Tod Brubaker
By Tod Brubaker, Creative Director, KHJ Brand Activation
A few days ago, I was having lunch with colleagues at a restaurant near our Seaport offices. We had great Mexican food and a fabulous view of the water.
But what really got my attention was the menu – an iPad. There was one for each of us.
From my days working as a waiter during college, I couldn't help wondering how many were spilled, dripped and slopped on. Our waitress admitted to trashing 3 of them.
Edward Berger
Reimbursement Row
Lisa McCallister
Continued from Part One…
From the second endoscopy center, we drove down to a hospital where they rep had recently sold a Beamer system, an electrosurgical unit which can be used to stop bleeding in the digestive track. Unlike surgeons, who love blood almost as much as vampires, the rep explained that the tension level in the endoscopy suite usually goes through the roof when there is a “bleeder”. He told me that some of the cautious G.I. doctors in rural areas will send their patients to urban hospitals at the first suspicion of blood.
Both internal and external fixation devices assist in proper bone healing. Despite this similarity, differences exist between devices and this is reflected in how they are tested.
ADMET testing machines are capable of multiple methods of testing fixation devices. This includes simultaneous Torsion and Tension testing and Torsion testing with a pulley counter balance weight. Read more.
Tim Mohn
Tim Mohn is an industry principal in Sparta Systems’ product management group. In this role, Tim is responsible for helping both Sparta and Sparta’s clients track and understand changes in the regulatory environment and trends in the life sciences industry. He previously served as worldwide quality systems manager at Ortho-Clinical Diagnostics, a division of Johnson & Johnson. At OCD, Tim championed eMDR and SAP integration activities, owned the CAPA process and supported multiple FDA inspections at OCD's locations. Prior to J&J, he worked at Pfizer Consumer Healthcare and Wyeth Pharmaceuticals. Tim holds a B.S. in Biology and a Masters in Manufacturing Management from Penn State.
There's nothing you can do about looming changes to the 510(k) program. But you can take the time to make sure your internal processes are up to snuff.
Arne Carlson, the former governor of Minnesota, recently contributed an opinion column to the Minneapolis Star-Tribune, voicing concerns about increased Food & Drug Administration regulation of the medical device industry stifling innovation. The column came as Dr. Jeffrey Shuren, director of the FDA's Center for Devices & Radiological Health, prepared to visit the state — one of the country's biggest medical device hubs — for a town hall meeting to discuss CDRH's 2010 Strategic Imperatives and hear feedback from industry officials.
07/05/2010 - 09:00
Will support for repealing the medical device tax repeal from Elizabeth Warren, who's dazzled liberals and raised big bucks from left-wing groups across the country in her run for the U.S. Senate, help generate more support among Democrats for killing the medical device tax?
Elizabeth Warren, who's hoping to become the junior senator from Massachusetts, has credited herself with providing the intellectual foundation for the Occupy Wall Street movement.
Her opponent, incumbent Sen. Scott Brown (R-Mass.), has portrayed her as a "far-left ideologue" who has the "Harry Reid Democrats, the Hollywood Crowd, the Far Left Juggernaut, the Occupy Wall Street Bunch, and the Massachusetts Machine raising money hand-over-clenched fist," according to a campaign email.
China's 12th Five-Year Plan outlines three initiatives with respect to medical devices:
- 1. Increase the development of China-made medical equipment.
- 2. Implement centralized procurement
- 3. Purchase domestic medical devices.
The health care reform for the domestic medical device industry provides unprecedented opportunities for Chinese biomedical development.
Tinker Ready
Kennedy passes the healthcare reform baton to Dodd
Sen. Ted Kennedy, ill and unable to attend the ongoing Senate health reform battles, appeared in a campaign video this week for his old friend, Sen. Chris Dodd (D-Conn.). Kennedy basically said Dodd is going to be key in the push for health reform that has been, according to Kennedy "the cause of my life." (Aside from running for president, perhaps?):
"Today more than ever, we have a real opportunity to bring health care reform to Connecticut and all across America. And I believe that, with Chris Dodd's leadership, our families will finally have accessible, affordable health care."
Tinker Ready
David Spenciner
Dollars and Spence
Blogs
By Merrill Goozner
Much has been written about the travails of the pharmaceutical industry. Generic competition is reducing profitability as leading blockbuster drugs like Pfizer's Lipitor lose patent protection. Biotech generic competition is on the horizon.
By: Marsha Henderson, M.C.R.P.
For one week in May, the nation celebrates women's health. I often find at these celebrations that no one mentions FDA. This is unfortunate, because throughout its100-year history FDA has played a leading role in advancing women's health.
By Stewart Eisenhart, Emergo Group
A new agreement between the Global Medical Device Nomenclature Association (GMDNA) and a key provider of clinical terminology should further drive global adoption of GMDNA codes among healthcare providers.
The Honorable Margaret Hamburg, Commissioner, FDA and Dr. Christopher Hickey, Country Director, FDA China
By: Christopher Hickey, Ph.D.
I love history. I especially love the story of Meriwether Lewis and William Clark who, in their famed venture to explore the newly-purchased Louisiana Territory at the direction of U.S. President Thomas Jefferson, fashioned a lean and mean team largely consisting of seasoned, highly qualified frontiersmen.
By Merrill Goozner
Over the angry protests of consumer groups, Congress is moving rapidly – and in bipartisan fashion – to give drug and medical device companies an easier path to Food and Drug Administration approval for some products in exchange for sharply higher user fees to fund the agency.
By John D. Halamka, MD
Recently, I've met with several internet startups, web thought leaders, and venture capitalists.
There's one word that's come up in every conversation and it's not Plastics. It's Gamification
Gamification, described by Wikipedia is applying gaming principles to non-gaming applications and processes,
By John D. Halamka, MD
I've written many times about the Bring Your Own Device movement (BYOD) and the need for increasing security controls.
For years, we've controlled device settings on Blackberry devices with the Blackberry Enterprise Server (BES). We force passwords, encryption, and device memory wipes for ten failed passwords so that every user has enterprise enforced security
