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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»

I think when a person signs up for their body samples to be used for research purposes, they lose the right to have a say regarding what happens to their samples or how they are being used for research. But…   Read more»

People who have chosen majors that coincide or overlap with healthcare are generally inclined towards knowing and understanding human body and its functions. Their mindset is geared towards working for solutions from a clinical perspective while engineers from other backgrounds…   Read more»

Two of the similar type of US corporation structures that can be compared with to Indian corporations are the LLP and C-Corp. The pros of an LLP in India are: 1. Corporation need not be terminated in the death of…   Read more»

I researched on the company Medtronics for the financial year ending April 2016. Gross Profit Margin: 68.7% Net Profit Margin: 31.9% Current ratio: 1.749 Given the healthy range of current ratio falls somewhere between 1.2-2.0, Medtronics is doing quite well….   Read more»

If I were to own a company, I would choose the C-corp type of ownership. With C-Corps, with the advantage of being taxed like sole ownerships, it allows to re-invest profits at a lower corporate tax rate. Unlike the LLP…   Read more»

I think Quality department cannot be treated as a stand-alone entity in the company ensuring quality at every stage of product development. As the quality department ensures quality in every other department and the whole process of product development, each…   Read more»

I think new technology that has huge potential should not be delayed in reaching to the people who really need it. But once the product reaches them, its stability, durability and reliability take center stage. There maybe patients who appreciate…   Read more»

The main purpose of an audit or inspection is to check if the regulatory standards are being followed in the way and magnitude that they need to be followed by the company. While I was working as a quality control…   Read more»

The report by the institute of medicine talks about how the 510k process has become burdensome and time-consuming and addressed the inadequacies of post market regulations of medical devices by the FDA. The report mainly focuses on under regulation of…   Read more»

Blood glucose monitor can be considered a combination product as the sensor/ test strips that detect the blood glucose and the software that computes the calculation of these glucose levels are two different aspects of the device. The test strips…   Read more»