I agree with rd389 and Ibraheem shaikh with regards to respecting a person’s consent. Nowadays, IBR makes it a must for potential participants to be briefed with full information of the outcome and benefits form the test. In the case of compensation, it is generally nominal but certainly, there is a room for improvement. I believe that we should…[Read more]

I agree with dipanpatel regarding the ownership of IP. I also believe in having a good lawyer to have a look at the agreement before they go onboard the with the study. Some firms have a strict policy of IP ownership and some are flexible with IP claims. Also, if the lab is not investing but assisting with the study, more or less, the innovation…[Read more]

In your case, Let us say that there is a new pill developed to treat Alzheimer’s. In the clinical trials, generally with an existing medicine or placebo, the new pill is tested and is it will be a randomized control test. If the doctors do not know which participant gets what, the results concluded by them are based on the findings from the test…[Read more]

Unlike many consumer products, MedTech companies cannot employ same strategies to promote their products. One serious way that can attract many physicians and healthcare professionals is by creating compelling case studies. Case studies share insight on positive patient outcomes, reduce operational costs, increase productivity, lower readmission…[Read more]

The only way to increase the market share of your company is by showcasing that your product is much more superior or sometimes cheaper than the others. To a certain extent, I would say the companies try to influence your decision rather than manipulation. If marketers employ covert tactics to manipulate customers, then they run the risk of being…[Read more]

I want to introduce a cellular network firm (JIO networs) that recently disrupted the market and already has more than 100 million subscribers within one year of its launch in India. The strategy that it employed was a freemium strategy when you lure in potential customers giving everything for free but charge a premium for additional features. By…[Read more]

The main three reasons for the Courts to pierce the corporate veil and impose personal liability on officers, directors, shareholders, or members when

1) There is no real separation between the company and its owners:
For instance, if the owner pays personal bills from the business checking account or ignores the legal
formalities that a…[Read more]

father can execute sale deed for transfer of assets and liabilities of sole proprietary concern by father in name of 2 sons. There are other ways such as simthshah said is by converting it into LLP. Another way is by executing the gift deed and transfer all the capital to his two sons as a gift but the only catch is, the gift deeds are very hard…[Read more]

I prefer to getting into a partnership with someone who understands the objective and gives valuable insights into how to grow the business big. A partnership is a major commitment and risk associated would have a dent on your personal savings. If a person is fully committed to the views and objectives of what the other person shares, then its a…[Read more]

I have no experience in this matter but, from product development cycle, I can pull out few points. R&D and QA may have major conflicts are during revisions of features while prototyping a deceive. R&D’s duty is to innovate and bring about a competitive edge to the company and keep the company in business. However, while in the stage of…[Read more]

I believe that medical devices act as a tool for treating or diagnosing a patient and hence, it may play a bigger role than doctors themselves in some instances. While doctors, nurses and other medical staff are held to a rigorous performance standard, It is the responsibility of Medical device manufacturers to meet the highest standard of quality…[Read more]

I believe that while FDA certifies devices and products for safety, the Quality of the device needs to just above the minimum requirement. Most competitive companies try to achieve much better quality to get the edge over others. No doubt certain times, regulatory bodies fall short in covering up loopholes while setting standards. When…[Read more]

Even Though it’s FDA’s responsibility to test and certify a product safe for clinical use, they are not held responsible for the mistake. The manufacturer are responsible to produce a safe and a reliable product. However, with every recalls, the FDA’s credibility is at stake. Also, with particular recalls, identifying such loopholes pave ways to…[Read more]

I Feel FDA rules are more like a filter to bad products from entering into market. With lot of competition in the market, some companies tries to cut corners and save time or even money. Since, any company’s main motto is to create a product that makes money and have a good business plan, FDA has to intervenes and protect public health by a…[Read more]

I agree with Ibraheem Shaikh. Many affordable medicine or medical devices are developed by new firms that are also smaller in terms of financial resources. When every aspect of innovation and translation to a product is a big hurdle, this revised fee may detrimental to such companies.Even though such bills go through several revisions before…[Read more]

I personally prefer to work in an industrial environment where the lifespan of the research is short. My motivation and driving force are the results from the research that I do. Since, research in industries have immediate results and have greater impact in short term, it’s easier to do get involved in many projects and see their success rather…[Read more]

I agreeance total with dag56,i would like to add few points. In an Industry, the deadlines are generally based on a necessity and the resources are allocated accordingly where money is not a constraint. When a new project is started and timelines are set, groups or teams with various skills are assigned to get the job done within the timeline.…[Read more]

I totally understand where this question arises from. Until we find another alternative, the only two options left are humans and animals. The objective of pre-clinical study is to find a solution i.e, a drug or a new device for humans (in general). There is also certain aspects of ethics during pre-clinical trials such as GLP without which it is…[Read more]