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 […]
Medical device industry laws in the wake of “Hard Brexit”
By Ronald Boumans, Emergo Group In 2016, we discussed the possible options for what a Brexit could look like and what the British prime minister meant with “Brexit means Brexit.” The official date of announcing formally that the United Kingdom wants to leave the European Union is fast approaching. Get the full story here at […]
RFID-coded welding tools add security to medical assembly
Herrmann Ultrasonics is going to introduce two features to ensure more safety when changing welding tools within the production process at MD&M West this year. An RFID reader has been integrated into the tooling that guarantees that the right tool is installed for the production. Not only is it built into the sonotrode, but also […]
FDA Advisory Committees: Independent, Informed, Essential, and Evolving
By: Robert M. Califf, M.D. One of the most common concerns raised when I meet with medical leaders is the need to improve the function of FDA’s Advisory Committees (ACs). ACs play a key role in FDA’s decision-making process by providing independent expert advice on extraordinarily complex issues. Just as importantly, they offer a forum […]