As NDA is a confidentiality agreement between two parties but information is still disclosed to a second party and does not guarantee complete protection. Whereas a patent is a document filed with the government and not another entity who has business interests that might involve using your original idea and breaching the contract. In any case,…[Read more]

I think the consultant was definitely violating the NDA agreement by using templates that even have ‘logos’ of other companies. It shows that he does not honor the terms and conditions of the NDA agreement with his client and puts into question his work ethics especially while dealing with confidential information. It might also give one an idea…[Read more]

I think in order to be a good team player and form a well-rounded project team, one has to make sure that the team has people with diverse skills who can add value to the project. Assuming that every team member can minimally maintain a professional relationship with every other member of the team, preference should be given to the value and…[Read more]

My personality traits are suited more towards middle management style of management. In my previous work experience, functioning as a team and dealing with problems from a team’s perspective rather than an individual perspective was one of my appreciated qualities at work. I think in order to climb up the ladder to become an efficient upper…[Read more]

A good product retains its original/intended use and provides the desired results. In order to check if the design of the product during the course of its development is delivering the desired outcome at every stage without compromising the end result, verification is required.

Verification helps to keep in check the timelines and the quality of…[Read more]

In my point of view, I think there can be three types of sources of design input:
1. Modifying a similar design from previous models to suit our present needs
2. Using previous designs as a basis to create new and improved design, not necessarily similar or a replica of the previous design
3. Using two or more previous designs to crate a new…[Read more]

I think communications management plan and team list/responsibilities plan are equally important part of DDP. Communications management plan provides instructions and guidelines on who to contact and the right questions to ask to resolve an issue during the course of a project. Team list/responsibilities plan is equally important as every member…[Read more]

Design controls are required to:
1. Deliver the intended use and functionality
2. Ensure safety and reliability
3. Ensure human factors pertaining to design control are considered and addressed in the final design of the device
Failure to meet the above criteria would mean that the device has not met the sufficient design control requirements.…[Read more]

Currently, the Indian medical device and pharmaceutical market is largely unregulated and medical devices can be freely imported into the country. The Ministry of Health and Family Welfare and the Central Drugs Standard Control Organization (CDSCO) are the two regulatory bodies that are responsible for overseeing medical devices within India. The…[Read more]

I think maintaining a DHF is necessary and beneficial from a company or device designer point of view but not for device approval. Every product goes through several iterations, changes and modifications before arriving at the final design. As the product is approved or submitted for approval based on the final model of the design, in favor of the…[Read more]