Medical Device Courses | hruship101 | Activity

hruship101 replied to the topic "Written Agreement v/s Verbal Agreement" -

Wed, 15 May 2019 18:57:00 -0400

This is a really interesting topic to discuss. There are many pros and cons of having a written agreement versus verbal agreement. Many medical device companies execute a supplier quality agreement with the suppliers on their approved supplier list (ASL)…. Read more»

hruship101 replied to the topic "Discussion Topic: Course conclusion and impressions" -

Wed, 15 May 2019 18:56:59 -0400

I agree with all of the participants in this post regarding Dr. Simon’s class. This is my second semester as Masters in Biomedical Engineering and also second time taking a class with Dr. Simon. Previous semester, in project management class,… Read more»

hruship101 replied to the topic "Forming a Project Team" -

Wed, 15 May 2019 18:54:54 -0400

This is a really interesting question! In order to successfully complete a project on time, project team must collaborate at a defined frequency and must work collectively to achieve the project goal. In choosing the right people for the team,… Read more»

hruship101 replied to the topic "Discussion Topic: Your organizational type" -

Wed, 15 May 2019 18:54:52 -0400

I believe my organization is consider to be Matrix Organization, but also overlaps with the functional organization. We have a CEO, followed by Group President, who oversees multiple medical divisions including Orthopedic, Trauma & Extremities, and Spine. Each individual medical… Read more»

hruship101 replied to the topic "Risk Identification" -

Wed, 15 May 2019 18:52:30 -0400

My company also uses the FMEA (Failure Modes Effects Analysis) technique to evaluate the risk associated with the medical device or production process for risk assessment. It is a process to identify all possible failures during all stages of design… Read more»

hruship101 replied to the topic "Risk management and Labels" -

Wed, 15 May 2019 18:52:27 -0400

This is an interesting topic for discussion! I agree with Dr. Simon that labeling or putting a warning on the package is not a direct way of mitigating risk. There are Instructions for use, also known as IFUs, which surgeons… Read more»

hruship101 replied to the topic "Discussion Topic: Risk Management, Risk Analysis" -

Wed, 15 May 2019 18:52:26 -0400

I agree with most of the participants on the above post. ISO 14971, major regulation detailing the Risk Management Requirements for Medical Devices. Medical device manufacturers must have a good understanding of Risk Management Process including the Risk Management Plan… Read more»

hruship101 replied to the topic "How to ensure your DHF is audit ready ?" -

Wed, 15 May 2019 17:10:11 -0400

This is an interesting discussion topic! In the medical device industry, it is very critical to have the most up to date DHF as the project moves forward with different phases. Many medical device companies have internal audit program, part… Read more»

hruship101 replied to the topic "Customer Needs, Business Requirements, Test Plan" -

Wed, 15 May 2019 17:10:11 -0400

I agree with most of the participants in the above posts. During my senior design class at NJIT, I learned more about the requirement and the test method documents and its importance. My professor constantly stressed every class that the… Read more»

hruship101 replied to the topic "Design Review Meetings" -

Wed, 15 May 2019 17:09:23 -0400

I do not have an experience with design review meetings in the industry, but I will share my experience participating in the design review meeting for my senior design project. A couple of weeks before the design review, each of… Read more»

hruship101 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" -

Wed, 15 May 2019 17:09:10 -0400

This is an interesting question. I agree with most of the participants that depending on the device classification, EU regulatory looks at the device development in the Tech File. While, in the US, Design Controls such as DHF and DMR… Read more»

hruship101 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" -

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

This is an interesting question! I agree with most of the participants that depending on the device classification, EU regulatory looks at the device development in the Tech File. While, in the US, Design Controls such as DHF and DMR… Read more»

hruship101 replied to the topic "Discussion Topic: Having a "clinical background"" -

Wed, 15 May 2019 17:07:19 -0400

This is an interesting question! I agree with most of the participants that having clinical background is a plus, but again it depends on the type of role within the CRA profession. For example, Statistician might not need as much… Read more»

hruship101 replied to the topic "Clinical Studies" -

Wed, 15 May 2019 17:07:19 -0400

I agree with most of the participants in the forum that clinical studies/trial comes with a risk and a side effects. However, it is crucial for the researchers and doctors to perform these clinical trials to determine the effectiveness of… Read more»

hruship101 replied to the topic "Grand Strategies" -

Wed, 15 May 2019 17:06:49 -0400

This is an interesting question. In my opinion, when recent graduates apply for the positions in the related field, they do not necessarily look whether the company is Limited Liability Company vs Corporation. In today’s world, it’s very challenging to… Read more»

hruship101 replied to the topic "Fuzz before launch of product." -

Wed, 15 May 2019 17:06:48 -0400

If given the choice to open my own business, I would file my business as Limited Liability Company (LLC) over a Corporation. There are many reasons in terms of Taxes, Business Ownership, and Business Operation. In an LLC, one has… Read more»

hruship101 replied to the topic "Manipulation or no?" -

Wed, 15 May 2019 17:06:48 -0400

Privately owned companies are privately held. This means that the company is owned by small group of people, or private investor. On the other hand, in public company, there are shareholders that claim to be a part of the company’s… Read more»

hruship101 replied to the topic "Public vs. Private Companies" -

Wed, 15 May 2019 17:05:18 -0400

hruship101 replied to the topic "Accepting job based on company." -

Wed, 15 May 2019 17:05:06 -0400

hruship101 replied to the topic "Types of Corporations" -

Wed, 15 May 2019 17:04:27 -0400

hruship101 replied to the topic "How Quality Departments React to Audits" -

Wed, 15 May 2019 17:03:32 -0400

This is a great question. Prior to FDA or BSI audit, the quality department of the company prepares for the audit in gathering few DHRs (Device History Records). From the auditor’s perspective, he/she ensures that the company meets its own… Read more»

hruship101 replied to the topic "Discussion Topic: The cost of Quality" -

Wed, 15 May 2019 17:03:31 -0400

I agree with most of the participants in terms of the importance of Quality Department in a medical device industry. I’ve worked as a Quality Engineer for 2 years in a medical device company and I’ve witnessed the importance of… Read more»

hruship101 replied to the topic "FDA on Recalled Items" -

Wed, 15 May 2019 17:01:57 -0400

Recently, in the April of 2017, Zimmer Biomet recalls Implantable Spinal Fusion Stimulators due to potential of harmful chemical which may be toxic to the tissues and organs. FDA has classified this recall as a Class I recall, most serious… Read more»

hruship101 replied to the topic "Discussion Topic: The de Novo 510(k) Process" -

Wed, 15 May 2019 17:01:48 -0400

A de Novo approach is efficient in getting the approval from the FDA and launching the products in the market rapidly. It’s used for new devices that has not been previously classified by the FDA. FDA uses a risk-based strategy… Read more»

hruship101 replied to the topic "Discussion Topic: Beyond experimental design issues" -

Wed, 15 May 2019 17:01:29 -0400

One of the major pitfalls that may arise in animal study is the delay in testing and the time the specimen is received from the supplier. Due to the demand for animals for many pre-clinical trials, it is important to… Read more»

hruship101 replied to the topic "Academia vs. Industry Research" -

Wed, 15 May 2019 17:01:25 -0400

I agree with most of the participants in the posts above that there are pros and cons of academia versus industry. I believe there is a mutual relationship between the two as industry is based on the research performed by… Read more»

hruship101 replied to the topic "Discussion Topic: Brand new biomaterial" -

Wed, 15 May 2019 17:01:22 -0400

There are multiple biocompatibility tests that needs to be carried out on the product prior to clinical trials. These tests must comply with the ISO 10993-1, Biological evaluation of medical devices. As per the ISO 10993 standard, biocompatibility tests include… Read more»

hruship101 replied to the topic "Obstacles while working on a project" -

Wed, 15 May 2019 16:59:41 -0400

During my undergraduate capstone project, we created a Gantt chart using Microsoft Project to guide us and better visualize the timeline of the project. In the Gantt chart, we divided the project into three parts, brain storming, designing, and testing… Read more»

hruship101 replied to the topic "Multiple Project Managers for one project" -

Wed, 15 May 2019 16:59:40 -0400

In my experiences, I have never worked in a project with multiple project managers. Many times, there are project leads that support various activities within a project. By having multiple project managers, it makes the communication with the team difficult…. Read more»

hruship101 replied to the topic "Advice for Biomedical Engineering Students" -

Wed, 15 May 2019 16:58:26 -0400

In my opinion, the greatest advice that I would give to incoming BME students is to network as much as possible. Networking is a key tool to get internships and co-op experience. Industry experience is important to succeeding in the… Read more»

hruship101 replied to the topic "Discussion Topic: Academia vs. Industry" -

Wed, 15 May 2019 16:58:25 -0400

hruship101 replied to the topic "Discussion Topic: Practical vs. Informational courses" -

Wed, 15 May 2019 16:58:24 -0400

In my opinion, I don’t think 70:30 is a good ratio of academic courses versus practical courses. Academic courses are great in terms of getting a good understanding of the concept and processes used within medical devices. However, practical courses… Read more»

hruship101 replied to the topic "Disconnect in rewarding motivation" -

Wed, 15 May 2019 16:57:37 -0400

I believe this type of issue is very common in workforce and I am not surprised. If one wants to convey his or her message across, then without arguing with the upper management, should plan an alternate way. There are… Read more»

hruship101 replied to the topic "Why do people leave work?" -

Wed, 15 May 2019 16:57:36 -0400

Many people leave work due to different reasons. For some, it’s the family or the commute and sometimes it’s the employer and the salary. Employers should have a career path set up for their employees to keep them motivated and… Read more»

hruship101 replied to the topic "Engineer vs. Manager" -

Wed, 15 May 2019 16:57:36 -0400

This is a great question to discuss. After graduating from college, I would start working as an engineer or at least be on the technical side of a project. I believe most people choose this path to gain some experience… Read more»

hruship101 replied to the topic "Let's Be Motivated!!!" -

Wed, 15 May 2019 16:56:46 -0400

In order for a team to be motivated, the PM should consider new ideas and challenging ways on the current project. And yes I believe that the PM level of motivation directly affects the team’s productivity as the PM is… Read more»

hruship101 replied to the topic "Why do people work?" -

Wed, 15 May 2019 16:56:44 -0400

In my opinion, I believe the results above are not surprising. After talking with few people in the industry and seeing it myself through internships for 2 years, it’s clear that employees need to be challenged and that the employers… Read more»

hruship101 replied to the topic "What’s Your Motivator?" -

Wed, 15 May 2019 16:56:43 -0400

This is a really interesting topic to discuss. What motivates me is something challenging and realizing that the work I do everyday improves human life. I like it when my brain is busy doing something for a good cause or… Read more»

hruship101 replied to the topic "Integration PM" -

Wed, 15 May 2019 16:56:03 -0400

During my capstone project, we had several mini projects to accomplish in order to complete our final project. For example, our project was to create a device which measures three parameters, blood glucose, activity, and oxygen rate and transfers this… Read more»

hruship101 replied to the topic "Discussion Topic: Scope creep....when your project changes" -

Wed, 15 May 2019 16:55:56 -0400

During one of the project in my internship, I had to perform Gage R&R studies on few parts in order to validate the measuring equipment. I planned out a strategy and started working on testing out few parts. After about… Read more»

hruship101 replied to the topic "Organizational structure" -

Wed, 15 May 2019 16:55:54 -0400

This is a really interesting topic to discuss as this type of situation often happens in a workforce. During my co-op experience, I was a part of the huge transfer project in which my company acquired another small medical device… Read more»

hruship101 replied to the topic "Device Class Confusion" -

Wed, 15 May 2019 16:55:11 -0400

During my work experience, if we need to file for 510k or FDA approval, we use the flowchart developed by the company and the FDA to guide us during the entire process. The process is so broad that there are… Read more»

hruship101 replied to the topic "Ideal PM Processes vs. Real life" -

Wed, 15 May 2019 16:55:10 -0400

In my past experience with project, it is very hard to see the complete process as they are very detailed. I have seen a project follow the normal process of, Initialing, planning, Executing, and Closing. However, I was mostly involved… Read more»

hruship101 replied to the topic "FDA Recall...Now What?" -

Wed, 15 May 2019 16:55:09 -0400

I agree with most of the participants regarding product recall due to a device failure. Product recall is the worst thing that can happen to a medical device company. It can affect the business assets, the people involved and the… Read more»

hruship101 replied to the topic "Engineering change order" -

Wed, 15 May 2019 16:53:49 -0400

Engineering change order (ECO) is an official change notice that one initiate upon seeing something wrong in the process or if there is a documentation discrepancies in the engineering drawing. After the initiator fills in the necessary action, it then… Read more»

hruship101 replied to the topic "Cost Analysis of Project" -

Wed, 15 May 2019 16:53:48 -0400

In my senior design project (capstone), we were supposed to come up with an estimated project cost and track as we progress with buying parts for the project. Just like in any project, our budget varied throughout as completion of… Read more»

hruship101 replied to the topic "Importance of Logging Work" -

Wed, 15 May 2019 16:53:42 -0400

During one of my co-op experience, I worked with the design and instrument validation of many measuring devices. As a result, I was involved keeping critical notes on file because validation of a device is not something that can be… Read more»

hruship101 replied to the topic "PM: Handling Team Issues" -

Wed, 15 May 2019 16:53:17 -0400

I agree with most of the participants above regarding the issues that may arise while the project manager is out on a leave. These issues are very common in the industry and the project team must get adhere to. As… Read more»

hruship101 replied to the topic "PM: Quality Assurance Process" -

Wed, 15 May 2019 16:53:01 -0400

I agree with all the participants in the posts above regarding the role of PM and his or her duties of Quality Assurance. Quality Assurance responsibility is a huge task within Quality in a medical device industry. Few tasks that… Read more»

hruship101 replied to the topic "Challenges PM face" -

Wed, 15 May 2019 16:52:54 -0400

One challenge that the project manager face on a daily basis is the ability to properly communicate the deadlines of multiple projects. There are many active projects going on in a company. Many times, the project manager doesn’t have the… Read more»