-
elm33 replied to the topic "Benefits for Patients in Clinical Research" – 3 months, 4 weeks ago
Coming back to read these responses, I agree with all of you. There are certain situations where it is ethical, but there are some that it is a flat out no. I personally think that the higher the risk, the… Read more»
-
elm33 replied to the topic "Feeling Safer?" – 3 months, 4 weeks ago
I have come back to read all of your responses and totally agree with your points. I, too, feel a lot safer knowing that these steps are taken in order to really validate and verify product on the market. Having… Read more»
-
elm33 replied to the topic "Company Insurance" – 3 months, 4 weeks ago
Coming back to this forum and reading all of your responses, I agree with all of you. There should be a plan in place just to make sure that the company continues to run smoothly. Nothing would be able to… Read more»
-
elm33 posted a new topic "Company Insurance" – 4 months, 1 week ago
Imagine you are the owner of a company, if something were to happen to you, would you think it would be beneficial to have a mapped out plan of legal proceedings and how to handle deals while you could not… Read more»
-
elm33 replied to the topic "Confidentiality and Transparency in Consulting Agreements" – 4 months, 1 week ago
I feel as though a balance of an NDA and transparency is a big skill when being a part of a company, especially when making deals. I believe NDA’s are good as long as no party is hurt or damaged… Read more»
-
elm33 replied to the topic "Verbal Contracts" – 4 months, 1 week ago
Verbal contracts are very hard to follow, especially when things go south. Although many people do verbal contracts, I feel as though there should be written evidence to an extent. Some examples of these can include text messages or emails… Read more»
-
elm33 replied to the topic "Traits of upper management versus middle management" – 4 months, 2 weeks ago
After seeing many sides of management I believe that the higher the level in management, the more versed the person is in the company and in the position. I think that upper management sort of leads the way of middle… Read more»
-
elm33 replied to the topic "Value-based healthcare: "Dos and Don'ts"" – 4 months, 2 weeks ago
I agree with the other poster above, healthcare workers are always working for the most cost effective but also most effective treatments for their patients. In the end, money is a big player in to what anyone does, and it… Read more»
-
elm33 replied to the topic "AI & IoT in medical device industries." – 4 months, 2 weeks ago
I believe that companies need to thoroughly adapt to new technologies as that is what is currently relevant in the world. I will talk more with AI as it seems to be an ever growing topic today. It is now… Read more»
-
elm33 replied to the topic "Hazard, Hazardous, Harm" – 4 months, 3 weeks ago
An example I can think of is similar to yours, with a biohazard. I know in New Jersey, when an animal has bit a person and is to be put down in the following 10 days, it is routine (as… Read more»
-
elm33 replied to the topic "Risk Acceptance" – 4 months, 3 weeks ago
As I mentioned in another post, sometimes what we do not know… we may not know as there are endless possibilities in the world. Unfortunately with many things in the past, with new research, they are now bad for you,… Read more»
-
elm33 replied to the topic "Residual risk during device development" – 4 months, 3 weeks ago
I find that there is residual risk in any medical device just like how there is always risk when you have a surgery or a procedure. There are infinite possibilities when thinking about the potential risks in a medical device,… Read more»
-
elm33 posted a new topic "Feeling Safer?" – 4 months, 4 weeks ago
The past week we have learned about Validation and Verification. After learning about these two topics, do you feel safer knowing that these can be applied to medical devices that we use/may use in the future? Explain how and give… Read more»
-
elm33 replied to the topic "Design "Overvalidation"?" – 4 months, 4 weeks ago
In my opinion I do believe that over-validation can happen easily as companies want to make sure their product is proper. I do though feel like teams want to secure the goal with as little work as possible in the… Read more»
-
elm33 replied to the topic "Minutes for meetings" – 4 months, 4 weeks ago
Hello! In my opinion, meeting minutes do matter as long as all topics and information was laid out on the table. Sometimes I find that when a meeting minutes time is established, people tend to worry on how long the… Read more»
-
elm33 replied to the topic "Design control and risk management" – 5 months ago
Design control does exactly that, control the design. This helps potential risk by keeping a track of how the design of the product can keep in line and not stray. It also helps with how to troubleshoot potential problems in… Read more»
-
elm33 replied to the topic "Design "Overvalidation"?" – 5 months ago
I find that over-validation does occur in many instances, but there should be a balance of wanting to do better and over-validation. Each company should have a baseline of what the company is expected to do, but I also believe… Read more»
-
elm33 replied to the topic "Details needed in a DHF for complex devices" – 5 months ago
I find that the DHF can be a bit overwhelming, the best way I can think of structuring it is like a lab report. You have your sections that you need but you always start with one part, for me… Read more»
-
elm33 replied to the topic "Double Blind Vs Single blind Study" – 5 months, 1 week ago
In my opinion, as much as single blind has its benefits, I believe that double blind studies are superior. I mainly believe this because then their can be absolutely no bias on how the tested item ends up working. The… Read more»
-
elm33 posted a new topic "Benefits for Patients in Clinical Research" – 5 months, 1 week ago
When running a trial for new pharmaceuticals, do you believe that the patients in the trial should be rewarded for being tested on? Do you believe that giving patients a ‘payment’ for the use of their bodies is ethical? Why… Read more»
- Load More