Medical Device Courses | jj52 | Activity

jj52 replied to the topic "When is giving gifts like the "old days" too much?" -

Sat, 02 Dec 2023 18:45:32 -0500

From recent training received at my job we were always told that gifts shouldn’t be higher than $50 dollars and should be able to be shared with others within the company or benefit the tasks needed to complete our studies…. Read more»

jj52 posted a new topic "Advamed Guidelines" -

Sat, 02 Dec 2023 18:30:24 -0500

During this week’s lecture, Advamed guidelines were briefly discussed. One guideline that stood out to me was that sponsored held events must be held at a reasonable location. When thinking of places that might not been seen as a reasonable… Read more»

jj52 posted a new topic "Verbal Contracts" -

Sat, 02 Dec 2023 18:14:07 -0500

This week, we learned about the legal basics in the medical device industry, one specific topic was the significance of both verbal and written contracts. Given that most contracts are required to be in writing, what strategies are used to… Read more»

jj52 replied to the topic "Forming a Project Team" -

Sun, 26 Nov 2023 20:41:11 -0500

Maintaining a balanced working relationship is crucial. While prior experience with a team member from a past project can facilitate the initiation of a new one, it is extremely important to ensure that these individuals bring substantial value to the… Read more»

jj52 replied to the topic "Upper vs Middle Management." -

Sun, 26 Nov 2023 20:35:10 -0500

Before addressing your question, I agree with your statement that being part of middle management can provide a solid foundation for an upper management position. Personally, while I am confident in my ability to succeed in both roles, I lean… Read more»

jj52 posted a new topic "Group Projects: Organizational Types" -

Sat, 25 Nov 2023 03:13:30 -0500

After being assigned to our project groups about two weeks ago, which organization structure (Functional, project-based, or matrix organization) do you think will benefit your group and the device development?

jj52 replied to the topic "Expense of Regulations" -

Mon, 20 Nov 2023 00:53:12 -0500

I actually questioned this myself this past weekend when creating the DID for the project Dr. Simon has assigned to us. Personally, I feel as though regulations should not cost since these regulations help ensure that devices are being designed… Read more»

jj52 posted a new topic "Risk Acceptance" -

Mon, 20 Nov 2023 00:33:23 -0500

This week we learned of 4 ways to deal with risks: avoidance, mitigation, acceptance, and transference. After learning the difference between the four, d0 you think risk acceptance creates a higher probability of risk? If so, when do you think… Read more»

jj52 replied to the topic "Hazard, Hazardous, Harm" -

Mon, 20 Nov 2023 00:09:44 -0500

I currently work in an in vivo lab and can think of several hazards in a hazardous situation with a specific harm. We often have certain test subjects that undergo doses of radiation and other test articles. The main hazards… Read more»

jj52 replied to the topic "Making up tests for design verification and validation" -

Mon, 13 Nov 2023 02:51:02 -0500

@vnd4 If verification test usually stay in house, do you think there is a specific department or procedures that ensure that this verification methods are suffice? I’m aware that inputs and outputs must equal but how can we confirm that… Read more»

jj52 replied to the topic "Document Corrections" -

Sat, 11 Nov 2023 04:24:14 -0500

This is sort of off topic of correcting specific documents such as DSD and DID but I wanted to mention the practices in Good Laboratory Practices (GLP) regarding data collection. In GLP, when errors occur during data collection there is… Read more»

jj52 replied to the topic "Medical Device Clinical Trials vs Drug Trials" -

Sat, 11 Nov 2023 04:01:34 -0500

Device trials are different in several ways when compared to drug trials such as: 1) medical device trials are usually smaller than drug trials. 2) Physician technique or bias is a larger role in drug trials. 3) medical devices modifications… Read more»

jj52 replied to the topic "Design Transfer" -

Sun, 05 Nov 2023 17:55:58 -0500

There have been lots of good points mentioned on the benefits of outsourcing or stay in house. The main point that was made is if it is cost effective for a company. I think staying in house is always more… Read more»

jj52 posted a new topic "Document Corrections" -

Sun, 05 Nov 2023 17:49:11 -0500

During this week’s lecture different types of documents were discussed such as DID and DSD. When there is a error found in these different types of documents is a change request issued? Or are there other ways to correct.

jj52 replied to the topic "Minutes for meetings" -

Sun, 05 Nov 2023 17:42:03 -0500

I agree that meeting minutes are important and that people usually don’t pay as much attention as they should to them. I also think meeting minutes are more important to those who were unable to attend the meeting. Meeting minutes… Read more»

jj52 posted a new topic "Placebo Effect" -

Sun, 29 Oct 2023 15:03:52 -0400

This week we have learned several different types of clinical studies. Throughout my elementary through high school education we were taught about placebo controlled studies and how patients may be subjected to a placebo effect. A placebo effect is the… Read more»

jj52 replied to the topic "Clinical Research Studies" -

Sun, 29 Oct 2023 14:51:19 -0400

As mentioned above there is a negative denotation with clinical trials although there are regulations instilled that protect both the patient and researcher. It’s important to mention that everyone involved in clinical trials are informed of the risks and have… Read more»

jj52 replied to the topic "What role would best fit your experience/skillset in clinical research?" -

Sun, 29 Oct 2023 14:43:44 -0400

With my skillset I believe I could be successful in the role of a clinical research associate (CRA), a data manager, or even a quality associate (CQA). In my current position I am a research scientist and complete several studies… Read more»

jj52 replied to the topic "What role would best fit your experience/skillset in clinical research?" -

Sun, 29 Oct 2023 14:43:20 -0400

jj52 replied to the topic "Digital Marketing" -

Mon, 23 Oct 2023 00:53:19 -0400

The internet has changed marketing by making it easier to reach your target market and gain exposure for your business. Social Media platforms allows businesses to set up ads which are seen frequently when scrolling through and you can purchase… Read more»

jj52 replied to the topic "Importance of building TRUST as a Sales Rep" -

Sat, 21 Oct 2023 06:35:53 -0400

Although I agree that sale reps have to take the time to build trust in order to maintain a healthy relationship I think it’s it important to define what doing extra is. Providing gifts in particular may be difficult when… Read more»

jj52 posted a new topic "Business Minor/Major" -

Sat, 21 Oct 2023 06:29:26 -0400

During this course we have been introduced to different aspects of medical device development including business. Although this is a BME course how beneficial do you think a business minor/major/certification to an aspiring engineer?

jj52 posted a new topic "LLP vs LLC" -

Sat, 14 Oct 2023 01:43:05 -0400

I have witnessed many individuals go into entrepreneurship and purchase their LLC. After learning the advantages and disadvantages of several types of corporations, I find that LLPs and LLCs are very familiar. Why do you think one would choose a… Read more»

jj52 replied to the topic "80% margin" -

Fri, 13 Oct 2023 02:52:23 -0400

@cem34 Do you think smaller companies would be able to afford the licensing from these major companies that want a large profit? You made an important though that companies are doing their job from a business standpoint but I wonder… Read more»

jj52 replied to the topic "Accepting job based on company." -

Fri, 13 Oct 2023 01:00:23 -0400

This is a great topic and I’m sort of embarrassed to say I really don’t do research on the companies I apply to, I focus more on my role at the company and if I am capable of the tasks… Read more»

jj52 posted a new topic "QA/QC Audits" -

Sun, 08 Oct 2023 20:50:05 -0400

This week we learned the roles of QA and QC and how they are implemented into systems to ensure products/services meet specific standards and requirements. We also learned that audits are examinations of these systems and the results are always… Read more»

jj52 replied to the topic "Issues with the Quality Department" -

Sat, 07 Oct 2023 04:53:11 -0400

The issues that I have seen throughout the quality department working in the industry is the inconsistency of ensuring proper protocols are followed. If researchers were not being QA’d certain protocols were not executed as properly and a lot of… Read more»

jj52 replied to the topic "Discussion Topic: Quality Assurance vs. Quality Control" -

Sat, 07 Oct 2023 04:45:28 -0400

Quality Assurance (QA) is assuring that specific procedures and protocols are being conducted properly to avoid any possible errors that may ruin the production of a device or a results of a specific study. Quality Control (QC) are procedures that… Read more»

jj52 replied to the topic "FDA rules too strict?" -

Fri, 29 Sep 2023 03:32:16 -0400

I believe the strictness of the FDA depends on the food, device, or drug that is under review in that moment. Although the FDA is often strict when a new drug is created or a previous drug is being study… Read more»

jj52 posted a new topic "Product Labeling" -

Fri, 29 Sep 2023 01:37:18 -0400

If a product is on a shelf at a store with a damaged label (label information is correct but damaged due to shipment/stocking and is half legible). Do you think the store is responsible and should make an effort to… Read more»

jj52 replied to the topic "Does the FDA guarantee safety?" -

Thu, 28 Sep 2023 03:43:47 -0400

As someone who is interested in the scientific field, I always feel like a hypocrite when I say that I don’t think the FDA does an efficient job of regulating products, especially medicine. To answer your question I don’t think… Read more»

jj52 replied to the topic "Ethics of Animal Testing" -

Fri, 22 Sep 2023 17:21:26 -0400

Although I wish there were ways to test medicines, devices, and etc without the use of animals, I do not find it unethical. In order to ensure these substances/devices are safe to the public there has to be some sort… Read more»

jj52 replied to the topic "Animals used for research and for food" -

Fri, 22 Sep 2023 17:15:58 -0400

This post has great points and I appreciate the statistics, I knew animals were consumed more than they’re tested on but not to that great extent. I believe animal research can often be seen as negative based on one’s perception…. Read more»

jj52 posted a new topic "Professors in Academia" -

Fri, 22 Sep 2023 16:42:45 -0400

Throughout this course thus far we have discussed the differences between academia and industry and how research also varies between the two. From our recent lecture we learned that within academia there is more opportunity to research the unknown and… Read more»

jj52 replied to the topic "When Does It Makes Sense To Give Up On A Project?" -

Sun, 17 Sep 2023 21:31:38 -0400

I believe that determining whether a project is feasible or not should occur in the initiating/planning phase where discussion of budgets, tasks, and team members are discussed as you previously mentioned. Also as stated above the project manager should be… Read more»

jj52 replied to the topic "Importance of people within the Project" -

Thu, 14 Sep 2023 02:55:24 -0400

Although I believe everyone on a project has to play their role to ensure a positive outcome, when deciding on which is most important im stuck between the stakeholders and the team members. Without stakeholders there is no funding, and… Read more»

jj52 replied to the topic "Project Management in the Age of Covid-19" -

Thu, 14 Sep 2023 02:45:54 -0400

I believe virtual communications have improved since covid-19 therefore providing benefits to project life cycles. As mentioned before there were already means of communicating virtually but not to the extent that we have now post covid. Although this is great… Read more»

jj52 replied to the topic "Academia or Industry Preference?" -

Fri, 08 Sep 2023 02:42:19 -0400

My ideal career would be designing, building, and working with prostheses. With this I feel like the industry would be best for me. Although discovering way to enhance these devices could be a form of research in academia, I… Read more»

jj52 replied to the topic "Grades and GPA's in graduate education" -

Thu, 07 Sep 2023 03:46:47 -0400

I 100% agree that grades don’t define a person’s ability to work in the industry. Although I wish I could rate it a 1 I think I will go with a solid 6. Although grades do not matter I think… Read more»

jj52 replied to the topic "Thoughts on BS, MS, and PhD in BME" -

Thu, 07 Sep 2023 03:30:55 -0400

Based off personal experience I have mixed feelings on which level of education is best. I do believe that as more people receive their undergraduate degree a BS tends to lose its value. This is why I was determined to… Read more»

jj52 posted a new topic "Clinical Trials" -

Mon, 01 May 2023 03:36:32 -0400

Clinical trials are very crucial to medical device development, they serve as prediction in a sense to how effective the device can be within the market. I believe its important that a clinical trial provides substantial data to prove that… Read more»

jj52 replied to the topic "Why Do People Leave?" -

Wed, 26 Apr 2023 16:54:51 -0400

As mentioned above, I believe there are several factors when analyzing employee retention and productivity. Job satisfaction is definitely an important factor that I hear from many people in the work force. Many have been offered positions where they… Read more»

jj52 replied to the topic "Quick, Fast, Good? Pick Two" -

Wed, 26 Apr 2023 16:47:12 -0400

I agree with everything mentioned above that it honestly depends on the nature of the task the project manager is dealing with. Good definitely should always be a number one choice because although time is an important factor the number… Read more»

jj52 replied to the topic "Overworked Americans vs. Motivation" -

Sat, 22 Apr 2023 05:37:33 -0400

I think this is actually an important topic to discuss that should be mentioned more often. I believe all reasons mentioned could serve as a reason that people work 40+ hours a week. But peer pressure may lead as… Read more»

jj52 posted a new topic "Nine Knowledge Areas" -

Fri, 14 Apr 2023 14:38:57 -0400

After this weeks lecture we were introduced to the nine knowledge areas. While they all are tied together which three do you think are most important?

jj52 replied to the topic "Familiarity of eachothers work" -

Fri, 14 Apr 2023 14:25:43 -0400

Although ensuring that everyone has an understanding of what everyone project entails may take away time from the deadline I view it as a necessity. A project team can be defined as a group of individuals that work with each… Read more»

jj52 replied to the topic "QA vs QC" -

Fri, 14 Apr 2023 14:15:08 -0400

Both quality assurance and quality control exist under the quality management system. Quality assurance is defined as ” quality management focused on providing confidence that quality requirements will be fulfilled” where Quality Control is defined as ” quality management focused… Read more»

jj52 replied to the topic "Preplanning for Risk" -

Sun, 09 Apr 2023 16:50:48 -0400

Unfortunately when dealing with projects its hard to avoid some kind of risk. The best measures to minimize risk utilize the risk management plan properly along with communication. When going through each task it’s important to keep risk documented…. Read more»

jj52 replied to the topic "How poor planning affects a project" -

Sun, 09 Apr 2023 16:31:52 -0400

Although I don’t have experience with working on actual project team, there have been instances where I was apart of a team that did not properly train well. Due to poor training the team was unsuccessful and unable to obtain… Read more»

jj52 posted a new topic "Power of Stakeholders" -

Sat, 08 Apr 2023 03:28:20 -0400

Over this past semester I’ve started to understand that a project team is only successful with both project team members and stakeholders working together to achieve a common goal. With that being said how much power do you think stakeholders… Read more»