Medical Edge Newsletter Archive
Medical Edge May 22, 2012
The first batch of organizations to receive Health Care Innovation awards are looking to use telehealth technologies to save money....
Medical Edge May 15, 2012
Last month’s MedicalDesign.com Reader Poll asked readers about how their companies approach industrial design. Only 13% said their companies use in-house industrial designers exclusively, while 20% said their companies use outside designers only....
Medical Edge May 8, 2012
Covidien and GE Healthcare , which are both known for patient development of monitoring and respiratory care devices, have announced a five-year, global collaboration to incorporate Covidien measurement technologies into GE Healthcare patient monitors. Covidien is clearly in a growth mode. This follows on the company’s recent acquisition of Oridion Systems to build on its respiratory care applications....
Medical Edge April 24, 2012
AdvaMed’s three-year, four-goal strategic plan is proactive, but it lacks certain details leaving us to wonder how the goals will be accomplished in the months ahead. ...
Medical Edge April 17, 2012
FDA has published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during premarket review....
Medical Edge April 10, 2012
New method for measuring the physical strain place on surgeons during procedures should shape device designs. ...
Medical Edge March 27, 2012
A significant change to the US advanced medical technology industry’s operating environment—such as the soon-to-be-implemented medical device excise tax—could cost tens of thousands of jobs, lower personal incomes, and reduce business opportunities worldwide, according to a new study released this week by AdvaMed....
Medical Edge March 20, 2012
If you’ve ever had to deal with multiple doctors for yourself or a loved one, chances are you’ve experienced frustration over what appears to be a void in effective information-sharing between the docs. Why does this happen? Dr. Vineet Arora, assistant professor of Medicine medicine at the University of Chicago, believes what’s causing the problem isn’t what people often assume. ...
Medical Edge March 13, 2012
The Patient-Centered Outcomes Research Institute (PCORI) held a National Patient and Stakeholder Dialogue February 27 as part of its effort to obtain feedback on its first draft National Priorities for Research and initial Research Agenda....
Medical Edge February 28, 2012
Tracking tax reform continues to be a high priority for AdvaMed as evidenced by its response to President Obama’s framework for business tax reform....
Medical Edge February 22, 2012
Sunshine Act: AdvaMed comments aimed at clarifying context, ensuring accuracy of posted data...
Medical Edge February 15, 2012
A tentative agreement on a new “Medical Device User Fee Act” by FDA, AdvaMed, and other trade associations, including MDMA and MITA, coupled with an announced tax reform push beginning with the repealing of the $20 billion medical device tax (2.3% levy), made this month an important one for medtech. ...
Medical Edge January 24, 2012
Ford in lead for in-car healthcare...
Medical Edge January 17, 2012
InHealth seeks study proposals to examine the impact of medical technology for controlling healthcare-acquired infections...
Medical Edge January 10, 2012
Battelle report and MedicalDesign.com poll show more R&D spending in 2012...
Medical Edge December 13, 2011
Legislation to modify FDA mission statement would encourage innovation and protect US jobs...
Medical Edge December 6, 2011
Polls reflect industry concerns...
Medical Edge November 22, 2011
Franken legislation would lift profit cap on some medical devices...
Medical Edge November 15, 2011
More portability and plastics in 2012...
Medical Edge November 8, 2011
FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation...
Medical Edge October 18, 2011
IBM's Watson wows 'em at Cleveland Clinic Summit...
Medical Edge October 11, 2011
FDA commissioner outlines steps to spur biomedical innovation ...
Medical Edge October 5, 2011
Are you ready for medtech's new normal?...
Medical Edge September 27, 2011
FDA has set in motion two new training programs designed to improve the consistency of medical device reviews “by enhancing the skills of those reviewing premarket applications at the Center for Devices and Radiological Health (CDRH),” the agency says. ...
Medical Edge September 20, 2011
This month’s Republican debate drew fire from National Nurses United (NNU>, a national organization of registered nurses, over a candidate’s response to a question about healthcare and the response of some audience members. ...
Medical Edge September 14, 2011
The medical device tax, if implemented, could cost tens of thousands of jobs, almost double the industry’s total taxes, raise the effective tax rate to among the highest in the world, and harm US competiveness, according to a study released today by AdvaMed....
Medical Edge August 23, 2011
In just a few short weeks, Sept 7 and 8, Medical Design's first-ever Medical Prototyping Conference (MPC) will be held in Minneapolis, home to a slew of medtech companies....
Medical Edge August 9, 2011
Behind the scenes: A candid chat with Ray Briscuso on AdvaMed 2011 ...
Medical Edge August 9, 2011
AdvaMed, the Advanced Medical Technology Association, announced last week that Boston will be the first city outside of DC to host its annual medical technology conference since it was launched in 2007....
Medical Edge July 26, 2011
The Subcommittee on Oversight and Investigations today held a hearing titled “Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs” to examine the state of the medical device industry and the impact regulations and policies at CDRH have on patient access, innovation, and job creation....
Medical Edge July 19, 2011
Medical Design’s first-ever Medical Prototyping Conference (MPC) is fast approaching, and if you have anything at all to do with the design and development of medical devices you and your colleagues really need to make plans to be in Minneapolis September 7-8....
Medical Edge July 12, 2011
Medical technology association AdvaMed has sent additional comments to the IRS regarding the taxation of certain types of devices including combination products, kits, and rented or leased items....
Medical Edge June 21, 2011
Value-driven engineering (VdE) is the focal point of a plan developed by a group of leading biomedical organizations that assembled last March at A Safe Haven Summit in Washington, DC...
Medical Edge June 14 2011
There is most certainly a better way to handle medical device approvals in the US. That was the consensus of testimony to the US House of Representatives Committee on Oversight and Government Reform hearing June 2. The hearing, titled ‘FDA Medical Device Approval: Is There A Better Way?’ elicited some new suggestions and reiterated many of the findings of recent studies....
Medical Edge June 7, 2011
Findings from an industrywide 510(k) study conducted by researchers at Northwestern University and funded by Washington, DC-based InHealth (Institute for Health Technology Studies), are significant, yet hardly surprising. More than 350 professionals engaged in medical device development participated in the online survey, which was discussed during a recent (5/24) webcast....
Medical Edge May 24, 2011
The leaders from nine medical technology associations worldwide have signed the "Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs)," in an effort to further advance ethical behavior globally. ...
Medical Edge May 18, 2011
Following up on the success of its Medical Silicone Conference (MSC) events, Medical Design is pleased to announce its first-ever Medical Prototyping Conference (MPC)...
Medical Edge May 10, 2011
Advances in semiconductors could change treatment of Parkinson's ...
Medical Edge April 19, 2011
FDA's Medical Device Innovation Initiative, a priority review program for breakthrough medical devices, is the subject of a recent eight-page AdvaMed document. Signed by Janet Trunzo, executive vice president of technology and regulatory affairs, it includes praises and a detailed critique of the FDA effort. ...
Medical Edge April 12, 2011
In the new world of healthcare, social media plays a big role ...
Medical Edge April 5, 2011
Air your views now...
Medical Edge March 22, 2011
The US medical device industry is increasingly focusing on how to reinvigorate innovation, and US companies are seeking new entrepreneurial models, both culturally and corporately, as they grapple with how to make that happen within their own organizations....
Medical Edge March 15, 2011
The world-famous Medical Silicone Conference—ok, maybe that’s a stretch—but it is a premier niche event and now’s your chance to be a part of it for just $100, so long as the job you call yours is with a medical device OEM...
Medical Edge March 8, 2011
A new study on the 510(k) process missed the mark and drew the ire of industry groups AdvaMed and the Medical Imaging & Technology Alliance (MITA)...
Medical Edge February 23, 2011
Last week’s U.S. House of Representatives Energy & Commerce Health Subcommittee hearing on the “Impact of Medical Device Regulation on Jobs and Patients"...
Medical Edge February 15, 2011
Innovation and competition. These go hand in hand and they are the topic of nearly every press conference and land on the agenda of almost every industry meeting...
Medical Edge February 8, 2011
With so many changes, reforms, and challenges facing the medtech industry, it’s essential for OEMs to keep up in order to stay ahead...
Medical Edge January 19, 2011
FDA’s Sentinel System, the national resource under development for medical product safety surveillance, was the topic of a workshop Jan 11 and 12. Convened by the Engelberg Center, the workshop focused on the impact of the system...
Medical Edge January 11, 2011
Predictions bode well for medtech...
Medical Edge January 5, 2011
Device companies with cash will dominate M&A activity...
