863/ Wed, 15 May 2019 21:34:38 -0400 Right to try law allows terminally ill patients to have access to drugs that are not yet approved by the FDA. If all other treatments have been attempted and resulted in failure and there is a high chance that the…   Read more»

]]> 103dd54d3acc4dd65259513ed2fddc9a https://medicaldevicecourses.com/activity/p/16861/ Wed, 15 May 2019 21:34:37 -0400 Clinical studies do come with risks but they are an important part of drug and medical device development processes. After getting favorable results from pre-clinical trials, companies need to further their studies and go into clinical trials to prove their…   Read more»

]]> fd80e34287b94d988a3985e04fa997b3 https://medicaldevicecourses.com/activity/p/16761/ Wed, 15 May 2019 19:42:20 -0400 Marketing is the activity of promoting, distributing and selling your product to a customer. It takes a good communicator to convince people into buying your products over others’. I think the whole manipulating the customer to buy what is being…   Read more»

]]> 1c248dbfd428c006511e1fcbc68b40dd https://medicaldevicecourses.com/activity/p/16758/ Wed, 15 May 2019 19:42:18 -0400 I think the way it works is that the companies have certain employees that they send out to conferences where they give presentations to physicians who might be interested in their products. Another way is to send sales representatives directly…   Read more»

]]> cf35a0d872023e967d60cfbde30a3a12 https://medicaldevicecourses.com/activity/p/16757/ Wed, 15 May 2019 19:42:18 -0400 I am choosing J&J to do a SWOT analysis. Strengths They provide to three different segments: consumer products, pharmaceuticals and medical devices. This helps them have a higher presence in the market compared to some other companies that provide only…   Read more»

]]> b7bda17a6ab1ae4921e299c8686cedb3 https://medicaldevicecourses.com/activity/p/16670/ Wed, 15 May 2019 19:41:27 -0400 Yes, I would definitely consider doing a partnership in the future. Partnerships are a great way to do business when you have family members or friends that you want to work with. It comes with many benefits including not having…   Read more»

]]> 7423218fa56e27352cb2985b4d97ec72 https://medicaldevicecourses.com/activity/p/16668/ Wed, 15 May 2019 19:41:26 -0400 One major difference between publicly and privately held companies is the way they deal with public disclosure. A public company has to reveal everything quarterly and annually to the SEC who reviews this information. The company has to hire accountants…   Read more»

]]> d2397b6acade3b9ead4e3510f0aad819 https://medicaldevicecourses.com/activity/p/16666/ Wed, 15 May 2019 19:41:25 -0400 If I was to have ownership of a business, I would most likely choose to go with the limited liability company option. This form of business allows the owners or partners to minimize their personal liabilities while giving them all…   Read more»

]]> c4119904469ad2bf174f9496e6f4de02 https://medicaldevicecourses.com/activity/p/16515/ Wed, 15 May 2019 19:39:56 -0400 I think every department needs to understand the importance of their individual roles. R&D shouldn’t blindly rely on the quality department to make sure the products they developed are safe. Quality control department seems to be the one to get…   Read more»

]]> 3c659238ab82ce7678982ad3d451a2a6 https://medicaldevicecourses.com/activity/p/16514/ Wed, 15 May 2019 19:39:55 -0400 In my opinion quality control is an integral part of any company and is worth every single dollar spent on it. Companies serve to customers who have specific needs and it is the quality engineers’ responsibility to make sure that…   Read more»

]]> 2cdde4d82f0a192a9ec5c575d97f3fee https://medicaldevicecourses.com/activity/p/16409/ Wed, 15 May 2019 19:38:58 -0400 It might be a lot of work on the companies’ end because of all the regulatory steps they need to follow to bring a product to the market. It seems to be tedious work but these products are used on…   Read more»

]]> 36cf7cea9707b4cd373ca726ca254f4c https://medicaldevicecourses.com/activity/p/16408/ Wed, 15 May 2019 19:38:57 -0400 An antibiotic-releasing hip stem is a combination product. If I was the regulatory person working with this product, the first thing I do would be to submit a request for designation to the office of combination products. They will determine…   Read more»

]]> 4d6140c0b7c055683271dfe213c14641 https://medicaldevicecourses.com/activity/p/16311/ Wed, 15 May 2019 19:38:00 -0400 If a new product is getting ready to be put into the market, there are a lot of testing that needs to be done in order to prove to FDA that it is biocompatible. The ISO10933 table provides a series…   Read more»

]]> adf004d3c8db506281b134a9c71bc197 https://medicaldevicecourses.com/activity/p/16309/ Wed, 15 May 2019 19:37:58 -0400 In academia, a project is born out of a desire or a passion you have towards a certain topic. It is done with the intention of discovering things no one has discovered before to help out humans in some way….   Read more»

]]> 5908b0649d377063f80a8e9c4aef062b https://medicaldevicecourses.com/activity/p/16307/ Wed, 15 May 2019 19:37:57 -0400 It’s sad that animals have to be sacrificed in order to try and test the safety and efficacy of drugs and biomedical devices but it seems that it’s the only option at the moment. Animal studies provide valuable information to…   Read more»

]]> 9a3db151b2b51c55506de6b65fbfff74 https://medicaldevicecourses.com/activity/p/16210/ Wed, 15 May 2019 19:18:21 -0400 When working on our senior design project, my teammates and I ran into a couple of unexpected obstacles. We were trying to procure the materials we needed to start developing our product and found out that the company we ordered…   Read more»

]]> a145345869fadd54007c670d57d20d46 https://medicaldevicecourses.com/activity/p/16208/ Wed, 15 May 2019 19:18:20 -0400 I think that the most crucial phases for the success of a project are the initiating and the planning phases. Initiating phase is where the project manager identifies the project objectives and determines whether the project meets a need in…   Read more»

]]> ad1f631b97ce184fe58496a3a8f6d484 https://medicaldevicecourses.com/activity/p/16207/ Wed, 15 May 2019 19:18:19 -0400 I never worked in the industry but for my senior design project, my teammates and I created a Gantt chart using Microsoft Project. This chart helped us organize our tasks all throughout the project time frame. We divided our tasks…   Read more»

]]> 9ba635f5804e09a56c5f292b5adb37f6 https://medicaldevicecourses.com/activity/p/16123/ Wed, 15 May 2019 19:17:20 -0400 Yes, it’s true that Biomedical Engineering curriculum exposes you to a variety of fields. You are required in your sophomore year of college to take some courses that introduce you to the different tracks that exist within the biomedical field…   Read more»

]]> 15a83cf6dc56ae341924bc20e854a88d https://medicaldevicecourses.com/activity/p/16117/ Wed, 15 May 2019 19:17:15 -0400 I’m not currently working in the industry but based on what I’ve seen so far and heard from the people around me it is very difficult to get a job without some sort of relevant experience. I think that the…   Read more»

]]> 3054ab19baf1d410037d4f6c9b9f9a7d https://medicaldevicecourses.com/activity/p/16106/ Wed, 15 May 2019 19:17:08 -0400 I don’t think that that is a good ratio at all. I think that the students should be able to receive an education that consists of an even number of academic courses and practical courses rather than an education where…   Read more»

]]> 97568d7b5b5c8156728068983fa1d317 https://medicaldevicecourses.com/activity/p/10750/ Wed, 15 May 2019 16:36:13 -0400 Dr. Simon mentioned in this week’s lecture that FDA can issue Form 483 to a company if its practices are not in compliance with the rules and regulations set by them. He gave the analogy that having Form 483 issued…   Read more»

]]> 081648d7c657a4dc78da0ebdf2943375 https://medicaldevicecourses.com/activity/p/10742/ Wed, 15 May 2019 16:36:09 -0400 Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to experience adverse effects…   Read more»

]]> 229ce9ee20395ff619e96f39c008a8ae https://medicaldevicecourses.com/activity/p/9204/ Sun, 02 Dec 2018 16:58:16 -0500 I think it makes perfect sense that there are rules and laws that prevent these things from continuing to happen. As Dr. Simon mentioned in this week’s lecture, there are products out there that could give better results for patients and morally the doctors should choose to work with whatever product they think will provide the best treatment for…[Read more]

]]> 0 211fe336eb4c89e4ccdd4b267c52b6bd https://medicaldevicecourses.com/activity/p/9203/ Sun, 02 Dec 2018 16:30:13 -0500 NDA is not a substitute for a patent. Patents give you a solid proof of ownership of an idea or a product itself whereas an NDA is just a contract that is signed by two people who promise to keep things confidential. I read an example on a website that really helped me understand the difference so I’d like to share it with you. Let’s say you have…[Read more]

]]> 0 4327eb8053311d28f957ef7363a8b1f8 https://medicaldevicecourses.com/activity/p/9202/ Sun, 02 Dec 2018 16:14:27 -0500 This course was definitely beneficial in giving us an idea of what to expect when we go out into the real world. Dr. Simon did a good job in keeping us all engaged throughout the semester by asking us to participate in these forums. It was helpful to read other peoples’ comments and opinions for when I was struggling to understand a certain…[Read more]

]]> 0 63bdc4a333ca7d355c91aac4e4f43b0e https://medicaldevicecourses.com/activity/p/9097/ Sun, 25 Nov 2018 15:16:06 -0500 I agree with @jr377 that in order to move up to the upper level positions, you would have to be promoted from a middle level position. Similarly, in order to move up to the middle level position, you would need to be promoted from a lower level position. I think I wouldn’t mind starting even at the lower management level but then over time with…[Read more]

]]> 0 82d9a2b5cbae791805cd1d10adc70885 https://medicaldevicecourses.com/activity/p/9096/ Sun, 25 Nov 2018 14:41:36 -0500 There are advantages to each type so it’s good to go over those first before you make a decision to be part of one. From a project manager’s standpoint, functional structure gives you the least power. This structure is good for smaller teams where everyone works in the same division: people you need and other resources are easily accessible to…[Read more]

]]> 0 ffb023443bf1c54d7370cb64cc4fdb87 https://medicaldevicecourses.com/activity/p/9095/ Sun, 25 Nov 2018 14:18:37 -0500 We are planning on having weekly meetings to make sure everyone is on track. So far, we have completed the DID and DDP. Our project manager created a document where we wrote down the date we expect to finish our own departments’ parts and send to him as he is the one responsible for putting it all together and submitting to the professor at the…[Read more]

]]> 0 4c09a31f3cc87abc2684a0f4a2e875a6 https://medicaldevicecourses.com/activity/p/8979/ Sun, 18 Nov 2018 16:23:41 -0500 When developing a new product or device, there is always a risk that things might go wrong. In order to effectively deal with and overcome these risks, companies need to come up with risk management plans. Dr. Simon mentioned in this week’s lecture that there are 4 ways in which this can be done: Accepting the risk, avoiding the risk, transferring…[Read more]

]]> 0 a84e4b2443f3a6f3bb004a7e4536b0c8 https://medicaldevicecourses.com/activity/p/8978/ Sun, 18 Nov 2018 16:03:14 -0500 Risk-benefit assessment is the foundation for FDA’s decision making process in terms of its medical device regulations. This assessment helps to determine whether the advantages a medical device brings to the public outweighs the risks that it might have associated with it. FDA not only focuses on the benefit, but also pays close attention to the…[Read more]

]]> 0 79943b45678f49154854c17b78fcd20c https://medicaldevicecourses.com/activity/p/8977/ Sun, 18 Nov 2018 14:25:20 -0500 Medical device companies are required to have an established risk management process in compliance with ISO14971. This process includes identifying hazardous situations that may come up with the medical device being developed, evaluation of these hazardous situations, ways in which these situations can be controlled or avoided and monitoring the…[Read more]

]]> 0 6617cab9e50171b1a4fe30fe2b6e6422 https://medicaldevicecourses.com/activity/p/8870/ Sat, 10 Nov 2018 16:01:42 -0500 All of the design meetings held throughout the design and development stages were to ensure that the product design inputs met the product design outputs. This means that your final product functions in the way that it was intended to and meets the customer needs. Design verification and validation falls under the design output category of design…[Read more]

]]> 0 74d92f7f725f3e35adb6bb0335217a6a https://medicaldevicecourses.com/activity/p/8867/ Sat, 10 Nov 2018 15:18:27 -0500 I’m so glad that we have capstone as a required class. I think it would be really nice if we got to do a capstone project for each year that we are in college. That way we would have the opportunity to expose ourselves to multiple projects that fall within the different tracks of BME. I feel like capstone gave me a good understanding of how…[Read more]

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