https://medicaldevicecourses.com/members/sara/activity/ Activity feed for sin3. Fri, 24 Apr 2026 21:38:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 9ada5b25a0dc5d45264f599d3c7727a5 https://medicaldevicecourses.com/activity/p/22289/ Sun, 25 Apr 2021 20:12:42 -0400 Whenever I think of the reasons as to why I work a 9 – 5 job, my top motivators are: exciting work at my company and having a supportive manager. I believe just these two motivators go hand-in-hand with career…   Read more»

]]> 2c29c69b399e90b322199f79a52e5b7e https://medicaldevicecourses.com/activity/p/22261/ Sun, 25 Apr 2021 01:31:39 -0400 @ih37 In response to your question regarding if tunnel vision and scope creep fall under the same category, I would say yes, they do fall under the same category. Both actions ultimately deviate from completing the overall project and put…   Read more»

]]> 70fc17e1be47275e5be1d00ca1280099 https://medicaldevicecourses.com/activity/p/22249/ Fri, 23 Apr 2021 03:37:53 -0400 Like many have said, the project manager’s level of motivation is critical to a team’s productivity. The project manager’s overall motivation can be a contributing factor in the overall success of a project. One thing I would do to keep…   Read more»

]]> 7c3288d5c34b77a89fd38e4f437a22fa https://medicaldevicecourses.com/activity/p/22202/ Mon, 19 Apr 2021 04:11:38 -0400 One way to tackle a loss of an employee in a project is to delegate that task to other employees who may have performed a similar task in the past, until a replacement is found. Transferring an employee’s workload to…   Read more»

]]> e3ef9e811ea9514b14edda24bb106fdf https://medicaldevicecourses.com/activity/p/22197/ Mon, 19 Apr 2021 03:59:48 -0400 Retaining top performers in a company can really make or break a company, specifically a medical device company. I have seen a risk management department fall apart due to the Human Resource department not focusing on retention of top performers….   Read more»

]]> 7d734c38ff7d1be62ecff37f49da7911 https://medicaldevicecourses.com/activity/p/22192/ Mon, 19 Apr 2021 03:48:48 -0400 Over my time of working in the medical device industry and working in the Quality Department, I also feel that communication is imperative to the success of a project. Although it may sound very trivial, communicating potential barriers to a…   Read more»

]]> 5d06d8d495ef1a38c2643fe8fc3ebac6 https://medicaldevicecourses.com/activity/p/21937/ Mon, 29 Mar 2021 03:58:36 -0400 I believe that it is worth shortening the time frame of a project depending on the risk being taken. When it comes to research, I believe the risk is very high, and the full suggested time needed for the research…   Read more»

]]> bf38e2d8e7e139dbf1030d64ef885ff9 https://medicaldevicecourses.com/activity/p/21936/ Mon, 29 Mar 2021 03:47:59 -0400 At work, we had an issue of not knowing what devices were evaluated and which devices were under evaluation of another employee. It was getting to a point where this issue started to escalate and devices that needed to be…   Read more»

]]> 586efd7f96ca93896f10d5a91d79fcbe https://medicaldevicecourses.com/activity/p/21932/ Mon, 29 Mar 2021 03:31:24 -0400   There could be many reasons a project fails. The major reason why a project fails is due to a project not meeting the customers needs. It can pass the verification, verification, and design of the product, but if the…   Read more»

]]> 7770caae5de4c03eee3767f7e4230f5d https://medicaldevicecourses.com/activity/p/21768/ Mon, 15 Mar 2021 02:38:17 -0400 As many of my classmates have mentioned, to avoid scope creep is to set a very particular/ specific objective that narrows down the scope of the task. I have also noticed that setting tight schedules with set deliverables can allow…   Read more»

]]> 1cc27384d352cc37d3c1e916dd0799b7 https://medicaldevicecourses.com/activity/p/21764/ Mon, 15 Mar 2021 02:23:26 -0400 I agree and disagree with the statement made. I agree that solicitation and source selection and managing vendor relations are one of the more important parts of a project, as if you don’t have the materials needed from your vendors,…   Read more»

]]> 41b0fdf546218c938c893113cc1e82cf https://medicaldevicecourses.com/activity/p/21761/ Mon, 15 Mar 2021 02:11:49 -0400 Verification and Validation can be lumped together as V&V activities, however there is a key difference between the two stages. Verification is concerned with if the company designed the device right, while validation is concerned with if the company designed…   Read more»

]]> babfa7f14a1d5b522720d73fe99811f7 https://medicaldevicecourses.com/activity/p/21552/ Sun, 07 Mar 2021 23:13:19 -0500 Great question Mark! When it comes to failures in a project, I agree that testing out all parameters can be a waste of time and money for a company. One thing I learned from working in a medical device company,…   Read more»

]]> 04ffb4656dfe5100bf6e4cac55c28da7 https://medicaldevicecourses.com/activity/p/21549/ Sun, 07 Mar 2021 22:50:49 -0500 I believe that returning to activities to an earlier phase is not necessarily a bad thing.  @srg36 mentioned, changes can happen due to unforeseeable events and I have seen that in the workplace. Returning to a previous state such as…   Read more»

]]> 2085663d4e759ae973f61d61e1522652 https://medicaldevicecourses.com/activity/p/21543/ Sun, 07 Mar 2021 21:58:45 -0500 So far, I feel that the information from this course has really allowed me to understand the behind-the-scenes activities in a medical device company, as well as the rules and regulation of the FDA. Prior to taking this course, I…   Read more»

]]> b017aa5ac6f869512cf2e60ec2678437 https://medicaldevicecourses.com/activity/p/21472/ Mon, 01 Mar 2021 03:32:18 -0500 I believe that verification should really take place during the Execution phase of the project, but it does not necessarily need to be a rigid rule.As seen in the first simulation, there were gaps in the verification protocol and changes…   Read more»

]]> 069299631fdc37156b2e34394bb3e887 https://medicaldevicecourses.com/activity/p/21463/ Mon, 01 Mar 2021 02:32:46 -0500 I have had a specific work experience where a my team was assigned to completed an investigation write-up for a CAPA. The day it was due, our boss had reviewed it and decided the investigation did not address the problem…   Read more»

]]> af5a3d42e107cc72b599de86bb08aa0d https://medicaldevicecourses.com/activity/p/21461/ Mon, 01 Mar 2021 02:19:45 -0500 When creating a timeline for a project, using timelines of similar tasks may aid in estimating a timeline for a project. However, one thing that I have seen that helps with timelines is having weekly meetings where each team member…   Read more»

]]> 40172a3529910e0b1a4c55e6fd691994 https://medicaldevicecourses.com/activity/p/21422/ Mon, 22 Feb 2021 05:00:13 -0500 Having worked in the complaints department, we work with risk documents very frequently. Risk management data used in the risk management documents are compiled from historical complaints data as well as anticipated failure rates that come from many many tests…   Read more»

]]> cee98bb579fab5400bbb39e5aea138d0 https://medicaldevicecourses.com/activity/p/21421/ Mon, 22 Feb 2021 04:51:47 -0500 From seeing how well my boss handled my team as a supervisor, especially during the COVID-19 Pandemic, there were a few key lessons I have learned that I would like to apply to when I become a project manager. One…   Read more»

]]> fd48d15fb564ea0fa85355b1976ec2ea https://medicaldevicecourses.com/activity/p/21419/ Mon, 22 Feb 2021 04:42:01 -0500 Having worked in Quality, risk is very important when it comes to projects and product development. It is what runs companies and allows them to continue developing products. From my experience working in the quality department, I have worked alongside…   Read more»

]]> 1b1450fb3fc34b0ef94144111b56b4d5 https://medicaldevicecourses.com/activity/p/21303/ Mon, 08 Feb 2021 02:46:57 -0500 The team I work on currently is a functional organization type. My department is very efficient when it comes to completing projects needed from our department. Communication is excellent across all individuals in our department. At times, individuals from the…   Read more»

]]> 0136b492483ad445e49f564cc0185f14 https://medicaldevicecourses.com/activity/p/21299/ Mon, 08 Feb 2021 02:29:43 -0500 When I was scrolling through the prior posts, I agreed that certain projects should not be cancelled and that they may be given lower priority if another project can maximize the company’s profit. However, after reading @sindhupriyapulagam’s response, I agree…   Read more»

]]> 245f6a41d57efd48757d91d367a65f9b https://medicaldevicecourses.com/activity/p/21298/ Mon, 08 Feb 2021 02:03:29 -0500 Each type of organization has their pros and cons, and largely depends on the company and its goals. For a company that provides products/solutions for specific clientele, a project-based or matrix organization would suit the company more than a functional…   Read more»

]]> 4fd03f1144b4361ac7dd34cb22e0aa04 https://medicaldevicecourses.com/activity/p/21291/ Sun, 07 Feb 2021 21:06:16 -0500 Posted by: @as934 My question is whether a recall would need to be submitted for issues involving missing information or label errors, even if there is no issue with the product itself. If the labels from our simulation were peeling…   Read more»

]]> fb9939ce7cdfba5b92d1b4a87a429c5e https://medicaldevicecourses.com/activity/p/21238/ Mon, 01 Feb 2021 01:53:27 -0500 From my experience working in a professional environment, and from my senior design course, one skill that I believe is essential for a project manager in order to succeed is organization. With organization, comes everything else, such as allocation of…   Read more»

]]> f2320da0d3051eea5c8510a5089e91e3 https://medicaldevicecourses.com/activity/p/21236/ Mon, 01 Feb 2021 01:28:37 -0500 If faced with such a crisis where my company’s manufacturing sites can not meet the demands of what the company requires, manufacturing of products would definitely see a decrease. From a supply and demand perspective, prices of raw materials or…   Read more»

]]> 7d1d30fb9f9cbc4cf9ed2b28c600d849 https://medicaldevicecourses.com/activity/p/21232/ Mon, 01 Feb 2021 00:51:13 -0500 Like many of my classmates have mentioned, no company should have to consider “embellishing a new device” in order to complete a 510(k) rather than a full-on PMA, it can be representative of how serious or not that company may…   Read more»

]]> 556331dcad7df81849eb7c2aaa445c06 https://medicaldevicecourses.com/activity/p/21147/ Mon, 25 Jan 2021 03:06:26 -0500 @jafar I agree with the key points you mentioned regarding how to identify your target market when proposing a project you wish to launch. From my experience in working in a medical device company, we focus on exactly those three…   Read more»

]]> 721d106597f2e07c27ae110b056a6085 https://medicaldevicecourses.com/activity/p/21143/ Mon, 25 Jan 2021 02:41:30 -0500 Working in a corporate environment, I feel that having the face-to-face interaction is definitely helpful, but not necessary. We have been able to navigate through the pandemic without the need to see each other every day. This can be attributed…   Read more»

]]> 0ee2f98d5f7c9ff0bc0cf3dec5244105 https://medicaldevicecourses.com/activity/p/21142/ Mon, 25 Jan 2021 02:30:14 -0500 Considering the fact, that success is broken down to 70% interpersonal skills, I believe that there should be a stressed importance on developing interpersonal skills in educational degrees, regardless the degree. In my professional career, I have noticed the importance…   Read more»

]]> 7a64575d899a8fdafff2907a258edbc4 https://medicaldevicecourses.com/activity/p/17372/ Wed, 15 May 2019 21:38:56 -0400 Both of these agreements can be enforced with valid evidence to back it up in case of any allegations held. However the main difference between these types of agreements is the chance of an individual not sticking to their word…   Read more»

]]> 1165d74462ad442c10d561c563e7dc68 https://medicaldevicecourses.com/activity/p/17371/ Wed, 15 May 2019 21:38:55 -0400 Like many of my classmates have said, this course has provided me with a lot of useful information that goes beyond the BME curriculum, and teaches practical skills that is needed in the workforce. The lectures provided very useful information…   Read more»

]]> 7bc550d705dd6a2524cb50bba0a99709 https://medicaldevicecourses.com/activity/p/17362/ Wed, 15 May 2019 21:38:51 -0400 Just a few days ago, Medtronic Spine is facing anti-kickback allegations for promoting a bone growth promoting device, Infuse (limited for use in the lower back) to physicians with methods not approved by the FDA. This device is used in…   Read more»

]]> 98619a89ca859a3916c8c378dfb00717 https://medicaldevicecourses.com/activity/p/17300/ Wed, 15 May 2019 21:38:21 -0400 The key to a successful project is a successful team. I believe the best working teams succeed when there is no prior relationships between any of the team members. When it comes to choosing people for a specific role, from…   Read more»

]]> 0ac0ad10d830e55103002b7d469958e4 https://medicaldevicecourses.com/activity/p/17298/ Wed, 15 May 2019 21:38:20 -0400 I also agree with what has been said about the success of organizational structure. I believe it can be applied to any type of project and works great for medical device development. The culture this type of structure brings is…   Read more»

]]> 4af96c71812085e1d8ebc744b2ef3ac2 https://medicaldevicecourses.com/activity/p/17245/ Wed, 15 May 2019 21:37:54 -0400 When learning of the upper management role and the middle-man role, I initially thought I would be capable of taking on the upper management role. After doing some research on these two roles, along with the link kak33 mentioned, I…   Read more»

]]> d8b67a829fe3ca45eb049f4d756fb0bf https://medicaldevicecourses.com/activity/p/17216/ Wed, 15 May 2019 21:37:36 -0400 Nowadays, people are willing to sue over anything and anyone. Therefore, companies must take all measures in avoiding, mitigating, transferring, and accepting risks without having any legal issues arise. However, there is a limit for how far a company can…   Read more»

]]> 7605300487f6c91bf857123efc87710a https://medicaldevicecourses.com/activity/p/17211/ Wed, 15 May 2019 21:37:34 -0400 I think that it is fair. I do not think there is anything more a company can do to prevent an overdose for example after all the risks have en avoided or mitigated. On many pain killer bottles, there are…   Read more»

]]> f9828cdef8571e55150fbf4e8e547d2f https://medicaldevicecourses.com/activity/p/17206/ Wed, 15 May 2019 21:37:32 -0400 A good way to run a risk management meeting is to plan ahead of time and leave the meeting with enough information to write a risk management plan. As part of the quality department, it is imperative to ensure that…   Read more»

]]> 3c1083f9369aac3c9e6e434dc537e9d0 https://medicaldevicecourses.com/activity/p/17066/ Wed, 15 May 2019 21:36:22 -0400 Like many of you have said, verification is key to a successful device that will benefit the end users. However, carrying through with this process is imperative to the success and potential risks a company is taking when producing a…   Read more»

]]> fb7724426e5e005d57234c0a783da68a https://medicaldevicecourses.com/activity/p/17065/ Wed, 15 May 2019 21:36:22 -0400 When working in research, there is no standard design document when conducting an experiment as experiments are always subject to change. Let’s take coming up with a new formulation for a hydrogel for example. Once we come up with an…   Read more»

]]> 2f2ba54947bff9833809bac325b59577 https://medicaldevicecourses.com/activity/p/17062/ Wed, 15 May 2019 21:36:20 -0400 I do not necessarily think that there are advantages versus disadvantages to these two documents as they both offer very crucial yet distinct purposes. The Design Input Document serves to provide the basic customer needs while the Design Specification Document…   Read more»

]]> efaa22ff047dc3061fea33731d8646a9 https://medicaldevicecourses.com/activity/p/16988/ Wed, 15 May 2019 21:35:42 -0400 Design inputs are mainly customer needs. An individual can come up with an innovative idea for a medical device, however it is the design inputs that will ultimately dictate what goes into the device itself. These design inputs are basically…   Read more»

]]> 7cd3eb771752d9e768d5b1105902c394 https://medicaldevicecourses.com/activity/p/16971/ Wed, 15 May 2019 21:35:34 -0400 The quality of a product does not necessarily depend on how many regulatory rules there are. One can require hundreds of rules on a device yet produce a very low quality product. I believe that the steps and precautions taken…   Read more»

]]> edcb45278c84a77f6e4a4c4ab0f58844 https://medicaldevicecourses.com/activity/p/16970/ Wed, 15 May 2019 21:35:33 -0400 I do not entirely agree with your argument where you say that meeting minutes are not cared for by the people at the meeting. Whenever my capstone group meets with any advisor, we always have some sort of document open,…   Read more»

]]> 4d1ff3877189071ad5a389b4671020e3 https://medicaldevicecourses.com/activity/p/16915/ Wed, 15 May 2019 21:35:04 -0400 For certain experiments, I think placebo controlled trials are beneficial in helping researchers investigate the affects of a drug. Placebos are usually used in comparison to the experimental drug and act as a control. Say for example there is this…   Read more»

]]> 0fffa21b307f9cce725bead8c25ce3c7 https://medicaldevicecourses.com/activity/p/16911/ Wed, 15 May 2019 21:35:02 -0400 My neural engineering professor, Dr. Alvarez always would mention her lab using “double-blind” procedures in her experiments. She always stressed how efficient this method was at eliminating any type of biases between the researchers and their subjects. A double blind…   Read more»

]]> 87198322cab86bb4913e36d56fd80711 https://medicaldevicecourses.com/activity/p/16776/ Wed, 15 May 2019 19:42:30 -0400 I had also researched Zimmer Biomet and came upon similar statements. First of all the mission and vision statement must be discussed and differentiated. Many people can confuse a companies mission and vision statement yet they are both distinct yet…   Read more»

]]> df9eeda39d1ed7ca2fa21ca23a357562 https://medicaldevicecourses.com/activity/p/16774/ Wed, 15 May 2019 19:42:29 -0400 The color choice used in branding can evoke different types of emotions and judgments made on the company subconsciously, which can ultimately be the determining factor in whether you spend your money on a product from that specific company. I…   Read more»

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