Business
Performing a Patent Search
The following are a range of online resources that can be used to search for existing patents: USPTO. The official U.S. patent database enables searches for issued patents and patent applications. Features of the site include both a quick and full patent search. Full-page images...
How Well Do Your Outsourcers Serve You? Hint: They Could Probably Do More.
It’s not enough these days for a contract manufacturer to simply provide a product or service. OEMs should be able to ask more from service providers, especially in the face of healthcare reform, a proposed device tax, and the ever-present pressure to reduce costs....
Looking Beyond Outsourcing to True Partnerships
Fluidics platforms are often used in medical applications such as clinical chemistry instruments, hematology instruments, and urine analyzers Medical and diagnostic device OEMs often look to outsourcing and contract manufacturing to reduce labor and assembly costs per unit...
Consultants Get a Voice
Adusei says that IAMTC will provide industry-driven, professional development and training courses to meet the needs of the consultants and the industry as a whole.  Several medtech professionals have banded together to create the International Association for Medical...
The Need for Compliance as a Business Strategy
   Numerof    Abrams    Rothenberg Viewed broadly, increasingly strict compliance requirements are part of an array of steadily growing pressures that the medical device industry faces, including rising product development...
California’s Biomedical Industry Healthy, but Could Lose Its Edge
The health of California’s biomedical industry, which constitutes one-third of the U.S. biotech, medical device, and diagnostic firms, is often considered an indicator of the well being of the entire sector. According to the “2010 Report: California Biomedical Industry,...
How To Avoid Off-Label Device Promotion
Sara E. Dyson Severe legal penalties await companies that promote the use of their medical devices for procedures unapproved by FDA. Federal law prohibits such off-label promotion, but the practice occurs frequently in the medical technology and life sciences industries....
The MX Q&A: QED’s Hiroyuki Fujita
Given the implications, seeing the words “MRI” and “rapid growth” in the same sentence are usually cause for anxiety, if not alarm, for the person reading them. Hiroyuki Fujita can read them with calm satisfaction, however. In just three years, Fujita’s...
Managing Compliance-Based Valuation of Start-Ups
  With the advent of IRS Section 409A and the introduction of certain fair value accounting rules, valuation issues have become increasingly important for start-up companies. In the past, industry specific start-up “rules of thumb” may have been sufficient to...
Essential Principles for a UDI System
■ UDI should be technology neutral. ■ The UDI database should use an existing, globally accepted data exchange process to share information about device safety. ■ Every manufacturer should maintain the uniqueness of its UDI code for a device worldwide. ■ Globally accepted...