How many of us have ever gone into the doctor to undergo some tests and then have to wait several days to get the results? Is it just me or can the wait be a bit maddening? I mean in all that time, the thoughts that can run through your head are overwhelming right? In a society where things are increasingly speeding up, it's incredible that there isn't a stronger push for making patients aware of their test results much earlier. One med-tech company is focused on developing tests that could garner rapid results for patients, and quite possibly eliminate...

It’s tempting to amuse oneself about healthcare IT by juxtaposing it with a more or less dusty fixture of pop culture. For instance, you can sing the Bob Seger song “Beautiful loser,” and substitute the words “meaningful user” to parody things, but there are huge problems with healthcare IT, and they’re not particularly funny. For instance, the head honcho at the Office of the National Coordinator appeared on Capitol Hill last week and gave the Senate Finance Committee a glowing report on healthcare IT adoption. However,...

As is the case with many other areas of the modern world, medical science has made enormous strides over the past century or so, and it seems as though the pace of change is accelerating. It’s like being with Edwin Hubble and Georges Lemaître when they first started looking at far-flung regions of the universe. They both realized the universe was expanding, but what was not immediately obvious was that the expansion was accelerating. To me, that’s where things stand with medical science now, and while the chatter about telomerase has...

Paying too much attention to something can be depressing if you’re hoping for change in a particular direction, so device makers might be forgiven for ignoring the goings-on inside I-495, that vaguely circular slab of pavement running ‘round our nation’s capital. So is there any cause for med tech optimism about inside-the-Beltway developments? I’ll just say that you might want to indulge more frequently in a time-tested mood elevator this summer, one that requires no prescription. Device tax repeal in limbo Device tax repeal legislation is...

  Writing about medical devices on a daily basis without ever seeing the inside of a life sciences laboratory or a healthcare facility would be a bit like a sports writer who never steps foot inside a stadium. And yet many of us journalists rarely get the opportunity to see where all the magic happens in the industries we cover so faithfully. Recently I had an opportunity, for the second time, to visit nearly a dozen life...

As a proud father of a two-year-old little girl, it's always stories the stories about children that grab my attention the most. Take for instance, a recent one that I wrote, discussing the risk of radiation-induced solid cancers in older children. The story comes from a study published in the journal JAMA Pediatrics and possible appendicitis was cited as a leading cause of abdominal/pelvic CT usage. The first question I asked myself, one that I had never asked before... was if I should be overly concerned if my daughter needs a CT scan. The good news is, one med-tech company...

A lot of warning letters and other FDA enforcement action are addressed to obscure companies, but lately a few big names have come under scrutiny. In a recent posting here at MDD Perspectives, we addressed a warning letter to Edwards Lifesciences, but they’re not the only big name to show up behind the FDA woodshed. Is this a trend or mere chance? I’ll let you decide. FDA recently posted the 483 from an inspection of Intuitive Surgical of Sunnyvale, California, which is not unheard of, but is not...

The Supreme Court finally published its decision in the case of Association for Molecular Pathology v. Myriad Genetics, a case that seemed to hover over the landscape of life science patents for an eternity. We might be tempted to think the decision shuts the door on a very contentious area of patent law. After all, we now know isolated DNA is not patentable, but complementary DNA is. So that’s it, right? Wrong. In fact, at least one observer believes the decision may collapse at some point. Richard Gilly...

We all know there’s no such thing as a free lunch, but what’s not always clear is the cost. The U.S. federal government in two of its incarnations recently put those in the life science industries on alert that the cost of doing business might go up to a degree that may surprise anyone who hasn’t been paying attention. FDA proposed recently to make freely available “de-identified and masked data derived from medical product applications,” citing as a “national priority” the need to improve “the efficiency and effectiveness of...

In a recent conversation with one of my good friends who has been in the music industry off and on for 20+ years, I realized that there are some glaring similarities between that form of entertainment and med-tech. Consider this quote from my friend if you will: "Nowadays Omar, you have to create a buzz around yourself. You have to get people's attention and do most of the leg work yourself before a major label (distributor) will even look at you, or invest in you." When he said this, I began thinking about how difficult it was to get funding...