Health Tech News This Week – June 18, 2022

What happened in health care technology this week, and why it’s important.

Image Credit: Shutterstock.com

Rune Labs’ Apple Watch-based Parkinson’s disease tracker gets FDA clearance

Nicole Wetsman in The Verge reports that software that helps people with Parkinson’s disease track symptoms through their Apple Watch received clearance from the Food and Drug Administration, the company behind the tool announced today. It automatically tracks things like tremors, and it lets patients report symptoms and medication usage. Neurology company Rune Labs built the software called StrivePD. It lets clinicians track their patients’ progress and any changes in symptoms from the neurological disorder, which causes involuntary movements and difficulty with coordination.

Why it’s important – The passive data collection means patients’ don’t have to try and remember those fluctuations. It’s also a rich source of data on how Parkinson’s patients respond to various medications. The FDA sign-off means clinicians have ways to bill patients when reviewing data from the watch and lets the findings be used as clinical trial data on various Parkinson’s disease treatments.


Infographic of the week – a nice graphic compilation of digital health medication adherence companies by The Digital Apothecary.com

Image Credit: The Digital Apothecary.com

Ekso Bionics exoskeleton cleared for use with MS patients

In other FDA clearance news, Sean Whooley reports that EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use in patients with MS, significantly expanding the device’s use to a broader group of patients. The latest generation of the Ekso Bionics platform, the EksoNR, received clearance for stroke and spinal cord rehabilitation in 2016, then acquired brain injury (ABI) in 2020.

Image Credit: Ekso Bionics

Why it’s important – EksoNR has the potential to assist significantly more patients and improve patient mobility.


Keeping Up to Date on SaMD Regulations

In the Mayo Clinic Platform blog, John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, outline how this kind of standalone software is having a significant impact on the delivery of medical care worldwide and when coupled with machine learning, has the potential to transform patient care in ways that were unimaginable a few years ago. They highlight the FDA’s new set of guidelines, Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD) Action Plan, the purpose of which is to accommodate the many iterations expected from these new digital tools as they respond to new data and adapt algorithms accordingly. And they provide an overview of the basics in understanding how Software as a Medical Device regulations will be used in health care.

Why it’s important – This is must-reading for health care executives and their teams to understand the new regulations and how the FDA will begin to expect real-world performance monitoring for artificial intelligence and machine learning-based software as a medical device.


3D PRINTED IMPLANTS ENABLE FACIAL DEFORMITY SURGERY SUCCESS

Haley Everett reports this milestone in an article in 3D Printing Industry online. Doctors in Dubai have successfully completed a series of surgeries on a young male patient to reform his facial deformities using 3D printed titanium implants. The surgery completely reconstructed the patient’s facial bones, which had been severely damaged from several benign tumors.

Why it’s important – The technology is being deployed to create biocompatible, patient-specific implants capable of facilitating bone cell growth and repairing structural deformities. Opting for the implants meant the patient did not have to undergo multiple soft and hard microvascular grafts from his abdomen and legs to reconstruct his facial bones, which would have seriously affected his quality of life.


Nanoparticle sensor can distinguish between viral and bacterial pneumonia

Anne Trafton at MIT reports that researchers have now designed a sensor that can distinguish between viral and bacterial pneumonia infections, which they hope will help doctors choose the appropriate treatment. They are currently developing versions for human use that could be administered using either a nebulizer or an inhaler similar to an asthma inhaler. They are also working on detecting the results using a breathalyzer instead of a urine test, which could give results even more quickly.

Why it’s important – Many different types of bacteria and viruses can cause pneumonia, but there is no easy way to determine which microbe is causing a particular patient’s illness. This uncertainty makes it harder for doctors to choose effective treatments because the antibiotics commonly used to treat bacterial pneumonia won’t help patients with viral pneumonia. In addition, limiting the use of antibiotics is an important step toward curbing antibiotic resistance. In designing their sensor, the research team focused on measuring the host’s response to infection rather than trying to detect the pathogen itself. Viral and bacterial infections provoke distinctive types of immune responses, including activating enzymes called proteases, which break down proteins. The MIT team found that the pattern of activity of those enzymes can serve as a signature of bacterial or viral infection.


CONSORTIUM UNVEILS GUIDELINES FOR USING DIGITAL TWIN TECHNOLOGY

Health Leaders Eric Wicklund reports that an organization called The Digital Twin Consortium has created a framework for the use of digital twin technology, which is just now being adopted in healthcare to help providers improve care management. Reality Capture: A Digital Twin Foundation lays out the groundwork for using the technology, which essentially uses sensors and AI to create a digital twin of an object, room, building, or landscape for use in planning and design. In healthcare, the strategy focuses on developing a digital twin of a patient, which can then be used to test the effectiveness of treatments before they’re tried on the patient.

Why it’s important – With its new document, the Digital Twin Consortium aims to lay the foundation for guidelines and standards of digital twin technology. The published white paper can provide information organizations can use to make the right investment decisions.


Scientists Develop “Nanomachines” That Can Penetrate and Kill Cancer Cells

A research team headed by Dr. Youngdo Jeong from the Center for Advanced Biomolecular Recognition at the Korea Institute of Science and Technology (KIST) has reported the development of a novel biochemical nanomachine that penetrates the cell membrane and kills the cell via the molecular movements of folding and unfolding in specific cellular environments, such as cancer cells.

Image Credit: Korea Institute of Science and Technology (KIST)

Why it’s important – In the last couple of months, promising results have been published about nanomachines in a medical setting. How does it keep healthy cells intact? In normal cells with a relatively high pH, the movements of the nanomachines were restricted, and they could not penetrate the cell.


Carilion Clinic, TytoCare team up to expand rural telehealth

Katie Adams in MedCity News reports that Carilion Clinic, a health system based in Roanoke, Virginia, that has a sizable rural patient population announced a partnership with TytoCare, a New York City-based telehealth company. The partnership aims to strengthen the health system’s ability to diagnose and treat patients remotely with virtual physical exams using TytoCare smart devices, such as its telehealth exam kits and pop-up remote health clinic.

Why it’s important – With access to health care in rural areas declining, using telemedicine approaches to manage chronic care is even more critical today than in the past. Carilion uses TytoCare’s telehealth devices to monitor pediatric asthma patients remotely and care for rural patients with chronic conditions. The health system also will deploy the TytoClinic solution, which can turn any location into a remote telehealth clinic, in rural schools to increase students’ and teachers’ access to primary and specialty care.


How researchers are using old phones to screen for Alzheimer’s

The DigiHealth Lab at UC San Diego, directed by Professor Edward Wang, looks at ubiquitous technology like smartphones to figure out how they can be used to monitor our health. The idea is that, by building digital health tools that work on more common devices, they can increase access to more people — particularly people who might not be able to afford the latest smartwatch or fitness tech. Matt Morales featured this video in his article on The Verge.

YouTube video credit: The Verge

Why it’s important – Great review of how the latest and greatest technology isn’t always required to monitor a person’s health. It also brings personal health monitoring to a broader population segment who might not be able to afford the latest smartphone.


Alimetry gets FDA clearance for wearable gut disorder test

Finally, this week, from Adam Ang in MobiHealthNews, we get this article on technology startup Alimetry, which has received clearance from the US Food and Drug Administration for its wearable device for diagnosing gastric disorders. Gastric Alimetry is a non-invasive test for common stomach disorders, including nausea and vomiting, gastroparesis, and functional dyspepsia. The Gastric Alimetry test is only performed in a clinical setting. Recordings are taken before and after a meal while patients simultaneously log their symptoms into a companion mobile app. The wearable device captures digestive patterns from the skin surface and then delivers clinical reports via the cloud, which ultimately informs the diagnosis of gastric diseases and supports personalized therapy.

Image Credit: Alimetry

Why it’s important – Existing gut tests are “frequently unreliable and inconclusive” with patients undergoing months or years of testing, which is often costly, invasive, and involves radiation. And the market for these is growing. Other wearable patches have been developed and marketed in the United States to track and identify gastrointestinal issues. In 2018, researchers from the University of California San Diego created a wearable device that can track electrical activity in the stomach over 24 hours. G-Tech Medical, also from California, has developed a wearable, disposable sensor patch for measuring electrical activity in the gastrointestinal tract.

One “Unified Health Record System” To Rule Them All? – I Think Not

“It’s Deja Vu All Over Again”

Yogi Berra, Baseball Legend and Philosopher
Image Credit: Shutterstock.com

Oracle’s chairman Larry Ellison outlined a bold vision last week for the database giant to use the combined tech power of Oracle and Cerner to make access to medical records more seamless. Days after closing its $28.3 billion acquisition of electronic health record company Cerner, Ellison said Oracle plans to build a national health record database to pull data from thousands of hospital-centric EHRs.

“We’re going to solve this problem by putting a unified national health records database on top of all of these thousands of separate hospital databases. So we’re building a system where the health records all American citizens’ health records not only exist at the hospital level but also are in a unified national health records database.”

Larry Ellison, Chairman and CTO, Oracle

Oracle also plans to modernize Cerner’s Millennium EHR platform with updated features such as a voice interface, more telehealth capabilities, and disease-specific AI models, Ellison said. He also highlighted a partnership between health tech company Ronin, a clinical decision support solution, and MD Anderson to create a disease-specific AI model that monitors cancer patients as they work through their treatments. (Sound familiar, IBM?)

Needless to say, Ellison’s bold vision was met with a healthy dose of skepticism by interoperability experts who have been striving for years to build technical “roadways” to make it easier to access and share health data.

“The concept is not new, and the barriers still remain. Saying that you’re going to build a national database and bringing that to fruition is a different story. This particular model is going to face the same barriers that have been there for many years and there’s no easy path to overcome those barriers quickly.”

Patrick Murta, Chief Platform Architect, BehaVR to Fierce Healthcare

Let’s get real here – This isn’t the first time big tech has come in to ‘fix healthcare.’ (I’ve written on this topic before) Big software and tech giants continue to push into healthcare with megadeals like Microsoft’s $19.7 billion bid for Nuance and two private equity firms picking up Cerner competitor Athenahealth in a $17 billion deal. But the health care landscape is littered with failed attempts to create “the mother of all EHRs” over the years, including Microsoft’s attempt to create a personal health record system, HealthVault, that shut down in 2019. Google Health’s personal health information service was introduced in 2008 and ended three years later because of low user adoption. How about IBM’s attempts with Watson Health? Or GE’s attempt with Edison? All of these were announced with great fanfare, and all failed despite the backing of big companies who were willing to spend billions in funding to ensure success.

Unifying national patient records involves more than just connecting all of the Cerner sites. There are already efforts underway to create a more unified database of health records, such as Epic’s Cosmos. a de-identified patient database combining the company’s EHR data of over 122 million patients. There are also plug-and-play networks like CommonWell and Carequality that enable healthcare providers to access patient data. You also have consortia like Truveta, which brings together health systems from around the country to aggregate their EHR data into a massive database for research.

Ellison’s “moonshot” commitment to ‘all medical records’ ignores the actual and valuable data issues and, frankly, immense work ahead of the industry to deliver value while aggregating and enhancing historical clinical data. It is nearly impossible to have a system that holds all medical records in the U.S. in real-time, at any given time. And, it won’t be easy to ensure all providers have the same level of maturity or even consent to providing the data. The extensive database also raises security questions. Throughout the presentation, Mr. Ellison noted patients would still have the “key” to their health records, which are anonymized until patients give providers access. How will that work exactly? What Ellison did not say was who would pay for its national electronic health records database.

And how would this effort tie into the Federal Government’s framework for nationwide data exchange called the Trusted Exchange Framework and Common Agreement (TEFCA)? TEFCA aims to eliminate individual legal agreements between health information networks, health plans, providers, and other entities by instituting one common agreement that qualified networks and their participants sign onto, paring back the administrative burden. The framework standardizes the operational side of data exchange while raising the privacy and security bar for entities that want to be certified as qualified health information networks (QHINs), groups of organizations that agree to the same data-sharing infrastructure. It’s composed of two parts: the Trusted Exchange Framework, which describes a set of principles for data-sharing across health information networks, and the Common Agreement, a legal contract signed by QHINs. TEFCA is entirely voluntary and will succeed or fail wholly depending on industry buy-in — historically, not a good prospect for a piece of health IT regulation — though experts note the competitive advantages to joining TEFCA could be a significant motivator.

Update 6/17/2022: On Thursday Epic announced that it will join the Trusted Exchange Framework and Common Agreement, and that when the application process opens later this year it will apply to connect to TEFCA as an inaugural Qualified Health Information Network.https://www.healthcareitnews.com/news/epic-will-sign-tefca


Moonshot announcements like Mr. Ellison’s make for great press and usually a bump in the stock price. But, as with most issues in healthcare, there’s a chasm between identifying the problem and being able to fix it. And to stay with the Lord of the Rings theme of the title of this post, I’m betting there’s someone in Verona, Wisconsin, ready to say:

GIF Credit: Giphy.com

Health Tech News This Week – June 11, 2022

What happened in health care technology this week, and why it’s important.

Image Credit: Shutterstock.com

A world first: Human liver was treated in a machine and then successfully transplanted

The Liver4Life research has developed a perfusion machine that makes it possible to implant a human organ into a patient after a storage period of three days outside a body. The device mimics the human body as accurately as possible to provide ideal conditions for human livers. A pump serves as a replacement heart, an oxygenator replaces the lungs, and a dialysis unit performs the functions of the kidneys. In addition, numerous hormone and nutrient infusions perform the functions of the intestine and pancreas. The article on the first transplantation of a liver prepared in a perfusion machine was published in Nature Biotechnology on May 31, 2022.

Image Credit: University Hospital Zurich (USZ), ETH Zurich and the University of Zurich (UZH)

Why it’s important – The therapy demonstrates that by treating livers in the perfusion machine, it is possible to alleviate the lack of functioning human organs and save lives. The next step in the Liver4Life project is to review the procedure on other patients and demonstrate its efficacy and safety in the form of a multicenter study. Its success would mean that in the future, liver transplantation, which usually constitutes an emergency procedure, would be transformed into a plannable elective procedure.


Infographic of the week – From the team at Gist Healthcare, a terrific graphic demonstrates how different organizations approach platform development in health care. If you are not following the work Chas Roades and Lisa Bielamowicz, M.D. do at Gist Healthcare; you should bookmark their website and sign up for their posts.

Image Credit: Gist Healthcare

Gel that repairs heart attack damage could improve health of millions

Andrew Gregory in The Guardian reports that British researchers have developed a biodegradable gel to repair damage caused by a heart attack in a breakthrough that could improve the health of millions of survivors worldwide. Researchers at the University of Manchester have created a gel that can be injected directly into the beating heart – effectively working as a scaffold to help injected cells grow new tissue.

“We’re confident that this gel will be an effective option for future cell-based therapies to help the damaged heart to regenerate.”

Katharine King, University of Manchester

Why it’s important – Until now, when cells have been injected into the heart to reduce the risk of heart failure, only 1% have stayed in place and survived. But the gel can hold them in place as they graft onto the heart.


The graveyard of health tech pilots: why some experiments flourish and others fizzle

Pilot programs are health tech’s proving ground: they let health systems test-drive new devices and software without spending millions of dollars or shaking up patient care too quickly. They’re also where some of tech’s biggest ideas have gone to die. STAT+ reporter Mohana Ravindranath interviewed several health care executives for this article. (Subscription required) STAT asked executives at large hospital systems about their failed pilots and why they fell apart.

“What I want to see is proof that people were willing to go to bat internally at a health system, and whether you made it past phase 1 or phase 2. What it shows me is that you were able to cultivate a champion at the health system who was willing to put their reputation on the line.”

Tom Cassels, President of venture fund Rock Health

Why it’s important – Knowing that health systems and tech companies have stress-tested and tweaked the product after previous failures could boost investor confidence. And health systems that have demonstrated a willingness to run pilots — successful or not — might attract other tech companies pitching their solutions.


Virtual Reality to Train Staff to Deal with Agitated Patients

Conn Hastings from Medgadget reports that Researchers at the National University of Singapore, Yong Loo Lin School of Medicine, have developed a virtual reality training system that lets healthcare staff learn how to deal with agitated or aggressive patients. This new system aims to mimic common scenarios for trainee nurses and doctors and allows them to make mistakes without causing harm or creating a risk. The system is quite sophisticated and mimics common distractors found in busy healthcare wards to make the experience as realistic as possible.

YouTube Video Credit: National University, Singapore

Why it’s important – Managing a situation with an agitated patient inappropriately could pose risks for patients and staff alike, and physical and verbal attacks on healthcare staff are unfortunately relatively common. Virtual reality represents an ideal way for trainee staff to learn to handle such situations without any real-world consequences.

Apple’s WWDC 2022 Health and Fitness Announcements

“If you zoom out into the future, and you look back, and you ask the question, ‘What was Apple’s greatest contribution to mankind?’ It will be about health.”

Tim Cook, CEO, Apple
Image Credit: Apple, Inc.

Apple fan-boys (including yours truly) around the world were tuned into the annual World-Wide Developers Conference (or “dub-dub” as we call it) this week to see what new software and hardware would be featured. The event was held in person at Apple Park in Cupertino, CA, this year, although the presentations were pre-recorded as they’ve done in the past two years. The opening keynote lasted almost two hours, with the usual parade of Apple executives and developers highlighting the latest updates to all software platforms and a few product announcements thrown in for good measure.

First, here’s a link to the YoutTube video of the event with the extract of the section on health presented by Dr. Sumball Desai, VP of Health for Apple starting at 49:25:00.

YouTube Video Credit: Apple, Inc

Here’s my summary of the announcements focused on health and fitness, with some comments about why I think each is important.

Watch OS 9– Apple Watch software includes several new features in the next release. First, the watch will now allow you to track your medications, allowing you to create a log of what medications you are taking, set up reminders to take your meds and track compliance, and warn you of potential drug interactions (currently, the U.S. only via an agreement with the publisher Elsevier), and scan your medicine bottles to input the medication information.

Image Credit: Apple, Inc.

Next, the new update allows you to track your atrial fibrillation history – an add-on feature to the existing AFib component of the software. The information will be stored in the Apple Health app and can be shared with your care provider as a pdf file.

The next release will also feature additional functions in the sleep function, including recording sleep stages (REM, “core,” “Deep,” and woke stages). This was a highly requested feature and well received by the developers and general audience.

Image Credit: Apple, Inc.

On the fitness front, Watch OS 9 will include some new running measurements, including vertical oscillation, stride length, and ground contact time. Also, the software will allow you to set up heart rate zones for things like triathlon mode and a custom workout.

Image Credit: Apple Inc.

“Even casual runners should benefit hugely from the ability to study their vertical oscillation, create custom workouts with their own distance and time intervals, or pace themselves against their own routes.”

Adrienne So, Wired

Why it’s important – The new functionality added to Watch OS 9 continues Apple’s commitment to innovate in the health and fitness space. But the biggest reason I think these will experience strong use is summarized in a single word – integration. The functionality introduced seamlessly integrates with the Apple Health App to allow the user to store critical health and fitness information in one place and easily share it with members of the health care team, all in a highly secure fashion. It puts the patient in control of their data, allows for easy sharing when and to whoever needs it and maintains patient privacy and security.


iOS 16 – A few functional additions to this next release that, while not directly health-related, tie into health and safety. First, Apple’s fitness app comes to the iPhone, even if you don’t have a Watch. Next, Family Sharing comes to the iPhone – even if only two accounts for the time being. This allows you to set up access functions for your kids or your parents if you are managing their health and safety remotely—a small start to be sure, but at least a start. The most important addition to this release from my perspective is Safety Check. If you’ve shared passwords with someone who later becomes abusive, you can tap Emergency Reset. One tap stops sharing your location; resets privacy permissions for all apps; signs out of Messages on all devices; restricts FaceTime and Messages to YOUR device in your hand.

Image Credit: Apple, Inc.

Why it’s important – Safety Check is the big news in this release. The fact that someone can stop location sharing, reset privacy permissions for all apps and limit FaceTime and Messages to the device in hand is crucial.


Finally, in another security-related feature, Apple introduced Passkeys in their next Mac software release, Mac OS Ventura. Passkeys is a next-generation credential that uses TouchID or FaceD. Behind the scenes, Passkeys supplies the password to the website or app. It can’t be leaked or phished. It even works when you’re using a computer (or PC) you don’t own, using a QR code on your iPhone. Passkey is Apple’s answer to the FIDO (Fast IDentity Online) authentication standard, which defines a fast and secure authentication mechanism for users to access websites and applications. Apple worked with members of the FIDO alliance, including Google and Microsoft, to ensure passkeys will work seamlessly across non-Apple devices, including the ability to use Passcodes via a QR code on the iPhone. Wide adoption will take time, but developers are already off and running in using Apple’s APIs to create solutions for their apps and products.

Image Credit: Apple, Inc.

Why it’s important – The FIDO alliance said its authentication creates more robust security by removing many of the problems that stem from password-based authentication and form authentication using traditional second steps. Specifically, FIDO authentication uses public-key cryptography. FIDO also helps to ensure that the credentials aren’t shared with malicious parties or other parties that do not own the credential, according to the alliance. Public key cryptography reduces the threat of potential database breaches.


So, there you have it—a summary of the new functionality coming into the Apple ecosystem. I’ll be looking forward to trying out these enhancements and seeing how well they work and how integrated they are into my daily workflow.

Summer Reading Recommendations – 2022

“There is no Frigate like a Book
To take us Lands away
Nor any Coursers like a Page
Of prancing Poetry –
This Traverse may the poorest take
Without oppress of Toll –
How frugal is the Chariot
That bears a Human soul.”

Emily Dickinson
Image Credit: Shutterstock.com

Since Memorial Day is usually considered the “unofficial” start of Summer, I thought I’d share some of my favorite reads from the first half of 2022 to consider adding to your beach reading list. Here are twelve books (both non-fiction and fiction) that I enjoyed:

First up – and I’ve mentioned this book in previous posts – is The Age Tech Revolution by Keren Etkin. In my view, this is the definitive book on the use of technology in aging and is a must-read for anyone interested in the topic. You should also follow Keren on her website, The Gerontechnologist, for regular updates on conferences, publications, and new entrants into the AgeTech space.


I first came across Jane McGonigal when I saw her TED talk on how to see the future. When I heard that she was publishing a book on the topic, I immediately pre-ordered it from Amazon. Imaginable is a fascinating read and covers a lot of ground on how futurists like McGonigal approach their future-focused research.


I’ve been interested in the field of synthetic biology for some time. Fortunately, I had the benefit of learning a lot about the area by tapping into the expertise of one of my former colleagues at Sg2, Justin Cassidy, who patiently explained the basics and clinical applications of the technology to this novice (Thanks for putting up with my dumb questions, Justin!). The Genesis Machine is another book that I discovered while watching a podcast interview of Amy Webb by Leo Laporte on Triangulation. You should also follow her work at The Future Today Institute, where you’ll find a wealth of information on Tech and Science trends. Amy and her co-author Andrew Hessel cover this fast-growing field—which uses computers to modify or rewrite genetic code—has created revolutionary, groundbreaking solutions such as the mRNA COVID vaccines, IVF, and lab-grown hamburger that tastes like the real thing. It gives us options to deal with existential threats: climate change, food insecurity, and access to fuel. But they also outline the risks involved and how to best address the opportunities in the bioeconomy.


I’ve read every biography that Walter Isaacson has written. His books on Leonardo da Vinci and Steve Jobs were two of my favorites. I love his writing style and comprehensive approach to researching the people he is profiling. His biography of Nobel Prize winner Jennifer Doudna, Ph.D., one of the inventors of CRISPR technology and gene editing, is one of those volumes that I couldn’t put down. Isaacson traces the arc of her life from early childhood to her ground-breaking discovery of CRISPR in his usual highly engaging fashion. A great read.


Dr. Peter Hotez has been a regular fixture on the cable channels throughout the COVID pandemic. Millions have seen his calm, rational voice during the many interviews he has given. His work in infectious diseases has been going on for decades now. In his book Preventing the Next Pandemic, he brings all of his knowledge about dealing with pandemics together, along with his keen assessment of what went right and what went wrong in our global response to the COVID pandemic, along with some recommendations about how to prevent those mistakes from happening again. I found his book to be more interesting than Bill Gates’ tome, although both are worth reading.


This was a book recommended by Dr. Bertalan Mesko, The Medical Futurist, on his website. In an age where critical thinking is in short supply, Think Again by Adam Grant examines the critical art of rethinking: learning to question your opinions and open other people’s minds, which can position you for excellence at work and wisdom in life. His stories and examples teach us to let go of views that are no longer serving us well and prize mental flexibility over foolish consistency. If knowledge is power, knowing what we don’t know is wisdom.


Mike Magee, M.D., former hospital administrator, and Pfizer executive, has spent years investigating the pillars of our health system: Big Pharma, insurance companies, hospitals, the American Medical Association, and anyone affiliated with them. His book Code Blue: Inside America’s Medical Industrial Complex gives readers a look behind the often opaque industry to expose the greed and sometimes questionable business practices that consume a large portion of the health care dollars spent in this country. He offers some suggestions for how we might change the system to make it more accessible and less costly – although many will find his arguments for a single-payer, multi-plan insurance arena controversial.


While not a new publication, I came across Self Tracking as part of my research into the current state of self-tracking devices and their expanded use in personalized health care. Gina Neff and Dawn Nafus describe what happens when people turn their everyday experiences—in particular, health and wellness-related experiences—into data and offer an introduction to the essential ideas and key challenges of using these technologies. They consider self-tracking as a social and cultural phenomenon, describing not only the use of data as a kind of mirror of the self but also how this enables people to connect to, and learn from, others. This book is especially relevant today, as we question things like who owns our health care tracking data, how it can be used, and whether patients should be compensated for the use (or misuse) of their data.


AI 2041: Ten Visions for Our Future is another book recommended by Dr. Mesko. The authors, Kai-Fu Lee, the former president of Google China and bestselling author of AI Superpowers, and novelist Chen Qiufan imagine our world in 2041 and how AI will shape it. This combination of real-world technology development and science fiction storytelling provides the reader with a fascinating look into the not-so-distant future of AI.


I usually read about a book a week. But, lest you think that all I spend my time reading are non-fiction books, here a few of my favorite fiction books so far this year:

I loved Andy Weir’s novel The Martian (not so much the movie version, though). So when he published his latest novel Project Hail Mary, I downloaded it on its release date and finished it in a single reading. Ryland Grace is the sole survivor on a desperate, last-chance mission—and if he fails, humanity and the earth itself will perish. Except that right now, he doesn’t know that. He can’t even remember his name, let alone the nature of his assignment or how to complete it. I loved the way Weir structured the entire novel. And the second half of the book, where Grace uncovers how to communicate with the alien being he’s encountered, is utterly fascinating. I know there’s a movie version in the works. Hopefully, I’ll enjoy this one better than the last adaptation of Weir’s The Martian.


Kim Stanley Robinson’s The Ministry for the Future is not a new publication (released in 2020), but somehow I missed adding this to my reading list. Robinson uses fictional eyewitness accounts to tell the story of how climate change will affect us all. Its setting is not a lonely, post-apocalyptic world but a future almost upon us. Cited by both Bill Gates and Barack Obama as critical reading for people wanting to understand how humanity can band together to solve the crucial issue of climate change, Robinson’s book makes an excellent read.


Stephanie Storey’s Oil and Marble: A Novel of Leonardo and Michelangelo is another “how did I miss this one” finds. First published in 2016, Storey’s novel covers the period of a few years at the very beginning of the sixteenth century when Leonardo da Vinci and Michelangelo Buonarroti both lived and worked in Florence. Leonardo was a charming, handsome fifty-year-old at the peak of his career. Michelangelo was a temperamental sculptor in his mid-twenties, desperate to make a name for himself. Having read Isaacson’s biography of Leonardo, I found the juxtaposition of his work and Michelangelo’s work at this critical point in each of their careers an excellent, engaging read.


Books I’m looking forward to reading in the second half of the year (release date in parentheses):

  • Portrait of an Unknown Woman (July 29) – Book 22 in Daniel Silva’s Gabriel Allon series. It can’t come soon enough for me.
  • The Omega Factor (June 7) – I Love Steve Berry’s novels
  • Exponential Organizations: The Essential Guide to Building ExO’s (June 25) – More on exponential organizations from Peter Diamandis
  • The Future Circle of Healthcare: AI, 3D Printing, Longevity, Ethics, and Uncertainty Mitigation (September 3) – This book brings together scholars whose areas of expertise represent different themes essential to understanding how healthcare might change and evolve over the next decade.
  • Escaping Gravity: My Quest to Transform NASA and Launch a New Space Age (June 21) – I’ve been a space nut my whole life. This book by the former NASA Deputy Administrator Lori Garver outlines her push to get NASA to partner with commercial space companies. I am looking forward to reading this one.

So there you have my dozen recommendations for your reading pleasure throughout the Summer. Let me know in the comments whether you have any other books I should consider adding to my list. I’m always looking for the next great reading adventure. Thanks for reading the blog and your comments and suggestions for other topics to research and post. Enjoy the Summer, and happy reading!

Health Tech News This Week – June 4, 2022

What happened in health care technology this week, and why it’s important.

Image Credit: Shutterstock.com

Tiny Robot Crab to Perform Tasks Inside Body

Conn Hastings in Medgadget reports on work by engineers at Northwestern University who have developed a tiny remote-controlled crab robot. The device is just half a millimeter wide, and can perform various impressive tasks, including jumping, twisting, bending, turning, and walking. The tiny devices do not require electricity and instead are powered through heating using a laser. The shape-memory alloy that forms the bulk of the robots rapidly changes shape when heated and returns to its original shape rapidly when the heating ceases, forming the basis for the device’s movements. While in its technological infancy, the method could have eventual applicability in medicine as a means to perform minimally invasive surgical tasks within the body.

Why it’s important – The future of micro-robotics can have them act as agents to repair or assemble small structures or machines in industry or as surgical assistants to clear clogged arteries, stop internal bleeding, or eliminate cancerous tumors — all in minimally invasive procedures.


Infographic of the week – Rare diseases affect 30 million Americans. And there are approximately 7,000 different known rare diseases today. Only ~5% have a treatment option available.

Image Credit: Viscadia

Artificial Skin Senses Pressure, Temperature, Humidity

More from Conn Hastings in Medgadget. Researchers at Graz University in Austria have created an artificial skin that is more sensitive than your fingertip. The skin contains 2,000 sensors per square millimeter, and the researchers designed it to sense humidity, temperature, and pressure, just like human skin. The tiny sensors within the skin material consist of a hydrogel core and a piezoelectric zinc oxide shell. The hydrogel expands or contracts depending on the temperature and when it absorbs moisture. Pressure can also affect the zinc oxide shell, and these changes lead to an electrical charge, forming the basis of the sensing technology.

Image Credit: Graz University, Austria

Why it’s important – The material could form a component of advanced prosthetic devices that allow their users to experience their environment more realistically. The resulting e-skin can outperform our skin in terms of sensing small objects. Human skin can detect things that are approximately 1 square millimeter in size, whereas this artificial skin can reportedly detect ones that are up to one thousand times smaller.


When will augmented reality glasses be ready for consumers?

Since Apple’s WWDC conference begins on Monday, and there’s a ton of speculation about whether they will introduce an augmented reality glasses product, Robert Scoble posts this look at when the technology will be ready for prime time in his Scobleizer blog. His take:

“Until this next generation of devices happens these glasses will mostly be used for R&D or enterprise uses, like controlling robots or production lines, or doing things like surgery, where field of view, brightness, etc aren’t as important as they will be for consumers. Lumus is selling their much better lenses to consumer-focused partners, but they don’t expect the really interesting glasses until 2024.”

Robert Scoble

Why it’s important – While I believe that augmented reality applications will ultimately be a more important use in health care than VR, it’s important to understand what works today and what needs to happen for mainstream adoption. I’ll be watching the Apple WWDC Keynote with interest on Monday. But I’ll need to temper my enthusiasm for their next “new big thing” with the reality of the current capabilities.


Gene Therapy Successfully Treats Spinal Cord Injuries Without Side Effects

An international team of researchers led by scientists at the University of California San Diego School of Medicine reported that a gene therapy that inhibits targeted nerve cell signaling effectively reduced neuropathic pain in mice with spinal cord or peripheral nerve injuries with no detectable side effects. The team published the results in the online edition of Molecular Therapy on May 5, 2022, and in an article on SciTech Daily.

Why it’s important – The results in this study suggest a possible new treatment option for a condition that may affect more than half of individuals with spinal cord injuries. Neuropathy involves damage or dysfunction in nerves elsewhere in the body, typically resulting in chronic or debilitating numbness, tingling, muscle weakness, and pain.


NZ-based AI firm launches tool to assess heart risk through retinal scans in US

Fierce Health’s Anastassia Gliadkovskya covered this announcement by Toku Eyes. This New Zealand-based healthcare AI company is launching its tool that assesses heart risk through a retinal scan in the U.S. The device, called ORAiCLE, uses an AI platform to identify cardiovascular threats more accurately than existing risk calculators, the company claims. The platform recognizes subtle changes in aspects like blood vessels and pigmentation to identify a person’s risk of a stroke or heart attack in the next five years.

Why it’s important – Many Americans with diabetes are at risk of long-term complications like heart disease and blindness. Early diagnosis is critical for mitigating morbidity, but the diagnosis has historically been a challenge. Since using a retinal camera and the AI software requires minimal training, it is more cost-effective and accessible, the company argues. The AI platform uses an image of the back of the eye to do its assessment. It then provides personalized health guidance or recommends a specialist referral.


Artificial Intelligence Can Now Accurately Describe Your Poop

In one of those “I never thought I’d see this headline” moments, Vice’s Ella Fassier reports on a new randomized clinical trial presented at the Digestive Disease Week conference in San Diego. Artificial Intelligence categorizes the poops into one of seven categories following the Bristol Stool Scale, a diagnostic stool tool.

Why it’s important – Irritable Bowel Syndrome (IBS) affects up to 1 billion people worldwide. And these apps are part of a growing trend of AI-assisted healthcare. At its best, the health-promoting technological design would be driven by the needs and desires of the most vulnerable patients, would be equally and freely accessible to all, and would allow communities to surpass gatekeeping inherent in the medical-industrial complex. Not as expensive as a smart toilet like the Tyto Wellness Toilet, which also performs fecal analysis, it is hoped that the use of an AI-assisted algorithm will encourage awareness in a more significant portion of the population.


Doctors Transplant 3-D Printed Ear Made of Human Cells

3DBio Therapeutics, a biotech company in Queens, said it had for the first time used 3-D printing to make a body part with a patient’s own cells. As reported in The New York Times by Roni Caryn Rabin, independent experts said that the transplant, part of the first clinical trial of a successful medical application of this technology, was a stunning advance in tissue engineering.

Image Credit: Dr. Arturo Bonilla, Microtia-Congenital Ear Institute

Why it’s important – Companies have previously used 3-D printing technology to produce custom-fit prosthetic limbs made of plastic and lightweight metals. But the ear implant, made from a tiny glob of cells harvested from the woman’s misshapen ear, appears to be the first known example of a 3-D printed implant made of living tissues. The new procedure can be done in a few hours and outside a hospital.

Health Tech News This Week – May 28, 2022

What happened in health care technology this week, and why it’s important.

Image Credit: Shutterstock.com

NY State is giving out hundreds of robots as companions for the elderly

The state of New York will distribute robot companions to the homes of more than 800 older adults. The robots cannot help with physical tasks but function as more proactive versions of digital assistants like Siri or Alexa — engaging users in small talk, helping contact loved ones, and keeping track of health goals like exercise and medication. James Vincent reports on the initiative in his article on The Verge. The project is being organized by the New York State Office for the Aging (NYSOFA) and is intended to help address the growing problem of social isolation among the elderly.

Why it’s important – An estimated 14 million Americans over the age of 65 currently live alone, and this figure is projected to increase over the next decade as the boomer generation ages. Studies have suggested that long-term loneliness is as damaging to an individual’s health as smoking. While deploying robots for elderly care is often controversial, advocates say robots are a necessary tool, especially when humans aren’t available.


Infographic of the week – CB Insights reports that funding for healthcare AI has dropped considerably in Q1 of 2022. Does this signal a shift in thinking about how broadly AI will be adopted?

Image Credit: CB Insights

Quote of the week – From Dr. Bertalan Mesko, The Medical Futurist

Image Credit: The Medical Futurist

Proton cancer centers continue to proliferate, despite shaky benefits and checkered financiers

Tara Bannow and Bob Herman of STAT (subscription required) report on the ongoing arms race for these facilities despite the treatment’s high price tag, spotty insurance coverage, and unclear benefits. Even though building a proton center is a risky financial bet, some believe the research that’s accumulating will eventually persuade insurers to expand their coverage of the therapy. And various companies and financiers are getting in on the action with hospital systems, betting that the fancy, expensive machines will draw patients back from the pandemic’s lull.

“There is something that gives prestige to health care systems when they can say they have the newest technology. It becomes a marketing device. ‘We do have technology. We do have proton therapy in our cancer center.’”

Steven Ullmann, health policy and economics, University of Miami

Why it’s important – The proton therapy gold rush is due at least in part to a Medicare decision many years ago. The evidence for proton therapy is stronger for tumors closer to vital body parts, like the brain and spine. But Medicare has never excluded any types of tumors from coverage. Medicare currently pays $1,321 per proton treatment in a hospital outpatient department. That means a Medicare patient with prostate cancer, who would likely get five treatments per week for eight weeks, would bring a facility nearly $53,000 in payments, even though other, cheaper forms of radiation are just as good for prostate cancer. And the marketing around these centers is off the charts. Ullman said he’s seen providers try to entice patients by offering to help with the referral documentation needed for insurance coverage. “If you build it, and they don’t come” is a recipe for financial disaster. The world of proton therapy is littered with bond defaults and bankruptcies. The simplest explanation is they spent too much on massive buildings and equipment — multiroom facilities easily top $200 million — and couldn’t woo enough patients or collect enough money from reluctant insurers. Color me skeptical. Studies to date haven’t shown a clear benefit of proton therapy beyond conventional radiation for all types of tumors. Many clinical trials run by the National Institutes of Health won’t produce results for several years.


Digital Twins And The Promise Of Personalized Medicine

Another interesting article from Dr. Bertalan Mesko” and his team at The Medical Futurist. in this post, he reviews the current state of development of digital twins and the various applications they will be used for in healthcare.

Why it’s important – in the future, if you could create a digital twin of a patient with all their organ functions all their cellular functions and can simulate this complexity, you would be able to predict weeks or months in advance which patients will get ill, how a particular patient will react to a specific therapy, which patients will benefit the most. As the authors point out, there are challenges to be overcome in the development of digital twins, including the amount of computing power necessary to run those simulations and navigating all of the ethical issues associated with using (and potentially profiting from) this massive amount of personal data.


Medtronic and DaVita announce New Kidney Health Technology Company

In a press release this week, Medtronic plc (NYSE: MDT) and DaVita Inc. (NYSE: DVA) today announced the intent to form a new, independent kidney care-focused medical device company (“NewCo” or “the Company”) to enhance the patient treatment experience and improve overall outcomes. The Company will focus on developing a broad suite of novel kidney care products and solutions, including future home-based products, to make different dialysis treatments more accessible to patients.

Why it’s important – while the transaction isn’t expected to close until the next calendar year, creating more home-based solutions to manage chronic conditions like kidney disease will allow patients and their families the ability to receive more care in the home and remove some of the scheduling, transportation, and coordination issues that exist in the current outpatient center-based model.


Smart Pacifier Monitors Electrolyte Levels

Conn Hastings in Medgadget reports that a team at Washington State University developed a smart pacifier that can provide continuous monitoring of electrolyte levels in saliva. The measurements could help to avoid twice daily blood draws for premature infants. The new pacifier uses microfluidic channels to draw saliva inside. Then, sensors within the device measure sodium and potassium ion concentrations and transmit the data wirelessly to a caregiver through Bluetooth.

Image Credit: University of Washington

Why it’s important – The measurements could help avoid twice daily blood draws for premature infants. Blood draws are currently routine to monitor for signs of dehydration, which can be dangerous for infants born prematurely. So far, the researchers have tested the device in several infants and found that the electrolyte measurements it provides are comparable to those obtained using conventional blood draws.


Scientists grow cells on a robot skeleton (but don’t know what to do with them yet)

Back to The Verge for this article by James Vincent on a proof of concept research idea in tissue engineering. The science of tissue engineering — or growing human cells for use in medicine — is very much in its infancy, with only the simplest lab-grown cells able to be used in experimental treatments today. But researchers say a new method of tissue engineering could potentially improve the quality of this work: growing the cells on a moving robot skeleton. As described in a paper published in Communications Engineering, they adapted an open-source robot skeleton designed by the engineers at Devanthro. They created a custom growing environment for the cells that can be fitted into the skeleton to bend and flex as required.

Why it’s important – This is very early research and experimentation. However, the team has shown that growing cells in a robot skeleton is undoubtedly possible. They need to find out if it’s worth the time. In the paper, though, the researchers enjoyed some optimistic speculation about the potential of this line of work. They reason that, in the future, detailed scans of patients could be used to create joint-perfect replications of their bodies, allowing tissue-like tendons to be grown for surgeries in human simulacra.

Health Tech News This Week – May 21, 2022

What happened in health care technology this week, and why it’s important.

Image Credit: Shutterstock.com

Researchers Pinpoint Reason Infants Die From SIDS

Sudden infant death syndrome (SIDS) accounts for about 37% of sudden unexpected infant deaths a year in the U.S., and the cause of SIDS has remained largely unknown. As reported in BioSpace online, last week, researchers from The Children’s Hospital Westmead in Sydney released a study that confirmed not only how these infants die but why. They found the activity of the enzyme butyrylcholinesterase (BChE) was significantly lower in babies who died of SIDS compared to living infants and other non-SIDS infant deaths. BChE plays a significant role in the brain’s arousal pathway, explaining why SIDS typically occurs during sleep.

“This discovery has opened up the possibility for intervention and finally gives answers to parents who have lost their children so tragically. These families can now live with the knowledge that this was not their fault.”

Carmel Harrington, PHD, Sleep Medicine, Sydney University in Australia

Why it’s important – This is huge. This finding represents the possibility of identifying infants at risk for SIDS before death and opens new avenues for future research into specific interventions. In the next few years, those in the medical community who have studied SIDS will likely work on a screening test to identify babies at risk for SIDS and hopefully prevent it altogether.


Infographic of the week – Terrific graphic from Harvard Medical School outlining the list of diseases linked to chronic inflammation.

Image Credit: Harvard Medical School

Hope for heart attack patients as scientists use stem cells to repair damaged organ in pigs

Colin Fernandez’s article in The Daily Mail reports on research by scientists from Germany, Sweden, and the drug company AstraZeneca who have created a new therapy using stem cells that can mend damaged heart tissue. They could regenerate heart cells in pigs using human ventricular progenitor (HVPs) cells.

Why it’s important – Previous studies that used heart cells grown from stem cells have resulted in patients suffering side effects such as irregular heartbeats and fatal arrhythmia. The new approach uses the more flexible HVP cell. The researchers said their results show that damage to the heart can be reliably repaired even in large animals with no severe side effects observed. The next step will be to translate their current research findings to develop a treatment for human heart patients over the coming years.


Using AI to Predict Bone Fractures in Cancer Patients

A new study suggests that scientists use artificial intelligence (AI) to predict how cancer may affect the probability of fractures along the spinal column. As reported in Axis Imaging News online, the study, published in the International Journal for Numerical Methods in Biomedical Engineering, describes how the researchers trained an AI-assisted framework called ReconGAN to create a digital twin or a virtual reconstruction of a patient’s vertebra. By training ReconGAN on MRI and micro-CT images obtained by taking slice-by-slice pictures of vertebrae acquired from a cadaver, researchers could generate realistic microstructural models of the spine.

Why it’s important – For a field like orthopedics, using a non-invasive tool like the digital twin can help surgeons understand new therapies, simulate different surgical scenarios, and envision how the bone will change over time, either due to bone weakness or to the effects of radiation. The digital twin can also be modified to patient-specific needs.


Magnetic marker liquid could be used to show if breast cancer has spread

Women with invasive breast cancer could be injected with a magnetic marker liquid to tell doctors if their disease has spread, according to a recommendation by the U.K. government’s health advisers. The substance, called Magtrace, has been shown to locate the presence of sentinel lymph nodes, which indicate if cancer has progressed beyond the breast. The National Institute for Health and Care Excellence (Nice), which advises ministers and the NHS on which treatments represent value for money in England and Wales, has issued draft guidance endorsing the use of Magtrace in conjunction with a probe called Sentimag.

Why it’s important – Once the sentinel lymph node has been located, surgeons remove it and undertake a biopsy, during which a pathologist checks if any signs of cancer are present. If so, they may carry out further surgery to remove more lymph nodes. People with breast cancer want to know if their cancer has been isolated or has spread to the rest of their bodies. The earlier this is established, the better the potential outcomes will be.


Health Tech News This Week – May 14, 2022

What happened in health care technology this week, and why it’s important.

Image Credit: Shutterstock.com

Vivalink announces availability of multi-vital BP patch

As reported in Med-Tech Innovation News, Vivalink, a provider of digital healthcare solutions, has announced the availability of a multi-vital blood pressure patch for remote patient monitoring for commercial research and development. The advanced multimodal continuous signal processing patch uses electrical signal-based technologies to capture ECG traces, heart rate, respiratory rate, and systolic and diastolic blood pressure on a single device. The device is FDA/NMPA cleared for ECG and heart rate, and CE cleared for ECG, heart rate, and respiratory rate. The blood pressure feature is integrated and available for research and development. Weighing 7.5 grams and the size of a small bandage, the reusable and rechargeable wearable patch requires no additional components such as a wristband or wires to capture blood pressure.

Why it’s important – A great addition to the medical sensor market for those organizations implementing remote patient monitoring programs. Designed for remote and ambulatory patient monitoring, such as hypertension diagnosis and management, the patch is a wireless network that automatically captures and sends a continuous stream of data to clinical applications in the cloud.


Graphic of the week – A new health consumer survey focused on organizations with the strongest branding and consumer experience.

Image Credit: Humanizing Brand Experience Vol 5, Monigle, the Society for Health Care Strategy & Market Development (SHSMD), and the American Hospital Association

Infographic of the week – The number of people with vision loss is growing. Projections show that vision loss will increase by 55%, or 600 million people over the next 30 years. Latest information from The International Agency for the Prevention of Blindness (IAPB).

Image Credit: IAPB Vision Atlas, Accessed 5/10/2022

Clinical Trial Focuses on Remote Monitoring of Cancer Patients

Continuing the remote patient monitoring theme, Scott Mace reported on this work at the University of Colorado in his article in Health Leaders. The system is testing the feasibility of remote patient monitoring for the early detection of febrile neutropenia, a common, life-threatening complication of cancer therapy that is typically treated as an oncologic emergency. Ten bone-marrow transplant recipients will initially participate in the trial at the University of Colorado Anschutz Medical Campus, also known as CU Anschutz. The phased approach, through a series of studies, will scale the trial up over time to 100 participants, overseen by an institutional review board, and will include the use of predictive analytics, telemedicine, portable imaging, and supportive therapies such as antibiotics and hydration via IV.

“What really excites me is bringing all of the different data from these remote patient monitors together, and developing new machine learning and other AI based algorithms to say, well, it’s not just temperature, it’s your heart rate’s going up, your breathing is getting a bit faster, you’re not as steady on your feet.”

CLAY SMITH, MD, DIRECTOR OF THE BLOOD DISORDERS AND CELL THERAPIES CENTER, AND MEDICAL DIRECTOR OF UCHEALTH AND CU INNOVATION CENTERS

Why it’s important – Febrile neutropenia leads to significant complications in 25% to 30% of patients and may lead to death in approximately 10% of patients. Time to antibiotic administration has been independently associated with mortality, and each delay in starting antibiotics can increase the risk of 28-day mortality by 18%. Historically, oncologists encouraged patients to buy thermometers and call their oncologist’s office if they feel bad or they notice their temperature going up. The new system represents a different, more personalized approach to detecting early infection.


Compact Wearable “Lab on the Skin” Continuously Monitors Glucose, Alcohol, and Lactate

More reporting on remote, continuous monitoring this week. Imagine being able to measure your blood sugar levels, know if you’ve had too much alcohol to drink, and track your muscle fatigue during a workout, all in a tiny device worn on your skin. Engineers at the University of California San Diego (UCSD) have developed a prototype of such a wearable that can continuously monitor several health stats—glucose, alcohol, and lactate levels—simultaneously in real-time. The University reported on this research in an article in SciTech Daily. The wearable consists of a microneedle patch connected to a case of electronics. Different enzymes on the tips of the microneedles react with glucose, alcohol, and lactate in interstitial fluid. These reactions generate small electric currents, which are analyzed by electronic sensors and communicated wirelessly to an app that the researchers developed. The results are displayed in real-time on a smartphone.

YouTube video credit: University of California, San Diego

Why it’s important – Most commercial health monitors, such as continuous glucose monitors for patients with diabetes, only measure one signal. The problem with that, the researchers said, is that it leaves out information that could help people with diabetes, for example, manage their disease more effectively. Monitoring alcohol levels is useful because drinking alcohol can lower glucose levels. Knowing both levels can help people with diabetes prevent their blood sugar from dropping too low after having a drink. Combining information about lactate, which can be monitored during exercise as a biomarker for muscle fatigue, is also helpful because physical activity influences the body’s ability to regulate glucose. This is very early in the development cycle but holds great promise in advancing continuous monitoring of multiple factors to help understand inter-relationships for chronic disease management.


More Supply Chain Woes as Contrast Agents for Medical Imaging in Short Supply

“There has been no improvement to any extent within the U.S.market to manufacture items, so we still predominantly rely on international supply. In addition, the distributors are allocating supply by their individual customers, and at times that can lead to other outages.”

Christopher O’Connor. President and Incoming CEO of Yale New Haven (Conn.) Health, Becker’s Healthcare Interview
Image Credit: Shutterstock.com

In what should probably be categorized in the “we never learn our lesson” department, we now hear of a temporary shortage of GE Healthcare’s iodinated contrast media—specifically, all concentrations and formulations of its Omnipaque™ (iohexol) products that are manufactured in a single facility in Shanghai, China (Shanghai is currently under COVID-19 lockdown). While the facility has reopened and ramped up production, GE anticipates an 80% reduction in supplies for the next 6-8 weeks. General Electric’s (GE.N) healthcare unit said on Tuesday it had increased output of contrast media used for medical scans and tests at its factory in Ireland and shipped products by air to help combat shortages caused by the suspension of its Shanghai factory.

Supply chain issues have dominated the news for months now as the pandemic slowed international trade and applied pressure on critical items. Usually only felt if it goes wrong, supply chain management has become an increasingly important consideration. Hospitals and health systems have faced significant issues with their supply chains, from personal protective equipment shortages at the start of the pandemic to a lack of crutches now. According to a Kaufman Hall study, ninety-nine percent of hospitals and health systems report challenges in supply procurement as of October 2021.

“I truly believe that we’re probably going to be faced with these challenges for another 12 to 24 months. I would suggest that the trend is that there’s going to be price pressures, we’re anticipating energy challenges throughout the next six to eight months.”

Michael McCullough. Senior Vice President of Supply Chain at Wellstar Health System, Becker’s Healthcare Interview

The vitality of the supply chain is undoubtedly among the top concerns facing hospitals and medical providers today. ECRI’s Top 10 Health Technology Hazards for 2022 rank supply chain shortages among the top three risks facing healthcare organizations. Unfortunately, it’s a multifaceted issue with no easy solutions. We are all aware of the backlog of cargo ships waiting to be unloaded on the West Coast. On top of that, we see COVID-19-related manufacturing disruptions in some Asian countries that produce many of the everyday items we use in the healthcare setting. We also have pressure on the trucking industry in this country due to the increase in e-commerce over the past two years. Traditional reliance on industry partners (manufacturers and distributors) for product availability and order fill can no longer be the norm. The list of scarce items is long. It includes latex and vinyl examination gloves, surgical gowns, laboratory reagents, specimen-collection testing supplies, saline-flush syringes, and dialysis-related products, according to the U.S. Food and Drug Administration.

“We’ve got the wrong products in the wrong location with the wrong shipping. It’s not one disruption; it’s a series of disruptions.”

Abe Eshkenazi, CEO, Association for Supply Chain Management

But what’s frustrating to me is that this latest problem feels a lot like a scene from the movie Groundhog Day. We keep repeating the same patterns over and over again. Today it’s iodinated contrast media. In the past, it’s been a shortage of radioisotopes for nuclear medicine studies. Or a previous shortage of gadolinium-based contrast agents for MRI studies. In each instance, critical imaging studies had to be postponed, and patient care suffered. The American College of Radiology (ACR) has published a list of recommendations on dealing with the current shortage, which is commendable. But, as before, we are not trying to solve the root causes of the problem.

Moving manufacturing offshore – Drugs used in the U.S. involve inputs from all over the world. Many of those chemical inputs are manufactured in India and China, and they’re shipped to the U.S. That gets tied up in all of the disruptions around shipping affecting all industries right now. A factory shutdown caused the current contrast media shortage in Shanghai. China’s shutdowns have a lag time of 45 to 90 days before their effects show up in the U.S., so supply-chain challenges will most likely continue well into 2023. The radioisotope shortage was caused by the decommissioning of the Chalk River reactor in Canada. Shortages in aluminum, semiconductors, wood and paper pulp, and resin disrupt medical devices’ supplies. Those shortages have led to uneven supplies of medical monitors, CT scan devices, packaging for medical supplies, and gloves.

The “single-point-of-failure” effect – Shortages among pharmaceuticals tend to primarily affect sterile injectable drugs and usually drugs that are older and less profitable. They tend to be drugs manufactured in and around the U.S., where companies maybe, over time, didn’t find it as profitable to make these older injectable drugs. They got out of the business, to the point where there’s just one manufacturer left. Any disruption happens there, and then the supply does dry up. Now there appears to be no end in sight to America’s baby formula shortage, according to the most recent data from a retail tracking group. The share of baby formula out of stock across the U.S. hit 40 percent on April 24, according to Datasembly. That’s up from 29 percent in March. The shortages were prompted in part by the shutdown of a key production facility in Michigan this year. The plant, owned by Abbott Nutrition, has been the subject of an FDA and CDC investigation following reports of contaminated formula that was linked to the deaths of at least two infants.

“Unfortunately, we don’t see this (shortage of baby formula) slowing down any time soon.”

Ben Reich, CEO, Datasembly

Time to rethink “Just in Time” ordering practices – For the often-used stocked items required to treat patients, the industry used to have fill rates of 96% to 98%, meaning that just a tiny percentage of orders remained unfilled. Today, the industry’s fill rate for these items is in the high 80s. According to industry experts, it used to be that hospitals would deal with 50 to 100 back-ordered items per day. Many institutions now deal with 800 to 1,000 backorders per day.


What’s the solution? – In 2020, the National Academies of Sciences, Engineering, and Medicine looked at the causes of medical-product shortages and ways to improve medical supply chains, both in normal times and in public health emergencies. Its 364-page report, Building Resilience into the Nation’s Medical Product Supply Chains, which came out earlier this year, called for the FDA to publicly track sourcing, quality, volume, and capacity information and to establish a public database; for health systems to include failure-to-supply penalties in contracts; and for the federal government to optimize inventory stockpiling to respond to medical-product shortages, among other things.

In their report, the NAS created a medical product supply chain resilience framework. They used this framework, which contains four tiers that address awareness, mitigation, preparedness, and response, to craft and inform their recommendations.

Under the awareness category, they proposed measures to collect, compile, and disseminate information about medical product supply chain risks and vulnerabilities. The committee recommends the U.S. Food and Drug Administration (FDA) make sourcing, quality, volume, and capacity information publicly available for all medical products approved or cleared for sale in the United States and establish a public database to share this information and to promote analyses of these data by interested parties

Under the mitigation category, they advocated steps to reduce the likelihood and magnitude of supply disruptions. The committee recommends that health systems deliberately incorporate quality and reliability, in addition to price, in contracting, purchasing, and inventory decisions

Under the preparedness category, they describe a range of options for preventing a supply shortage from impacting patients and medical personnel. The committee recommends the Office of the Assistant Secretary for Preparedness and Response (ASPR) modernize and optimize inventory stockpiling management as protection against medical product shortages at the national and regional levels and that ASPR and FDA complement stockpiling with capacity buffering policies to enhance cost efficiency and to improve protection in major emergencies.

Under the response category, they suggest policies for building organizational capabilities that protect health during emergency disruptions. The committee recommends negotiating an international, plurilateral treaty with other major medical product exporters to make more effective use of limited global supplies by ruling out export bans on vital medical products and components and that ASPR and the Centers for Disease Control and Prevention establish a domestic working group to examine ways to improve the effectiveness of the final delivery stage within the United States (“last mile”) of medical product supply chains and to engage end-users in planning for an emergency response to medical product shortages.

These are all excellent recommendations, to be sure. But none of these fixes will happen in the short term, and in the meantime, hospitals and health systems are trying to cope. Some of the best recommendations I’ve seen to date on how hospitals and health systems that want to improve their supply chains can manage the current situation come from the team at Kaufman Hall in their State of Healthcare Performance Improvement Report, 2021. Their key recommendations include:

  • They are identifying historically challenging supplies and developing acceptable substitutes.
  • They are diversifying suppliers and partnering with several alternative suppliers.
  • Focusing on inventory management and using technology to gain early insight into supply chain issues.
  • Gathering supply chain data and building supply-demand models per category or supply items, as well as sharing this data with vendors and requesting the same visibility from them.
  • Managing vendors and thoroughly vetting all vendors.

For the remainder of 2022 and potentially 2023, enhanced healthcare supply chain management will require transparency, collaboration, and frequent communication between distributors and suppliers. Organizations across the medical supply chain must work together to help improve production and smooth out problem areas to achieve a “new normal.” Flexibility, teamwork, and planning will prove critical components of effective supply chain management in the months ahead.