By Stewart Eisenhart, Emergo Group Emergo’s latest survey of more than 3,000 medical device industry participants finds renewed focus among companies on US and European markets, as well as more bearish expectations for BRIC markets and greater challenges addressing regulatory compliance. Get the full story here at the Emergo Group’s blog. The opinions expressed in […]
FDA offers Pre-RFD program for combination products
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has issued new draft guidance clarifying the agency’s Pre-Request for Designation (Pre-RFD) process whereby combination product manufacturers may request initial feedback regarding classification and regulatory oversight questions. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post […]
How UnitedHealthcare and Qualcomm are boosting wearables
UnitedHealthcare and Qualcomm are taking employee fitness to the next level—by offering $1,500 a year to employees who participate in wellness program and reach the set daily fitness goals. Qualcomm has expanded the UnitedHealthcare Motion wellness program that gives employees activity trackers for free. It is available for self-funded employers who have 5 or more […]
This 3D bioprinter can make functional human skin
A group of scientists in Spain has created a 3D bioprinter that can 3D print functional human skin, one of the first living human organs created with bioprinting. The bioprinted skin mimics the structure of human skin. It has an external layer—the epidermis with its stratum corneum—that protects against environmental factors and a thicker, deeper […]
Building the business case for clinical research training
Most clinical research study sponsors recognize that having a properly trained research staff is key to ensuring compliance and bringing their device to market faster. The question is, how do you implement an effective training program that achieves your organization’s desired goals? This paper addresses the three Bs – buy-in, bandwidth and budget – and […]
Does your medical device and IVD sales need an import license in India?
By Stewart Eisenhart, Emergo Group India’s medical device registration system is still transitioning to a more formalized and predictable framework, which has raised questions from foreign manufacturers about what regulators do and do not currently require for market authorization in the country. In many cases, one requirement foreign firms can be sure of is the […]
The ICH E6(R2) Addendum: An intro to the what and why of the changes
By Katie Mitchell Since finalization in May of 1996, the Guideline for Good Clinical Practice E6(R1) produced by the International Conference on Harmonization (ICH), has provided clinical trial research with a set of procedural standards to ensure quality data and protection of human subjects. The document has continued to be a guiding presence in the industry […]
Inside the largest medical acquisition in history
Heather Thompson/Senior Editor Trust between Medtronic and Covidien officials helped them overcome the political blowback from the two companies’ $50 billion merger of equals, which moved Medtronic’s official headquarters from Minnesota to Ireland. That was a major takeaway when Brett Wall, former president of Covidien and current president of the neurovascular business at Medtronic, interviewed […]
Women in medtech: Making gains but not there yet
Sarah Faulkner/Associate Editor When IBM Watson Health general manager Deborah DiSanzo, a 30-year medtech veteran, began as a project manager at Apollo Computer, there were plenty of women working beside her. Three decades later, DiSanzo said, “I can now point to one woman who’s still in medtech from that.” The anecdote illustrates the continuing gender […]
FDA delays final guidance plans for laboratory developed tests
By Stewart Eisenhart, Emergo Group US medical device regulators at the Food and Drug Administration have put on hold plans to publish final guidance regarding laboratory developed tests (LDTs) in order to develop a more appropriate oversight approach, according to the agency. The opinions expressed in this blog post are the author’s only and do […]
Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology Center of Excellence launch
Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers. The FDA is taking important steps to formalize […]