Medical Device Courses | pn266 | Activity

pn266 replied to the topic "Consultants in the Medical Device Industry" -

Mon, 30 Nov 2020 04:14:17 -0500

I currently work as a Technical Writer for a company that offers healthcare technology solutions such as biomedical equipment rentals, technology management, as well as technical service for hospitals and medical facilities. Since my company is ISO 13485 certified, we… Read more»

pn266 replied to the topic "Advice before signing an NDA" -

Mon, 30 Nov 2020 04:13:57 -0500

I have signed many NDA’s and my advice is to read the entire document carefully prior to signing. After signing, I strongly advise asking exactly what details are bound by the NDA. Sometimes an NDA covers a lot of information… Read more»

pn266 replied to the topic "Factors to consider when executing the NDA" -

Mon, 30 Nov 2020 04:13:17 -0500

My company recently acquired a contract which would increase our business by 35%. My department was reallocated to help build the infrastructure for the company to successfully operate this new business venture, and it all began by signing an NDA…. Read more»

pn266 replied to the topic "Your Organizational prference; but why?" -

Mon, 23 Nov 2020 04:47:36 -0500

I would prefer to work for a company that employs a functional organizational structure because it seems to be the most intuitive form of corporate hierarchy. I currently work as a technician for a company that follows a functional structure… Read more»

pn266 replied to the topic "Upper vs Middle Management." -

Mon, 23 Nov 2020 04:17:16 -0500

In order to succeed in an upper management position, it is important to understand the industry. In my opinion, the best way to fully understand an industry is to work from the ground up. I had the pleasure of working… Read more»

pn266 replied to the topic "Discussion Topic: Your organizational type" -

Mon, 23 Nov 2020 04:15:14 -0500

I currently work for a healthcare technology solutions company that provides rental service, inventory management, and technical service for medical equipment in hospitals throughout the country. The operation of this company boils down to three core branches: sales, logistics, and… Read more»

pn266 replied to the topic "FMEA Reviews and Brainstorming" -

Sun, 15 Nov 2020 23:19:53 -0500

Brainstorming is a fantastic method to quickly generate a list of potential risks, however sometimes a brainstorming session seems to hit a limit. I have found from my own experience that introducing the actual product to a brainstorming session can… Read more»

pn266 replied to the topic "Risk Management Tools" -

Sun, 15 Nov 2020 23:18:32 -0500

When thinking back upon my previous projects from academia, I realize my project teams always followed the same process when performing risk management. We would initially get together as a team and have a brainstorming session in order to list… Read more»

pn266 replied to the topic "Benefits of post-market surveillance" -

Sun, 15 Nov 2020 23:17:51 -0500

Another benefit of post-market surveillance is determining whether preventive actions from risk management processes have been effective. This can be done by simply reviewing the risk register along with data from the post-market surveillance and observing the frequency and impact… Read more»

pn266 replied to the topic "Design Control Experience" -

Mon, 09 Nov 2020 03:25:24 -0500

My closest experience working with design controls was when I developed a surgical stapler testing apparatus for my undergraduate senior year capstone project. My team and I implemented the twelve-step engineering design process to effectively develop our idea from concept… Read more»

pn266 replied to the topic "Important Part of DDP" -

Mon, 09 Nov 2020 01:35:55 -0500

Each part of the Design Development Plan has its own importance however the scope management plan is especially important because it sets boundaries for the project. A project can have excellent communication and quality protocols however without a strong grasp… Read more»

pn266 replied to the topic "examples of controlled device changes" -

Mon, 09 Nov 2020 01:21:18 -0500

After a device has been released it may experience common failures that lead to a recall. When a recall is issued, the manufacturer typically investigates the failure and develops a recall remediation. This may be a software update, a component… Read more»

pn266 replied to the topic "Customer Needs and Design Input" -

Sun, 01 Nov 2020 19:03:23 -0500

The design input document and design specification document each play an important role in design controls as they are the documents that proclaim official descriptions of the design. After gathering a list of user needs and requirements, the design team… Read more»

pn266 replied to the topic "Making up tests for design verification and validation" -

Sun, 01 Nov 2020 19:02:56 -0500

Verification and validation testing are performed to ensure that the project results align with the correct user needs and specifications. Rather than looking at it from the perspective of satisfying the FDA, validation and verification testing should be viewed from… Read more»

pn266 replied to the topic "Minutes for meetings" -

Sun, 01 Nov 2020 19:02:33 -0500

Meetings can often cover a lot of material and if meeting minutes are not recorded then there is a decent chance that some of the topics will not be acted on after the meeting. I have participated in meetings regarding… Read more»

pn266 replied to the topic "Right to Try Law" -

Mon, 26 Oct 2020 20:43:23 -0400

In most circumstances, I advocate the “Right to Care” act due to the simple fact that this may be the last resort for terminally ill patients. Rather than focusing on the pros of this act, I would like to focus… Read more»

pn266 replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" -

Mon, 26 Oct 2020 20:18:21 -0400

I understand that placebo studies may provide the necessary research in order to advance technology and healthcare, however I believe they can sometimes be unethical. For example, if a patient is battling a vigorous disease and they believe they are… Read more»

pn266 replied to the topic "Clinical Studies" -

Mon, 26 Oct 2020 03:03:26 -0400

Clinical studies are necessary for the advancement of medical technology and medication. Assuming the application of the product provides ideal results, the primary advantage of a clinical trial is simply the access to this particular treatment over other common treatments…. Read more»

pn266 replied to the topic "The Expert" -

Sun, 18 Oct 2020 23:38:03 -0400

This is my first time watching “The Expert” but not my first time finding humor in certain corporate policies and norms. What makes “The Expert” funny is subtle truth behind the content. My coworkers and I laugh quite frequently at… Read more»

pn266 replied to the topic "Advertising" -

Sun, 18 Oct 2020 23:25:43 -0400

I recently saw an advertisement from GoPro that did an excellent job promoting their newest line of cameras. For starters, the entire advertisement was filmed using the product that they were promoting. This was really impressive because the advertisement contained… Read more»

pn266 replied to the topic "Brand Coloring" -

Sun, 18 Oct 2020 23:24:47 -0400

I work for a medical device servicing company where I manage products from dozens of manufacturers. It did not take long for me to realize that many of these products contain similar color schemes which naturally project an impression of… Read more»

pn266 replied to the topic "Accepting job based on company." -

Mon, 12 Oct 2020 03:16:25 -0400

I have never considered this question when applying and interviewing for new opportunities because I was not aware of how it could affect me. After learning about the different types of companies and the potential disadvantages each have, the type… Read more»

pn266 replied to the topic "Discussion Topic: Inc. vs. LLC in the US" -

Mon, 12 Oct 2020 02:57:11 -0400

Although there are many advantages of running a mid-sized company as an LLC, there are just as many disadvantages to watch out for. Different states can have different rules and regulations for LLC’s which can complicate the overall operation of… Read more»

pn266 replied to the topic "Public vs. Private Companies" -

Mon, 12 Oct 2020 02:22:29 -0400

The difference between a public and private company is the availability of obtaining a stock within the company. Both companies are owned by shareholders who share ownership of the company through stocks. If the stocks are only owned by a… Read more»

pn266 replied to the topic "Issues with the Quality Department" -

Mon, 05 Oct 2020 00:33:49 -0400

My coworkers and I regularly follow work instructions throughout the day and occasionally we come across issues or illogical steps within work instructions. Sometimes they are simple mistakes such as one or two steps, however other times an entire section… Read more»

pn266 replied to the topic "organizational skills for QC" -

Mon, 05 Oct 2020 00:16:07 -0400

I do not work in quality assurance however I have experienced multiple audits from the quality department of my company. As explained in this week’s lecture, there are work instructions for every possible job duty in my company. Whether performing… Read more»

pn266 replied to the topic "Discussion Topic: The cost of Quality" -

Sun, 04 Oct 2020 23:54:56 -0400

Just last week I overheard my coworkers complaining about how certain quality policies have gone too far and may be causing more damage than good. My company recently opened a new location and the manager ordered 10 new workstations for… Read more»

pn266 replied to the topic "Discussion Topic: Make a few, sell a few" -

Sun, 27 Sep 2020 19:22:59 -0400

Assuming the physician is able to find investors and business partners with ease through their extensive professional network, they will have to overcome obstacles regarding the new product development process, regulatory and legal affairs, as well as manufacturing and post… Read more»

pn266 replied to the topic "Delay in Recall." -

Sun, 27 Sep 2020 19:04:04 -0400

I recently worked on a recall remediation project for a device that has been on the market for over 10 years. The recall was issued only one year ago, which means the product has been on the market for over… Read more»

pn266 replied to the topic "FDA on Recalled Items" -

Sun, 27 Sep 2020 18:46:06 -0400

I recently worked on a project remediating a recall on Alaris Medley 8100 Infusion Pumps. The recall was issued due to a hardware component failure after the component material was downgraded to reduce costs. The failure consists of cracks and… Read more»

pn266 replied to the topic "PM in Pre-Clinical/Clinical Studies" -

Sun, 20 Sep 2020 21:15:04 -0400

The project management body of knowledge provides the fundamental information to form a foundation for projects of all sizes, however it is not pertinent to apply the entirety of the body of knowledge to every project. I believe it is… Read more»

pn266 replied to the topic "Research for the Fututre or Now?" -

Sun, 20 Sep 2020 15:51:02 -0400

Having a result driven mentality, I prefer the fast-paced approach of industrial research rather than the long-term approach of academic research. Both industrial and academic research play pivotal roles in the advancement of modern science and technology, however I believe… Read more»

pn266 replied to the topic "This vs That" -

Sun, 20 Sep 2020 14:07:31 -0400

In my opinion, the advantage of working in academic research is the ability to choose specific projects that may interest you. These projects may cover different subject areas, be in different stages of completion, or have different budgets and resources… Read more»

pn266 replied to the topic "Applying for Project Manager positions." -

Mon, 14 Sep 2020 04:04:11 -0400

The responsibility of a project manager can vary greatly depending on the size of the project among other factors. Before you apply to a project management position, I think it’s important to determine the size of the project and honestly… Read more»

pn266 replied to the topic "Manager Vs Engineering" -

Mon, 14 Sep 2020 03:37:30 -0400

I think it can be beneficial for a project manager to have worked in one or more of the roles that they manage prior to becoming the project manager. This would give them insight into the limits and boundaries of… Read more»

pn266 replied to the topic "Obstacles while working on a project" -

Mon, 14 Sep 2020 02:40:48 -0400

I was recently working on a recall remediation project that had a deadline approaching within 1 month. My team and I were responsible for swapping a recalled component with a revised component on over 1000 units. We were initially confident… Read more»

pn266 replied to the topic "Advice for Biomedical Engineering Students" -

Mon, 07 Sep 2020 20:49:41 -0400

As someone who works in industry and has a clear idea of my long term academic and career goals, I encourage Biomedical Engineering Students to spend time researching the many opportunities and paths they can take after graduation. Rather than… Read more»

pn266 replied to the topic "The Advantages and Disadvantages of Being Overqualified" -

Mon, 07 Sep 2020 20:27:24 -0400

I currently have a Bachelor of Science in Biomedical Engineering and work in a position that only requires an Associate of Science in Technology. As someone who aspires to be a leader of technical management, being overqualified can help me… Read more»

pn266 posted a new topic "The Advantages and Disadvantages of Being Overqualified" -

Mon, 07 Sep 2020 20:26:56 -0400

Academically speaking, would you rather be overqualified for your job or meet the bare minimum qualifications? What are some short term and long term pros/cons for either situation?

pn266 replied to the topic "Overworked Americans vs. Motivation" -

Sun, 03 May 2020 19:26:07 -0400

I think the answer to these questions greatly depends on the individual, their company, and the project they are working on. I know someone who was certainly overworked by their company and it eventually caused them to not only leave… Read more»

pn266 replied to the topic "Skills Learned in this Class" -

Sun, 03 May 2020 18:52:42 -0400

Aside from learning about the fundamental process groups and knowledge areas of project management, this course taught me that even following the body of knowledge cannot prepare a team for certain obstacles. Sometimes a project will encounter such a hardship… Read more»

pn266 replied to the topic "How was this class helpful" -

Sun, 03 May 2020 18:23:22 -0400

I am actively pursuing a career in product development for a medical device manufacturer and this course has provided an excellent foundation of project management. Prior to this course, I was unaware of the project management institute and the body… Read more»

pn266 replied to the topic "Why do people work?" -

Mon, 27 Apr 2020 03:59:05 -0400

At this particular point in my career, working in a position that provides career growth and development is of utmost importance to me. I am just beginning my career and I am willing to sacrifice fair pay, benefits, and working… Read more»

pn266 replied to the topic "What it an NCMR" -

Sun, 26 Apr 2020 20:11:01 -0400

My company provides repair and maintenance service for general biomedical equipment, so we deal with a lot of parts and suppliers. Every now and then we come across a brand-new component that is defective or damaged. In this case, we… Read more»

pn266 replied to the topic "Priorities for Projects" -

Sun, 26 Apr 2020 19:56:56 -0400

From my experience, I have found that projects often have more than one priority. I am currently working on a recall remediation project that has three distinguished priorities. The recall affects a specific component within infusion pumps that were manufactured… Read more»

pn266 replied to the topic "Changining staff" -

Mon, 20 Apr 2020 03:22:28 -0400

During my senior design capstone project our sponsor changed the designated project manager multiple times which caused delays throughout our design process. Our team could not sacrifice delays because our project course had very strict deadlines for grading purposes. Unfortunately,… Read more»

pn266 replied to the topic "Human resource management" -

Mon, 20 Apr 2020 02:53:29 -0400

Assuming this situation has been anticipated months in advance, I believe the company should consider hiring a temporary or contract employee to fill in for her. This temporary employee would begin before she leaves for maternity leave in order to… Read more»

pn266 replied to the topic "Communication Management" -

Mon, 20 Apr 2020 02:38:14 -0400

Although my team eventually found success in our senior design capstone project, we faced many hurdles throughout the year that were brought on by inadequate communication. We developed and implemented a communication management plan during the preliminary planning phase of… Read more»

pn266 replied to the topic "Communication and Responsiveness" -

Mon, 13 Apr 2020 03:30:15 -0400

I believe it is important to understand how the employee is being unresponsive and what may be causing them to not cooperate. Once this is established, arrange a time to speak with the employee about your expectations and see if… Read more»

pn266 replied to the topic "Which of the following project would you say is better and why" -

Mon, 13 Apr 2020 03:00:49 -0400

Assuming the schedule variance and cost variance are both very high values, I would rather have a negative schedule variance and positive cost variance. I believe it is easier to catch up on a project schedule than it is to… Read more»