hruship101

Forum Replies Created

RE: Discussion Topic: The de Novo 510(k) Process

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. F...

In forum Regulatory Basics for Medical Devices

8 years ago
RE: Discussion Topic: Beyond experimental design issues

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, i...

In forum Pre-clinical Device Development

8 years ago
RE: Academia vs. Industry Research

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 ...

In forum Pre-clinical Device Development

8 years ago
RE: Discussion Topic: Brand new biomaterial

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....

In forum Pre-clinical Device Development

8 years ago
RE: Obstacles while working on a project

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...

In forum Intro to Project Management

8 years ago
RE: Multiple Project Managers for one project

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 m...

In forum Intro to Project Management

8 years ago
Milestones Missed: Failure or Success?

During a project, we set milestones to achieve. However, due to certain circumstances, we cannot meet the deadline that results in missing a milestone. Missing a milestone can be either a failure by...

In forum Intro to Project Management

8 years ago
RE: Advice for Biomedical Engineering Students

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...

In forum Introduction to Medical Device Development

8 years ago
RE: Discussion Topic: Academia vs. Industry

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...

In forum Introduction to Medical Device Development

8 years ago
RE: Discussion Topic: Practical vs. Informational courses

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 ...

In forum Introduction to Medical Device Development

8 years ago
RE: Disconnect in rewarding motivation

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 alter...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Why do people leave work?

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 employe...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Engineer vs. Manager

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 ...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Let's Be Motivated!!!

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 produc...

In forum Project Management Application: Clinical Trial

8 years ago
RE: Why do people work?

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...

In forum Project Management Application: Clinical Trial

8 years ago
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