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reshamn replied to the topic Discussion Topic: The cost of Quality in the forum Quality Control and Quality Assurance 8 years ago
Quality control is very essential in building a successful business that will deliver products and exceeds customer’s expectations. There are many reasons why quality control plays such an important role for a company. It allows to compete in the industry well. If a company is following proper quality standards, it is obvious that it will be a far…[Read more]
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reshamn replied to the topic Discussion Topic: Android app for measuring blood glucose in the forum Regulatory Basics for Medical Devices 8 years ago
In January, 2015 permitted the marketing of mobile apps for continuous glucose monitoring. That release was specific to Apple iOS supported applications. As mentioned above, Dexcom Share Direct Secondary Displays system is first of its kind to offer a legally marketed solution for continuous monitoring. This device has a small wire like sensor…[Read more]
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reshamn replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 8 years ago
FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products.” E-cigarettes are included in the category of ENDS — Electronic Nicotine Delivery Systems — products that use a liquid containing nicotine and varying amounts of flavor, glycerin, propylene glycol and other ingredients. This liquid is heated into an aerosol that…[Read more]
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reshamn replied to the topic Discussion Topic: Revamping the 510(k) Process in the forum Regulatory Basics for Medical Devices 8 years ago
The FDA is continuously improving its 510k process to keep themselves aligned with the evolving technology and new devices. However, the Institute of Medicine report points out that the existing process was never meant to screen out the inefficacy in products. The biggest issue at hand is that the existing process only requires the companies to…[Read more]
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reshamn replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 8 years ago
Apart from the ISO Standard, Carcinogenicity is a crucial test for a biomaterial.Carcinogens are classified according to their mode of action as genotoxic or nongenotoxic carcinogens. The conventional test for carcinogenicity is the long-term rodent carcinogenicity bioassay.There could be even co-carcinogens that do not necessarily cause cancer on…[Read more]
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reshamn replied to the topic Discussion Topic: Beyond experimental design issues in the forum Pre-clinical Device Development 8 years ago
Why wouldn’t these same departments be as as slow at a CRO? -Josh
According to Pharmamodels, “When evaluating the growth of CROs, the statistics show it all. Seven years ago, the biotech and pharmaceutical industry spent $60 billion of which $15 billion was outsourced. This means that CROs accounted for 25 percent of the market seven years ago, a…[Read more]
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reshamn replied to the topic Approaches to Research in the forum Pre-clinical Device Development 8 years ago
Flexibility is the biggest advantage for an academic research scientist. There is not only flexibility in terms of your working schedule but also the flexibility on the topic of research as well. However, scientists working in the industry, for an instance in a startup, are working around the clock to achieve results due to limited funds and work…[Read more]
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reshamn replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management 8 years ago
Apart from the abiding by the FDA rules and the medical device industry being highly regulated, the actual execution the project management cycle is very critical. If a company is building a skyscraper that it is not a novelty. The basics of architecture are already known and been applied many times over. The architect may be creative and slightly…[Read more]
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reshamn replied to the topic Project Life Cycle in the forum Intro to Project Management 8 years ago
All phases of the project life cycle are very important in order for a successful project. However, planning phase is extremely crucial for the project. This stage basically the core of the project where every aspect of the project is properly laid out. It is almost like a blueprint for the project. Many aspects of the planning phase are very…[Read more]
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reshamn replied to the topic Obstacles while working on a project in the forum Intro to Project Management 8 years ago
I was working on a software enhancement project which consisted of a large team of 15 people. Since the team was so big and mostly comprised of fresh graduates, communication became a huge problem. Due to this, the team did not meet the mid-way deadlines for the go-live of a component within the software. After the mishap, the project leader…[Read more]
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reshamn replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 8 years ago
Coming from own personal experience, the amount of practical classes should be increased especially in the undergraduate programs. I agree the foundation needs to very strong in order to be successful. However, companies look for specific skill sets. Different tools, machines, or knowing certain softwares separate you from your entire graduating…[Read more]
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reshamn replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development 8 years ago
Fortunately I was able to work both in academia and industry. Personally, I prefer the industry simply for the reason that you sooner or later you will be rewarded for your effort. There is room for lot of growth in the industry both experience wise and financially. Although one is restricted to a 9-5 lifestyle but the company that I worked for…[Read more]
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reshamn replied to the topic Advice for Biomedical Engineering Students in the forum Introduction to Medical Device Development 8 years ago
Though you may not like to take that career route but while applying for my first job, a lot of job positions required knowing one programming language. To be very frank, MATLAB is very restricted to labs only. I have yet to come across some across a company who use MATLAB regularly. Besides it’s always good to know basics of coding as the…[Read more]
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reshamn replied to the topic Advice for Biomedical Engineering Students in the forum Introduction to Medical Device Development 8 years ago
While I agree with the posts above, but not so long ago I used to get the same advice from my seniors. However, getting an internship is extremely very difficult regardless of your grades and experience. Sometimes it’s just plain luck. One advice from me would be to get proficient with at least one programming language. As an NJIT alumni, Dr. Erdi…[Read more]
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reshamn became a registered member 8 years ago