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,...
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....
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...
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...
Richard Flynn
Although device company executives may dream of developing the next pacemaker, the reality is that most successful products are more modest than one of the industry’s most significant medical breakthroughs. When looking at a device manufacturer’s...
Sustainable manufacturing practices in the medical device industry are based to a great extent on the concept of resource productivity. These practices seek to manufacture products using fewer resources (i.e., energy, water, and materials). The materials that are used should have...
Adapting social media to the business world obviously requires more than just tweaking the Facebook or Match.com models. The belief that a well-constructed social media platform can be an effective business tool for the device industry fired the imagination of Peter von Dyck. A...
Amid the ebb and flow of our national debate over healthcare reform there is one certainty: The business of making and selling healthcare products as we have known it is a thing of the past. Our reform mandate of “better care at lower cost” requires medical device...
James Juo
The medical device industry is one of the more litigious when it comes to patents. The legal scenario described next is all too common. A competitor sends you a letter asserting that your company's new medical breakthrough device infringes its patent...
Candela Corp. and Syneron Medical Ltd. have merged in an all-stock transaction, following a shareholder vote on January 5, 2010. Upon completion of the transaction, Syneron shareholders own approximately 80% of the combined company and Candela shareholders own approximately 20%....