Alina Kolenovic

Forum Replies Created

RE: The Role of Different Users in Device Development

This prompt brings up a really good point about how diverse user needs can be. We already know that user needs are the driving factor behind design controls and the development of a new medical device...

In forum Introduction to Design Controls

7 days ago
RE: Why Packaging and Labeling Matter in Medical Devices

The requirements of device design are incredibly important to ensure the device performs successfully and prevents any harm to the patient, but packaging and labeling are just as important in both of ...

In forum Introduction to Design Controls

7 days ago
RE: When meeting the Spec is not Enough: Verification vs. Validation

Design verification and design validation are two incredibly important processes that work in tandem to ensure successful device design and future manufacturing. Device verification focuses on the tec...

In forum Introduction to Design Controls

7 days ago
RE: Validation Study Success Defined

One of the major processes that a team must take in order to define their success criteria is learning and understanding their customer needs. There is little value in creating a device that does not ...

In forum Introduction to Design Controls

2 weeks ago
RE: How Many Design Reviews Are Enough?

It is difficult to say how many design reviews are “enough” because the amount of reviews really depends on the product, its intended use, and any associated risks. I think that all teams should have ...

In forum Introduction to Design Controls

2 weeks ago
RE: Customer Needs and Design Input

Both documents are necessary to communicate key aspects of the device design. The DID design input document is primarily used for addressing high-level, broader design inputs such as the specific user...

In forum Introduction to Design Controls

2 weeks ago
RE: Diversity and Inclusion in Clinical Trials

I agree that diversity and inclusion in clinical trials is very important. As mentioned in the prompt, white males used to dominate the clinical research field, which is problematic because researcher...

In forum Clinical Research Basics

3 weeks ago
RE: Benefits for Patients in Clinical Research

I do believe that patients taking part in clinical trials should be paid for their contribution. People may have to take time off from work, spend money on gas or public transport, pay for childcare, ...

In forum Clinical Research Basics

3 weeks ago
RE: Can AI Replace Human Participants in Clinical Trials ?

I don’t think that AI will ever be able to fully replace human participants in clinical trials. The human body contains too many complex processes and interactions to be captured by a computational mo...

In forum Clinical Research Basics

3 weeks ago
RE: Importance of building TRUST as a Sales Rep

Personally, I know a little bit about sales through my father who has spent a lot of time working as a sales rep for, first Quest Diagnostics, and now LabCorp. For his work he is specifically focused ...

In forum Marketing and Sales

4 weeks ago
RE: Branding as an Engineer

I do not have any background in branding, and I do not know if I would be a great fit with my current qualifications. I feel like branding is more along the lines of what a marketing or communications...

In forum Marketing and Sales

4 weeks ago
RE: Is the Best Medical Device Always the Best Selling Product ?

I would say that the best medical device is not always the bestselling product. I feel like the quality of the medical device is incredibly important, but that the marketing strategies of the company ...

In forum Marketing and Sales

4 weeks ago
RE: S or C Corperation

S-Corps and C-Corps are two types of corporations that share a number of key benefits: limited liability, stability in the case of shareholder death, ability to sell shares to raise money, and ability...

In forum Business 101

1 month ago
RE: 80% margin

I agree with the idea that a profit margin of 70-80%, at the minimum, for medical device sales is unethical. There must be so many medical devices that have sufficient safety and efficacy but will nev...

In forum Business 101

1 month ago
RE: Business Courses for Engineering Students?

I feel as though an additional business-only course would be very beneficial to all engineering students. Prior to taking IE492 I had little exposure to project management or business concepts outside...

In forum Business 101

1 month ago
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