Activity | ec52 | Medical Device Courses

ec52 replied to the topic "FDA on Recalled Items" – 5 years, 11 months ago

I agree with srg36 that there is always the potential for unforeseeable risks that were not visible to the manufacturer or the FDA at the time of approval. Last month medical device maker Abbott voluntarily recalled 465,000 pacemakers to install… Read more»
ec52 replied to the topic "Discussion Topic: Revamping the 510(k) Process" – 5 years, 11 months ago

There has been some updates to the 510(k) information in response to the IOM report to clarify that FDA includes in its 510(k) review the safety and effectiveness of the medical device, although no significant changes were made to the… Read more»
ec52 replied to the topic "Combination Product" – 5 years, 11 months ago

Combination product: Insulin glargine pen injector The pen injector is intended to deliver long-acting insulin used to tread adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for control of… Read more»
ec52 replied to the topic "Discussion Topic: Brand new biomaterial" – 5 years, 11 months ago

Assessing the material biocompatibility of the product (including the material of construction and final device) is critical for successful commercialization. The tests should follow ISO 10993 and type of tests will depend on application and exposure. For example, for an… Read more»
ec52 replied to the topic "Research for the Fututre or Now?" – 5 years, 11 months ago

There is a great rewarding feeling when a product realization you worked on reaches hands of people including closed ones and help them live a better life. Both long and short term research are important and necessary. Long term research… Read more»
ec52 replied to the topic "Academia vs. Industry Research" – 5 years, 11 months ago

Research in the industry is generally faster and tend to be more successful. I would attribute many factors to the difference in performing research in the industry vs. academia. As per the lecture notes, the main reason for research in… Read more»
ec52 replied to the topic "Multiple Project Managers for one project" – 5 years, 11 months ago

In my experience, I have encountered two project managers in a project. The project managers responsibilities were split; one was responsible for overseeing development activities at suppliers and the other development activities at our company. This approach was successful and… Read more»
ec52 replied to the topic "Discussion Topic: Portfolio, Program, Strategy" – 5 years, 11 months ago

Portfolio is composed of all the programs that the company has and programs are composed of projects which in turn are composed of tasks as described in this week’s lecture. Companies make strategic choices in which activities to implement in… Read more»
ec52 replied to the topic "Discussion Topic: Project Management in a medical device setting" – 5 years, 11 months ago

Some of the challenges for doing project management for medical devices compared to building a skyscraper are; the requirements of highly regulated medical device industry and the level of collaboration that need to be orchestrated across the project team. There… Read more»
ec52 replied to the topic "Advice for Biomedical Engineering Students" – 5 years, 11 months ago

My advice would be to try to get into co-ops/ internships/ part-time or full-time job if possible even if not directly related to the area you would like to work. As Dr. Simon indicated, there is high demand for certain… Read more»
ec52 replied to the topic "Discussion Topic: Practical vs. Informational courses" – 5 years, 11 months ago

I believe the current academic vs. practical ratio of courses provided by NJIT is the right balance. I think it is primarily important to have a strong academic background based on theoretical concepts of the disciplines studied which will then… Read more»
ec52 replied to the topic "Discussion Topic: Academia vs. Industry" – 5 years, 11 months ago

There are pros and cons in academia and industry careers and it will be a decision of preference in lifestyle that the person would like to live. Some people start in academia and retire in the industry, while I have… Read more»
ec52 replied to the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

This is a good point you bring up, however I do not fully agree with the skepticism disconnect in how the industry rewards motivation. While this is definitely an issue within any industry, based off my experience it is in the minority of cases and heavily dependent on the company’s culture. In addition, it can be attributed to the lack of l…[Read more]
ec52 replied to the topic Choosing a CRO in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

For many companies, particularly the smaller ones engaged in clinical trials, outsourcing might not be so much a choice, but a necessity. As we know, clinical trials can be often very complex projects and it isn’t often feasible to conduct the whole process in-house, nor does it make sense from a financial perspective. Thus, it is critical to c…[Read more]
ec52 replied to the topic Priorities for Projects in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

When identifying project priorities it is important to keep in mind some guidelines that can help balance these priorities within the project scope. Before funding a product design project, priorities must be studied, particularly in the case of medical devices. One approach to work with multiple priorities is to rank them (e.g. 1-low, 2-medium,…[Read more]
ec52 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

What motivates me is the desire to make products for those less fortunate and to know that I have made a positive difference in someone’s quality of life. An example is my current job in which I am part of a team that develops devices for combination products. It is rewarding to see comments in the internet about how the product helped improve p…[Read more]
ec52 replied to the topic Overworked Americans vs. Motivation in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

Studies show that Americans work longer hours and have more stress-related illness than their European and Japanese counterparts. Some of this is due to stagnant wages and outdated overtime laws, but some of the problem is embedded into, particularly in technology and finance jobs. I believe that motivation is part of the reason why Americans work…[Read more]
ec52 replied to the topic Factors to look for while preparing schedule and budget for Clinical Trial in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

In order to prepare a schedule and budget for a clinical trial there are several factors to consider.
The schedule of clinical trials is basically an outline that contains all the activities that will be performed during the clinical trial. This schedule serve as a plan that will allow sites to strategically and smoothly conduct a study. Look at…[Read more]
ec52 replied to the topic QA vs QC in the forum Project Management Knowledge Areas 5 years, 11 months ago

QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations.

Quality assurance is process oriented and focuses on defect prevention, while quality control is product oriented and…[Read more]
ec52 replied to the topic Six Sigma and Project Management in the forum Project Management Knowledge Areas 5 years, 11 months ago

The Six Sigma methodology offers a structured and disciplined process for solving business problems and ensuring product/processes are within acceptable margins of error. Six Sigma uses tools designed to identify root causes for the defects in processes that keep an organization from providing its customers with the consistent quality of products…[Read more]
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