Anyone in the medical device business knows there is a sizeable intellectual property hazard to doing business in China, but one wonders if the rewards merit the risks. The answer at this point in time is apparently yes, but will it stay that way? As this report points out, China’s government hacked three medical device firms last year, and it is widely known in Washington that China (and Russia, while we’re at it) has an official policy for hacking and IP theft....

Much to my father’s utter disappointment I’m sure, I did not inherit the sci-fi appreciation gene. I never understood the cult phenomenon created by Star Trek and have always preferred living in the now over fantasizing about the future. While I’ll never be able to call myself a Trekkie, I have slowly gained an appreciation over the years for technology that seems to have been plucked right off the fictional starship USS Enterprise. A fascinating example of this, as Spock would say, is the rise of 3-D printing. The advancement of 3-D printing, also known as additive manufacturing, is predicted...

The news is out that the Supreme Court (SCOTUS) passed on the chance to hear Medtronic v. Stengel, one of the more recent cases tackling FDA’s preemption of state tort law for PMA devices, so maybe it’s time for a preemption check-up. First, it may be instructive to ask “why not Stengel?” The case had bounced from a district court (which dismissed the suit against Medtronic) to the U.S. Ninth Appeals Court, which handed it back to the lower court after seeming to suggest...

This week in med-tech history:  Nine years ago this week the biggest news in Medical Device Daily was Guidant’s recall of nearly 50,000 implantable defibrillators, coupled with the company’s failure to alert customers of the danger of one of the devices for nearly three years after it was aware of a problem. On June 21, 2005 MDD reported that the Guidant recall created a serious issue for Johnson & Johnson, which at that time was planning to buy Guidant for $25.4 billion. But of course when we fast forward a bit to January 2006, we know that deal never went...

Sometimes it's fun to revisit events in the past and see how things have changed in the meantime. Here are three stories that made the pages of Medical Device Daily five years ago. 2009’s drug balloons Germany’s Nena sang of 99 red balloons in 1983, but TCT 2009 included a session on drug-eluting (or drug-coated) balloons. In the September 28, 2009, edition of MDD, I covered a discussion at TCT of whether the then-novel guidance for drug-eluting stents was of any value for developing drug-coated...

The behind-the-scenes story of Medicare coverage of low-dose CT (LDCT) screening for lung cancer is not the kind that makes page A1 in the major daily newspapers, but maybe it should. Physicians and device makers have lobbied extensively on the issue, as is their right, but I wonder if getting Congress to weigh in on this issue is really a smart move. To start at the beginning, more or less, the Centers for Medicare & Medicaid Services recently opened a coverage analysis for LDCT, and...

To say someone has floated a policy proposal in Washington is akin to saying the traffic in the DC area was bad yesterday. It happens every day, so who cares? Here are three policy proposals that emerged over the past year (or three), proposals that have either slipped beneath the waves or are struggling to stay afloat. FDA’s clinical trial disclosure proposal: Dead duck The idea that FDA would just up and disclose the results of clinical trials has been bouncing around...

When I was first diagnosed with ulcerative colitis 15 years ago my instinct was to learn everything I could about the disease. Unfortunately, my doctor at that time discouraged me from educating myself. He handed me a pathetic little brochure that didn’t answer any of my questions and told me to stay away from the Internet. It seemed that to him, an uninformed patient was an ideal patient. I never knew if that doctor was afraid my wee little layperson’s brain wouldn’t comprehend...

While orthopedic implant maker Stryker (Kalamazoo, Michigan) said today that  it did not intend to make an offer for Smith & Nephew (S&N; London) after a report in the Financial Times forced its hand, it seems likely that such a union for S&N with  Stryker or another willing partner is inevitable. Stryker responded at the request of the UK Takeover Panel and confirmed that the company does not intend to make an offer for S&N. Post this announcement, UK takeover rules now prohibit Stryker from making a bid for S&N for six...

Three years ago, med-tech companies were bracing for a massive shakeup on the healthcare landscape. The medical device tax, the implementation of the Affordable Care Act and vanishing venture capital funding, were all topics that caused a great deal of anxiety for many in the space. Forget thriving in the space. Many just wanted to survive. Yet earlier this month, thriving in the medical device industry was the focus of the Southeastern Medical Device Association's annual conference held in Atlanta. In fact, the title of the conference was "Thriving During Healthcare Reform." With the landscape more clearly defined, medical device...