-
su65 replied to the topic Discussion Topic: The Fifth "P" of Marketing in the forum Marketing and Sales 7 years, 9 months ago
Social medias have become popular advertising sites too. The fifth p, participation, is easily now a days being used in social medias like facebook, twitter, instagram, linkedin etc.Companies adverstise their product by making a short videos which can attract and seek attention of people so that they watch it. This happens a lot in facebook.…[Read more]
-
su65 replied to the topic Family Businesses in the forum Business 101 7 years, 10 months ago
Sole proprietorship cannot be passed on or transferred from dad to his sons. Unfortunately if dad dies, then the assests/company cannot be taken by his childern. His sons has no rights on the company their dad created. So in case of sole proprietorship, the company held by a person is solely his/hers. It cannot be transferred to their future…[Read more]
-
su65 replied to the topic Partnership characteristics in the forum Business 101 7 years, 10 months ago
I would prefer considering Partnership in future. Partner should share a common goal and should agree the hoped-for outcomes, impacts and business for their partnership as a whole. Partners should recognise and accept that each partner organization has the right to accept benefits specific to them. The partners should ensure that specific goals…[Read more]
-
su65 replied to the topic Public vs. Private Companies in the forum Business 101 7 years, 10 months ago
Public companies has shares which can be traded publicly on a stock market. Private company becomes a public company when it offers the shares of the company to public. Public companies are run by a board of directors. This is because the firm will be compelled to increase shareholder value. Shares that increase in value are more desirable for…[Read more]
-
su65 replied to the topic Discussion Topic: The cost of Quality in the forum Quality Control and Quality Assurance 7 years, 10 months ago
The cost of the quality is very much important for a company. Quality department ensures that the product is safe before marketing. Product is tested for its safety and standard regulations set up are followed. This sets up the confidence in the customers about the product’s safety and reliability. This brings the company profit by putting the…[Read more]
-
su65 replied to the topic R&D vs Quality in the forum Quality Control and Quality Assurance 7 years, 10 months ago
R&D department works on advancement of technolgy to give a product which would help people. Quality department monitors the safety of the product before reaching the people. Quality department sees all the department as to whether the quality requirements and standards are being maintained throughout the product development. Both the departments…[Read more]
-
su65 replied to the topic Relation of Quality with other department. in the forum Quality Control and Quality Assurance 7 years, 10 months ago
The bad relationship or conflicts between R&D department and quality department can be tried to sorted by involving the quality department into other teams, meetings and discussions from the beginning of the project. Team representatives from quality department should be involved in the discussions during the development of the ideas for the…[Read more]
-
su65 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 7 years, 10 months ago
Recently, Bella Pharma voluntarily recalled its unexpired sterile drug products like B-complex, Methylcobalamin, Mannitol etc. The lots from April to August 2017 wree recalled. This happened due to lack of sterility assurance. The sterile drug component which had to be sterile was not sterile and that would cause serious infections which was life…[Read more]
-
su65 replied to the topic Combination Product in the forum Regulatory Basics for Medical Devices 7 years, 10 months ago
Transdermal patch is a combination product which is used to deliver drugs through skin. Currently around 17 drug molecules are approved by FDA for transdermal delivery. The patch has micro needles which will deliver the drug through the skin. The application pathway for this would be submitting application at CDER under NDA/ANDA because the the…[Read more]
-
su65 replied to the topic Discussion Topic: The de Novo 510(k) Process in the forum Regulatory Basics for Medical Devices 7 years, 10 months ago
The de Novo 510K process is classification procedure to classify the new medical devices which are not previously classified. The new rule has made the process easy by getting approval without the submission of 510K approval. An application is sent to the FDA, FDA evaluated the risk possessed by the device and classifies it into Class 1,2 or 3…[Read more]
-
su65 replied to the topic Approaches to Research in the forum Pre-clinical Device Development 7 years, 10 months ago
Research in academia is mostly ones passion to denote their time in innovations and research for the unknown outcome. It might also be personal in addressing a problem to find a solution. Research in academia is not money oriented and it is based on individuals interest to carry out research on their own with no limited time frame.
Research in…[Read more] -
su65 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 7 years, 10 months ago
Depending on the usage/category of Biomaterials, like surface biomaterials, implants, they must undergo different types of testing which are set by ISO 10993 standards like cytotoxicity, genotoxicity, sensitization, chronic toxicity, carcinogenecity. For example, a surface biomaterial should be tested for its interaction with body tissues and also…[Read more]
-
su65 replied to the topic Research for the Fututre or Now? in the forum Pre-clinical Device Development 7 years, 10 months ago
I was very much interested in doing research in academia which would benefit people after a long time. But after working in academia research and seeing people getting benefited right away from industrial research, my passion started drifting towards industrial research. Seeing people getting benefited from the research product you develop is…[Read more]
-
su65 replied to the topic Project Life Cycle in the forum Intro to Project Management 7 years, 10 months ago
Planning and execution phase remains the most important phases. This is because in planning phase all the proper steps which are to be performed are laid out properly and in an orderly manner like allocating resources, setting deadlines, budget and cost estimation etc. The work or steps to be carried out in all the other phases is set right here…[Read more]
-
su65 replied to the topic Milestones Missed: Failure or Success? in the forum Intro to Project Management 7 years, 10 months ago
Missing a milestone in the path of the project is considerd as a failure. However, that is not the end of the project or that doesnt mean that there is any compromise in the project in regard with its quality/reliability/safety/durability. There should be another plan ready to be executed incase of failure. If the delay for the milestone to be…[Read more]
-
su65 replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management 7 years, 10 months ago
Being a project manager for a medical device company is more challenging than a project manager for skyscraper building company. Medical devices should pass the FDA regulations which is more complicated than the regulations followed by a skyscraper building company. Medical device should pass regulations like good manufacturing process (GMPs),…[Read more]
-
su65 replied to the topic Professions in Academia and the Industry in the forum Introduction to Medical Device Development 7 years, 10 months ago
Academia and Industry have their own advantages and disadvantages. I have been working in academia (research at NJIT) from 6 months and also have previous industry experience for an year. In research field, to put our ideas, create and/or invent is time consuming and the result at the end would be promising. Also, a person can choose the…[Read more]
-
su65 replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 7 years, 11 months ago
I believe academic and practical classes ratio should be 50:50. Knowing the basic required knowledge on a subject is as important as knowing where and how it is applied. Industry demands more practical knowledge than theoretical knowledge. But the base for practical knowledge do come from theoretical or information knowledge. Real world experience…[Read more]
-
su65 replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development 7 years, 11 months ago
In academia, you can do the project having flexibility in the timing. Sometimes i used to go to lab at nights and finish my work. You can extend the deadlines depending on the time taken by the work to complete. This is where your personal efforts matter a lot and to be more responsible in completing the project since there is no one to give you…[Read more]
-
su65 became a registered member 7 years, 11 months ago