NDA would not substitute for the patent. NDA is helpful for your legal case when the person who signed the NDA uses company’s idea as his own. However, NDA is not useful when the person who signed the NDA reveal…   Read more»

I think that oral agreement are often looked upon warily because they are not easily enforceable. Contract that are written are can be easily presented for a legal defense than the oral testimony. It is also difficult to remove contract…   Read more»

I work at the company which manufactures dental prosthetics. I consider this organization as a functional based one since this organization structure is a hierarchical organization structure wherein people are grouped as per their area of specialization. Each department have…   Read more»

One of the method to use from the design perspective is R & M or reliability and maintainability. As a Design engineer, I want to make sure that the product will be reliable after further use. The product should also…   Read more»

There were a lot of mistakes can be made while implementing the FMEA. The mistakes cause the FMECA not meeting the objectives of it. Conceptually, Poka Yoke is able to fit into the Process FMEA. Failure Mode and Effect Analysis…   Read more»

I believe that design controls should be part of the process used to determine the commercial viability of a product in development. Design input requirements can help customers and stakeholders identify and satisfy product requirements. Another vital part of the…   Read more»

A mission statement communicates the organization’s reason for being, and how it aims to serve its key stakeholders. Customers, employees, and investors are the stakeholders most often emphasized, but other stakeholders like government or communities can also be discussed. A…   Read more»

The four branch model as the construct of emotional intelligence: (1) the ability to accurately perceive, appraise and express emotion; (2) the ability to use emotion to facilitate thinking; (3)the ability to understand the temporal course and probable outcome of…   Read more»

I have not been a part of the audit during the the FDA or BSI visits. However, I have been called during the visit regarding the documents that I have written. Their main objective was to clear out the inconsistencies…   Read more»

In 2016, the FDA issued a final deeming regulation that will regulate e-cigarettes as tobacco products, but the regulation, while addressing some key policy issues, still leaves significant regulatory gaps. In addition, the regulation will be phased in over the…   Read more»

There are many differences between doing research in academic and industry. I have had experienced both during my career. Amount of time given to the research in industry may not be as comparable to academics. However, proper structure in industry…   Read more»

The tests to assess the biocompability of the material should follow ISO 10993. The following tests should be done on the biomaterial for verification and validation of the product: Evaluation and testing within a risk management process, tests for genotoxicity,…   Read more»

While working on a project, we hit a roadblock during the verification phase. Before this obstacle, we have already spent most of our time and budget on the project. Before submitting 510k for our product, we had to complete a…   Read more»

I think the challenges are different for other industries as opposed to medical device. These differences are in the regulations involved on a project of respective industries such as building a school. For instance, projects in the medical device industries…   Read more»

I think initiation and planing phase is most important because in this phase you define your baseline. During these phases we gather the requirements and specifications for the project. Scope is defined in these phases which gives better picture of…   Read more»

Since working in both academia and industry, I have experienced both pros and cons. Working in academia allows you to take in-charge of your project and choose your own direction. You can freely choose your own objectives and goals regarding…   Read more»

I think this is not an appropriate ratio because students need more exposure to the practical tools to succeed in the industry. Practical knowledge allows you to gain the specific techniques that become the tools of your trade. Practical knowledge…   Read more»

I want to keep working as an Engineer because I will be directly involved in the project. Engineer also have an important part to perform in the project. If an engineer’s job is done so poorly as to make the…   Read more»

I would take the opportunity to review the financial stability of the vendor as problems often mean an unprofitable company.I would also look at the performance of the vendor coupled with their direct and indirect benefits is compared to the…   Read more»

There was an instant when one of our lead Engineer was removed from our team. This really pushed our timeline of our project back several week since we had to evaluate and assign his tasks to another member. The project…   Read more»