https://medicaldevicecourses.com/members/mfc5/activity/ Activity feed for mfc5. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7e32ab3caadf9d6aa7c38de678354ba7 https://medicaldevicecourses.com/activity/p/30316/ Sat, 30 Nov 2024 22:34:02 -0500 Although there’s not a substantial difference between verbal and oral agreements, there are some notable differences to note. Verbal agreements are classified as those that are through any form of communication, whether it be email, phone calls, etc. However, oral…   Read more»

]]> a9ee0bfecd8231c36302e73e049d9e6f https://medicaldevicecourses.com/activity/p/30315/ Sat, 30 Nov 2024 22:25:12 -0500 No, an NDA is not a substitute for a patent. An NDA is an agreement that protects confidential information between business when collaborating. It is a temporary agreement that requires resigning every certain duration (typically 2-5 years) to reinstate it….   Read more»

]]> 0941ce316dd29125c9d8a0b73e65a714 https://medicaldevicecourses.com/activity/p/30312/ Sat, 30 Nov 2024 21:08:20 -0500 When finalizing a consulting agreement, it is important to clearly outline the expectations of the services provided by the firm, a timeline of when the service will be completed, and the payment details. It is also required that prior to…   Read more»

]]> d72b4e4dbb5373d9f27fca3680280a39 https://medicaldevicecourses.com/activity/p/30125/ Tue, 12 Nov 2024 19:54:49 -0500 I am currently interning at a biomedical equipment manufacturer, and we use PFMEAs I am currently interning at a biomedical equipment manufacturer, and we use PFMEAs for all of our products, as per ISO 13485. The PFMEA of each of…   Read more»

]]> c80c12d9b19d47cc89a96e9fc165543f https://medicaldevicecourses.com/activity/p/30124/ Tue, 12 Nov 2024 19:22:38 -0500 A risk assessment consists of a risk analysis, which identifies potential hazards, and a risk evaluation, in which each hazard is evaluated in terms of its probability and severity. Risk assessments are critical in medical device development, as they serve…   Read more»

]]> 8c0c0d4355e81992e2fcc10c25e6f4db https://medicaldevicecourses.com/activity/p/30123/ Tue, 12 Nov 2024 15:46:38 -0500 The entire medical device development process, including the planning phase, has been carefully and strategically structured to minimize any unnecessary time or finances spent. If anything, risk management saves money and time for companies, as a lack of risk management…   Read more»

]]> e61167e47f409b90b9ad95a3b76829ed https://medicaldevicecourses.com/activity/p/30085/ Sun, 10 Nov 2024 18:44:23 -0500 In the development phase of product development, the process of verification occurs. This process verifies that the product aligns sufficiently with the requirements in place. The process includes a variety of inspecitions and testing that serve to answer the question…   Read more»

]]> 6aed6c3baf45b415bd3e7ff05fa934d2 https://medicaldevicecourses.com/activity/p/30084/ Sun, 10 Nov 2024 18:30:28 -0500 Insufficient design controls can have negative repercussions on many aspects of the medical device industry, such as creating unnecessary costs, high defect rates, and in extreme cases, a company can be banned from producing insufficient products. However, the most prominent…   Read more»

]]> 8bc3aaaceca703156ee78481e2faa2da https://medicaldevicecourses.com/activity/p/30083/ Sun, 10 Nov 2024 17:56:06 -0500 Meeting minutes are essential for staying on track with a project and being able to recollect information. I have used meeting minutes for numerous courses and clubs I have been involved in on campus. Without the use of meeting minutes,…   Read more»

]]> f7d13542fa76db4677a83df11ca54fe0 https://medicaldevicecourses.com/activity/p/29931/ Wed, 23 Oct 2024 19:02:46 -0400 I think it is a great idea and highly beneficial that students spend time in a clinical setting to learn about the field’s needs and shortcomings. Getting actual experience in a clinical setting would help students get such useful first-hand…   Read more»

]]> 79c35b5554ae0a435ef185508330e6b0 https://medicaldevicecourses.com/activity/p/29930/ Wed, 23 Oct 2024 18:50:18 -0400 Inclusivity in clinical trials is such an important concept, as it benefits not only the research, but also a diverse pool of participants. It’s unfortunate that previous research trials have been more geared towards the inclusivity of white males. As…   Read more»

]]> d7bfccc1e4245c9553932e892ecc21ac https://medicaldevicecourses.com/activity/p/29929/ Wed, 23 Oct 2024 18:41:34 -0400 Clinical trials often offer its participants benefits of some sort, whether it be monetary compensation or some sort of personal health benefit with access to experimental therapies that may treat the participant’s condition. Also, for those that have a personal…   Read more»

]]> b59a9b3ea34315480f40f91654583fea https://medicaldevicecourses.com/activity/p/29871/ Thu, 17 Oct 2024 14:55:49 -0400 A lot of medical device companies seem to use blue for the coloring of their logos, which is supposed to signify trust and strength within the brand. Of course, other medical device companies use different colors, such as Johnson &…   Read more»

]]> f183a0a0f54491b7dc83d062745c1c03 https://medicaldevicecourses.com/activity/p/29870/ Thu, 17 Oct 2024 14:42:44 -0400 During this course we have been introduced to different aspects of medical device development including business. Although this is a BME course how beneficial do you think a business minor/major/certification to an aspiring engineer?  For an aspiring engineer with little…   Read more»

]]> 4d7ab7f6609c64216686cb8b7b1f1d8e https://medicaldevicecourses.com/activity/p/29869/ Thu, 17 Oct 2024 14:00:45 -0400 Maintaining a diverse demographic across clinical trials is beneficial not only for collecting efficient data, but it is also advantageous in the sense that people across all backgrounds are given opportunities to experience and likely benefit from their participation in…   Read more»

]]> b527aeb6ef390c00fa8711505a8436d5 https://medicaldevicecourses.com/activity/p/29783/ Wed, 09 Oct 2024 23:27:07 -0400 Two businesses currently supplying medical devices on the market include Medtronic and Getinge. Medtronic is a publicly traded company with about 95,000 employees across the globe. In 2023, Medtronic’s reported revenue was $31.227 billion. Similarly, Getinge is also a global,…   Read more»

]]> a0fb2fd08129e14cbf5477813770fa67 https://medicaldevicecourses.com/activity/p/29782/ Wed, 09 Oct 2024 23:01:11 -0400 I, too, would prefer working for a large and publicly owned company due to the benefits relating to salary and stock options. Also, compared to a smaller company, there are more opportunities in most cases to hold different positions within…   Read more»

]]> 847d13df0b2ce2b2b7d469e578531609 https://medicaldevicecourses.com/activity/p/29781/ Wed, 09 Oct 2024 22:46:29 -0400 While not all engineering students are interested or plan on perusing a career in industry, I feel that taking an additional business course should not be required. However, in the event that engineering students are planning to take the industry…   Read more»

]]> 18343fc22252cf0f5033deb879a2b402 https://medicaldevicecourses.com/activity/p/29722/ Fri, 04 Oct 2024 13:42:45 -0400 QA is a proactive process that seeks to prevent defects from occurring within the product development process. QA designs the processes and improves upon them to maintain quality. On the other hand, QC is a reactive process that identifies and…   Read more»

]]> 83759c27687c0a25b7562b8fa841db37 https://medicaldevicecourses.com/activity/p/29721/ Fri, 04 Oct 2024 12:05:22 -0400 In my professional work experience at a biomedical equipment manufacturer, I have gotten insight into the issues that are commonly encountered within the Quality Department. The main issue being a lack of communication between the department and upper management. It’s…   Read more»

]]> 04f54018c08bd4fbb7f403b341182f42 https://medicaldevicecourses.com/activity/p/29682/ Sun, 29 Sep 2024 19:23:40 -0400 As an engineering intern at a biomedical equipment manufacturer, I have had the opportunity to perform tasks within the quality assurance and compliance realm, such as modifying SOPs that adhere to ISO18485 and GMP. I tend to have a strong…   Read more»

]]> 6b5027b42b0b486912ae44245a5a0205 https://medicaldevicecourses.com/activity/p/29679/ Sun, 29 Sep 2024 18:32:12 -0400 Working with a diverse team, whose members come from varying backgrounds and perspectives, is essential for any project. As a director of a diverse team, I would greatly appreciate these differences and encourage my team to maintain open-mindedness in decision-making…   Read more»

]]> 5e265c78451b172e1ab5d5a498ac90a0 https://medicaldevicecourses.com/activity/p/29678/ Sun, 29 Sep 2024 17:50:41 -0400 Although both major functions, product development and post-market management, have their own unique impacts on a project as a whole, I consider product development the more significant of the two. The uncertainty and approval surrounding the product development process makes…   Read more»

]]> f4cd9104f23a53c3fd11f206220cb745 https://medicaldevicecourses.com/activity/p/29575/ Thu, 19 Sep 2024 15:09:12 -0400 If I were to have the option to conduct research in academia or industry, I would choose academia. When researching in academia, you are given almost a free range of possibilities to peruse what interests you most. You are able…   Read more»

]]> dd96047d033365102af54cdab949da24 https://medicaldevicecourses.com/activity/p/29574/ Thu, 19 Sep 2024 14:52:37 -0400 Generalizing professors and their interests is unjust, so it is safe to say that the answer to this question varies based on the professor, which we have all experienced first-hand as students. Some professors are solely concerned about their research…   Read more»

]]> 338c5f38e27494dd9d1eb226b3d29db7 https://medicaldevicecourses.com/activity/p/29573/ Thu, 19 Sep 2024 13:53:50 -0400 The Institutional Animal Care and Use Committees (IACUCs) exists to achieve the balance between necessary, safe animal testing and maintaining animal welfare, minimizing the use of animals in pre-clinical trials when possible. Although the IACUCs have federally required guidelines that…   Read more»

]]> 1dfb572aa331866668188e98c2d8ea1f https://medicaldevicecourses.com/activity/p/29543/ Sun, 15 Sep 2024 22:59:42 -0400 The balance between thorough detail and flexibility are important in project planning. Too much detail, such as consistent step-by-step can be a burden for team members when attempting to achieve meaningful work and providing their own unique skill sets and…   Read more»

]]> 1d89e790bdd2cd72ccfa24453251283f https://medicaldevicecourses.com/activity/p/29542/ Sun, 15 Sep 2024 22:49:32 -0400 A project should no longer be considered feasible once a team has reached a “dead end” countless times and spent a noteworthy amount of budget in the persuit of the project. The team has also analyzed the possibilities of if…   Read more»

]]> 06322044e0f5aa1a6687fda29dc80948 https://medicaldevicecourses.com/activity/p/29539/ Sun, 15 Sep 2024 22:05:06 -0400 Project managers must first identify clear parameters as to what must be accomplished. This includes constructing a Gantt chart with strict deadlines and incorporated slack time for potential delays. All tasks should be further broken down into more specific tasks…   Read more»

]]> 1fe68360c4314f75df4a545dea4e9ef6 https://medicaldevicecourses.com/activity/p/29299/ Sat, 13 Apr 2024 18:26:22 -0400 To evaluate how to develop a project team, it is important to identify the areas that the team can build upon and improve. With these areas in mind, human resource management can create team building activities, trainings, etc. that address…   Read more»

]]> 3eba167254fe781b06d43848a0c28762 https://medicaldevicecourses.com/activity/p/29298/ Sat, 13 Apr 2024 18:11:21 -0400 Quality control is sometimes lacking in smaller organizations due to the nature of smaller organizations/projects commonly being relatively new. With limited experience in their field and awareness of the benefits of quality management, smaller, newer project members can tend to…   Read more»

]]> 9be920e7427b4f106b17330ab2b57a7a https://medicaldevicecourses.com/activity/p/29297/ Sat, 13 Apr 2024 17:54:07 -0400 Quality management is not common to find in smaller companies due to the nature of smaller companies commonly being relatively new. With limited experience in their field and awareness of the benefits of quality management, smaller, newer companies can tend…   Read more»

]]> be8dda02c02c9addac28046f0e57bc25 https://medicaldevicecourses.com/activity/p/29254/ Mon, 08 Apr 2024 00:57:50 -0400 An example of a medical device in development that would likely not require validation is a simple adhesive bandage. As mentioned in the prompt, verification testing would be enough in the case of this product. The verification testing would serve…   Read more»

]]> d5f33f8fe18f9af95c99deaaea7782c8 https://medicaldevicecourses.com/activity/p/29249/ Mon, 08 Apr 2024 00:09:21 -0400 I believe that the project planning phase is most important. With poor planning, clear objectives aren’t outlined and communicated, causing confusion among a project team of what is expected of them. The planning phase is critical in identifying risks, thereby…   Read more»

]]> f5750316cc848af261ce0f23e9999be4 https://medicaldevicecourses.com/activity/p/29248/ Sun, 07 Apr 2024 23:58:57 -0400 There are many aspects of medical device projects that require tedious monitoring and controlling across several areas. Stakeholder communication is an example. Ensuring efficient communication with stakeholders, clients, and internal staff is vital for the project’s success. Supervising and regulating…   Read more»

]]> 33a368c5fc68d51c52a3253267972454 https://medicaldevicecourses.com/activity/p/29171/ Wed, 20 Mar 2024 21:23:14 -0400 I believe that Stryker should not be neglecting the foot&ankle team just because it is considered a low-priority project. Styker needs to decide if a.) the foot&ankle project is so low-priority that it should be scrapped entirely and the team…   Read more»

]]> 55dc160547baa6f49b97b47087a3df1a https://medicaldevicecourses.com/activity/p/29170/ Wed, 20 Mar 2024 20:40:23 -0400 Before beginning a project as a team, it is important that the team delegates tasks and assigns responsibilities to each individual teammate based on his/her strengths. To establish early on what will be expected of each team member throughout the…   Read more»

]]> 69a5c3acd134a4cfcb56ff879c5c0e4f https://medicaldevicecourses.com/activity/p/29086/ Mon, 04 Mar 2024 04:19:56 -0500 A challenge faced by project managers is risk management. Every project comes with its set of risks, which can range from unforeseen technical difficulties, changes in market conditions, to delays in deliverables from third parties. These risks can significantly impact…   Read more»

]]> 0986e0a5e6ead45f556e1af296ab46f1 https://medicaldevicecourses.com/activity/p/29085/ Mon, 04 Mar 2024 04:15:46 -0500 The most difficult part of a project for me often revolves around maintaining momentum and addressing any unforeseen challenges that have emerged. One of the key challenges is ensuring that the project remains on schedule. Delays can occur due to…   Read more»

]]> de95c0f083cb7631188cfacbc2af1df5 https://medicaldevicecourses.com/activity/p/29084/ Mon, 04 Mar 2024 04:11:35 -0500 Ensuring that I provide the most complete and robust solutions to my team, even with limited time and contextual information, involves a multifaceted approach. First, I would prioritize establishing strong communication channels within the team and management. This ensures that…   Read more»

]]> 14f4296169430bd7768bc0679789805d https://medicaldevicecourses.com/activity/p/29018/ Sun, 25 Feb 2024 20:01:37 -0500 One topic of this weeks lecture that I found really interesting was the estimation of costs and resources and the possible setbacks/pitfalls that can be associated with this. It made me think of my time in the medical device industry…   Read more»

]]> 60b86ef6623d6b0c19bc7dd3ab3724a9 https://medicaldevicecourses.com/activity/p/29017/ Sun, 25 Feb 2024 19:43:46 -0500 I have also found it interesting that the meaning of “stakeholders” has a much more extensive meaning than I had originally thought. Stakeholders exist outside of the traditional roles we associate stakeholders with and are essentially classified a any individual…   Read more»

]]> b3454e29ec69ad350d5f9b9ffeff925a https://medicaldevicecourses.com/activity/p/29015/ Sun, 25 Feb 2024 18:12:55 -0500 (1) A specific medical product that is likely to be completed by late finish is any pharmaceutical drug. All pharmaceutical drugs require extensive preclinical research, clinical trials, FDA approval, production, and post-market surveillance. This thorough process makes it likely that…   Read more»

]]> ff3466f441d56eddb381dd28721080ff https://medicaldevicecourses.com/activity/p/28969/ Mon, 19 Feb 2024 02:46:00 -0500 It’s crucial to conduct a thorough risk assessment during the project planning phase to identify potential factors that could lead to delays in task completion. This includes considering factors such as resource availability, dependencies between tasks, and external constraints. Once…   Read more»

]]> a2f1837abc60e5898a2d91dfe867dd3d https://medicaldevicecourses.com/activity/p/28968/ Mon, 19 Feb 2024 02:43:54 -0500 Absolutely, the initiation phase of a project sets the tone for its entire lifecycle, and I’ve definitely encountered situations where better planning could have greatly improved outcomes. Capstone comes to mind where the initial scoping and requirements gathering were not…   Read more»

]]> 74b199e8412ebedbbd972c7a896aba0e https://medicaldevicecourses.com/activity/p/28949/ Sun, 18 Feb 2024 17:25:52 -0500 I have been enrolled in previous asynchronous courses where we were formed into groups by the professor for a project. Because the courses were asynchronous, this hindered the communication among our group overall. We were given weeks to work together…   Read more»

]]> e145c1cc43fb65257d5bbd6b783b83d5 https://medicaldevicecourses.com/activity/p/28881/ Sun, 11 Feb 2024 02:17:09 -0500 Genetics are everything, and they without a doubt scientifically contribute to who we are. So yes, someone with strong leadership abilities did get to that point via genetics, in part. However, I believe that the primary contribution to a person’s…   Read more»

]]> a9fe11cc487f77ae12c9f29070a08ad7 https://medicaldevicecourses.com/activity/p/28880/ Sun, 11 Feb 2024 02:02:18 -0500 I prefer to work independently when possible, so when working in teams, I definitely favor a smaller-sized dynamic. Being apart of a smaller team that is comprised of people from various backgrounds is most suitable for me, as it allows…   Read more»

]]> 697757b63721bd0b37b76cd8868448ad https://medicaldevicecourses.com/activity/p/28879/ Sun, 11 Feb 2024 01:52:31 -0500 I would prefer to work under a project manager that primarily communicates in person. It is simply more natural and effective to communicate in person with others, which is important when collaborating with people, especially my manager. Having in-person interactions…   Read more»

]]> 8be5b03427702309170d6d46c9666690 https://medicaldevicecourses.com/activity/p/28836/ Mon, 05 Feb 2024 02:28:57 -0500 The concept of a “born leader” has been around for a while, but I myself lean towards the belief that leadership is primarily nurtured through experiences and upbringing rather than being an inherent trait. While some individuals may inherit certain…   Read more»

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