https://medicaldevicecourses.com/members/llefevre/activity/ Activity feed for llefevre. Fri, 24 Apr 2026 17:34:39 -0400 https://buddypress.org/?v= en-US 30 hourly 2 2ed838bb6f955eab163652db38f3a6de https://medicaldevicecourses.com/activity/p/22723/ Tue, 22 Jun 2021 22:56:28 -0400 My personal reflection is that this course really took the time to break down the many different aspects of medical device development and I appreciated the information that we received during this class. There were some things that I knew…   Read more»

]]> 042630f8dfcfb38899cf321d35294488 https://medicaldevicecourses.com/activity/p/22722/ Tue, 22 Jun 2021 22:42:22 -0400 There was a time where pharmaceutical companies and medical device developers used to have lavish accounts and spending on physicians to be able to prescribe or use their products. Incentives included concert tickets, sporting events, lavish dinners, gift baskets, expensive…   Read more»

]]> 527325bed14cc7fac883a373f05fc890 https://medicaldevicecourses.com/activity/p/22721/ Tue, 22 Jun 2021 22:33:21 -0400 This is an interesting topic because like Maslow’s hierarchy of needs, organizations have a hierarchy of needs as well. Maslow’s theory is based on the motivation of people based on psychological, safety, belonging and love, social or esteem and self-actualization….   Read more»

]]> 639f5c0f6deeb77bdb70f140e1a0b7f7 https://medicaldevicecourses.com/activity/p/22720/ Tue, 22 Jun 2021 22:20:45 -0400 Similar to pharmaceutical drugs that are being implemented for human consumption there is inherent risks associated with medical device development but there is also this idea of scaling risk, scaling for the level of severity or harm or the probability…   Read more»

]]> 0feda024fdbb165011db15ba104f6953 https://medicaldevicecourses.com/activity/p/22719/ Tue, 22 Jun 2021 22:07:23 -0400 The point of post market surveillance is to maintain a product quality as well as its performance. Despite the fact that in the United States it is a regulatory requirement, it allows you to improve your device for a future…   Read more»

]]> 0291df113ed40c9c575e0ac20112de88 https://medicaldevicecourses.com/activity/p/22718/ Tue, 22 Jun 2021 21:46:09 -0400 Some of the biggest mistakes and medical device companies make include but are not limited to designing the wrong product. Sometimes the market isn’t big enough and in some cases there is no market to begin with. This happens when…   Read more»

]]> c0b4e87a45f4636be0bb0b0ee61146fb https://medicaldevicecourses.com/activity/p/22661/ Thu, 10 Jun 2021 18:46:48 -0400 According to the FDA, Human factors/usability engineering focuses on the interactions between people and devices. this includes understanding the user-device system, it’s importance to understanding the ways people perceive information from the device, the way they interpret the information and…   Read more»

]]> af64aa2f906215877d6bdf1a3faaea20 https://medicaldevicecourses.com/activity/p/22660/ Thu, 10 Jun 2021 18:34:33 -0400 Thank you @rgb29 for bringing this conversation to the forefront. As a secretary to a nonprofit organization, I can attest to how important it is to take accurate minutes of the proceedings of meetings and the importance of minutes. I…   Read more»

]]> 7b378dcfcb7f4a2b726873e7619ca371 https://medicaldevicecourses.com/activity/p/22659/ Thu, 10 Jun 2021 18:21:13 -0400 In the People’s Republic of China, the manufacturing, marketing, distribution, and sale of medical devices, are mainly regulated by the Regulations on Supervision and Administration of Medical Devices. These laws were developed by the State Council and are governed by the…   Read more»

]]> 9f94100ef0f34e52a21a70fcb86632c2 https://medicaldevicecourses.com/activity/p/22601/ Sat, 05 Jun 2021 20:28:52 -0400 The placebo is usually a saline solution. Something that is harmless to inject (and is often used to dilute actual vaccines), but has no medical benefits. Although in some cases an unrelated and already approved vaccine is used as placebo….   Read more»

]]> e38ea86d76770bac7d6f65e989dc79f1 https://medicaldevicecourses.com/activity/p/22600/ Sat, 05 Jun 2021 20:15:23 -0400 According to the National Institute of Health web site on clinical trials, there are over 225,506 studies currently being conducted throughout the United States and 192 countries. Less than 1% of the total number of studies being conducted addresses the…   Read more»

]]> 36ae9018ca7b19956135fcb5a7434bcc https://medicaldevicecourses.com/activity/p/22599/ Sat, 05 Jun 2021 20:00:11 -0400 Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research.  Lacks was the unknowing…   Read more»

]]> fa2b79b8ac0cf33d89ed028e250c2ad1 https://medicaldevicecourses.com/activity/p/22541/ Mon, 24 May 2021 23:33:54 -0400 It is estimated that globally, the market for Clinical Trials is in upwards of $44 Billion as of 2020 and is expected to grow by approx 6% over the next 7 years, mostly fueled by the need to address chronic…   Read more»

]]> 04fe46093c906b901a4707e3e844760c https://medicaldevicecourses.com/activity/p/22540/ Mon, 24 May 2021 22:50:55 -0400 Emotional intelligence also known as the emotional quotient is the ability to understand someone’s feelings and someone else’s thoughts it is probably responsible for more than half of the success in professional marketing. According to the world economic forum emotional…   Read more»

]]> e4d9c1190f7536b6f2ee0d8cf227e6be https://medicaldevicecourses.com/activity/p/22539/ Mon, 24 May 2021 22:29:28 -0400  Brand coloring is as essential as the product that the organization is advertising. Some of the most iconic companies in the healthcare industry also utilize this technique in their branding which others can readily identify from generic products. Johnson &…   Read more»

]]> 8e4f55309970510ce3cab04f9b566cf8 https://medicaldevicecourses.com/activity/p/22507/ Fri, 21 May 2021 03:26:07 -0400 Diversity is the bedrock of all successful enterprises. The more diverse your workforce the more honorable people a company will amass for their leadership and employee pool. An honorable person is selfless, forthcoming, and honest. Honor requires you to have faith,…   Read more»

]]> fa3ed486b19dda169013f41e002158b2 https://medicaldevicecourses.com/activity/p/22503/ Thu, 20 May 2021 05:16:07 -0400 I totally understand how jaded you feel about the state of medicine and the treatment vs cure conversation. I get it. Just thinking about diseases like  pancreatic cancer and how much of a death sentence it has become in our society,…   Read more»

]]> 1b7a491b1f3a438446ee55af4002b8cf https://medicaldevicecourses.com/activity/p/22502/ Thu, 20 May 2021 04:58:05 -0400 I can think of a few drugs that are banned in the US including angiotensin receptor blocker / heartburn medication Ranitidine (Zantac) was recalled in 2020 due to the presence of low levels of a contaminant NDMA and are no…   Read more»

]]> 83ceeb08bc4250199a099c8a23128196 https://medicaldevicecourses.com/activity/p/22462/ Sat, 15 May 2021 01:57:43 -0400 Animal research is unique in a sense that you can’t ask the animal if he or she would like to participate in an experiment because we are not at the level of communication where an animal can consent, at least…   Read more»

]]> 2d940704cea602bbbf408360ba33f2b7 https://medicaldevicecourses.com/activity/p/22461/ Sat, 15 May 2021 00:59:26 -0400 Posted by: @hm243 In industry, research is done to make discoveries for products that can help people right away, while in academia, research create results for the long run. I feel that both types of research are important and necessary….   Read more»

]]> b71835656457e395051719cc3d725488 https://medicaldevicecourses.com/activity/p/22460/ Thu, 13 May 2021 17:54:31 -0400 I’ve had a fortununate opportunity to work with both academia and industry in terms of research and I noticed many parallels but there are some subtle differences that I will outline. While working in an industry I had to deliver…   Read more»

]]> bf6c60f2795294f8b7cd125b50766ec0 https://medicaldevicecourses.com/activity/p/22418/ Thu, 06 May 2021 21:55:07 -0400 I cannot imagine how frustrating it probably has been on your job hunt in terms of searching for the right project management position and despite the expensive amount of education that you have in order to gain the experience that’s…   Read more»

]]> ccd7ee068290008d63809398880ef67a https://medicaldevicecourses.com/activity/p/22417/ Thu, 06 May 2021 21:35:23 -0400 Extraordinary measures have been put into place to develop the core of coronavirus vaccines that we’ve seen on the market that have received emergency use authorization by the FDA. But these processes were not developed overnight or in a matter…   Read more»

]]> f8b9b75ad7dca5dd30810c0c7421d03a https://medicaldevicecourses.com/activity/p/22416/ Thu, 06 May 2021 21:15:15 -0400 Advanced degrees come with the caveat but at the same time that specialized knowledge can be used and applicable to so many different disciplines within the medical device industry. That being said, you could still get the same job whether…   Read more»

]]> 16ed552476ca4dd3ca05fd400bf45c2c https://medicaldevicecourses.com/activity/p/22219/ Tue, 20 Apr 2021 16:16:30 -0400 I cannot stress enough how important communication is success of projects and how fundamentally important it is to have open lines of communication between project teams and not develop silos in the process. On one of the projects I was…   Read more»

]]> 6f55b85f6ee6d200caef2c6deccb9602 https://medicaldevicecourses.com/activity/p/22218/ Tue, 20 Apr 2021 16:09:33 -0400 @delany Great job with this post. I too did not participate in the simulation but I can tell you from being involved in several different projects that having multiple vendors is never a bad idea. Part of the planning process…   Read more»

]]> 2545481f5161d0f549baedcfbe305aed https://medicaldevicecourses.com/activity/p/22217/ Tue, 20 Apr 2021 15:48:33 -0400 Human resources is a valuable resource in the development of medical devices and projects and supports the development and sustainment of teams that can provide solutions to see projects through to the closing phase. Having the right people that are…   Read more»

]]> 3fa083f3235fe470e4e0d1ac858170e3 https://medicaldevicecourses.com/activity/p/22117/ Wed, 14 Apr 2021 15:44:34 -0400 In September 2017, I traveled to the state of Florida in support of hurricane Irma disaster relief efforts with the American Red Cross out of the greater New York region. I volunteered in the mass care department which is responsible…   Read more»

]]> 77b980b1d1c9d0feb78f6d7064208eb8 https://medicaldevicecourses.com/activity/p/22095/ Mon, 12 Apr 2021 22:27:07 -0400  I don’t consider having to go back to amend the plan a backward step. In fact I look at it as iron sharpening iron. I remember working with the American red cross on a project that involves disaster situation and…   Read more»

]]> 51d4070f82fa4a6d9ef17a7527399eae https://medicaldevicecourses.com/activity/p/22094/ Mon, 12 Apr 2021 22:03:24 -0400  The one thing that I’ve come to realize is that project management is such a valuable skill set to have in the workforce. I was recently on a call for a nonprofit organization that I volunteer with and they were…   Read more»

]]> 5d50b3c10939670469ac4fbfca5f10db https://medicaldevicecourses.com/activity/p/22017/ Wed, 07 Apr 2021 15:37:03 -0400 For context, I included this article that gleans at this question of sustainability of projects in the biotechnology sector. https://www.cnbc.com/2018/04/11/goldman-asks-is-curing-patients-a-sustainable-business-model.html Imagine you are a project manager at a leading biotech firm that is expanding their portfolio of therapeutics with the…   Rea…[Read more]

]]> 004044a40afaf9e45a8b0e8849d9e648 https://medicaldevicecourses.com/activity/p/22010/ Tue, 06 Apr 2021 17:38:22 -0400 Unexplained costs can be expected or unexpected increases the cost of materials, equipment, labor, or overhead that includes administrative, finance and legal costs. This can be shielded by employing building reserves and regular checks on suppliers and materials contracts and…   Read more»

]]> 06573085fb7bb063ad069f23a575b278 https://medicaldevicecourses.com/activity/p/22009/ Tue, 06 Apr 2021 02:57:29 -0400 OK I’m just gonna flat out and say it. If you don’t have a project scope statement In place from the beginning not only will scope creep sit in, it should be an expectation. Had a manager once set up…   Read more»

]]> ae539a27f8e8aac51c905e2ab4632e54 https://medicaldevicecourses.com/activity/p/22005/ Tue, 06 Apr 2021 02:04:41 -0400 I know all the teams that I’ve been on in the past, if a team member had to go out and was absent because of a vacation, it was usually a planned event. When that occurred the project manager usually…   Read more»

]]> ab3de46d3b8f64b955dd3f8c1b287cfb https://medicaldevicecourses.com/activity/p/21960/ Sat, 03 Apr 2021 18:23:22 -0400 So while working on my capstone for my Masters in public health, I worked for a healthcare consulting company. The project that I was working on was evaluating payment model methodology using statistical analysis software that analyzed qualitative data as…   Read more»

]]> e12968fe5578df1232164c3b5d07f82c https://medicaldevicecourses.com/activity/p/21959/ Sat, 03 Apr 2021 18:08:26 -0400 Once success factors and processes have been assessed and prioritized, the project manager and his team should identify the potential impact of uncontrolled, non-specific events on these business functions and processes. Non-specific events should be identified so that management can…   Read more»

]]> 8de6753cc610cce1df90d995c222c635 https://medicaldevicecourses.com/activity/p/21955/ Fri, 02 Apr 2021 05:02:42 -0400 Posted by: @rv347 time complications that must be dealt with in order for the project to proceed A prime example of an unexpected time delay can be seen in the current vaccine role out in terms of the biotechnology sector…   Read more»

]]> a71f355c910f9dfcf1cf9de93e6b5790 https://medicaldevicecourses.com/activity/p/21872/ Fri, 26 Mar 2021 22:57:47 -0400 A milestone is a significant point or event in a project, also milestones have zero duration because they represent a specific point or event. It’s inevitable that not all milestones are going to be met on time every time due…   Read more»

]]> 689bb093325dc4927c788a84c79aab1d https://medicaldevicecourses.com/activity/p/21852/ Wed, 24 Mar 2021 04:21:04 -0400 The most important project management process to ensure a high success rate on associated projects, I believe, is the risk management process. Responding to the risks associated with any project allows the project manager and the team of professionals to…   Read more»

]]> 973628bd186d0ab3de17192cc568e528 https://medicaldevicecourses.com/activity/p/21840/ Mon, 22 Mar 2021 18:58:00 -0400  They say the 5 Ps are prior planning prevents poor performance.  The planning stage plays such an important role in the project management process that often projects do fail because you fail to plan properly. There are some cases where…   Read more»

]]> b77ce50d019bf42c2c2bb0d65e673f6c https://medicaldevicecourses.com/activity/p/21803/ Thu, 18 Mar 2021 18:00:39 -0400 The project lifecycle’s success is based on the level of effort that is invested into a project and often these processes do overlap. The product life cycle, on the other hand, is based on sales volume which can change over…   Read more»

]]> 0ee7ec6f6db353e6fe2151597e350557 https://medicaldevicecourses.com/activity/p/21800/ Thu, 18 Mar 2021 00:55:29 -0400 Hi Keshia, thank you for the question and I wanted to address what organization that I would work under. I think I would have to agree with you and say that the matrix organization is probably one of the ones…   Read more»

]]> 32912ee49d7876d232a895e5c6a437cb https://medicaldevicecourses.com/activity/p/21793/ Mon, 15 Mar 2021 23:16:03 -0400 One of the significant challenges of a first time project manager is meeting your team where they are at to achieve the preset goals of the project. Often times, new managers are bursting at the seams with new ideas and…   Read more»

]]> 950a302c2653e5aa536f3d1c92265d8e https://medicaldevicecourses.com/activity/p/21628/ Wed, 10 Mar 2021 19:49:12 -0500 Projects have a lifecycle that have a start and finish and to simply start a project and not see it all the way through does not bode well for any company. Even the smaller projects deserve prioritization if they were…   Read more»

]]> 9cc3de9ec7657bcbb082a5ecfbcdd3dc https://medicaldevicecourses.com/activity/p/21627/ Wed, 10 Mar 2021 19:13:15 -0500 b77407dbfa3e29e6a9e8f595baeaeb72 https://medicaldevicecourses.com/activity/p/21626/ Wed, 10 Mar 2021 19:11:54 -0500 9d5de1f4d45ce97bc4322f6db2c1248c https://medicaldevicecourses.com/activity/p/21621/ Tue, 09 Mar 2021 23:44:36 -0500  I believe that there are certain fundamental skill sets that team members need somebody in order to it be the most ideal thing possible. First you need a very capable leadership from a project manager who is forward thinking and…   Read more»

]]> ed1f6b71a9d888b5f7b4ec66f3c67937 https://medicaldevicecourses.com/activity/p/21613/ Tue, 09 Mar 2021 02:51:22 -0500 After action reports are a good way to asses if the project had any pitfalls or if there are ways to optimize performance in future projects. This allows for an assessment of mistakes made and best practices for future projects….   Read more»

]]> e688409dd13ee6d7ec6731ea3476fb59 https://medicaldevicecourses.com/activity/p/21529/ Sat, 06 Mar 2021 00:04:38 -0500 Given the pandemic I’m going to go with number two in your question and consider a product as simple as a mask infused with menthol. As we approach the one year anniversary of the lockdown many of you may have…   Read more»

]]> 01ddb2910d8ed408ee2e902beb5f55fb https://medicaldevicecourses.com/activity/p/21522/ Fri, 05 Mar 2021 00:02:00 -0500 While studying behavior, learning, individual reactions and group dynamics, I learned that the four components of emotional intelligence includes perceiving emotions which involves recognizing emotion via body language and other cues, understanding emotions which involves the ability to correctlyattribute emotions…   Read more»

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