https://medicaldevicecourses.com/members/jh597/activity/ Activity feed for jh597. Sat, 16 May 2026 08:28:56 -0400 https://buddypress.org/?v= en-US 30 hourly 2 4c3ca3fae2338754bfd71522d4cefc76 https://medicaldevicecourses.com/activity/p/28582/ Sun, 03 Dec 2023 05:04:20 -0500 Verbal contracts can be followed through ensuring that the agreement is as clearly defined as possible to attempt to prevent the opposite party from identifying and exploiting loopholes. When these verbal contracts are not specific, it can result in both…   Read more»

]]> f553dd0c6603e333bca68d6567f2cc55 https://medicaldevicecourses.com/activity/p/28581/ Sun, 03 Dec 2023 04:47:37 -0500 Although a scenario like this may appear to be too restrictive, I believe that it is best to maintain these strict practices to ensure that ethics are not being compromised. As mentioned by others, the Sunshine Act was established to…   Read more»

]]> a7d4b0e0c6ec107c2405d5b68055821d https://medicaldevicecourses.com/activity/p/28577/ Sat, 02 Dec 2023 21:17:34 -0500 The days of giving gifts like the “old days” are in the past for most companies today. The company that I am currently working at actually assigns a specific training relating to this exact topic and gives different instructions on…   Read more»

]]> 316349d31487a818005b64f62e9758b9 https://medicaldevicecourses.com/activity/p/28522/ Thu, 23 Nov 2023 19:22:41 -0500 Currently, I work within a matrix organization in which I work within a certain department and am involved within different project groups. This style of organization is a good fit for me as it allows for me to work with…   Read more»

]]> a62877a1bb9c48dc6091288e2c7b6fab https://medicaldevicecourses.com/activity/p/28521/ Thu, 23 Nov 2023 18:41:08 -0500 Upper management typically includes executives whereas middle management can be managers over particular departments or teams. In upper management, the executives typically evaluate decisions from a business perspective and are more focused on the big picture. In middle management, the…   Read more»

]]> 22dc8e5f90635281d432b49276203cec https://medicaldevicecourses.com/activity/p/28520/ Thu, 23 Nov 2023 18:07:10 -0500 My team has had two meetings so far virtually since it is difficult to meet in-person due to each person having different class schedules as well as working during the day. As of now, we have completed the DDP, a…   Read more»

]]> 7b5835eba4a6a04b15f1c73f303484d9 https://medicaldevicecourses.com/activity/p/28470/ Fri, 17 Nov 2023 17:49:02 -0500 Risk management should be a team effort and should thus be equally as important across all functional areas. Although Quality may be the department that actually develops the documentation pertaining to risk management, such as an FMEA, every department should…   Read more»

]]> 198b8d59879a2365550f99f2068c9bd2 https://medicaldevicecourses.com/activity/p/28469/ Fri, 17 Nov 2023 17:38:40 -0500 It is important to understand both. In order for a device to be successful, the rewards have to be evident to appeal to the market. Although it can be tempting for companies to be solely focused on the rewards, it…   Read more»

]]> 0c69458e4c3f4afaa6a0b3fe6a6b8566 https://medicaldevicecourses.com/activity/p/28468/ Fri, 17 Nov 2023 17:21:04 -0500 Risk assessments are crucial for medical devices as they lay out potential risks that can occur in the device. A risk assessment allows a team to see the different risks possible and find a way to mitigate or eliminate those…   Read more»

]]> 8125df6e466839e2ffbe5c2893fad521 https://medicaldevicecourses.com/activity/p/28401/ Wed, 08 Nov 2023 05:43:13 -0500 Companies should have a high sense of corporate responsibility, particularly within the medical device and pharmaceutical industry due to their products having a direct impact on patient health. The implications that can result from not valuing corporate responsibility could be…   Read more»

]]> f50447f4253ff3dbbff703e18ecb02ea https://medicaldevicecourses.com/activity/p/28400/ Wed, 08 Nov 2023 05:09:48 -0500 Within a design review meeting, it is important to ensure that each department involved in the project should be represented at the meeting. This may include the project lead as well as the quality lead, regulatory lead, research and development…   Read more»

]]> 44078e430d7a024bdd90728732d2f813 https://medicaldevicecourses.com/activity/p/28399/ Wed, 08 Nov 2023 04:49:11 -0500 Minutes for meetings are crucial as they allow for team members to be aligned on what was discussed throughout the meeting. This can be helpful in ensuring that team members are aware of what tasks need to be completed as…   Read more»

]]> ccef87822b4ce703e6eb9544baaaff9e https://medicaldevicecourses.com/activity/p/28362/ Fri, 03 Nov 2023 01:20:14 -0400 Different departments within a medical device company have a hand in working with design controls. A quality assurance department may be focused on developing the inputs and outputs for the device, the regulatory department may be focused on ensuring that…   Read more»

]]> 76a2db28685243f3e2337de4c9174992 https://medicaldevicecourses.com/activity/p/28361/ Fri, 03 Nov 2023 01:06:08 -0400 When revising design controls it would be important to observe whether they follow the desired inputs and outputs for the device. From there, the first and most important step to implement to keep operations moving smoothly would be to ensure…   Read more»

]]> e431772210220df4839acef07f355e9f https://medicaldevicecourses.com/activity/p/28360/ Fri, 03 Nov 2023 00:11:26 -0400 A factor to consider when developing a test method and protocol is repeatability. It is essential that the test can be performed at a different instance with a different operator. For example, in my current role, I do some mechanical…   Read more»

]]> 571dc4aef08624fc0c86d90e20645986 https://medicaldevicecourses.com/activity/p/28298/ Sat, 28 Oct 2023 01:47:20 -0400 In order to eliminate the placebo effect, researchers have to ensure that both products look as close to identical as possible. For example, if a clinical trial is being conducted using auto-injectors and syringes, with the placebo being water-filled syringes…   Read more»

]]> 955e7c075ddafec0f7d646adfbcd908a https://medicaldevicecourses.com/activity/p/28297/ Sat, 28 Oct 2023 01:23:22 -0400 During undergrad, I had a course called FDA Regulations of Medical Devices which served as a good precursor to how medical devices are developed in accordance with FDA regulations. In that course, we were tasked with developing a semester-long mock…   Read more»

]]> cc23b31f6e287e80a81d2fb542ed1cb0 https://medicaldevicecourses.com/activity/p/28296/ Sat, 28 Oct 2023 00:59:47 -0400 A way that companies could incentivize participation in a clinical trial is through having benefits that could improve their health. For example, if a company is conducting a clinical trial on a specific drug, it could offer free medical screenings…   Read more»

]]> a4e575773f8cc519367c2b0109cbcf91 https://medicaldevicecourses.com/activity/p/28257/ Sat, 21 Oct 2023 05:20:14 -0400 Participation has become a huge factor in marketing due to the popularity of social media. Social media has provided companies with the opportunity to turn their marketing into a two-way conversation, whereas other marketing avenues, such as television commercials, are…   Read more»

]]> 32eaeda9b1cb609b9cf75b6d5df89663 https://medicaldevicecourses.com/activity/p/28256/ Sat, 21 Oct 2023 04:25:39 -0400 Transitioning from engineering into sales or marketing would be an interesting potential future opportunity, but personally, I would currently prefer working in engineering. Sales and marketing have a lot of positives such as more direct interactions with prospective patients and…   Read more»

]]> 0d960b1090c354beb2ca64d3248f671f https://medicaldevicecourses.com/activity/p/28255/ Sat, 21 Oct 2023 03:59:10 -0400 In the current age of social media, it has proven to be a very successful way of reaching a wide audience. Social media allows for a more interactive experience with an audience through the use of polls and a comment…   Read more»

]]> 6cd95028b7f4410639e17e9361429eab https://medicaldevicecourses.com/activity/p/28204/ Sun, 15 Oct 2023 14:54:36 -0400 The type of corporation would ultimately depend on the goal of the company, but I would choose a Limited Liability Company (LLC). An LLC allows for multiple owners, which can be extremely valuable when forming a start-up. For example, if…   Read more»

]]> d90cefa4f484dcb5f481e84e93467cdc https://medicaldevicecourses.com/activity/p/28200/ Sun, 15 Oct 2023 03:42:15 -0400 From what I’ve heard from other more experienced individuals within industry, most individuals who have worked at a start-up company emphasize the amount of learning that they had during that opportunity. Since start-ups are smaller companies, typically an individual is…   Read more»

]]> de5fcfb4fb14ee070026b0f9f5f5e441 https://medicaldevicecourses.com/activity/p/28198/ Sun, 15 Oct 2023 03:22:10 -0400 Engineering students should take an additional business course to be better prepared for entering industry since business classes would provide valuable information that could help in the transition from school to career. When engineers enter into the work field, sometimes…   Read more»

]]> d106bafea6b4789616cb939c21aaab93 https://medicaldevicecourses.com/activity/p/28119/ Thu, 05 Oct 2023 04:10:33 -0400 In my experience working in Quality last summer as an intern, Root Cause Analyses were used very frequently. They are used frequently as a starting point for Corrective Actions and Preventive Actions within medical device companies. In order to properly…   Read more»

]]> 5acbe890dc0c60a8e89dd2012d75dae1 https://medicaldevicecourses.com/activity/p/28118/ Thu, 05 Oct 2023 03:50:31 -0400 Last summer I worked as an intern in Quality Compliance at a medical device company. Within that function, my role was centered on working on Corrective Actions and Preventive Actions (CAPAs). The work consisted of monitoring CAPAs from the Request…   Read more»

]]> 4e2305e4bca76365cfdf5533ac026c40 https://medicaldevicecourses.com/activity/p/28049/ Wed, 27 Sep 2023 03:37:56 -0400 The challenges that a physician would face in trying to create a medical device is that they may not have experience with design controls, such as understanding how to develop design inputs, outputs, verification, and validation. Additionally, the physician may…   Read more»

]]> a96fea21e98aeb3f479a43103c0dc797 https://medicaldevicecourses.com/activity/p/28047/ Wed, 27 Sep 2023 02:57:19 -0400 An example of a combination product is an auto-injector. An auto-injector contains a pre-filled syringe and the device releases a plunger that contains a spring when activated to inject the drug product into the patient. Auto-injectors can be used to…   Read more»

]]> d48f3cde0568414d4166eb1043911f65 https://medicaldevicecourses.com/activity/p/28046/ Wed, 27 Sep 2023 02:30:27 -0400 Over the course of the last year, the FDA recalled Smiths Medical’s Computerized Ambulatory Delivery Device pump, which is a combination product which delivers a drug at a programmed time and dose. This device was recalled due to issues with…   Read more»

]]> 8728c92dd9f5fd13ed3fe1644256a4c7 https://medicaldevicecourses.com/activity/p/28018/ Sun, 24 Sep 2023 05:17:54 -0400 There is value in both types of research, as they are both important to future contributions to the field. In my experience, I would rather do research that I am able to see have an impact in my lifetime. This…   Read more»

]]> 0da3c749638ac56498a3be02ce7fed68 https://medicaldevicecourses.com/activity/p/28014/ Sat, 23 Sep 2023 20:33:09 -0400 From my experiences, I would prefer research in industry over academia, as having stricter timelines, although potentially stressful, ensures that projects are being completed. Additionally, in industry, companies are usually willing to spend more than in academia on new devices…   Read more»

]]> b288732122862a59fadb2a6c9c443733 https://medicaldevicecourses.com/activity/p/28013/ Sat, 23 Sep 2023 19:37:05 -0400 In terms of the consequences of not completing a project in academia, it would depend on the project. If it is a project that has not really evolved from an idea into tangible work, or even if the project is…   Read more»

]]> 5c7981c1bb3ad5289a6b60a3c314f0c2 https://medicaldevicecourses.com/activity/p/27946/ Sat, 16 Sep 2023 01:11:54 -0400 Typically a missed milestone is a failure, but it would depend on why the milestone was missed. If the milestone is the result of poor management or team members being unable to complete a milestone due to any reason that…   Read more»

]]> aa1c8f97701bc342c64594c3c64d598a https://medicaldevicecourses.com/activity/p/27945/ Sat, 16 Sep 2023 00:13:24 -0400 It is important for project managers to be flexible in order to be able to successfully manage projects. Flexibility allows for project managers to be able to make tough decisions, particularly in regards to budget. Since medical devices are so…   Read more»

]]> c14864eb30566916830cdbe532a6e354 https://medicaldevicecourses.com/activity/p/27944/ Fri, 15 Sep 2023 23:39:28 -0400 The challenges presented by doing project management for medical devices rather than for construction stem from the fact that the medical device industry is one of the most highly regulated industries in the world. As a result, it is critical…   Read more»

]]> 0fc6398a98221bd5cfc573fd0f15b410 https://medicaldevicecourses.com/activity/p/27892/ Sun, 10 Sep 2023 03:52:16 -0400 Academia and industry both have their own sets of benefits and present different work environments. In academia, the work is typically much more research-oriented and allows one to directly contribute to the field of biomedical engineering. Academia also opens up…   Read more»

]]> 165f28e9120f8d9b38a7462daf850016 https://medicaldevicecourses.com/activity/p/27891/ Sun, 10 Sep 2023 03:26:56 -0400 I think it is important to have both types of classes as the informational knowledge is needed to be able to work in a practical setting. For example, if someone is working within risk management and they are working on…   Read more»

]]> 786097a27f81046448eea206ebb22b86 https://medicaldevicecourses.com/activity/p/27889/ Sun, 10 Sep 2023 01:49:06 -0400 In my experience, both working remotely and onsite have their own set of benefits. Last summer I interned at a medical device company working in Quality where I primarily worked remotely. Currently, I work at a pharma company focused on…   Read more»

]]> 57f5e44f9b39d1cf5d3496a17df30210 https://medicaldevicecourses.com/activity/p/27737/ Sat, 29 Apr 2023 01:35:53 -0400 This question does not have a clear answer as different individuals may value different things. To some, financial compensation may be the most important factor, which may, in turn, require them to sacrifice other factors such as work-life balance. If…   Read more»

]]> b54fd98b87c68f4585fbefe914591df9 https://medicaldevicecourses.com/activity/p/27736/ Fri, 28 Apr 2023 23:46:03 -0400 Long-term, I would hope to go into a management role, but right out of school, I would prefer to work in a more technical role. Through working in a technical role, it gives an individual the opportunity to grow in…   Read more»

]]> bcd691d778abe7317a804bf38eb8c90b https://medicaldevicecourses.com/activity/p/27733/ Fri, 28 Apr 2023 22:42:32 -0400 I agree with the notation that Americans work more hours per week than most other countries due to the peer pressure that is felt by others working long hours, even outside of the 40-hour work week. To many in America,…   Read more»

]]> 75918b399250b230a837cffb878b2bb3 https://medicaldevicecourses.com/activity/p/27607/ Fri, 21 Apr 2023 03:25:59 -0400 The project team can learn many different things from a failed project. Firstly, it can show the importance of having a good project plan. A good project plan is one that plans for the unplanned. This is done through conducting…   Read more»

]]> d9f00d82c6cacdf544f36fd1404f7e59 https://medicaldevicecourses.com/activity/p/27606/ Fri, 21 Apr 2023 03:01:36 -0400 A bigger priority should be to prevent demotivation within their current workplace since the number of employees at the company would be greater than the number of employees they would hire. It is important to ensure that employees are motivated…   Read more»

]]> 9c57e4617c61632ff5bd9d1fa76edb1f https://medicaldevicecourses.com/activity/p/27605/ Fri, 21 Apr 2023 02:31:48 -0400 This question is a bit difficult to answer since each individual may weigh each factor differently. To some, compensation and benefits may be the most important while others may prioritize the ability to work on interesting projects and career advancement…   Read more»

]]> a5f556fff179785a1c8e7532d7c4b77c https://medicaldevicecourses.com/activity/p/27462/ Fri, 14 Apr 2023 04:38:39 -0400 Since project team changes can occur, it is essential to ensure that the project manager has a good plan in place to address these changes. If a project is contingent on one particular person, then the project is being set…   Read more»

]]> 6f256e3c05c036726063cd7e9ab2b713 https://medicaldevicecourses.com/activity/p/27455/ Thu, 13 Apr 2023 22:04:20 -0400 It is important for different members of a project team to be familiar with what others are working on to understand the progress of the project and to ensure that the project is being completed successfully. It does not have…   Read more»

]]> 8bf411943e8b3b2af361207abb375421 https://medicaldevicecourses.com/activity/p/27454/ Thu, 13 Apr 2023 21:27:51 -0400 In this scenario, it is important to ensure that good documentation is maintained in order to be able to explain one’s role to another. It should never be the case that only one person knows how to work a certain…   Read more»

]]> 780cfcb0343a2d38f78a25a6daa17ddb https://medicaldevicecourses.com/activity/p/27348/ Sat, 08 Apr 2023 04:08:38 -0400 The risks with these dates can be minimized so that the task would not be significantly affected by lateness through allowing for slack. Slack allows for extra time to be assigned for tasks to compensate for any potential delays that…   Read more»

]]> f04d191b46012e6416fb79fd43d5ec3b https://medicaldevicecourses.com/activity/p/27331/ Fri, 07 Apr 2023 19:19:55 -0400 A challenge that a project manager may face is dealing with so many different personalities. Across a project, there may be many individuals that come from backgrounds. For example, a medical device project team may have people with more technical…   Read more»

]]> 0e9979cc41da2cf1e389110b557467a4 https://medicaldevicecourses.com/activity/p/27329/ Fri, 07 Apr 2023 18:29:33 -0400 In order to ensure that the team is given the most complete solutions when they need them, communication is key. This can be done through ensuring that everyone on the team clearly understands the information being given, to make sure…   Read more»

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