sm2744

Forum Replies Created

RE: Benefits of post-market surveillance

Post market surveillance is required but also it is very important. It is important because when you design a device, you can try to account for many risks but you will probably not account for all ri...

In forum Risk Analysis for Medical Devices

3 years ago
RE: Risk Management Team =/= Project Team

As mentioned by my peers, conflict of interest would most certainly be the biggest issue with the risk management team being made up of members of the project team. If its a company that lacks morals,...

In forum Risk Analysis for Medical Devices

3 years ago
RE: Risk Management in Different Project Phases/Areas

As others have mentioned, I also believe that risk management is the most important during the planning phase. It is because in this phase, the developer should think of all possible interactions that...

In forum Risk Analysis for Medical Devices

3 years ago
RE: Minutes for meetings

Taking meeting minutes is very important. It summarizes important project information such as design changes or deadlines. It covers what the meeting was about. In addition to summarizing information ...

In forum Introduction to Design Controls

3 years ago
RE: Gantt Chart Thought Process and Considerations

As mentioned by some of my peers, my exposure to Gantt charts was primarily with Capstone 1 and 2. In creating ours, my team and I split up the tasks into different sections: research, acquiring mater...

In forum Introduction to Design Controls

3 years ago
RE: Consequences Of Insufficient Design Controls

Insufficient design controls can lead to failure of the device on the market and mass recalls. With medical devices, there is also a the risk that it could fail during use which could be very dangerou...

In forum Introduction to Design Controls

3 years ago
RE: Validation failure

As a validation engineer, in the event that the customer had a complaint, I would first record how we didn't meet the customer need. I would hold a meeting with the customer representative and discuss...

In forum Introduction to Design Controls

3 years ago
RE: Design Specification document

As mentioned by my peer, capstone was a great introduction to what may go into a design specification document. My group worked on creating a microfluidic device that could hold stem cells in scaffold...

In forum Introduction to Design Controls

3 years ago
RE: Design Review Meetings: Attendance & Causes for Scheduling

I think that both a customer representative and manufacturer should be included in the design review meetings when possible. The customer representative could offer insight into areas overlooked by th...

In forum Introduction to Design Controls

3 years ago
RE: Informed consent: What if Henrietta Lacks checked No for research use?

I think that patients should always have the option to elect "no" for research use regardless of how impactful it may be for the larger scientific community. In a perfect world, civilians would help t...

In forum Clinical Research Basics

3 years ago
RE: Placebo-controlled trials: Are they ethical? Are they necessary ?

I think that placebo controlled studies are ethical and necessary for clinical trials. Conducting a PCT provides the researcher with data that can show if the treatment that the patient receiving is h...

In forum Clinical Research Basics

3 years ago
RE: Clinical Research Experience/Course work for Biomedical Engineers

As my peers have mentioned, I also believe that students would greatly benefit from a class that dives more into the clinical aspect of industry. As mentioned in the responses, the only way that stude...

In forum Clinical Research Basics

3 years ago
RE: Discussion Topic: The Fifth "P" of Marketing

A clever marketing tactic that I noticed was for a celebrity that owned a clothing line. They know that their fanbase goes crazy over any of their announcements so instead of just posting an instagram...

In forum Marketing and Sales

3 years ago
RE: Marketing vs. Sales

I agree with ag2357, I think that both careers have an overlap in knowledge and that they rely on each other. I'd say that the biggest difference between the two would be that marketing is more focuse...

In forum Marketing and Sales

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

I think that starting out, I would prefer Market Research just like Atharva. I could work in commercial insights & analytics and see what opportunities the company can take to increase their reven...

In forum Marketing and Sales

3 years ago
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