Advertising, Distribution, and Sales
Streamlining the Complaint-Handling Process
In merchandising, customer satisfaction plays a significant role in measuring a product’s postmarket performance. It is also an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for...
As Social Media Evolves, the Device Industry Must Also
A growing number of companies—from technology start-ups to the Fortune 500—are participating in a phenomenon that goes by several different names, such as social media, social networking, the social Web, and Web 2.0. Although the experts can argue over the nomenclature,...
RAPS Takes Regulations to China
Photo by iStockphoto With its healthcare sector undergoing rapid development, China needs a strong foundation of regulatory knowledge for its researchers, engineers, healthcare professionals, and even the government. The Regulatory Affairs Professionals Society (RAPS;...
Psst: Your Customer Knows Something You Don’t
Welcome to an all-too-familiar customer service experience. You call into a customer service department because your new gizmo isn’t working. Ring. Ring. A machine voice answers and leads you through a generic menu that doesn’t address your problem. “Representative...
Iran: A Missing Piece of the Puzzle
Image by iSTOCKPHOTO There is an important export market for U.S. medical devices that manufacturers may not know about: Iran. Despite the imposition of strict economic sanctions that generally block all U.S. exports to Iran, U.S. law specifically permits companies to...
Best Practices
 Medical device manufacturers have much to gain by using social media, such as increased access to patients and users. The benefits, however, are tempered by restrictions that FDA has placed on companies. Therefore, OEMs must be diligent and careful in their use of social media...
Health Reform in 140 Characters
While Congress is abuzz over the prospect of healthcare reform, many in the medical device field are atwitter over the explosion of Internet-powered healthcare reforms already taking root. Regardless of whether Congress passes a public health insurance option, a bent cost curve, or...
Social Media Uses in Health Care
 Common uses of social media in the healthcare arena include the following:  Public relations and media. Advocacy and stakeholder relations. Building communities. Cause marketing. Disasters and public health emergencies. Customer service. Clinical trial recruitment. Data...
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....
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...