A patent is when we do/think of something unique and has not been done yet, only then we are eligible to apply for a patent. While an NDA is something that can be applied to the thing in which you…   Read more»

I think the gift restriction is a good thing as not all companies are at the same level in terms of their budget, one company has the best product but not much capital can easily fall short in pleasing the…   Read more»

A written agreement is the one done on paper and signed by the people agreeing on the contract/ terms within the document. A verbal agreement is when both parties agree to certain terms verbally and that’s it.The advantage of a…   Read more»

So, we had decided to meet on video call as its difficult to manage to come for an in-person meet every week, we have completed the DDP, DID and have come up with Pre-Clinical, clinical and regulatory first draft.So we…   Read more»

While forming a team I don’t think getting a person who you know on a team will benefit unless the person is good at the job that he/she has to perform as in the end we want a completed project…   Read more»

I would prefer working in a matrix organization as there is direct communication within the team and there are no silos nor is there any competition within themselves are they are assigned a simple task of completing the project on…   Read more»

For a low severity risk, we can accept the risk depending on its occurrence or try to mitigate the risk.While or the high severity of the risk should be either avoided but it will be a huge loss as it…   Read more»

The first option is to design it out, which is ideal as the product is not in the market yet and if there are any design changes that can be done to reduce the risk then they should be adopted.The…   Read more»

FMEA is ideally used for risk management as it gives an idea as to where and how the product might fail and what impact each of the failures will cause on the overall project.Also, rate each risk according to its…   Read more»

FDA will first see that the product does not provide any risks to the person, also make sure that the standards set by the FDA are followed by the manufacturer and have a look at the Design Control Document especially…   Read more»

Design controls are FDA guidelines that are required for making a device. Design control has a set of files under them such as the DID, DSD, DHF, etc which are essential in bringing a device in the market which is…   Read more»

Gantt Chart gives an idea of all the tasks that are needed to complete and project or a part of a project within a particular time frame considering the working hours, sick leave, time required for procurement of material from…   Read more»

Design control is important as it sets the workflow of the product in the market if is insufficient Design Control then there will be no direction as to how the product will be built and there will be a lot…   Read more»

Design inputs are basically determined by the management, market research, users, Sales representative, and the research Scientist if he can make the product. The Design inputs are not specific as the DSD is responsible for the exact specifications for the…   Read more»

Meeting minutes are written documentation for the attendees and the non-attendees to know what happened in the meeting and highlight all the important changes that were discussed in the meeting, additionally, it helps to keep a track of the timeline…   Read more»

Single Blind study is the one where only the Patient is not aware as to what drug he is getting, while in Double-Blind Study both the investigator as well as the patient is not aware of the drug being the…   Read more»

Update to the topic:The right to try law passed in May 2018 has only 2 patients as of June 2019 being accepted for experimental therapy.Even I see no negative issues with the law and ideally, more people should have made…   Read more»

Placebo-controlled trials are the trials where we place a dummy device on a group of patients randomly selected individuals.I feel it is ethical and is necessary for studies as mentioned by Dr.Simon in his video that the information provided to…   Read more»

I have seen a lot of food joints using red and white, while the red color as mentioned above invokes hunger, the white color represents innocence, a purity so lots of food companies do use it.On the other hand, lots…   Read more»

Emotional intelligence is to be aware of the person’s emotions and handle the situation accordingly.I support the article but it should also be considered that both sides are trying the best for themselves, the sales rep trying to get a…   Read more»