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 ethics in medical research is still a grey area. For example, culturing cells to identify and understand the patterns and functioning of a…[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 tend to have mindsets that are focused on a direct problem-to-solution…[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 a partner
2. Other partners in the company are protected from the consequences of actions of another partner.
C-Corps of US can be…[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.
Quick ratio: 1.357
Quick ratio gives an index of the company’s liquidity position…[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 and most other partnership-based type of corporations, C-Corp does not need to get dissolved in the case of death of a partner or…[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 department should be trained about quality procedures of all other departments also. This…[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 the mind blowing technology the device uses, but all of the patients care about how well they can rely…[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 associate in the medical imaging operations of a clinical research company, we were trained twice a year on audits and inspections for…[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 medical devices even though sporadic cases of adverse effects of the device have been reported.…[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 are as important as the stability of the software running the device. In a recent article, the FDA…[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 are as important as the stability of the software running the device and both need to be regulated…[Read more]

I don’t think e-cigarettes should be classified as a Class III medical or drug delivery device. From this week’s module, in order for a device to be considered as a medical device, the manufacturer first needs to make a claim that his device would have medical benefits. Although e-cigarette companies advertise that e-cigarettes help cessation from…[Read more]

In a university setting, a university sets aside funds for an entire year for all the projects going on in the university irrespective of the type of financial need each department has in terms of research. For example, electronic parts are much cheaper and research is much easier to conduct than to buy material for say a wet lab or research that…[Read more]

There are various types of biocompatibility tests depending on the type of therapy the material is involved in delivering. One of the most important is cytotoxicity test that goes hand-in-hand with hemocompatibility. Cytotoxicity tests check for sustenance and maintaining the health of all the tissues in the body post administration of the drug.…[Read more]

I was part of clinical research where I was working on the quality control of medical images from the beginning of the trial to the end of the study. Most of the trials are carefully planned and executed as there are many lives involved and billions of dollars spent in conducting the trial. However there are a few cases where the trial is abruptly…[Read more]

While working in a team, it is usually expected that every person in the team contributes equally efficiently to all the tasks assigned to the team. This way of project management would be ideal when all the members of the team are skilled in all the tasks assigned to them. While I was working on a clinical trial study with a few new recruits, the…[Read more]

From my experience working in clinical trials projects, assigning multiple project managers for a single project depends on the size of the project, the areas of expertise that each project manager has pertaining to different areas of the project and also the geographical locations where the trial is taking place. For instance a study that is…[Read more]

After working in the industry for two years, I can say two points: companies either want a highly skilled professional in one area or someone with a variety of skills who is versatile and can adapt to any kind of role in the company. Apart from having an internship or a list of projects, I think its important that your resume points to a…[Read more]

I think the differences between working in an academic setting and working in an industry can be compared in two ways: a. efficiency and productivity and b.creativity-and-time-limitation. While working in an industry, one is required to be accountable for every minute that is spent at the work place. Industry puts emphasis on efficiency and…[Read more]

I think there needs to be a right balance of practical and informational courses in the curriculum. In any field, the requirement for informational courses would out-weigh the number of practical courses as we need a solid theoretical knowledge as a good base to excel at practical understanding.

On the other hand, there can also be a 50/50 ratio…[Read more]