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Forum Replies Created

RE: The Four P's

I feel that all 4 of these P's need to work in unison in order to truly market a product towards a successful lifecycle so it's hard to single one out as "most important". If I had to choose, I would ...

In forum Marketing and Sales

3 years ago
RE: Branding as an Engineer

I have had no previous experience in branding or graphic design, but I have felt that I think I have an eye for what looks good or what looks pleasing to a consumer. When I see certain types of logos ...

In forum Marketing and Sales

3 years ago
RE: Auditing Bodies

In addition to the poster above - there may be changes in regulations when transitioning to MDSAP. Because the program is now including at least 5 different regulatory organizations that all have diff...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: FDA vs EMA drug approval rate

To bounce off of the ideas from the poster above me, the fact that the FDA is only managing the drug/device development process within a single country while EMA must govern the entire continent of Eu...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: FDA Approval During Public Health Emergencies

I think that the EUA is a great way to push forward critical use medical devices and applications to the general public in times of dire crisis and emergency. For a regulatory agency such as the FDA w...

In forum Regulatory Basics for Medical Devices

3 years ago
RE: Stability testing importance

One common device that comes to mind where stability is extremely important would be a stent. A stent is like a type of scaffold that is designed to help keep arteries open to allow blood to flow easi...

In forum Pre-clinical Device Development

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

For me, I would like to feel confident that the project is going to see completion. This aligns with many of the points that previous posters have already called out - a timeline with actions for each...

In forum Pre-clinical Device Development

3 years ago
RE: Academia or Industry

I am currently working in industry and I love the fast-paced environment and pressure. It almost feels like I've grown up in this environment and it's all I know so far, however I would be curious to ...

In forum Pre-clinical Device Development

3 years ago
RE: Clinical trials when exporting medical devices to other countries.

It's definitely trickier because outside countries have much different regulations than the US or wherever the medical device originates from. There may even have to be a redesign of the project or at...

In forum Project Management Application: Clinical Trial

3 years ago
RE: Engineer vs. Manager

It can be said that it is an ultimate goal for most people to end up in a managerial position (perhaps even a director or even higher), while I have held some managerial positions as well as engineeri...

In forum Project Management Application: Clinical Trial

3 years ago
RE: Lessons Learned Documents: When to look back

It's always important to look back at any lessons learned document because as you said, knowledge transfer is key. I've seen too many times where a new hire comes onboard and really lacks a lot of cri...

In forum Project Management Application: Clinical Trial

3 years ago
RE: Quality control in small projects.

I agree with @anthonynjit above - sometimes budget is not there for smaller projects therefore there is less QA/QC support on that end. A company needs to prioritize at the end of the day. I think in ...

In forum Project Management Knowledge Areas

3 years ago
RE: Complications with Management Sectors

Recently I've taken on a role as a production scheduler at my company, so in terms of being a "leader" for one of the management sectors I've taken on planning for some of these projects. I think one ...

In forum Project Management Knowledge Areas

3 years ago
RE: Vendor Decision

My decision in the mini-sim was to go with only one other vendor. The ask was for at least one other vendor to source the coating from for the project therefore I thought it unnecessary to look for 2 ...

In forum Project Management Knowledge Areas

3 years ago
RE: How to speed up the problem-solving process

I think I would ask my team where we think the roadblock is coming from and see what I can do to help the situation. Problem solving sometimes is best done as a group and I wouldn't want my team to fe...

In forum Project Management Process and Medical Device Development

3 years ago
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