Medical Device Courses | amandaally1029 | Activity

amandaally1029 replied to the topic "Written Agreement v/s Verbal Agreement" -

Wed, 15 May 2019 18:55:28 -0400

There is definitely a difference between verbal agreement and written agreement. Verbal agreements don’t seem very solid, and can be manipulated if there isn’t proof of the agreement. Written agreements seem a bit more trusting, since there is physical proof,… Read more»

amandaally1029 replied to the topic "Restrictions for physician's gifts" -

Wed, 15 May 2019 18:55:27 -0400

amandaally1029 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Wed, 15 May 2019 18:55:27 -0400

amandaally1029 replied to the topic "Collaboration projects" -

Wed, 15 May 2019 18:53:07 -0400

I also agree with Adrian. If there is a set up for a collaboration, the organizational structure shouldn’t matter, but more so that the companies are working together and being efficient. However, companies individually can decide how they want to… Read more»

amandaally1029 replied to the topic "Forming a Project Team" -

Wed, 15 May 2019 18:53:07 -0400

amandaally1029 replied to the topic "Discussion Topic: Your organizational type" -

Wed, 15 May 2019 18:53:06 -0400

amandaally1029 replied to the topic "How to run a risk management meeting ?" -

Wed, 15 May 2019 18:51:41 -0400

amandaally1029 replied to the topic "What is Risk-benefit analysis ?" -

Wed, 15 May 2019 18:51:41 -0400

one factor to consider is the assessment of the risks of the device. With this assessment you can determine the severity and number of harmful events associated with this device. Also, the probability of harmful events, duration, and the risk… Read more»

amandaally1029 replied to the topic "Discussion Topic: Risk Management, Risk Analysis" -

Wed, 15 May 2019 18:51:40 -0400

Risk Management is required by the ISO 14971, and must be completed by the company. The company will go through the cycle of assessing, evaluating, managing, and then measuring the risks. The company is responsible for taking all aspects of… Read more»

amandaally1029 replied to the topic "a successful validation process" -

Wed, 15 May 2019 17:09:50 -0400

I think a successful validation process involves repetition and numerous trials of testing. I haven’t had experience in the industry with medical devices, but I have done research where we were required to do experiments and make sure that our… Read more»

amandaally1029 replied to the topic "Why VERIFICATION is important? and Your ideas to improve Verification process ?" -

Wed, 15 May 2019 17:09:49 -0400

Everyone raised some good points regarding verification and its importance. Verification is indeed an essential process in design control, and it can also aid in risk analysis. By verifying every aspect of a medical device (dimension, function, biocompatibility, life expectancy),… Read more»

amandaally1029 replied to the topic "Customer Needs, Business Requirements, Test Plan" -

Wed, 15 May 2019 17:08:23 -0400

I also had to complete Requirement Documents and Test Plans for my capstone senior project. I agree that it does take a lot of time to complete because of the major details that are involved. However, these documents are definitely… Read more»

amandaally1029 replied to the topic "What FDA Looks For In A Design Control System ?" -

Wed, 15 May 2019 17:08:20 -0400

I’d also like to add on the importance of risk analysis for a Design Control System. Overall, everything boils down to the well-being of the people, and that is why the FDA needs to ensure that the product performs as… Read more»

amandaally1029 replied to the topic "How to ensure your DHF is audit ready ?" -

Wed, 15 May 2019 17:08:20 -0400

I also agree, the DHF documents should always be updated throughout the project. I have not had experience dealing with DHF files but based on what I have learned so far, I think that updating these documents frequently will be… Read more»

amandaally1029 replied to the topic "Discussion Topic: Having a "clinical background"" -

Wed, 15 May 2019 17:06:27 -0400

I guess it depends on what role you decide to pursue. When it comes to clinical studies where it involves dealing with patients, then I think a clinical background may be necessary. Dealing with different types of people isn’t always… Read more»

amandaally1029 replied to the topic "Marketing Strategy" -

Wed, 15 May 2019 17:05:37 -0400

One product that is very popular today are GoPro cameras. They do not use television to advertise their product but instead they have used youtube. However, they did not directly advertise their product but instead you see people using the… Read more»

amandaally1029 replied to the topic "Discussion Topic: Mission and Vision statements" -

Wed, 15 May 2019 17:05:33 -0400

A vision statement is what the company wants to accomplish and the mission statement is how the company does its business. I think that these statements are important for a company to have because it represents what they intend to… Read more»

amandaally1029 replied to the topic "Discussion Topic: The Fifth "P" of Marketing" -

Wed, 15 May 2019 17:05:32 -0400

I agree that social media has become a popular way of advertising in today’s society. There is also the idea where sellers involve the customers in the product production/improvement. Sellers of products now allow customers to send them comments on… Read more»

amandaally1029 replied to the topic "Types of Corporations" -

Wed, 15 May 2019 17:04:26 -0400

I think it all depends on the type of business you would like to pursue. For instance, if I wanted to pursue a company that produced medical devices, I’d want to have ownership of a C-Corp. With medical devices, you’d… Read more»

amandaally1029 replied to the topic "Corporate Veil" -

Wed, 15 May 2019 17:04:24 -0400

In order for the court to pierce the corporate veil, there must have been an unlawful situation within the corporation. For instance, if the corporations assets have been used for personal finances as opposed to using it just for the… Read more»

amandaally1029 replied to the topic "R&D vs Quality" -

Wed, 15 May 2019 17:03:06 -0400

I agree with @asimbana, both departments have different objectives, which is why you’d find R&D and Quality on different ends. I think that they both have the right idea, and they are just doing their jobs, but it can be… Read more»

amandaally1029 replied to the topic "Discussion Topic: The cost of Quality" -

Wed, 15 May 2019 17:02:40 -0400

I can see how people might think quality is a burden, because of all the testing and extra work that is required to make sure a product is safe. However, I do think it is necessary because like you said,… Read more»

amandaally1029 replied to the topic "Combination Product" -

Wed, 15 May 2019 17:01:49 -0400

An example of a combination product is a cell seeded scaffold, which is used to repair tissue damages. I believe that this product falls under the CBER regulation because it is designed to be therapeutic and aid in damaged tissue,… Read more»

amandaally1029 replied to the topic "Discussion Topic: e-cigarettes" -

Wed, 15 May 2019 17:01:40 -0400

The FDA does in fact regulate electronic nicotine delivery systems, such as e-cigarettes, hookah pens, and vapes [1]. I think that e-cigarettes are different from normal cigarettes in terms of regulation because, with e-cigarettes its tobacco-less, and it contains just… Read more»

amandaally1029 replied to the topic "Discussion Topic: Brand new biomaterial" -

Wed, 15 May 2019 17:00:12 -0400

As the others stated above, its essential to follow the ISO 10993 table in regards to implants, or orthopedics. However, when it comes to neural biomaterials, or drugs used to aid in other areas of the body, you should also… Read more»

amandaally1029 replied to the topic "Approaches to Research" -

Wed, 15 May 2019 17:00:11 -0400

One way in which research is approached in academia is that professors, post-docs, or grad students have the flexibility in developing there own idea or project. If the idea is worthy enough they are able to receive grants and carry… Read more»

amandaally1029 replied to the topic "Project Life Cycle" -

Wed, 15 May 2019 16:58:34 -0400

I think that the most important phase in the project life cycle is the planning phase. The planning phase is what lays out everything about the project and how to get it done. If this is done correctly then everything… Read more»

amandaally1029 replied to the topic "Obstacles while working on a project" -

Wed, 15 May 2019 16:58:33 -0400

An obstacle I encountered while working on a project was not doing certain tasks correctly, and having to redo them. This ended up causing delays in completing the project because certain tasks had to get done before you can do… Read more»

amandaally1029 replied to the topic "Discussion Topic: Project Management in a medical device setting" -

Wed, 15 May 2019 16:58:32 -0400

The challenges presented in project management for medical devices compared with project management for building a school or skyscraper, is that products or treatments need to be reviewed several times before being used or sold to people. This ends up… Read more»

amandaally1029 replied to the topic "Discussion Topic: Academia vs. Industry" -

Wed, 15 May 2019 16:57:43 -0400

I agree, I prefer the industry over academia. Although I do not have experience in industry, I do have experience in academia and I have found myself working very hard when it comes to research. There were days where I… Read more»

amandaally1029 replied to the topic "Discussion Topic: Practical vs. Informational courses" -

Wed, 15 May 2019 16:57:40 -0400

I don’t think that this a good ratio because students should be more prepared for the industry when they graduate and leave school. Academics is great and is a good bases for understanding the concepts of medical device, but learning… Read more»

amandaally1029 replied to the topic "Discussion Topic: Academia vs. Industry" -

Wed, 15 May 2019 16:57:39 -0400

The argument I’d present for working in Academia would be time flexibility. In Academia, you have the leisure to work on projects at a time that is easiest for you, rather than a fixed 8am to 5pm schedule everyday like… Read more»

amandaally1029 posted a new topic "Verification Protocol" -

Wed, 15 May 2019 16:34:48 -0400

Verification is an important part in developing medical devices or products, and can really help in making sure the products set out to do what they are supposed to. For instance, take tylenol for example; the purpose of tylenol is… Read more»

amandaally1029 posted a new topic "Clinical Trial Roles" -

Wed, 15 May 2019 16:34:43 -0400

There are different types of roles involved in clinical research, whether you are directly working on the study or aiding in other ways to help the study carry out. If you were involved in clinical research, what role would you… Read more»

amandaally1029 posted a new topic "Clinical Studies" -

Wed, 15 May 2019 16:34:42 -0400

With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are the advantages and… Read more»

amandaally1029 posted a new topic "Marketing Strategy" -

Wed, 15 May 2019 16:34:39 -0400

In the lecture this week, we learned that not all methods of marketing works for every product. For instance, there won’t be a television advertisement for some medical devices, or software programs. Name one or two products that you know… Read more»

amandaally1029 posted a new topic "Public vs. Private Companies" -

Wed, 15 May 2019 16:34:37 -0400

What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public company, and state the successes.

amandaally1029 posted a new topic "Experience in Quality Assurance and Quality Control" -

Wed, 15 May 2019 16:34:32 -0400

I understand that there are certain types of testing, depending on the company, for quality assurance and quality control. IF any of you had experience in quality assurance or quality control, what testing methods did you use for the company… Read more»

amandaally1029 posted a new topic "FDA on Recalled Items" -

Wed, 15 May 2019 16:34:29 -0400

Every Medical Device that has been developed, whether its for our everyday consumption and benefit, or for surgical use, had to be FDA approved. FDA is known for performing numerous tests, and filing plenty of paperwork in order for a… Read more»

amandaally1029 posted a new topic "Academia vs. Industry Research" -

Wed, 15 May 2019 16:34:26 -0400

I have had experience working in Academia and conducting research, and I must say that it is true that there are many delays, but a lot of flexibility when it comes to time management. However, I am curious to know,… Read more»

amandaally1029 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics

Tue, 28 Nov 2017 19:48:34 -0500

amandaally1029 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics

Tue, 28 Nov 2017 19:37:37 -0500

I agree with the fact that if there is a business deal between two people, it shouldn’t involve other family members. Therefore, I don’t think that the restrictions are too much. Because its a dinner to discuss projects, it should be treated as a professional meeting, rather than a social meet. As for the gift giving, I also think that the…[Read more]

amandaally1029 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics

Tue, 28 Nov 2017 19:16:27 -0500

Dr. Simon, I learned a lot from this course, and I think I have a better outlook on what to expect in terms of going into the industry. I haven’t had any experience in the industry yet, and before taking this course, I didn’t know what to expect. However, now I don’t feel like I would be entering the industry with a blind eye. This course…[Read more]

amandaally1029 replied to the topic Collaboration projects in the forum Organizational Development in Device Companies

Tue, 21 Nov 2017 22:19:28 -0500

amandaally1029 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies

Tue, 21 Nov 2017 21:54:16 -0500

I think its best to work with people who are more knowledgeable in their area, than with people you are close to. I think its a bad idea to work with people you are close to just in case something goes wrong within the project, that will cause disagreements, and potentially ruin the relationship. However, as long as your team is willing to…[Read more]

amandaally1029 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies

Tue, 21 Nov 2017 21:39:35 -0500

I do not currently work in an organization, but if I had to pick the type it would be a matrix organization. I like that with this type of organization you can transfer knowledge about the project with other departments without it being an issue. I think to successfully run a project everyone must work together to ensure that production is…[Read more]

amandaally1029 replied to the topic How to run a risk management meeting ? in the forum Risk Analysis for Medical Devices

Mon, 13 Nov 2017 20:11:15 -0500

First, I’d want to make sure that everyone in the project understands what the device is, its purpose, its design, and how it will be processed. Once we understand the device and what is going to happen, we can then as a team decide together what we think the risks would be. Based on what we learned in lecture, we must consider the risks for the…[Read more]

amandaally1029 replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices

Mon, 13 Nov 2017 19:54:14 -0500

amandaally1029 replied to the topic Discussion Topic: Risk Management, Risk Analysis in the forum Risk Analysis for Medical Devices

Mon, 13 Nov 2017 19:25:33 -0500

amandaally1029 replied to the topic a successful validation process in the forum Introduction to Design Controls

Wed, 08 Nov 2017 20:57:03 -0500