The newly completed immunoassay and chemistry analyzer, Atellica Solution, designed to address common clinical laboratory challenges. It integrates immunoassay and clinical chemistry analyzers with the new standard in sample-management technology so you can focus on driving better outcomes. It was…   Read more»

Vision Statement: Describe the company values and purpose. Also emphasize on desire future of the company Mission Statement: Defines clearly how the company does business, Its goals and its approach to reach those objectives. Both Vision and Mission statement are…   Read more»

A clever use of Participation will be through social media. Participation requires brand responses and engagement on at least the major social medias like facebook, twitter, instagram and snapchat. Adidas usage of theme/ hashtag and creative influencer campaigns on social…   Read more»

Becton, Dickinson and Company Financial Report 2016 Revenues $ 12,483 Gross Profit Margin 48.0% Return on Revenues 7.8% Return on Total Assets(G) 5.6% Return on Equity 13.2% Debt to Capitalization(H) 57.2% Net Income 976 Operating Income 1,430 Dividends Per Common…   Read more»

If I were to have ownership of a corporation, I would choose Corporation (S Corp. or C Corp.) Pros 1. Personal asset protection. 2.There is limited liability for business debts and obligations 3. Tax flexibility on personal income. Cons 1….   Read more»

Public companies sold all or a portion of itself to the public. It’s Issues publicly traded stock and there is no limits to numbers of shareholder it could has. While, private companies are own by a small numbers of shareholders/…   Read more»

The company will be better off to exist as an “Inc.” corporation than an “LLC”, first Corporation has limited liability, so the investors and owners are not generally liable for business debts and other liabilities. While an LLC, does has…   Read more»

I can see how quality is a burden if it’s not well executed, GxP for example which guides quality manufacture, testing, development and approval of drugs. These guidelines ensure that a product is safe and fulfills its intended use. If…   Read more»

To have a good quality control department the following should be done; A. Have a document management system in place. This will speed up documentation and no longer have to wait weeks for paper documents to make their way around…   Read more»

The ways to overcome such shortcoming and making sure procedures are also followed using R&D and Quality team as an example: first, the quality team must have appropriate product-specific technical expertise. They should have experienced in R&D field and contribute…   Read more»

Documentation control involves tracking document changes, revisions, and maintain of relevant versions company’s policies and procedures. This process takes significant amount of time when manaully done. The use of documentation management system would help reduce the lagging time for review…   Read more»

What kind of regulatory pathway would be required for an antibiotic-releasing hip stem? CDRH Regulatory. Class 2 – Special Controls Is it a device, drug, biologic, or combination? Combination What is its “primary mode of action? Treatment of hip joint…   Read more»

combination product: Vosevi. It is use for treatment of adults with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with mild cirrhosis. It’s department is under Biologics Regulation, CBER. And requires Premarket Approval Application (PMA). A CBER ->…   Read more»

De Novo classification process involves new, novice unclassified devices using a risk based strategy to determine their class; class I, II or III. An application drafted by Medical Device Sponsor is sent to FDA to determine device type along with…   Read more»

FDA is not rigid instead they’re doing their best to protect public health by assuring the safety and efficacy of drugs. It will be devastating to its mission statement if a life-threatening product is approved and release to market. The…   Read more»

It’s unethical but was the best method until recent when computer models are developed to simulate human biology. Animals like mice and rats share many physiological and genetic similarities with humans, animal experimentation can be tremendously helpful for furthering medical…   Read more»

Issues that would need to guard against when outsourcing an animal study to a university located about 1000 mi (1600 km) away from the company are as follow; Poor study design, time management, not enough money, communication and inappropriate bond…   Read more»

An animal study is one of the most important steps in the process of translating biomaterials to clinical applications. But before going further to clinical trials, ISO 10993 standard will be ran to find out the initial biocompatibility of the…   Read more»

Industry projects are faster and tend to have higher rates of success due to large capital available for research and the quality level of experience team of engineers and scientists put together to work on the product. Also, not to…   Read more»

Working in the industry, not meeting project deadline happens all the time. As a product engineer in a reliability engineering department, obstacle faced was design failed to work and new design team was formed to redo project. Mechanical part of…   Read more»