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Forum Replies Created

RE: Clinical Research Experience/Course work for Biomedical Engineers

I think hands on coursework focusing on clinical trials is a fantastic idea. Echoing ag2357, having at least the option to take a class that helps with clinical trials would be extremely helpful. Ther...

In forum Clinical Research Basics

3 years ago
RE: New Drug/Device: A Clinical Trial is Limited?

I think it's important to mention that the efficacy and safety of a drug that has recently completed clinical trials has been supported, not proven by the FDA. That being said, you do get a comprehens...

In forum Clinical Research Basics

3 years ago
RE: Transitioning into Clinical Research, with Developmental (R&D) Experience (or Vice Versa)

One of my professors told me that graduate students can volunteer on a Institutional Review Board (IRB). I don't know of any clinical trials that NJIT is performing, but Rutgers University Hospital (N...

In forum Clinical Research Basics

3 years ago
RE: Which Subtype of Marketing would you prefer?

While Atharva's points about Market Research excite me (particularly looking into analytical data processing and interfacing with end consumers), I would probably most like to be a Product Manager lik...

In forum Marketing and Sales

3 years ago
RE: The Four P's

While I agree with gdecarvalho's & kaf43's assessments that all of the 4 Ps are essential, I want to make a case for "Placement". Placement determines everything about the how, where, and when the...

In forum Marketing and Sales

3 years ago
RE: Market Forecasting Techniques

Like Atharva said, time series forecasting is a popular method which has a substantial academic presence (it was the principal method used in my Supply Chain classes). Like kaf43 said, the quantitativ...

In forum Marketing and Sales

3 years ago
RE: Aspiring Entrepreneur

Speaking from experience working in (not owning) a small startup as well as a large corporation, I think your idea of starting a company may work but has a couple of very difficult challenges to overc...

In forum Business 101

3 years ago
RE: MBA/ Business degree for Engineers

I agree with the majority here that a MBA is not necessary, but helpful degree for an engineer starting his/her/their own firm. Contrasting with some of the cited reasons of credibility and networking...

In forum Business 101

3 years ago
RE: Medical device startup: Partnership vs LLC vs S-Corp

Echoing ag2357, I would not be inclined to incorporate as a partnership. Having a partnership can lead to personal issues between the partners making their way into the company. I am more inclined to ...

In forum Business 101

3 years ago
RE: organizational skills for QC

I agree with as934's assertion of need for investigative tools and mindset. I have used similar frameworks, including FMEA & 5 Why's analysis in my previous job. AVParker's description of the need...

In forum Quality Control and Quality Assurance

3 years ago
RE: Examples and ways to improve quality assurance

In the commodity chemical industry, workers safety and quality control have a lot of overlap. A lot of instrumentation, particularly reagent measurement, can have Safety Critical and Quality Critical ...

In forum Quality Control and Quality Assurance

3 years ago
RE: Regulatory Classification of Internal Adhesives

For internal surgical use, I don't see much leeway to be classified anything other than a Class III medical device. Unless it is designed to be metabolized or there is any other chemical mechanism of ...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: FDA Approval During Public Health Emergencies

This is a fantastic question, and it made me think of a couple devices that I have used in the past couple years that have had EUAs. The one I think I have used most frequently have been COVID19 tests...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: Switching to a Regulatory Career

My previous experience was not purely regulatory but had a lot of components of regulatory compliance. Things like quality testing and reporting, verification of weights and measures, and environmenta...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: Academia Grant Proposal for Medical Device Development

I concur with mmodi's response on the team member's merits, intellectual merit, and impact. I would add that the feasibility of the proposal is another important consideration. Feasibility is inclusiv...

In forum Pre-clinical Device Development

3 years ago
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