What happened in health care technology this week, and why it’s important.
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.
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.
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.
What happened in health care technology this week, and why it’s important.
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.
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).
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.
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.
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.
“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
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.
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.
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.
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.
“I thought I could beat anything. Then my doctor said: ‘You have skin cancer’ Melanoma is not the most common of skin cancers, but it is the most dangerous if not found in the early stages.”
Jane Green, Author
Skin cancer is one of the most common cancer types worldwide: one in five people in the U.S. is expected to receive a skin cancer diagnosis. Early detection and treatment are invaluable: almost all skin cancers (both melanoma and nonmelanoma) can be cured if found and treated early. The American Cancer Society reports that across all stages of melanoma, the average five-year survival rate in the U.S. is 92%. The estimated five-year survival rate for patients whose melanoma is detected early is 98%. Prevention and detection are the key. One of the impacts of the COVID-19 pandemic has been a decrease in the number of patients visiting dermatologists to check for suspicious moles or changes in their skin. One fact dermatologists pointed out in a recent survey was that about 21% of melanomas might have gone undetected in 2020.
The annual cost of treating skin cancers there is estimated at $8.1 billion: about $4.8 billion for non-melanoma skin cancers and $3.3 billion for melanoma, which is a huge number. Fortunately, digital technologies are on their way to help dermatologists diagnose and treat skin diseases better and more effectively. After reviewing the current research on the topic, here are the key technologies that will help support the practice of dermatology in the coming years.
Teledermatology – Smartphones coupled with super-fast internet connections make it easy to send pictures or footage anywhere, so telehealth solutions appeared naturally in dermatology. The options of teledermatology services, as well as self-care platforms, are soaring. Companies like FirstDerm, Direct Dermatology, iDoc24, and SkinVision all work based on the same principle: they promise patients the option to self-check their symptoms and connect to a dermatologist online for consultation within a very short time. Usually, people can load up their photos to a particular platform, and smart algorithms and/or dermatologists give advice based on them. COVID-19 has given rise to telemedicine practices across the entire healthcare industry, but dermatology has been one of the easiest to adapt to the digital age. As the Journal of the American Academy of Dermatology” puts it, COVID-19 has removed “many restrictions that have roadblocked telehealth adoption.” There has historically been an immense shortage of dermatologists in the U.S. A 2017 estimate found that there were only 3.4 dermatologists per 100,000 people nationwide, and the average wait time to see one of them is 32.3 days. Even with all the obvious checks in the “pro” column—affordability, convenience, and accessibility—teledermatology still isn’t perfect. So, it’s essential to understand what conditions are best treated with teledermatology and which require an in-person visit.
Primary Care Physician Office – The DermaSensor is a handheld objective skin cancer sensing device that utilizes both pulses and light and spectroscopy to non-invasively identify information about a skin lesion at the subcellular level. More specifically, this device uses Elastic Scattering Spectroscopy (ESS), which measures and records photon scattering patterns as they reflect off different cellular structures following the input of quick bursts of light. ESS technology has been validated in more than 30 clinical publications that have demonstrated this technique’s utility in analyzing the macroscopic structure of both cellular and subcellular particles. Since malignant lesions scatter light at different intensities, the DermaSensor algorithm, derived from thousands of spectral samples of pathologically verified lesions, will immediately categorize a skin lesion as “Higher Risk” or “Lower Risk.” The DermaSensor device is intended to be used by primary care physicians in annual patient visits to check for suspicious skin lesions or changes in the skin since the last visit. PCPs will be able to use DermaSensor™ as an adjunctive tool to assess skin lesions better and determine whether an additional evaluation is needed.
High-resolution, whole-body imaging – Explicitly designed for dermatology, the VECTRA WB360 whole-body 3D imaging system from Canfield Scientific captures the entire skin surface in macro quality resolution with a single capture. The fully integrated software allows clinicians to map and monitor pigmented lesions and distributed skin diseases. Other applications include documenting pigmented lesions, psoriasis, and vitiligo.
Wearable sensors – The clip-on QSun can detect UV exposure using five LED displays to indicate UV index. Once you shake it, it’ll let you know your UV index. That’s your measurement of how powerful ultraviolet radiation beaming from the sun is. The iOS and Android-friendly wearable keeps track of how long you have been out in the sun before you start to burn. When your time is up, it’ll vibrate to let you know that you should get in the shade. The QSun’s AI considers skin type to help determine the time that should be spent out in the sun. The Shade disc-shaped device is packed with sensors that can measure UVA and UVB rays and are even sensitive enough to do that with indoor light. The iOS and Android compatible wearable uses a magnetic clasp to wear on pretty much any piece of clothing, and it’ll keep you protected for five days before you need to power it up. If you like your wearables invisible, LogicInk will keep you safe in the sun with its Logic UV temporary tattoo. You stick the tat to your skin and watch its two rings throughout the day. There’s no phone or smartwatch involved. Simply keep your eyes on the tattoos. The smaller inner ring tells you how harsh the sun is by changing from white to purple. The outer, larger ring will turn bright pink from purple when you’re getting close to burning your skin.
The dermatology app environment – Over the past few years, developers have created smartphone apps that help users monitor moles and lesions for any signs of progression to skin cancer. Popular apps include the following:
UMSkinCheck – The University of Michigan launched a free app that guides users through a complete home skin check exam. This app also offers the opportunity to create a mole library. This will enable people to compare and track any skin changes over time.
MoleMapper – The Oregon Health & Science University developed this app. It allows users to take photos and gather measurements of any moles on their bodies. Similar to UMSkinCheck, the app will enable users to take regular pictures of their moles to facilitate change tracking over time.
Miiskin – This app also allows users to take pictures to track their moles over time. Users can also pay for a version that lets them track large areas of skin. This may help them identify new marks and moles they might not have seen.
MoleScope – This is a high-resolution camera compatible with many different smartphones. This camera uses high magnification and special lighting to take more detailed and better quality photos than other skin cancer apps. It also contains many features that other apps do, such as skin mapping, image management, and regular reminders.
SkinVision – This app helps users identify high-risk moles that require further testing. The app classes each photo as either high or low risk. SkinVision also provides advice on the next steps to take.
Cureskin – The artificial intelligence-based app was developed by two engineers previously working by Google, and it aims to compensate for the lack of dermatologists in India. It can diagnose six common skin conditions – pimples, acne, scars, dark spots, pigmentation, and dark circles. The user takes a photo, the algorithm analyses the skin issues, the app’s chatbot asks a few questions, and, depending on the inputs, the A.I. recommends an eight-week skincare regimen.
Dermatology A to Z – The American Academy of Dermatology developed the Dermatology A to Z, specifically designed to serve consumers looking for skin health information. The app gives users evidence-based, dermatologist-approved health information, insights on diseases affecting skin, hair, and nails, and the latest medical and cosmetic treatments. Utilizing the smartphone’s GPS tracking system, the app can show the UV Index in real-time to fight against the dangers of ultraviolet radiation and find the nearest dermatologist in the area.
Eczema Tracker – Through the app, users can check pollen, mold, temperature, and humidity levels for any location, track the flare-up of eczema and get valuable advice on how to control and manage the condition for all ages. Through constant monitoring, patients have the chance to follow what triggers their symptoms and whether their medication can alleviate them.
But are these apps accurate? Although the developers of some of these apps claim that they identify problematic moles and lesions accurately, research has shown that this might not be the case. A 2019 article in Trusted Source in the BMJ found several downsides to the available skin cancer apps, including a lack of testing to verify their effectiveness, a shortage of expert input when developing the technology, and issues with the technology itself. More scientific research will help doctors more clearly determine the accuracy of these apps. There are, however, some significant benefits to the regular reminders and the ability to photographically track moles or skin changes. For example, many people do not regularly check their skin. It can also be challenging to remember what a mole looked like last month or six months ago. Apps can provide valuable information to support advice from a doctor.
Where we’re going – Using advanced technologies to reduce the number of skin cancer issues could be crucial in pushing back the disease. Perceived value, trustworthiness, privacy, design, and costs are important barriers and facilitators regarding the use of mobile health applications (mHealth apps) for skin cancer screening, according to study findings published in the British Journal of Dermatology.
What happened in health care technology this week, and why it’s important.
Future wearable health tech could measure gases released from skin
Scientists have taken the first step to create the next generation of wearable health monitors. Tatyana Woodall reports on this research in Ohio State News online. A new study suggests that a wearable sensor may monitor the body’s health by detecting the gases released from a person’s skin. This team’s method would allow the technology to sense biomarkers related to metabolic disorders, like heart disease or diabetes.
Why it’s important – Discerning health issues through the skin is the ultimate frontier. This research is still in the early stages, but in six months, they should have proof of concept, and in a year, they’d like to have it tested on people.
Infographic of the week – From an article in Science by Jocelyn Kaiser, this terrific infographic shows how preventative cancer vaccines will work.
Walmart Health Introduces Telehealth Diabetes Program To Help Businesses Support Employees Through Education and Behavioral Care
To better provide for patients with Type 1 or Type 2 diabetes and assist employers and other institutions in supporting the specific health needs of their employees, national telehealth provider MeMD, part of the Walmart Health family, today launched the Walmart Health Virtual Care Diabetes Program. The announcement was made in a press release from the company. Available as a standalone or as part of a comprehensive medical and behavioral telehealth program, the Walmart Health Virtual Care Diabetes Program was developed for employers and payors to help their employees and members close gaps in diabetes management among employees and their families through early intervention, which could lead to better health outcomes. Robert Gabbay, M.D., chief scientific and medical officer for the American Diabetes Association, said the partnership with Walmart Health helps to increase education and access to clinical care to more effectively manage diabetes.
Why it’s important – More than 37 million Americans have been diagnosed with diabetes, and its prevalence is expected to grow 54% by 2030. According to the National Institutes of Health (NIH), fewer than 20% of people with diabetes in the United States meet recommended treatment management goals, costing employers more than $20 billion per year. And Walmart’s reach into communities where access to health care can be problematic helps ensure that underserved populations get access to this critical program.
Researchers Using AI and Apple Watch ECGs to Detect Weak Heart Pump
Researchers at the Mayo Clinic have created an artificial intelligence algorithm that can use single-lead ECGs taken by the Apple Watch to find patients who have a weak heart pump, according to research data shared this week at the Heart Rhythm Society conference. Juli Clover reported on the research in her Mac Rumors article. The study included 125,610 ECGs collected for six months from 46 states and 11 countries. Each person submitted many ECGs, and the cleanest readings were used for the algorithm. Several hundred of the participants had clinical testing to measure pump strength, and that data was used to determine whether the Apple Watch could detect an issue.
Why it’s important – A weak heart pump, or left ventricular dysfunction, is an issue that affects two to three percent of people around the world and up to nine percent of people over age 60. Like atrial fibrillation, another heart issue the Apple Watch can detect, a weak heart pump can have no symptoms. It can also be accompanied by symptoms that include racing heartbeats or shortness of breath. Researchers plan to launch global prospective studies to do further testing in more diverse populations to demonstrate the benefit of the single-lead ECG feature in the Apple Watch.
University of Sydney researchers create sensor bracelet for hand-impaired persons
From Adam Ang in MobiHealthNews, researchers from the University of Sydney’s School of Computer Science have developed a 3D-printed sensor bracelet to enable people with hand impairment to use computers and play video games. The bracelet works by picking up subtle movements in a user’s wrist when they move their fingers. From the sensors, these movements are transmitted via Bluetooth to a computer program which then interprets, classifies, and adapts them using machine learning.
Why it’s important – Cerebral palsy is a group of disorders affecting a person’s ability to move and maintain balance and posture. About 50% of people living with this condition find speech difficult or impossible, while two-thirds have trouble moving one or both arms. The researchers also want their computer program translated into a free mobile app version.
FDA clears wearable 3D breast ultrasound for cancer screening
A company called iSono Health, which aims to make personalized whole-breast imaging accessible to all women worldwide, has received FDA clearance for its automated, wearable, 3D breast ultrasound, the company announced Tuesday. Michael Schroeder reported on the announcement in MedCity News. In just two minutes, the portable system automatically scans the entire breast, independent of operator expertise, and offers 3D visualization of the breast tissue, according to the company. The technology is integrated with machine learning models that provide clinical decision-making support.
Why it’s important – “A portable and automated whole breast ultrasound augmented with machine learning would be the most practical technology to reduce breast cancer mortality globally, specifically in countries with limited resources,” said Dr. Mohammad Eghtedari, a breast radiologist and an assistant professor at University of California San Diego. The technology would also provide another breast cancer screening option for younger women who are not eligible for mammograms or women who otherwise lack access to mammograms.
How patient-on-a-chip tech could be the future of drug discovery
Testing drug compounds on a chip designed to mimic human organs sounds closer to science fiction than reality, yet the technology already exists and is already being put to use. Ben Hargreaves in PharmaPhorum online writes about how the technology could provide more accurate safety predictions and even discover new treatments. The advance in technology has allowed organ-on-a-chip technology, which uses microfluidics to mimic the physiology and functionality of human organs on a chip. This technology could more accurately reflect drug development in the human body by incorporating multiple cell types and introducing microfluidic channels that can provide a controlled nutrient fluid flow or concentration of the drug that the organ is exposed to. A patient-on-a-chip comprises a collection of several different miniaturized, three-dimensional organ-on-a-chip (such as liver, brain, etc.) interconnected by a blood-like circulation.
Why it’s important – As I highlighted in a previous post, the advantage provided by these connected organs-on-a-chip is in being able to detect better the toxicity of drugs that could be missed by mice studies and generally provide an overall more accurate response to a drug’s pharmacokinetics and pharmacodynamics in the human body. There’s still work to be done to prove the efficacy of the chip approach. But the research looks promising and is moving rapidly. So I would expect that we will see broader technology adoption in drug development soon.
Matricelf Moves Closer to Curing Paralysis with In-house 3D Printable Human Stem Cells
Israeli regenerative medicine firm Matricelf has reached a new milestone in developing its 3D printed neural implants for paralyzed patients with spinal cord injuries. Hayley Everett reported on the developments in her article on 3D Printing Industry. The firm has successfully produced its own in-house induced pluripotent stem cells (iPSCs) from human peripheral blood cells, which will be combined with a unique hydrogel to form 3D printed implants which could potentially cure paralysis. Founded in 2019, Matricelf leverages a patent-pending 3D bioprinting technology that has been under development at Tel Aviv University (TAU) for the last decade in the lab of Professor Tal Dvir, one of the founders of the Matricelf and the firm’s Chief Scientific Officer.
Why it’s important – By combining their self-developed iPSCs with a unique thermo-responsive hydrogel, Matricelf will produce 3D printed neural implants that could enable patients with spinal cord injuries to walk again. The 3D printed implants allow the regeneration of damaged tissues within and around the spinal cord using a cellular and ECM component originating from individual patients. The firm is currently gearing up to enter into human trials with its 3D printed spinal cord implants in 2024, which they believe could provide a potential cure for paralysis within just a few years.
Curebase thinks the future of clinical testing is decentralized and raises $40M to prove it
Curebase provides the infrastructure — physical and digital — for distributed clinical trials and will be doubling down on its success with a new $40 million funding round. Devin Coldewey reported on the new funding in his TechCrunch article. Curebase combines an app-based experience for the patients with a supervised and standardized process on the provider side to ensure that the data is as good in a decentralized study as it would be in one conducted at a single location.
Why it’s important – As I’ve written before, clearly there’s value here, as the company has seen significant growth (it’s done 50 studies so far, with the yearly number tripling or more each year it has existed) and now attracted significant strategic funding from pharmaceutical company Gilead. The funding will enable further expansion in a general sense for Curebase, activating partnerships at more institutions and hiring the people necessary to oversee the trials that will use them.
“Mental health problems don’t define who you are. They are something you experience. You walk in the rain and you feel the rain, but you are not the rain.”
Matt Haig, Author & Journalist
In the United States, the Centers for Disease Control and Prevention (CDC) reported that in 2019, 4.7% of adults aged 18 years or older reported regular feelings of depression, and 11.2% reported frequent feelings of worry, nervousness, or anxiety. Forty percent of Americans with a 12-month history of severe mental disorders do not receive treatment. The ongoing COVID-19 pandemic has increased mental health care needs while simultaneously restricting access, with unknown long-term consequences. From August 2020 to February 2021, the CDC described an increase in the proportion of adults reporting recent symptoms of anxiety or depression from 36.4% to 41.5%, with the fraction saying unmet mental health care needs increasing from 9.2% to 11.7%. Among children and adolescents, the proportion of mental health-related emergency department visits for those aged 5 to 11 years and 12 to 17 years increased by 24% and 31%, respectively, compared with 2019.
Mental health issues have shed much of the stigma they carried three decades ago, and parents and adolescents are more at ease when discussing the subject among themselves and seeking help.
Mental health is moving far beyond the psychiatrist’s couch. Technological advancement has pushed digital therapeutics to the forefront of convenience—in people’s pockets, on their laptops, and even within Facebook messenger. And with that, the category expands to include a suite of wellness products and services. It’s a new ecosystem that sees individuals relying on a wide range of tools—chatbots, apps, and digital support groups—to combat modern-day issues such as burnout, loneliness, and anxiety. Combined with traditional medical models, it encompasses a holistic approach to psychological wellbeing. So, reviewing the current research, here are the major technologies that can support mental health and well-being.
Telehealth and Virtual Therapy – Tech is redesigning traditional care by improving access and customizing the experience. Virtual therapy apps such as TalkSpace, BetterHelp, and Amwell give patients the ability to call, text, and video teleconference with professional counselors on their schedule and in the comfort of their own homes. These frictionless options, often a fraction of the price of clinic appointments, serve individuals with time constraints or those in rural areas who lack access to care. Online platforms such as Rethink My Therapy, which offers unlimited therapy for $60 a month, particularly appeal to millennials who want their medical appointments as easy as ordering in dinner. Millennials are far more likely to address their mental health than generations prior, with seven out of 10 saying they feel comfortable seeking help.
Other virtual therapy apps center on counselor matchmaking and addressing specific patient needs. Regain specializes in professional couples therapy, and Pride Counseling serves LGBTQ individuals, while Henry Health targets black men. The newly launched Ayana connects marginalized communities with therapists from their culture, background, and race. Other virtual therapy apps center on counselor matchmaking and addressing specific patient needs.
Wearables – Mental wellness wearables such as headsets and bracelets slowly see traction, though many are still in the early stages of clinical trials. The Muse brain-sensing headband helps you get the most out of your meditation practice by giving you real-time biofeedback about what is going on in your mind. The Muse is not some dystopian headset trying to alter your brain. Instead, its makers, InteraXon, want to train you to modify it yourself. The routine is simple. You put the Muse headset on, and you complete the breathing exercises to the sound of waves (neutral), storms (bad), and tweeting birds (good) which indicate how focused and calm you are. If your mind is too active, the Muse gives you feedback to help you clear your thoughts.
Korean startup YBRAIN has raised $4.1 million to develop hardware for brainwave monitoring and brain stimulation for mental health professionals. The startup’s MINDD SCAN headset is a wireless EEG system that screens visualizes, and processes brain activity in real-time. Traditional EEG scans typically take an hour, while MINDD SCAN takes care of the examination and ensuing analysis in five minutes. YBRAIN’s second product, the MINDD STIM headband, helps activate communication between neurons in the cerebral cortex using electrical stimulation, which is beneficial for conditions like depression, anxiety, and insomnia.
Sweden startup Flow Neuroscience has raised $1.1 million to develop a brain stimulation headset that can treat depression without medication. Similar to the YBRAIN device we discussed earlier, the Flow Neuroscience device sends gentle electrical signals to the brain’s frontal cortex, which activates brain cells. Early results appear promising. In a trial, 23% of users overcame depression entirely, and 41% felt significantly better after six weeks of using the headset alone. Flow provides a CBT app that helps introduce positive lifestyle changes as well to maximize patients’ chances of recovery.
Feel has raised $1.8 million to develop a wristband that assists CBT therapy by identifying emotions. Feel’s technology monitors skin electricity conductance, heart rate, and temperature throughout the day and relays this data to machine learning algorithms that translate it into emotional patterns. The connected mobile app provides personalized recommendations based on users’ emotional states. For example, if you’re feeling anxious and agitated, your heart rate increases, and skin conductance changes suddenly. Feel’s wristband relays this information to the app, which suggests a calming breathing exercise. By doing the exercise, your body will feel calmer, promoting a clear emotional response as well. Feel has created a mental health program combining this feedback mechanism with remote therapist sessions and homework tutorials that help practice self-help techniques. The startup offers its programs through health plans and employers.
Fitbit and Apple Watch – Fitbit has a Relax app on its Blaze and Ionic models. The app is a breathing exercise that can last for 3 or 5 minutes and is designed to help the user slow down breathing and heart rate. It’s a quick yet still efficient exercise to find a few minutes of calmness every day. It also shows the progress you have made over time and how much you could reduce your heart rate during the exercise, which guarantees that you come back to it day after day. While you can’t quite track mental health on Apple Watch, that doesn’t mean that there aren’t features that can help with anxiety. For example, Apple has the Breathe app onboard. Deep breathing is one of the most straightforward tools to lower your body’s stress levels. In layman’s terms, when you breathe deeply and slowly, it sends a message to your brain that everything is OK, and the brain doesn’t need to release epinephrine (adrenaline) to fuel your fight or flight response. In other words, it helps relax you.
Founded in 2015, startup Somatix has raised $7.5 million to develop real-time gesture detection technology that helps in the behavioral and physical monitoring of patients. The startup’s platform uses sensors in commercial off-the-shelf smartwatches, smart bands, and IoT connected devices to track gestures in real-time and recognize physical and emotional indicators. Gesture data is sent to the cloud, combined with user-specific information like calendar appointments, contacts, and social media posts, and analyzed by machine learning algorithms to find significant behavior patterns.
The mental health and wellness app environment – Mindfulness and meditation apps such as Headspace, Calm, and female-focused Sanity & Self offer audio tracks to relax listeners and strengthen mental resilience. Frequently, they’re paired with breathing exercises, visual aids, and journaling guides. Israeli social network Wisdo connects individuals struggling with mental conditions, as well as those overcoming difficult emotional situations. Some apps take their cues from entirely different genres, evidenced by the ever-growing anti-anxiety gaming space. Nearly a million people have played SuperBetter, an app that gamifies mental health upkeep. Players accrue points by persevering through stressful situations, completing breathing exercises, and breaking bad habits. Mindstrong is an app that analyzes how users interact with their phones—how they type or scroll—to identify mood states. Its machine learning can reportedly detect a range of potential mental health patterns. It is now being tested on California patients through the state’s public mental health system. Then there’s U.K. Startup Thymia, which has developed a simple set of mobile video games that might, with the help of AI, pick up on depression signals and any office examination, according to the founders. When clinical trials begin later this spring, Thymia will try to improve and even save lives as it alerts doctors to warning signs they might otherwise miss. The Thymia games, downloadable free from its site, are minimalist. They involve simple tasks in whimsical natural settings; in one, a player tries to track bees buzzing around sets of flowers. But the machine is gathering critical information. Mental health advocates also generally worry that cheaper app-based approaches to mental health could deter insurance companies from paying for human doctors. Thymia founders say that this is one of the reasons patients will not be allowed to use the service themselves and instead must go through their clinician. The company says Thymia does not share data with third parties, including insurers.
Chatbots – Chatbots are also on the rise.Woebot is an AI-enabled “robot friend” who looks like Wall-E and engages users through uplifting or sympathetic conversations. The adorable digital therapist is now available in 120 countries, serving more than half a million people. Woebot is a “fully automated conversational agent” developed by Woebot Labs in San Francisco. The app’s daily check-ins began with a question about where you are and what you’re doing but didn’t push with open-ended questions. Instead, it asked you to choose a quick emoji that describes your feelings. Over time, Woebot charts those emoji responses to help visualize trends and then shares that chart with the user. Next is Wysa, a playful artificial intelligence penguin that operates on iPhone and Android platforms.
Where we’re going – Mental health tech will move into the mainstream as cultural norms continue to shift. The widespread use of smartphones means that every person carries a supercomputer that can be used for personalized mental health care. Millennials’ embrace of convenient treatment, as well as interest in self-care, will transform how employers, universities, and local governments offer subsidized care. The ongoing public conversation on toxic workplaces and burnout is already pushing big companies to take action and realize that prevention is more affordable than treatment. In the coming years, expect more well-being tools that work in conjunction with medical care. The new consumer might find themselves weekly teleconferencing with a therapist, then relying on a meditation app during moments of stress. Or maybe they’ll wear a bracelet that will warn them when a panic attack is forthcoming. The future will be full of intrusive and feel-better tech readily available at an individual’s fingertips.
What happened in health care technology this week, and why it’s important.
AI technique narrowed to only propose candidate molecules that can be produced in a lab
Pharmaceutical companies are using artificial intelligence to streamline the discovery of new medicines. Machine-learning models can propose new molecules with specific properties that could fight certain diseases, doing in minutes what might take humans months to achieve manually. Adam Zewe reports on a new approach from MIT researchers that constrains a machine-learning model, so it only suggests molecular structures that can be synthesized. The method guarantees that molecules are composed of materials that can be purchased and that the chemical reactions between those materials follow the laws of chemistry.
Why it’s important – Compared to other methods, their model proposed molecular structures that scored as high and sometimes better using popular evaluations but were guaranteed to be synthesizable. Their system also takes less than one second to present a synthetic pathway, while other methods that separately propose molecules and then evaluate their synthesizability can take several minutes. In a search space that can include billions of potential molecules, those time savings add up. The work is fascinating because it could eventually enable a new paradigm for computer-aided synthesis planning.
Infographic of the week – I love this graphic representation of how technology disrupts the human needs equation from Rock Health.
A multi-organ chip with matured tissue niches linked by vascular flow
Engineered tissues can be used to model human pathophysiology and test the efficacy and safety of drugs. Yet, to model whole-body physiology and systemic diseases, engineered tissues with preserved phenotypes need to communicate physiologically. In an article in Nature Biomedical Engineering, the authors reported on the development and applicability of a tissue-chip system in which matured human heart, liver, bone, and skin tissue niches are linked by recirculating vascular flow to allow for the recapitulation of interdependent organ functions.
Why it’s important – The development of multi-organ chips is another move forward in developing whole-body digital twins that will model and predict responses to drugs and therapies in the future. In this case, the interlinked tissues maintained their molecular, structural, and functional phenotypes over four weeks of culture, recapitulated the pharmacokinetic and pharmacodynamic profiles of doxorubicin in humans, allowed for the identification of early miRNA biomarkers of cardiotoxicity, and increased the predictive values of clinically observed miRNA responses relative to tissues cultured in isolation and to fluidically interlinked tissues in the absence of endothelial barriers.
Cartoon of the week – Everyone’s exhausted with the COVID-19 pandemic. I love this cartoon from Wiley Miller.
U.K. Hospital Trials Brain Implant to Treat Parkinson’s
A hospital in the U.K. is the first to implant a brain device to reverse the symptoms of Parkinson’s – and its test patient calls it “amazing.” Surgeons at Southmead Hospital in Bristol, England, are implementing a tiny deep brain stimulation (DBS) device into the skull. An article in Newsweek and provided by Zenger News reported on the project in which the implant overrides the abnormal brain-cell firing patterns caused by Parkinson’s.
Why it’s important – Traditional operations for Parkinson’s involve implanting a reasonably large battery into the chest with wires that run under the skin through to the top of the head. The new DBS system, the smallest that has ever been created, involves a tiny battery system for the device implanted into the skull. It takes just three hours to carry out the new operation, about half the time it used to with the larger battery. For more on technology and Parkinson’s disease, read my post from last week.
Many hospital executives don’t have a digital strategy
Many healthcare organizations are spending a great deal of time on finding new digital solutions, but many aren’t sure about the options they have chosen. That’s a key takeaway from a new report on healthcare technology by Panda Health, a digital marketplace for health systems. The company, which evaluates health vendors to help hospitals find the right partners, was founded by CentraCare, Gundersen Health System, and ThedaCare.
Why it’s important – The hospitals that had digital health strategies found themselves better able to pivot during the COVID-19 pandemic, the report suggested. Hospitals with comprehensive digital plans were more likely to move forward with digital health solutions during the pandemic than those without strategies (71% to 41%).
How Google could own healthcare
Google’s response to the pandemic is a microcosm of how the company intends to lead the entire healthcare industry: helping people stay as healthy as possible through wellness care and managing the journey to receive care when needed. Adam Dorfman reports on Google’s strategy in his article on VentureBeat. Google, like Apple, has an advantage in personal healthcare: a data platform tied to devices. Hardware, though, is the key to Google’s foray into health. Devices, ranging from Chromebooks to Pixel phones to home devices, provide the means for Google users to manage their data and for Google to monetize it. The second part of Google’s healthcare strategy is to own the patient journey to getting care. And here, Google is the undisputed Big Tech leader. The company has positioned itself as the default resource for people to research symptoms and access care. Google influences every phase of the patient journey, from awareness to consideration.
Why it’s important – I’ve written on the challenges Big Tech faces in targeting healthcare earlier. Google will continue to move into healthcare using devices and software/data analytics to expand its reach. Google will also benefit by attracting more advertisers (engagement and volume are like gold to online advertisers).
Researchers create AI model to predict pediatric no-shows
Kat Jercich from Healthcare IT News reports that a team from Boston Children’s Hospital and Yonsei University used local weather information to help forecast the possibility of patients missing scheduled appointments. By adopting a data imputation method for patients with missing information in their records, developing an interpretable approach that explains how a prediction is made, and exploiting local weather information, the team created a model identifying 83% of no-shows at the time of scheduling.
Why it’s important – No-shows cost the industry approximately $150 Billion per year in the U.S. alone. And as the researchers pointed out, “no-shows” can negatively impact patient health and hospital and clinics’ resource utilization. For this study, researchers noted that their model showed minimal predictive performance differences across racial groups. And of course, other health system leaders have pointed out that no-shows can be reduced via different technologies such as telemedicine and patient engagement platforms.
“Clinical trials are the most expensive part of developing a drug. And, it’s very hard to do a clinical trial testing the new drug’s interaction with every other drug that might be out there.”
William F Feehery, CEO of Certara
Traditional clinical trials are equivalent to billions of dollars and years of hard work with no guarantee for the new drug to be approved by regulatory bodies, not to speak about the dangers of testing medication on animals or humans. According to CB Insights, on average, it costs $2.6B to research and develop a successful drug and takes 10+ years to come to market. It’s estimated that in-vivo testing (testing on animals and humans) accounts for more than 75% of the total cost, with recruitment alone being one of the most significant barriers to drug development — only 6% of clinical trials are ultimately completed on time.
Then there’s the issue of clinical effectiveness. According to the US Food and Drug Administration (FDA), medication ineffectiveness ranges from 38 to 75% for various illnesses ranging from depression to osteoporosis. The primary cause is each individual’s genetic makeup. It is so diverse and their interaction so unique that medicines designed for the “ideal patient” may not be appropriate for the “actual patient.”
Amid a global health crisis, the challenges only multiply: Covid-19 interrupted an estimated 80% of non-Covid-related clinical trials. One way to modernize the drug testing process is by applying technologies to the traditional framework, such as online platforms to seek out participants. An alternative method is to build an entirely new setting. That new setting leverages the multiplier effect of several exponential technologies to virtualize the clinical trial process.
If you’ve been following this blog, you know that I’ve written on several of the critical topics before in my “Straight Talk” series of posts. Here are the major ones:
For this post, I want to focus on two additional areas recently getting attention: digital twins and in-silico trials. These are generally lumped together. But for this review, I’ve chosen to keep them separate.
As part of the move to personalized medicine, researchers are interested in developing digital twins that could integrate known human physiology and immunology with an individual patient’s clinical data in real-time, then produce predictions of what would happen during various medical events. A digital twin is a virtual representation of a single person where every known medicine for that person’s illness can be tested. This will allow the best treatment to be determined. It can even monitor the virtual “person” and notify you if a medical condition develops as a side-effect enabling preventive actions. As a result, the digital twin has numerous applications across multiple therapeutic areas in healthcare.
It’s been reported that 66% of healthcare executives expect increasing investment in digital twins over the next three years. This is because digital twins improve healthcare organization performance, discover areas for improvements, provide customization and personalization of medicine and diagnosis, and enable the development of new medications and devices.
If we return to the list of exponential technologies above, digital twins use all of them to create a complete picture of an individual’s vitals, medical state, response to drugs, therapy, and the surrounding environment. Companies are creating digital twins to specifically look at chronic diseases like diabetes, where a chronic diabetes patient’s lifestyle, daily food habits, and blood sugar data are analyzed. The model notifies the patient about prescriptions, dietary habit modifications, medical consultations, and so on.
Another excellent example of the advancement of the field is the Oncosimulator project. The In Silico Oncology Group is developing an in silico experimental platform, as well as an advanced medical decision support tool called Oncosimulator, in collaboration with several research centers in Europe and Japan to optimize cancer treatment. The oncosimulator is an integrated software system simulating in vivo tumor response to therapeutics within a clinical trial environment. It aims to support clinical decision-making for individual patients.
Several companies have created digital twin representations of human organs. For instance, Hewlett Packard Enterprise collaborated with Ecole Polytechnique Fédérale de Lausannes (EPFL) on the Blue Brain Project, using its supercomputer to develop digital models of the brain for scientific purposes. Siemens Healthineers offers a Digital Twin model, and Philips offers their own virtual heart. Dassault Systèmes launched its Living Heart Project in 2014 to crowdsource a virtual twin of the human heart. The project has evolved as an open-source collaboration among medical researchers, surgeons, medical device manufacturers, and drug companies. Meanwhile, the company’s Living Brain project is guiding epilepsy treatment and tracking the progression of neurodegenerative diseases. The company has organized similar efforts for lungs, knees, eyes, and other systems.
Although digital twins have a promising future in health care, the full impact of the technology will be determined by its capacity to integrate knowledge into accurate medical advice at scale. Better data, new interactions between patients and providers, and a regulatory framework to confirm these promises will be required to support this transformation.
In-silico trials simulate the effects of a new treatment using virtual populations to supplement or even partially replace in vivo testing. Researchers can use modeling and simulation to predict trial outcomes before advancing to real-world clinical trials and ultimately design studies that are more likely to succeed. Virtual populations can diversify the biological variability of traditional trials and enable the exploration of irregular phenotypes that would be difficult to recruit for. Control or placebo arms in trials can be simulated so that real-life patients who need treatment are guaranteed to receive it. This helps encourage potential subjects to enroll in the first place. Finally, in silico methods can lead to more exploratory research outcomes that might not be feasible with conventional trials. For instance, a recent in-silico trial looked at the same virtual population twice to see how the presence or absence of a secondary risk factor affected treatment.
The technology is mainly early-stage, but it has recently seen increasing adoption from medical device and pharma players. Using statistical models of disease progression, researchers can better simulate clinical outcomes for a given cohort of patients, down to the level of how specific traits impact treatment. This could result in a hyper-personalized approach to assessing a patient’s fit for a given intervention.
In-silico technology, though, is not without its drawbacks. For one, using computer-generated patient populations relies on real-life, historical data for modeling, making it tricky to test for unexpected or novel side effects to treatments. Instead, in-silico trials might be more suited to test a treatment’s efficacy (i.e., to validate “expected” results). Soon, in-silico testing will primarily be used to augment or optimize traditional in-vivo testing rather than replace it altogether. Watch the regulators too. The U.S. Food and Drug Administration also picked up on the potential of in-silico trials, and it’s actively supporting the development of virtual models – for the testing of new medical devices. The FDA and the EUA in Europe are creating frameworks outlining best practices for collecting and analyzing data like digital evidence. And the FDA is already planning for a future in which more than half of all clinical trial data will come from computer simulations.
After reviewing the current literature, I would sum up the benefits and drawbacks of virtual clinical trials like this:
Larger number of trial subjects
No consequences for either animals or humans
Better patient engagement
Can lead to more exploratory research outcomes
Not compatible with all types of clinical trials
Difficult to test for unexpected side effects
EHR interoperability challenges
While completely simulated clinical trials are not feasible with current technology and understanding of biology, their development would be expected to have significant benefits over current in-vivo clinical trials. Under the right conditions, they could rapidly supplant traditional in-person approaches and dramatically enhance the scale, data collection, geographic range, cost-effectiveness, and speed of clinical trials. Certainly, decentralized clinical trials are here to stay. As we’ve seen in other areas of health care, the last 24 months have crystalized the potential of the virtualized research model, driving a rate of deployment and progress that might otherwise have taken 5-10 years to materialize.
What happened in health care technology this week, and why it’s important.
Mayo Clinic to launch staffing tool app to find ‘right nurse for the right role’
Mike Millard reports in Healthcare IT News that Mayo is working with KLOC HEALTH to develop the mobile, on-demand scheduling tool to help it predict staffing options more accurately and flexibly. Mayo Clinic has entered a know-how agreement with the startup to co-create an on-demand tool that can help match nurses for immediate, short- and long-term assignments based on variable data such as availability, location, certifications, skill sets, and interests. The goal is to enable real-time communication with nursing staff to help find “the right individual, for the right position, at the right location and at the right time,” according to KLOC HEALTH.
Why it’s important – Innovations like these are coming just in time, as beleaguered nurses are worn down and struggling after more than two years of pandemic stress. One recent survey found that as many as 90% of nurses are considering leaving the healthcare profession due to job dissatisfaction and burnout. Mayo Clinic nurses will be empowered to build their own profiles on the tool and offer real-time feedback on their performance, job satisfaction, and peer reviews.
Infographic of the week – Estimated amount of data created on the Internet in one minute in 2021. Any bets on what this will look like at the end of 2022? (Vote in the poll below)
NHS England announces plans for £240M federated data platform
In the EMEA edition of Healthcare IT News, Tammy Lovell highlights this NHS platform is intended to be “an ecosystem of technologies and services.” It will be built around five major use cases: population health and person insight, care coordination, elective recovery, vaccines and immunization, and the supply chain.
Why it’s important – The virtual database takes data from various sources and converts them to a standard model, providing a single data source for front-end applications. This can facilitate access to sensitive health data, offering a potential solution to address the issue of siloed health data and barriers to data sharing.
CRISPR pioneer expects to see gene-edited babies within 25 years
It’s been ten years since CRISPR gene-editing pioneer Jennifer Doudna published the landmark paper that landed a Nobel Prize for her and colleague Emmanuelle Charpentier. The researcher already sees advancement toward some of its loftier goals. The Seattle Times’ Angelica Peebles interviewed Doudna in this article.
Why it’s important – In an email following the interview, Doudna said she is “not advocating for human germline editing, simply stating that it is likely to happen in the next 25 years given the direction of research and technology development. It often takes decades for new technology to impact the whole research landscape or actual applications. It’s extraordinary that CRISPR, within a decade, is already there. Is there more work to be done? Of course. There’s always more.”
Fujifilm develops AI tech for predicting Alzheimer’s progression
Adam Ang in MobiHealthNews reported on this clinical trial, which has shown that it can predict AD progression with 88% and 84% accuracy in American and Japanese patients, respectively. The AI predictive technology was built using Fujifilm’s advanced image recognition technologies. Using both AI and deep tech, atrophy patterns as seen on 3D MRI brain images were extracted and calculated from the hippocampus and the anterior temporal lobe, both regions that are strongly correlated with the progression of AD. From these patterns, AD progression is predicted.
Why it’s important – Despite advances in AD treatment in recent years, many clinical trials have not been successful, given the low percentage of patients who progress from mild cognitive impairment to AD within two years. Many of such patients remain unchanged even if placed under a placebo. Moving forward, the partners seek to predict the speed of patients’ progression to AD and investigate the possibility of improving the success rate of their clinical trials by excluding patient participants who do not progress to AD and reducing the gap in the distribution of progression speed between control and treatment groups. They also plan to conduct more clinical trials soon.
Does Health Care AI have a Credibility Problem?
A great post by John Halamka, M.D., president of Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform. The authors argue that many physicians ignore the recommendations provided by machine learning algorithms because they don’t trust them. A few imaginative software enhancements may give them more confidence in an algorithm’s diagnostic and therapeutic suggestions.
Why it’s important – While developers continue to provide innovative AI tools that have the potential to redefine the practice of medicine, most physicians and nurses do not have the background in data science required to grasp what’s “under the hood fully,” one reason why many hesitate to incorporate the diagnostic and treatment recommendations coming from these algorithms. The authors provide two ways this dilemma can be addressed. A must-read post from two of the best in the business.
Samsung Medical Center goes mobile with hospital admission process
More reporting from Adam Ang on news that Samsung Medical Center has introduced a mobile admission process to simplify patient hospitalization. According to the hospital, it now takes five steps – down from 10 – to get admitted to SMC. A patient will first receive access to the mobile admission site via text message. They can select available rooms, complete a COVID-19 questionnaire and test, and sign administrative forms. After this, the patient can proceed to the center’s payment or registration desk, where they will receive an ID wristband and hospitalization guide leaflet. Once received, they can be admitted to the inpatient ward.
Why it’s important – SMC says that its new admission process – which has been in place since end-October – takes about five minutes to complete, compared to the average time of 20-30 minutes previously. Aside from providing convenience, the mobile admission process has also minimized the risk of infections, especially from COVID-19, due to minimal physical interaction. The consumer satisfaction benefits from implementing this technology which results in reduced wait and procedure time, allowing them to deliver medical services more quickly, should be considered as well.
Everything You Need To Know Before Getting An RFID Implant
Another great post from Dr. Bertalan Mesko and his team at The Medical Futurist Institute. Here’s what you should know about RFID chips before implanting them into your body.
Why it’s important – As with all of their research, this post covers the landscape of implantable RFID chips in considerable detail, highlighting the good, bad, and risks associated with implementing this technology on a broad scale. A great read!
Hologram doctors beamed to space station to visit astronauts
In 2021, a team of hologram doctors was “holoported” to space to visit astronauts living aboard the International Space Station, NASA has revealed in a new post. The hologram teams, led by NASA flight surgeon Dr. Josef Schmid and Fernando De La Peña Llaca, CEO of software provider Aexa Aerospace, were the first humans ever to be “holoported” from Earth to space. Chelsea Gohd reported on this in her article on Soace.com. The medical teams holoported to the station on Oct. 8. Using the Microsoft Hololens Kinect camera and a personal computer with custom Aexa software, European Space Agency astronaut Thomas Pesquet, who was on board the station, had a holo-conversation with Schmid and De La Pena’s teams. The holograms of the doctors were visible live in the middle of the space station.
Why it’s important – Even though this might seem like just an exciting story to a “space geek” like me, many NASA innovations eventually find their way into the practice of medicine here on earth. And if you can make the technology work at the distances highlighted in the article, imagine how useful this would be in remote areas of the planet.
CDC launches new infectious disease forecasting center
The Centers for Disease Control and Prevention (CDC) officially launched a new center to forecast infectious disease outbreaks. The Center for Forecasting and Outbreak Analytics is “the equivalent of the National Weather Service for infectious diseases,” the agency said in a statement Tuesday. Nicole Westman covered the story in her article on The Verge. Along with experts in data analytics and disease modeling, the center will also have communications specialists on staff to interpret the information for the public.
Why it’s important – The CDC has never had a dedicated infectious disease forecasting program. It has spent the past two years struggling to compile and distribute information about the spread of COVID-19 promptly. Researchers at the center have already produced data helping improve understanding of the omicron variant of the virus, showing that it caused less severe outcomes than the delta variant in the U.S. The challenge will be whether this creates another layer of burden on efforts to communicate effectively.
Can Robots Save Nursing Homes?
The pandemic has given new urgency to developing robots and ‘virtual assisted living’ that can help care for aging adults, physically and emotionally. John Leland reports on a program at the University of Minnesota, Duluth, in his NY Times article. The robot program in Duluth is just one of several newly energized efforts to use robots and other technology to solve some of the problems in nursing homes and assisted living facilities — or to help people stay out of them. The trend began before the pandemic, but Covid-19 gave it new urgency. With $2 million from the Minnesota Department of Human Services, Dr. Khan plans to place two robots in eight nursing homes operated by Monarch Healthcare Management. This for-profit company has about 40 homes around the state. One robot, a two-foot-tall model called NAO, priced at about $12,500, will lead classes in yoga, tai chi, and strength training. The larger robot, Pepper, which costs about $32,000, will socialize, tell jokes and play games with residents.
Why it’s important – The title of the article is clearly click-bait. However, for specific repetitive and low-skilled tasks, there is a place for robots in assisted living facilities. The question is: how far do you go? The use of robots in nursing homes raises a range of ethical issues. Who should get access to the robots’ extensive monitoring data — only the residents and doctors, or should their families also have it? And will the robots ultimately diminish human-to-human contact, an essential part of care? On the plus side, unlike human workers, robots never get in a bad mood or tire of having to repeat themselves. On the negative side, staff concerns about whether robots will replace their jobs have prompted executives to be cautious about the broad implementation of the technology. We can probably learn a lot from the experiences in Japan, where the use of companion robots is much more prevalent.
These hospital robot vulnerabilities were promptly caught and killed
Staying with the robot theme, Zachy Hennessey in The Jerusalem Post reported that Cyber security start-up Cynerio, specializing in healthcare Internet of Things (IoT) security solutions, discovered five vulnerabilities that affect commonly used robots found in hundreds of hospitals worldwide. According to the company, the group of vulnerabilities – referred to as JekyllBot:5 – can be used to disrupt the delivery of medication or supplies, impede staff, and remotely surveil patients and doctors. Following Cynerio’s discovery, the manufacturer of the robots in question, Aethon, has released several patches to mitigate the vulnerabilities.
Why it’s important – While cybersecurity threats are generally front-of-mind for health systems around the world, often less attention is paid to IoT-connected systems like intelligent autonomous robots, which are designed to handle healthcare-related tasks such as distributing medication, cleaning, and transporting hospital supplies. The robots leverage radio waves, sensors, cameras, and other technology to open doors, take elevators and travel throughout hospitals unassisted without bumping into people and objects. However, the technology that enables the robots to move around the hospital independently makes their vulnerabilities dangerous in the hands of a potential attacker. This is something that should be added to the checklist for review in cybersecurity plans for every organization.
Hospital Robots Are Helping Combat a Wave of Nurse Burnout
It’s a robot trifecta this week. Khari Johnson reports in Wired that since February, the nurses at Mary Washington Hospital in Fredericksburg, Virginia, have had an extra assistant on their shifts: Moxi, a nearly 6-foot-tall robot that ferries medication, supplies, lab samples, and personal items through the halls, from floor to floor. After two years of battling Covid-19 and related burnout, nurses say it’s been a welcome relief. Moxi is one of several specialized delivery robots that has been developed in recent years to ease the strain on health care workers.
Why it’s important – The simple things Moxi does can make a difference. It can save nurses the 30 minutes it might take to go from the fifth floor to the basement to pick up medication that can’t go through the tube system from the pharmacy. And picking up after-hour meals for patients is one of Moxi’s most popular tasks. Since two Moxi robots began operating in the halls of Mary Washington Hospital in February, they’ve given workers back approximately 600 hours of time.
“Parkinson’s is very hard to diagnose. So when I finally went to a neurologist, and he said, ‘Oh, you have Parkinson’s disease,’ I was completely shocked. I miss singing every day. I can’t sing anymore. My voice doesn’t work. I have Parkinson’s disease, and it sometimes takes my words away from me.”
Linda Ronstadt, Singer Songwriter
Parkinson’s Awareness Month is observed in April and is an opportunity to increase awareness about the ailment and its symptoms, as well as to support patients. Parkinson’s is a long-term disorder where the central nervous system degenerates, affecting the motor system. Motor symptoms like trembling, stiffness, and rigidity are usually associated with Parkinson’s disease. Symptoms typically occur slowly. One side is often affected first, but as Parkinson’s disease progresses, both sides are affected. Technology has improved life for people living with Parkinson’s Disease over the past decade with new wearable, monitoring, or assistive technology.
As symptoms of Parkinson’s disease change and progress, many people with the condition find themselves struggling with tasks they once performed with ease. But there’s no need to reinvent the wheel when finding solutions to these daily dilemmas and frustrations. Existing technology and inspiring innovations are helping people living with Parkinson’s disease manage symptoms now—and create hope for the future. Here are a few of the most exciting and innovative technologies showing real promise.
Technology to support gripping – With Parkinson’s disease comes many motor symptoms, including tremors, rigid muscles, and instability. Enter PopSockets, an accessory for a phone that offers a secure grip, easy mounting options, and a built-in stand. Attach one to the back of any mobile device to more easily text, talk, take photos or use Parkinson’s disease apps.
Technology to assist with typing – BigBlu Kinderboard is a specially designed keyboard for Parkinson’s patients with large keys. This is a wireless keyboard that has large keys. It is a suitable typing device for Parkinson’s patients as the bold, large numbers and letters make it easy to type. The size of this keyboard is more than a regular keyboard because of the large keys. Vision board keyboard is a large keys keyboard in black color, and the letters are painted white. The big Track-Ball mouse is the biggest trackball mouse you will ever see. This mouse is designed for Parkinson’s patients who have trouble using a regular mouse. The left and right clicks are placed behind the trackball so that you can avoid wrong clicks. You can set the speed to use it more conveniently.
Technology to assist with speaking – Many people with Parkinson’s disease experience speech-related symptoms, such as stuttering and a much lower speaking volume. It’s also common to not produce clear speech regularly and feel like your speech is either extremely slow or very fast. SpeechVive is an in-ear device that helps people speak louder and more clearly, especially in busy places with background noise. SpeechVive looks exactly like a hearing aid and sits discretely in the ear. It works by playing an inoffensive background sound in the ear as they speak and as they hear the stimuli, they naturally, speak up louder and with more articulation. Then, as they stop talking, the background noise immediately turns off.
Technology to assist with swallowing – Trouble swallowing is a common problem for people with Parkinson’s disease, occurring in up to 80 percent of cases. Swallowing problems can lead to drooling, increased risk of pneumonia, and difficulty eating. One of the best ways to improve swallowing is to swallow more at home as an exercise. The problem is that most people with Parkinson’s Disease, their caregivers, or healthcare providers are usually unaware of the presence of dysphagia until later stages when the disease progresses and dysphagia gets more complicated. True Angle, a Canadian company, has developed a wearable device called Mobili-T®, which is composed of a wireless device that is placed under the chin and an app that provides real-time biofeedback on a mobile device. The device’s beauty is that it allows the patient to perform these swallowing exercises at home.
Technology to assist with walking – About one-third of people with Parkinson’s disease experience freezing episodes—sudden, short blocks of movement that primarily occur while trying to walk. Visual cues have been shown to help trigger movement to prevent and overcome freezing. LaserCane, for example, projects red or green laser lines on the ground in front of you, encouraging you to take longer steps and steadying your gait. PathFinder is truly among the next generation of assistive devices. It’s a simple device that attaches to the toes of shoes and provides visual cues in the form of green laser lines, which are helpful to people who feel unsteady on their feet. It marks out each step, so even people with a freezing gait can move with confidence. The lasers can be adjusted manually, so they match the natural length of the person’s steps. Currently, the PathFinder is only available in Europe, but the company will ship anywhere in the world. It retails for around $460. Although it may look like a simple back brace, Calibrace is more than a simple assistive device. It’s improved posture and balance long-term instead of just functioning as a temporary measure. It’s designed for people experiencing neuromuscular disorders, including those from Parkinson’s disease.
Technology to assist with eating – For the millions of people with hand tremors and irregular hand movements caused by Parkinson’s disease, essential tremor, spinal cord injuries, or just old age, using utensils can turn an enjoyable meal into a frustrating experience. Eatwell is a set of tableware created by a young designer named Sha Yao. Although it seems like a standard set of flatware and dishes, Yao designed it specifically for people with cognitive, motor, and physical impairments. The dishes are made of bright colors, which have been proven to stimulate the appetite, and are slanted on the bottom to allow for easier scooping of food. The spoons match the curve of the bowl and plate exactly and feature a curved shank to make them easier to grip and a special head that won’t move even if jarred by hand tremors. All the dishes are equipped with anti-tip features, including a secure, rubberized base. Liftware Steady and Liftware Level are specialized eating utensils consisting of a handle and a detachable utensil head (available in a soup spoon, normal spoon, fork, or spork options). Liftware Steady’s handle has an onboard computer that detects tremors and then adjusts the utensil head to move in the opposite direction. In contrast, Liftware Level has internal motors that can change its position to accommodate larger movements such as hand or arm twists. As a result, both devices keep their utensil heads level in the face of unintentional movements.
Technology for fall protection – Technology company Tango has recently put out a new personal safety belt that effectively protects people from sudden falls. Many people with Parkinson’s disease have issues maintaining stability and often feel unbalanced or unstable. Tango Belt is a new device that fits securely around the hips and will deploy an airbag immediately before impact if it senses a fall is imminent. This protection is designed to prevent broken hips, and studies have shown that it reduces the impact of a fall by 90 percent. The technology found in the belt is highly accurate in detecting falls.
Technology to assist with sleeping – Insomnia is another common scourge of the 10 million Parkinson’s sufferers globally, more than three-quarters of whom have sleep-related symptoms, according to the Parkinson’s Foundation. Sleep can be affected by uncontrolled shaking which wakes patients up, while another factor is a lack of a dopamine, common in people with Parkinson’s. The medication apomorphine is normally used to replace dopamine, lessening symptoms such as shaking and stiffness. But when taken orally, the drug can cause dopamine to spike and then drop, leading to muscle spasms. A device similar to an insulin pump that delivers continuous apomorphine throughout the night could solve the problem, according to a study published in the journal Lancet Neurology.
Smartphone apps for patients with Parkinson’s disease – The smartphone is one device that can support people with Parkinson‘s disease. The apps work hand in hand with wearable sensors to track, record, and store data. The sensors are integrated into these smartphones to gather information regarding the patient‘s condition and progress. The sensors include those that track finger tapping, memory conditions through playing memory games, walking, and speaking. Below is a list of some apps specifically developed to support those with Parkinson‘s disease:
Parkinson mPower app – This app uses sensors in the patient‘s smartphone to measure their balance, gait, and tremor. The app tracks and stores this information anytime the patient engages in certain activities specifically designed to generate these details.
DAF Professional – This is an app for Android and iOS devices. With this speech therapy app, Parkinson‘s disease patients can slow down their speech, making it sound clearer to people around them.
Parkinson Home Exercises – This is a video app for android and iOS devices downloadable from Google Play or Apple Store. It features Parkinson‘s-friendly exercises that target posture, flexibility, walking, and balance.
Lift Pulse – This app for iOS and Android, initially designed for research purposes, can significantly help PD patients and caregivers. Through algorithms and sensors built in the patient‘s phone, the app recognizes, tracks, records, and calculates the extent of the individual’s hand tremor. (This app may not be available in all regions)
Parkinson‘s EasyCall – People with PD can easily make phone calls with this smartphone app. (This link is for the Android version)
Parkinson’s LifeKit – Parkinson’s LifeKit is a suite of tools to track dyskinesias and tremors, physical movement (including voice and central nervous system), cognitive function (including memory and mental agility), and emotional state, and medication phases.
Technology can support people with Parkinson‘s and improve their quality of life. However, a technology designed to help people with neurodegenerative conditions like Parkinson’s disease should be more user-friendly than the average technology. Providing those with Parkinson’s disease with such technology goes a long way in enhancing their independence.