https://medicaldevicecourses.com/members/cruzdonato/activity/ Activity feed for Cruz Donato. Fri, 24 Apr 2026 21:55:24 -0400 https://buddypress.org/?v= en-US 30 hourly 2 53027a869629610203689fbb53738a7a https://medicaldevicecourses.com/activity/p/23988/ Sun, 14 Nov 2021 16:52:22 -0500 The factors that you listed are definitely considerable when assigning risk index numbers. Much of risk management involves estimation, so often using your best objective judgment is helpful for determining the severity and probability of failures. It also depends on…   Read more»

]]> a807060f8613c4f6fd241ca48ec48bda https://medicaldevicecourses.com/activity/p/23987/ Sun, 14 Nov 2021 16:43:39 -0500 Post-market surveillance seems to be a great way at determining how well a product is received, further determining user needs and inputs. The process may even contribute towards design validation even after design controls cease. PMS is also a useful…   Read more»

]]> e58202177db93f075fe8e4da3911d815 https://medicaldevicecourses.com/activity/p/23986/ Sun, 14 Nov 2021 16:36:07 -0500 From what I’ve learned from the Human Factors team at my job, not many customers tend to read the instructions for use (IFU) and may even discard them which can lead to potentially dangerous situations. There’s only so much risk…   Read more»

]]> 47b6ae7c2910835e114bc8a0aab802ce https://medicaldevicecourses.com/activity/p/23919/ Tue, 02 Nov 2021 15:22:30 -0400 Depending on how many device inputs there are, a team will need to draft and propose test methods for each of these inputs. Designing test methods may require looking at previous test methods for other devices alongside some creativity with…   Read more»

]]> 34cce03dc380297779bbcf09caacceae https://medicaldevicecourses.com/activity/p/23918/ Tue, 02 Nov 2021 15:12:30 -0400 In this week’s lecture, Dr. Simon discussed the various processes that go into design controls. For design verification, inputs must equal your outputs, and for design validation, inputs must equal the user needs. However is there ever a time when…   Read more»

]]> c3447d03c90a3725433e25194fc57eab https://medicaldevicecourses.com/activity/p/23917/ Tue, 02 Nov 2021 15:04:06 -0400 A Gantt chart is used quite often in project management to establish a trackable timeline over the course of a project. I’ve heard it mentioned in a couple ME courses, in this course, and most recently in my job, but…   Read more»

]]> abf66190d6e391f6e9abd1cf21dcb1e2 https://medicaldevicecourses.com/activity/p/23856/ Wed, 27 Oct 2021 14:29:56 -0400 Even if changes did not need to be made on the device after verification, it does not necessarily mean that users will particularly like using the device. It’s always safe to run a human factors study to understand how one…   Read more»

]]> d54e9c1bce49983e5a3f25ba00e181a8 https://medicaldevicecourses.com/activity/p/23855/ Wed, 27 Oct 2021 14:19:56 -0400 Meeting minutes are great to help keep track of team members tasks. I remember working on a design project with three other students for one of my courses, and I often logged what was discussed to prevent us from getting…   Read more»

]]> 8eea7fb9a94b2ed6c28673bd00e68ee7 https://medicaldevicecourses.com/activity/p/23854/ Wed, 27 Oct 2021 14:06:46 -0400 During my internship, I recently worked with a couple engineers in reevaluating test methods for a device they’re currently developing. It’s a mechanical-based device, so some of the tests are done via an Instron. For some of the tests, we…   Read more»

]]> 5332b79cccd0d0042abc3f1b4b621277 https://medicaldevicecourses.com/activity/p/23804/ Wed, 20 Oct 2021 15:01:57 -0400 In a single-blind study, the investigator knows what they are administering while the patient does not whereas in a double-blind study, both the investigator and the patient are unaware if a drug or a placebo is being used. Double-blind studies…   Read more»

]]> ad1caf215a51bdd7f94b4e7c0e6d1e1f https://medicaldevicecourses.com/activity/p/23792/ Tue, 19 Oct 2021 20:01:36 -0400 A great incentive to attract patients for clinical trials is often money. The informed consent form attached to this week’s agenda has an excerpt discussing payment for each completed visit towards the arbitrary, potential patient. Sometimes, there are also flyers…   Read more»

]]> 1e6dbacda016172181f570be4bf1584c https://medicaldevicecourses.com/activity/p/23791/ Tue, 19 Oct 2021 19:35:27 -0400 I think it is important to tackle that question early on in clinical trials as opposed to after the vaccine rollout. We can’t really know how the vaccine affects other certain individuals if they’re not included in clinical trials to…   Read more»

]]> 466d4ed4f905f197c6bff0760f3be143 https://medicaldevicecourses.com/activity/p/23708/ Wed, 13 Oct 2021 15:43:57 -0400 Emotional intelligence (EI) is one’s ability to pick up on another’s emotional state and adapt their own emotions in order to effectively communicate and “produce beneficial outcomes”. EI, like any intelligence, requires work and application in order to hone it…   Read more»

]]> 14f164eda65c55fe03658b26cc23494f https://medicaldevicecourses.com/activity/p/23707/ Wed, 13 Oct 2021 15:02:04 -0400 The product is quite specific to dentistry, so I’d sooner reach out to specialized physicians as opposed to hospitals and retailers. Dentists will be the ones mostly using these tools, so it makes more sense to primarily sell to them….   Read more»

]]> 65bc35b76bb925edfc8b7198ec43ae1d https://medicaldevicecourses.com/activity/p/23706/ Wed, 13 Oct 2021 14:50:25 -0400 In this day and age of streaming sites instead of cable television, it can be quite difficult to have a consumer sit through a commercial. However, some streaming sites like Hulu or YouTube will still show ads or commercials if…   Read more»

]]> 25833d34919b2cf14736b90678e00f28 https://medicaldevicecourses.com/activity/p/23619/ Wed, 06 Oct 2021 16:09:50 -0400 This lecture discussed the differences behind public and private companies with one being owned by a slew of shareholders and the other owned by select individuals respectively. While both value the opinions and financial goals of their shareholders, private companies…   Read more»

]]> 5ca2980ad69ecfab984adf4b39c730a4 https://medicaldevicecourses.com/activity/p/23618/ Wed, 06 Oct 2021 15:52:11 -0400 Personally, I am not someone who is looking to start a big business, so I would most likely prefer a sole proprietorship if I’m thinking small-scale. However, if I was really looking to start one, I would definitely go into…   Read more»

]]> 34088229f65622a1b49a1e13924ae475 https://medicaldevicecourses.com/activity/p/23617/ Wed, 06 Oct 2021 15:37:15 -0400 Double taxation is definitely a huge disadvantage, but S-Corps can still be highly limited in terms of ownership. The more owners there are in a company means less risk to them, unless one of the owners is involved in fraudulent/shady…   Read more»

]]> 0419c2c6259d54af9e88d7e017613452 https://medicaldevicecourses.com/activity/p/23587/ Sun, 03 Oct 2021 23:51:40 -0400 As I’ve said in a previous reply, Quality is a necessary delay. There needs to be a sort of “checks and balances” in a company during a project. While the engineers and researchers have the practical knowledge to act on…   Read more»

]]> ecc3dd7ac11f4eff5e460caf53b50176 https://medicaldevicecourses.com/activity/p/23586/ Sun, 03 Oct 2021 23:35:20 -0400 While I’m sure it is incredibly frustrating for R&D to be delayed by the Quality department’s need to follow and enforce compliance, it is a necessary delay. If a project moves forward at any point and the procedure(s) is not…   Read more»

]]> a55fe8d59ea1a3002890777be415214d https://medicaldevicecourses.com/activity/p/23585/ Sun, 03 Oct 2021 23:22:18 -0400 Speaking from my experience at my internship, document control works well when all documentation is organized and tracked consistently over the course of the project. It is quite easy for documentation to get mixed up or lost in one’s files…   Read more»

]]> 178a9c6d10b2ea6d989eed73d6831b7e https://medicaldevicecourses.com/activity/p/23471/ Sat, 25 Sep 2021 23:15:24 -0400 During my internship, I recently learned about measurement system analyses (MSA) also known as gage R&Rs (repeatability and reproducibility) and how important it is to perform them when prototyping, researching, and/or testing a device. The intent of an MSA is…   Read more»

]]> b9c8d5bb5ec0da0fb1afffff12b6bea3 https://medicaldevicecourses.com/activity/p/23469/ Sat, 25 Sep 2021 23:02:17 -0400 Diversity in the workplace is necessary in order to synthesize different perspectives towards a common goal. People specialize in some things more than others because of their backgrounds and drives, and bringing those specialties together can propel a project forward…   Read more»

]]> f704e1fcce137f0e27287085507d5ee0 https://medicaldevicecourses.com/activity/p/23468/ Sat, 25 Sep 2021 22:52:09 -0400 Medical devices need an extensive amount of testing and research before a PMA can be sought after which requires plenty of documentation and time. This, plus the amount of other devices in the process of approval as you mentioned can…   Read more»

]]> e07f50db511572f3ff8b6141ba104545 https://medicaldevicecourses.com/activity/p/23352/ Thu, 16 Sep 2021 23:47:13 -0400 Research in industry can be volatile due to time and money constraints. Sometimes, corners need to be cut in order to meet deadlines or cut down costs. What do you believe is the deciding factor between a viable study and…   Read more»

]]> befe78ae4911051b9eb73e04f54628dd https://medicaldevicecourses.com/activity/p/23351/ Thu, 16 Sep 2021 23:29:42 -0400 Putting in the due diligence when determining your material selection is key for any project, but it is especially so when you’re interfacing it with the human body. Biomaterials not only need to have favorable mechanical properties, but they must…   Read more»

]]> 83eb1822b871c88909d7ec698f074168 https://medicaldevicecourses.com/activity/p/23350/ Thu, 16 Sep 2021 23:08:14 -0400 Hello arianaburch,  While both paths are feasible, I would personally go into industry. In industry, I feel like you’d sooner see the fruits of your labor when working on a project. Research can be incredibly fulfilling when it makes advances…   Read more»

]]> acc40905f89d88a6a6e1a34928a02e05 https://medicaldevicecourses.com/activity/p/23316/ Mon, 13 Sep 2021 01:08:53 -0400 Hello cem34,  I think if there is an issue taking much longer than expected, it is important to communicate that with your team members in order to put your heads together and solve the issue a little more readily. Things…   Read more»

]]> 099981ff71ac384717bfb0e79a3828c9 https://medicaldevicecourses.com/activity/p/23315/ Mon, 13 Sep 2021 01:08:52 -0400 b862f2dfecc3d602a789e60a3161c670 https://medicaldevicecourses.com/activity/p/23314/ Mon, 13 Sep 2021 01:08:51 -0400