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 the anxiety these patients could have.
MBio Diagnostics (Boulder, Colorado) said that one application that it is working on is a low-cost point-of-care HIV antigen/antibody combination diagnostic device.
One thing that sets MBio apart from other companies making point-of-care diagnostic tests is that it can do protein detection assays and cellular analysis, and potentially combine some tests into a single device.
It would also allow clinics across to world to run these tests without having to send out a blood sample to a centralized lab and track down the patient later.
Answering these questions rather quickly for any disease state is key as we move into this new era of healthcare. Although there are some things that are already in place, I think that there aren't enough of these diagnostic tests available to the public at large and unfortunately the anxiety in waiting for the results still exists.
[caption id="attachment_2626" align="alignleft" width="242"] The good ol' Trash 80: As relevant as meaningful use?[/caption]
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, Farzad Mostashari informed the committee (only after someone asked) that 10,000 providers had dropped out of the meaningful use program, a seemingly small number when compared with the 300,000 providers that had enrolled.
The problem? The taxpayer has coughed up $15 billion in incentives to those 300,000 providers, which is an average of about $50,000. Take those 10,000 departing providers and multiply them by $50,000, and you have something like half a billion dollars down the rabbit hole.
As the saying goes, a million here, a million there … who says Senator Dirksen is irrelevant?
Even the providers that are still on board are carping about meaningful use standards, however, a sure sign the HITECH Act was ambitious beyond rational thinking. Sen. Orrin Hatch recently proposed that ONC slow down on the meaningful user program, but he wasn’t the first. A group of six senators made the same suggestion in April.
Let’s not forget that more providers will dump the whole meaningful use thing when the ICD-10 squeeze starts to feel like a python, and you have the makings of a bona fide exercise in absurdity, even by government standards.
Do as I say, not as I do
The workflow debate is still cruising along, with ONC’s Mostashari repeatedly asserting that providers will have to adjust their workflows to the software rather than the other way around. At a July 9 briefing in Washington, he said of existing workflow patterns: “If you merely pave over the cowpath, you have a streetmap that looks like Boston,” which sounds like a great description of the government's approach to interoperability.
Mostashari also compared this workflow dilemma to factory workflows upon the introduction of electricity. I reminded him that the typical doctor has much more influence over the HIT workflow debate than the typical 19th Century factory worker had over his working conditions. Mostashari heard me, but was undaunted. He remarked that the government is “only about 5% of the way through” the process of forcing a change of workflow onto practitioners.
Apparently Mostashari hasn’t heard about the influence MDs have on policy in this town. I wonder whether he likes his humble pie served a la mode.
The final ingredient: Interopera-bull
This interoperability discussion has wandered like a deranged ruminant for nearly a decade, and now we hear that the market, not government, will determine what constitutes interoperability. Seems to me we could have left it up to the market back in 2005, when HHS secretary Mike Leavitt first started yakking about it.
Still, government’s concession on the interoperability clanger serves as a nice denouement for what has been much ado about not very much so far. The taxpayer is on the hook for $15 billion to date, and another $15 billion or more to come. It strikes me that even our government could have found a more meaningful way to squander $30 billion.
[caption id="attachment_2620" align="alignleft" width="300"] Little strands with big potential?[/caption]
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 been around for two decades or so, it appears the push to develop this enzyme may soon reach a critical mass. The question – assuming this idea has any legs under it at all – is whether it’ll be worth pursuing.
To quickly recap, telomerase is the agent that repairs the telomeres at the end of strands of DNA. What’s really interesting, though, is the number of disease states that seem to be associated with telomere degradation (which of course leads to degradation of DNA). The list runs from heart disease to neurodegenerative states and a range of items between, including diseases of the bone marrow.
Geron (Menlo Park, California) came up with what seems to have served as a blueprint for other efforts with a 1998 experiment with human tissues treated (apparently in vitro) with a human telomerase catalytic sub-unit, during which treated cell lines “exceeded their normal life span by 20 doublings.”
And there’s no lack of clinical interest in evaluating telomere integrity to determine whether there’s an association with disease states. For instance, clinicaltrials.gov yields 50 hits if you use telomerase as a search term.
A little skepticism is called for in this situation, however. For instance, the chatter that surrounded tissue scaffolding in times gone by now seems a bit premature. After all, patients still have to rely on ventricular assist devices and artificial pancreases, so there are fields of pursuit that just never seem to catch fire, although that’s not to say these are necessarily dead ends. Among the limitations of the telomerase concept is that the correlation between age and telomere length is not always straightforward. At the very least, this should feed a little skepticism about telomerase as a fountain-of-youth drug.
Still, the telomere/telomerase discussion is a little unique in that it offers some prospect of repairing living things at a seemingly fundamental level. The ability to administer telomerase in a targeted fashion could reverse the damage seen in heart failure if some of the current research has it right, but one has to ask whether some cancers could be treated by blocking telomerase.
But in the final crunch, even successful telomerase therapy won’t mean much if it doesn’t help us stay on the job longer. After all, we can afford only so many miracle drugs and devices before healthcare in general and Medicare in particular suck the life out of the economy, and the only way to avoid that problem is to maintain physical and mental vigor for another four or five years beyond the typical age of retirement as is now defined. We should also acknowledge that much of that problem has to do with diseases of lifestyle.
Healthcare spending would make much more sense if we could just find a way to leverage these miracle treatments into GDP growth outside the confines of the healthcare economy. The problem is that to date, all the growth in healthcare has benefited seemingly no one who’s not employed in healthcare. Can telomerase break that dynamic?
[caption id="attachment_2601" align="alignleft" width="300"] Is gridlock worse on the Beltway or inside the Beltway?[/caption]
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 nearly invisible right now despite that the embarrassing IRS scandal and the story about DoJ’s surveillance of the press have died down. Still, Congress and the White House may have to raise the debt ceiling again later this year. Another issue is that the House and Senate have a chasm between them where the fiscal 2014 budget is concerned.
This latter predicament is based on the presumption in the House that the sequester will be honored and the Senate’s inclination to drop the sequester like a blind date with halitosis. They don’t have much time to come up with a compromise, either. The new fiscal year starts in less than three months, and one of those months is the August recess.
Both the Medical Device Manufacturers Association and the Advanced Medical Technology Association sounded off in support of the tax reform effort by Sen. Max Baucus and Rep. Dave Camp. However, AdvaMed and MDMA may asking an awful lot to assume Camp and Baucus will be able to work a device tax repeal into their larger tax reform effort.
Baucus sired the device tax, after all, so what’s in it for him? Camp might have to choose between a successful tax reform effort minus a device tax repeal, and a tax reform bill with a device tax repeal that’s DOA in the Senate. Care to guess which he’d choose?
ACA = Actuarially Compromising Activity?
As for the Affordable Care Act, we’ve heard about the Obama administration’s one-year suspension of the employer mandate. There seemed to be some controversy over whether the administration had proposed that health insurance exchange enrollees would not have to document their incomes in order to qualify for subsidies. That seems to have died down, though. The consensus now is that the administration does indeed propose no proof of income to get a subsidy, as was reported in the July 9 edition of Medical Device Daily.
Why should device makers care about this? Only one reason: The oncoming subsidy gold rush invites massive fraud (additional expense), and the loss of penalty cash from employers and individuals who choose not to join the party will lower the revenues needed to make the Affordable Care Act affordable. It’s yet another source of red ink for the ACA, and thus another compelling reason not to repeal the device tax.
My recommendation to opponents of the device tax is to unfold that 9-foot umbrella on the deck, invite the neighbors over, and break out the charcoal. The only way you’re going to dodge the Beltway Blues this summer is to stop thinking about what’s going on inside the Beltway.
[caption id="attachment_2589" align="alignleft" width="150"] A researcher with Interface Biologics works in the company's lab. The company develops polymers additives and drug delivery devices.[/caption]
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 sciences facilities during a four-day tour of Ontario’s medical device industry which included stops in both Toronto and Ottawa. The tour, organized by the Ontario Ministry of Economic Development Trade and Employment, included journalists from seven different countries around the globe. I participated in a similar tour of the province in November 2011 and was grateful for the opportunity to visit Ontario’s medical device industry again in June.
Appropriately, the tour began in a truly unique facility in the heart of Toronto’s life sciences research community, an innovation center dubbed the MaRS Discovery District. Built with the intention of bringing together researchers and entrepreneurs to collaborate on new life sciences technologies, MaRS is home to 140 tenants, 80 of which are start-ups, and is set up to accommodate both executive offices and laboratory facilities, often located just a few steps from one another.
During the first day of the tour, Minister Reza Moridi of the Ontario Ministry of Research and Innovation told us that Ontario sees innovative research as a journey. And indeed, after four long days of visiting companies and research facilities in Toronto and Ottawa, it certainly felt like we had been on quite a journey. I think I was the only one in the group who got really excited the first time we were asked to slip into a white lab coat and safety goggles before walking through a lab, it was the first time I felt like I was dressing up like a scientist! By the fourth or fifth lab we visited, the luster of the white lab coat had worn off, but it was still neat to see researchers hard at work trying to advance the field of medicine.
And in Canada’s capital, where people from all over the country were gathering to celebrate Canada Day on July 1, we got to see the opposite end of the innovation spectrum, the manufacturing facility of Best Theratronics, where welders and other plant workers were building cyclotron systems for research and radioisotope production, external beam therapy units for cancer therapy, and self-contained irradiators for blood and research purposes.
[caption id="attachment_2591" align="alignleft" width="150"] Richard Wassenaar, PhD, of Best Theratronics shows journalists the company's Cyclotron systems[/caption]
Most impressive at the Best Theratronics stop was the 70 MeV Cyclotron. Over the past few years the company has had to upgrade a 5,900 square foot dedicated room in order to build such a massive machine in-house.
All in all the tour provided us with a comprehensive picture of Ontario’s medical device industry and the take-home message was quite clear, the life sciences are important to Ontario.