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Tag: Medical Devices

Health Care Organizations Must Prioritize Cybersecurity Before Undergoing Digital Transformation

By TRAVIS GOOD

The health care industry is rapidly embracing new technologies. Covid-19 changed the way many industries operate, and healthcare is one industry that was particularly affected by the pandemic. Many health care organizations were already undergoing digital transformations, but Covid exponentially sped up those processes. Health care providers and health-tech companies were forced to adapt to the new normal and change the way they operate. Here are 3 major ways health care has changed in recent times. 

1. Increased popularity of telehealth services:

Covid made telehealth appointments a necessity, but even in a post-Covid world virtual visits are likely to remain a core component of modern healthcare. According to McKinsey, telehealth utilization was 78 times higher in April 2020 than in February 2020. It remained nearly 40 times as popular in 2021 as compared to pre-pandemic levels. 

Research shows that both patients and physicians are fans of telehealth. Many patients prefer the convenience of being able to speak to their doctor from home and physicians feel that offering telemedicine allows them to operate more efficiently. Phone and video-based medical appointments became mainstream in 2020, and they are unlikely to go away anytime soon. 

2. More wearable medical devices with connected ecosystems:

The number of wearable medical devices in use has skyrocketed over the past 5 years. The wearable medical device market is expected to reach $23 million in 2023, a major increase from $8 million in 2017. Gadgets like heart rate sensors, oxygen meters, and exercise trackers are all becoming increasingly popular. Many popular consumer products such as cell phones and smartwatches ship with built-in medical tracking technology.

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What a Sock Business Can Teach Health Care Companies

By KOUSIK KRISHNAN, MD

As recent events in northeastern Syria make clear, the number of displaced people in the world is rising — as are their health needs. 

In 2018 I went with a team of other doctors to a Syrian refugee camp in Lebanon. At one stop, a woman offered us homemade bread as we examined her husband, although the couple had very little money and not enough food for themselves. As we ate the bread, she asked if we could leave them extra medications since they didn’t know when the next humanitarian mission would come through their camp.

Her request was reasonable in the situation – indeed, many other refugee families we treated asked us the same thing. Their host countries’ healthcare systems are simply not equipped to handle their needs. Lebanon alone has almost 1.5 million refugees, an increase of 1/4 of their population.  

But expecting vulnerable and displaced people to hoard needed medicine is neither sustainable nor humane. Instead, we must make it part of the social contract for healthcare corporations to use some of their massive wealth to help reduce disparities in global access to healthcare. Pharmaceutical companies and the retail industry have already created efficient models healthcare corporations could follow. 

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Despite Youth On Farm, Abbott Ventures Chief Avoids Spreading Manure

By MICHAEL MILLENSON 

Abbott Ventures chief Evan Norton may have spent part of his youth on a farm, but there’s no manure in his manner when speaking of the medical device and diagnostics market landscape. The key, he says, is to avoid being blindsided by the transformational power of digital data.

“We’ve been competing against Medtronic and J&J, so that has the risk of us being disintermediated by other players that come into the market,” Norton told attendees at MedCity Invest, a meeting focused on health care entrepreneurs. “Physicians are coming to us and asking for access to data for decisions, and they don’t care who the manufacturer [of the device] is. Are we enabling data creation?”

Abbott, said Norton, wrestles with whether they are simply data creators or want to get paid for providing algorithmic guidance on how the data is used. (Full disclosure: I own Abbott shares.) Other panelists agreed making sense of the digital data deluge remains the central business challenge.

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GAO: FDA Can’t Monitor Device Recalls

The Government Accountability Office has weighed in on the failure of the Food and Drug Administration to properly monitor medical device recalls. Its review of the 3,510 recalls between 2005 and 2009 — 40 percent of which were cardiovascular radiological or orthopedic devices — found:

Several gaps in the medical device recall process limited firms’ and FDA’s abilities to ensure that the highest-risk recalls were implemented in an effective and timely manner. For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices.

“The gist of this report is that the FDA can’t tell if recalls of high-risk devices were carried out successfully because it lacks criteria for assessing device recalls and doesn’t routinely review recall data,” said Sen. Charles Grassley, R-Ia., who along with Sen. Herb Kohl, D-Wis., called for the report. “Recalls are typically voluntary, and patients would be better served if the FDA took a thorough approach to post-market surveillance of medical devices.”

 

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The Economics of Reimplantation

From The Annals of Internal Medicine doctors from the US have shown that ICDs can be safely resterilized and re-used for indigent patients in another country. In their study, Pavri et al collected 106 ICDs with three or more years of estimated battery life from either deceased patients or patients having devices explanted because of “upgrades” or infection and implanted then in 81 patients in a single hospital in Mumbai, India. From the Methods section of their paper:

We deleted all identifying patient information and lead information; programmed them to nonpacing mode, when possible, or lowered the outputs to the minimum possible values; turned off all sensing and therapies for ventricular tachycardia (VT) and ventricular fibrillation (VF); and deactivated all ICD alerts (auditory and vibratory). When a sufficient number of devices were collected, they were transported to India in batches. Transport was most often done by physicians (or friends and family members of physicians) who were traveling from the United States. The devices were placed in checked-in baggage in a clear plastic bag, and 2 letters were placed in prominent view. The first letter was signed by the donating physician, stating that the devices were of no commercial value and that they were being donated for reuse in patients who could not afford such devices. The second letter was signed by the Chief Executive Officer of Holy Family Hospital, stating that the hospital was expecting the devices for donation to such patients. Contact information for all physicians was provided in the letters.

Attempts at sending explanted devices by courier or mail proved difficult; without precedent, it was simply not possible to describe the purpose and nature of the shipment to shipping authorities or to insure the contents. We finally resorted to carrying the devices during travel to India in our personal baggage, as described. Some difficulties (requiring lengthy explanations) were encountered during baggage screening and, especially, at Customs in Mumbai.

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Proposed Drug and Device Laws Should Be Pushed to 2017

flying cadeuciiSenate leaders now say they won’t consider companion legislation to the House-passed 21st Century Cures Act until September, after months of delay.  Lawmakers would then have to reconcile the differing House and Senate versions, presumably by year’s end during a lame-duck Congress.

We believe the summer delay is a good thing, and that Congress should actually extend consideration of the complex legislation into 2017 when must-pass FDA funding through industry user-fees will be on the congressional calendar.   That way, lawmakers can debate the implications of the proposed bills in the context of the resources FDA needs.

Why further delay?  Because the legislation—which makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices—is flawed.  As currently crafted, it lowers standards for drug and device approvals and safety, and risks adding to the rising cost of prescription drugs.
The ostensible rationale for the legislation—being pushed by drug and device companies—is that the FDA stifles innovation and advances in treatment by approving drugs and devices too slowly compared with other countries.

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Will Tech Revolutionize Health Care This Time?

the scanadu
After decades of bravely keeping them at bay, health care is beginning to be overwhelmed by “fast, cheap, and out of control” new technologies, from BYOD (“bring your own device”) tablets in the operating room, to apps and dongles that turn your smart phone into a Star Trek Tricorder, to 3-D printed skulls. (No, not a souvenir of the Grateful Dead, a Harley decoration or a pastry for the Mexican Dia de Los Muertos, but an actual skullcap to repair someone’s head. Take measurements from a scan, set to work in a cad-cam program, press Cmd-P and boom! There you have it: new ear-to-ear skull top, ready for implant.)

Each new category, we are told, will Revolutionize Health Care, making it orders of magnitude better and far less expensive. Yet the experience of the last three decades is that each new technology only adds complexity and expense.

So what will it be? Will some of these new technologies actually transform health care? Which ones? How can we know?

There is an answer, but it does not lie in the technologies. It lies in the economics. It lies in the reason we have so much waste in health care. We have so much waste because we get paid for it.

Yes, it’s that simple. In an insurance-supported fee-for-service system, we don’t get paid to solve problems. We get paid to do stuff that might solve a problem. The more stuff we do, and the more complex the stuff we do, the more impressive the machines we use, the more we get paid.

A Tale of a Wasteful Technology

A few presidencies back, I was at a medical conference at a resort on a hilltop near San Diego. I was invited into a trailer to see a demo of a marvellous new technology — computer-aided mammography. I had never even taken a close look at a mammogram, so I was immediately impressed with how difficult it is to pick possible tumours out of the cloudy images. The computer could show you the possibilities, easy as pie, drawing little circles around each suspicious nodule.

But, I asked, will people trust a computer to do such an important job?

Oh, the computer is just helping, I was told. All the scans will be seen by a human radiologist. The computer just makes sure the radiologist does not miss any possibilities.

I thought, Hmmm, if you have a radiologist looking at every scan anyway, why bother with the computer program? Are skilled radiologists in the habit of missing a lot of possible tumors? From the sound of it, I thought what we would get is a lot of false positives, unnecessary call-backs and biopsies, and a lot of unnecessarily worried women. After all, if the computer says something might be a tumor, now the radiologist is put in the position of proving that it isn’t.

I didn’t see any reason that this technology would catch on. I didn’t see it because the reason was not in the technology, it was in the economics.

Years later, as we are trending toward standardizing on this technology across the industry, the results of various studies have shown exactly what I suspected they would: lots of false positives, call-backs and biopsies, and not one tumor that would not have been found without the computer. Not one. At an added cost trending toward half a billion dollars per year.

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Medical Devices and Patient Safety: A Promising Path Forward

flying cadeuciiIn an era of sophisticated information technology and rapid communication, the medical device community lags far behind other fields in its ability to alert patients about safety concerns.

For example, auto manufacturers and government regulators are able to quickly identify potential safety concerns by linking reports of crashes, malfunctions and defects with individual vehicle identification numbers (VINs).

They can then communicate recalls to affected customers by using their VIN. Manufacturers will issue notifications via mail or e-mail, or offer customers the ability to search the manufacturer’s website using their VIN.

In health care, drugs are tracked using a system established in the 1970s called National Drug Codes (NDCs). The 10-digit NDCs are assigned to all manufactured medications. The code tracks the vendor, product, and package code, which can then be captured in electronic health records and the FDA’s national database.

Unfortunately, we do not yet have a similar national system that can identify and communicate potential concerns for the tens of millions of patients with implantable devices such as pacemakers, glucose meters, artificial joints, and defibrillators.

Patients are bombarded by news stories about device recalls, but unless they have access to information about the exact make and model of their device, they have no way of knowing if they should be concerned. Since most medical device procedures take place in a hospital, a patient’s health care providers may also lack this critical, sometimes life-saving information.

The patient is then burdened with the task of tracking down their specialist or surgeon, in hopes that they documented the specific device information.

Clearly, the current health care information infrastructure does not yet support a robust surveillance system.

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10 Ways Innovation Could Help Cure the U.S. Health Spending Problem

flying cadeuciiThe United States spends more than $2 trillion per year on health care, surpassing all other countries in per capita terms and as a percentage of gross domestic product.

New, expensive medical technologies are a leading driver of ballooning U.S. health care spending. While many new drugs and devices are worthwhile because they substantially extend lives and reduce suffering, many others provide little or no health benefit.

Many studies grapple with how to control spending by considering changing how existing technologies are used. But what if the problem could be attacked at its root by changing which drugs and devices are invented in the first place?

Recently, my colleagues and I explored how medical product innovation could be redirected to reduce spending with little, if any, sacrifice to health and to ensure that any spending increases are justified by sufficient health benefits.

The basic approach is to use “carrots and sticks” to alter financial incentives for drug and device companies, their investors, health care payers and providers, and patients.

The ten policy options below could change which technologies are invented and how they’re used. In turn, this could cut spending or increase the value (health benefits per dollar spent) derived from new products that do increase spending.

We urge policymakers—both public and private—to consider these options soon and to implement those that are most promising. Policymakers should also consider how to reduce spending and get more value from health services that don’t involve drugs or devices.

The longer the delay, the more money will be badly spent.

1. Encourage Creativity in Funding Basic Science

The National Institutes of Health (NIH), the leading funder of basic biomedical research, typically favors low-risk projects. Funded researchers who fail to achieve their goals are much less likely to secure additional NIH funding. Encouraging more creativity and risk-taking could increase major breakthroughs.

2. Reward Inventors with Prizes

Public entities, private health care systems, the philanthropic sector, or public-private partnerships could award prizes to the first to invent drugs or devices that satisfy certain performance criteria, including a potential to decrease spending. Winners could receive a share of future savings that their product brings the Medicare program, which spends more than $500 billion annually.

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Hacking the Hospital: Medical Devices Have Terrible Default Security

 Screen Shot 2014-04-29 at 10.28.40 AM

Scott Erven is head of information security for a healthcare provider called Essentia Health, and his Friday presentation at Chicago’s Thotcon, “Just What The Doctor Ordered?” is a terrifying tour through the disastrous state of medical device security.

Wired’s Kim Zetter summarizes Erven’s research, which ranges from the security of implanted insulin pumps and defibrillators to surgical robots and MRIs. Erven and his team discovered that hospitals are full of fundamentally insecure devices, and that these insecurities are not the result of obscure bugs buried deep in their codebase (as was the case with the disastrous Heartbleed vulnerability), but rather these are incredibly stupid, incredibly easy to discover mistakes, such as hardcoded easy default passwords.

For example: Surgical robots have their own internal firewall. If you run a vulnerability scanner against that firewall, it just crashes, and leaves the robot wide open.

The backups for image repositories for X-rays and other scanning equipment have no passwords. Drug-pumps can be reprogrammed over the Internet with ease. Defibrillators can be made to deliver shocks — or to withhold them when needed.

Doctors’ instructions to administer therapies can be intercepted and replayed, adding them to other patients’ records.

You can turn off the blood fridge, crash life-support equipment and reset it to factory defaults. The devices themselves are all available on the whole hospital network, so once you compromise an employee’s laptop with a trojan, you can roam free.

You can change CT scanner parameters and cause them to over-irradiate patients.Continue reading…

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