Thursday, March 28, 2013

The U.S. Food and Drug Administration (FDA) Medical Devices Information

FDA website is a rich resourse for learning industry medical devices. Warning letter to related companis can be studied to  sum up experience. Warning Letters. 

Establishment Registration & Device Listing in Medical Device Database provides detailed information of the company in a medical device which is same with your product.

Production Classification provides medical device classifications, product codes, FDA premarket review organizations, and other regulatory information.

Recognized Consensus Standards, 510(k) Premarket Notification, and Premarket Approval databases are very useful as well.

Saturday, March 16, 2013

A Good Summary of Medical Device Regulations in the Main Global Markets.

A Good Summary for fast learning medical device regulations in the main global markets can be download from SGS.

Saturday, March 9, 2013

Identify Opportunities in New Product Development from Errors

We can learn and identify new opportunities from our mistakes as the famous saying "Failure is the mother of success."

In addition to surgical needs and market analysis, problems、adverse events, and errors of existing products is an effective way to find the opportunities for new product development. They also provide important information for risk management of medical device. The following online resources can be used as references.

Sunday, March 3, 2013

Free Online Class in edX: Financial Analysis and Decision Making

A very good and free online Classroom: edX.
Financial Analysis and Decision Making class from Tsinghua University in China.

Stocks investor need read company annual report. How to analysis and evaluate a company and its operation is a basic skill for stock investors. Although reading serveral good books in this areas before, this online class in edX let me recall and summary company's finance, especially some special entries of balance sheet, income statement, and cash flow statement in China companies' reports.

Saturday, March 2, 2013

Business-Driven Research and Development

As a R&D scientist and engineer in industrial area, although I think they share some common parts in problem-solving skills and applying knowledge people have mastered, business or market-driven R&D has many different points with interest, paper or even funding-oriented research. 

The book "Business-Driven Research and Development:Managing Knowledge to Create Wealth" by Ashok S. Ganguly, who was the Unilever R&D manager, enhance my understanding about industrial R&D. The author grew from a researcher to a R&D manager. This experience makes the author to be more closer real world of industrial R&D, which is not impossible for professors in businees schools. The book states that the primary role of industrial R&D is to fulfill strategic objectives of the company within a framework of time and cost targets. The author tries to give the means to improve competitive advantage of the company through overcoming the gap between R&D and the market place.