Tiny sensors with Bluetooth technology that measure useful biomarkers may eliminate need for invasive blood draws used for clinical laboratory tests
What if a baby’s pacifier could be used to measure electrolyte levels in newborns? An international research team has developed just such a device, and it has the potential to reduce invasive blood collections required to provide specimens for clinical laboratory testing of critical biomarkers. At the same time, this device may allow continuous monitoring of electrolyte levels with wireless alerts to caregivers.
Typical blood draws for NICU babies can cause information gaps as they are usually only performed twice a day. This can be problematic in cases where more frequent monitoring of these biomarkers is required to monitor the infant’s condition.
“We know that premature babies have a better chance of survival if they get a high quality of care in the first month of birth,” said Jong-Hoon Kim, PhD, Associate Professor at the WSU School of Electrical Engineering and Computer Science, in a WSU news release. “Normally, in a hospital environment, they draw blood from the baby twice a day, so they just get two data points. This device is a non-invasive way to provide real-time monitoring of the electrolyte concentration of babies.”
The smart pacifier (above) developed by researchers at the Washington State University School of Electrical Engineering and Computer Science—in collaboration with scientists in two South Korean institutions—provides continuous monitoring of sodium and potassium ion levels. This can help detect and prevent potentially dangerous dehydration issues in NICU babies without invasive blood draws for traditional clinical laboratory testing. (Photo copyright: University of Washington.)
How the Smart Pacifier Works
The miniature system developed by the WSU researchers utilizes a typical, commercially available pacifier outfitted with ion-selective sensors, flexible circuits, and microfluidic channels that monitor salivary electrolytes. These flexible, microfluidic channels attract the saliva when the pacifier is in the infant’s mouth which enables continuous and efficient saliva collection without the need for any type of pumping system. The gathered data is relayed wirelessly to caregivers using Bluetooth technology.
When the researchers tested their smart pacifier on infants, they discovered that the results captured from the device were comparable to information obtained from normal blood draws and standard clinical laboratory tests. Kim noted in the press release that technology currently in use to test infant saliva for electrolytes tend to be bulky, rigid devices that require a separate sample collection.
“You often see NICU pictures where babies are hooked up to a bunch of wires to check their health conditions such as their heart rate, the respiratory rate, body temperature, and blood pressure,” said Kim in the press release. “We want to get rid of those wires.”
The researchers intend to make the components for the device more affordable and recyclable. They also plan to perform testing for their smart pacifier on larger test groups to prove efficacy and hope the gadget will help make NICU treatment less disruptive for infant patients.
Going as far back as 2013, Dark Daily has covered research into the use of sensors placed in wearables and disposables to detect and monitor health issues.
“It should be noted that the ability to put reliable diagnostic sensors in disposables like diapers has been around for almost a decade and does not seem to have caught on with either caregivers or the public,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication, The Dark Report. “Because the researchers who developed the pacifier are attempting to solve a problem for NICU babies, this solution might find acceptance.”
This is another example of how researchers are thinking outside the box as to how to measure critical biomarkers without the need to send a specimen to the core clinical laboratory and wait hours—sometimes overnight—for results.
Though the new technology could speed diagnoses of cancers and other skin diseases, it would also greatly reduce dermatopathology biopsy referrals and revenue
What effect would elimination of tissue biopsies have on dermatopathology and clinical laboratory revenue? Quite a lot. Dermatologists alone account for a significant portion of skin biopsies sent to dermatopathologists. Thus, any new technology that can “eliminate the need for invasive skin biopsies” would greatly reduce the number of histopathological referrals and reduce revenue to those practices.
“What if we could entirely bypass the biopsy process and perform histology-quality staining without taking tissue and processing tissue in a noninvasive way? Can we create images that diagnosticians can benefit from?” asked Aydogan Ozcan, PhD (above), Chancellor’s Professor of Electrical and Computer Engineering at UCLA’s Samueli School of Engineering, one of the scientists who developed UCLA’s new virtual histology method, during an interview with Medical Device + Diagnostic Industry (MD+DI). (Photo copyright: Nature.)
Could Skin Biopsies be Eliminated?
The UCLA researchers believe their innovative deep learning-enabled imaging framework could possibly circumvent the need for skin biopsies to diagnose skin conditions.
“Here, we present a deep learning-based framework that uses a convolutional neural network to rapidly transform in vivo RCM images of unstained skin into virtually-stained hematoxylin and eosin-like images with microscopic resolution, enabling visualization of the epidermis, dermal-epidermal junction, and superficial dermis layers.
“This application of deep learning-based virtual staining to noninvasive imaging technologies may permit more rapid diagnoses of malignant skin neoplasms and reduce invasive skin biopsies,” the researchers added in their published study.
According to the published study, the UCLA team trained their neural network under an adversarial machine learning scheme to transform grayscale RCM images into virtually stained 3D microscopic images of normal skin, basal cell carcinoma, and pigmented melanocytic nevi. The new images displayed similar morphological features to those shown with the widely used hematoxylin and eosin (H&E) staining method.
“In our studies, the virtually stained images showed similar color contrast and spatial features found in traditionally stained microscopic images of biopsied tissue,” Ozcan told Photonics Media. “This approach may allow diagnosticians to see the overall histological features of intact skin without invasive skin biopsies or the time-consuming work of chemical processing and labeling of tissue.”
The framework covers different skin layers, including the epidermis, dermal-epidermis, and superficial dermis layers. It images deeper into tissue without being invasive and can be quickly performed.
“The virtual stain technology can be streamlined to be almost semi real time,” Ozcan told Medical Device + Diagnostic Industry (MD+DI). “You can have the virtual staining ready when the patient is wrapping up. Basically, it can be within a couple of minutes after you’re done with the entire imaging.”
Currently, medical professionals rely on invasive skin biopsies and histopathological evaluations to diagnose skin diseases and cancers. These diagnostic techniques can result in unnecessary biopsies, scarring, multiple patient visits and increased medical costs for patients, insurers, and the healthcare system.
Improving Time to Diagnosis through Digital Pathology
Another advantage of this virtual technology, the UCLA researchers claim, is that it can provide better images than traditional staining methods, which could improve the ability to diagnose pathological skin conditions and help alleviate human error.
“The majority of the time, small laboratories have a lot of problems with consistency because they don’t use the best equipment to cut, process, and stain tissue,” dermatopathologist Philip Scumpia, MD, PhD, Assistant Professor of Dermatology and Dermatopathology at UCLA Health and one of the authors of the research paper, told MD+DI.
“What ends up happening is we get tissue on a histology slide that’s basically unevenly stained, unevenly put on the microscope, and it gets distorted,” he added, noting that this makes it very hard to make a diagnosis.
Scumpia also added that this new technology would allow digital images to be sent directly to the pathologist, which could reduce processing and laboratory times.
“With electronic medical records now and the ability to do digital photography and digital mole mapping, where you can obtain a whole-body imaging of patients, you could imagine you can also use one of these reflectance confocal devices. And you can take that image from there, add it to the EMR with the virtual histology stain, which will make the images more useful,” Scumpia said. “So now, you can track lesions as they develop.
“What’s really exciting too, is that there’s the potential to combine it with other artificial intelligence, other machine learning techniques that can give more information,” Scumpia added. “Using the reflectance confocal microscope, a clinician who might not be as familiar in dermatopathology could take images and send [them] to a practitioner who could give a more expert diagnosis.”
Faster Diagnoses but Reduced Revenue for Dermatopathologists, Clinical Labs
Ozcan noted that there’s still a lot of work to be done in the clinical assessment, validation, and blind testing of their AI-based staining method. But he hopes the technology can be propelled into a useful tool for clinicians.
“I think this is a proof-of-concept work, and we’re very excited to make it move forward with further advances in technology, in the ways that we acquire 3D information [and] train our neural networks for better and faster virtual staining output,” he told MD+DI.
Though this new technology may reduce the need for invasive biopsies and expedite the diagnosis of skin conditions and cancers—thus improving patient outcomes—what affect might it have on dermatopathology practices?
More research and clinical studies are needed before this new technology becomes part of the diagnosis and treatment processes for skin conditions. Nevertheless, should virtual histology become popular and viable, it could greatly impact the amount of skin biopsy referrals to pathologists, dermatopathologists, and clinical laboratories, thus diminishing a great portion of their revenue.
Survey shows more than 50% of hospitals and health systems plan to increase virtual care services within two years, a development that can change how patients access clinical laboratory testing services
If anything positive came out of the COVID-19 pandemic, it’s the growing acceptance by physicians and health payers of telehealth—including telepathology, teleradiology, and other types of virtual doctor visits—as a way for patients to meet with their physicians in place of in-office healthcare.
In earlier coverage about the rapid adoption of telehealth and virtual doctor visits, Dark Daily has observed that this trend creates a unique challenge for clinical laboratories. If the patient has a virtual consultation with his or her physician, how would a clinical laboratory get access to this patient to do a venipuncture and collect the samples necessary to perform the medical laboratory tests ordered by the physician?
Nevertheless, according to multiple reports, healthcare providers are planning to increase investment in telehealth technologies.
Disparate Technologies Led to Technical Difficulties for Virtual Healthcare Providers
The terms telemedicine and telehealth are often used interchangeably. However, according to the American Academy of Family Physicians (AAFP), there are subtle differences worth noting.
Telehealth is a broad term which refers to “electronic and telecommunications technologies and services used to provide care and services at-a-distance [while] telemedicine is the practice of medicine using technology to deliver care at a distance.
“Telehealth is different from telemedicine in that it refers to a broader scope of remote health care services than telemedicine. Telemedicine refers specifically to remote clinical services, while telehealth can refer to remote non-clinical services,” the AAFP notes.
Kelly Lewis, former Vice President of Revenue Strategy and Enablement at telehealth provider Amwell, told Healthcare IT News (HIT News) that “the COVID-19 pandemic caused telehealth adoption to skyrocket.
However, “Because much of this adoption was driven out of an abundance of necessity, there was little time for organizations to think strategically about their technology investments,” she added.
“With urgency at a high, payers, provider organizations and clinicians all turned to the quickest options available so patients could continue to get care. The result, however, was what we are calling platform ‘sprawl’—the use of a number of disparate solutions that are leading to a confusing and frustrating care delivery system and experience.”
Nevertheless, according to a survey conducted by HIT News and HIMSS Analytics, “More than half (56%) of hospital and health system leaders say they are planning to increase their investment in telemedicine during the next two years.” This, “shows that the huge surge in and mainstreaming of telehealth during the ongoing pandemic has caused the C-suite and other healthcare leaders to embrace the technology that has for so long existed on the periphery of medicine,” HIT News noted.
“The clear message is that telehealth is here to stay and will continue to expand,” Lewis told HIT News, adding, “The majority of payers without virtual care offerings also reported planning to add them in the next 24 months.”
“Clinicians agree that moving toward a fully integrated telehealth platform would be beneficial. More than 80% believe investing in a fully integrated virtual or hybrid care system would have a positive impact on clinical outcomes and patient experiences,” Kelly Lewis (above), former VP at telehealth provider Amwell, told Healthcare IT News. Considering the growing demand for telehealth, pathologists and clinical laboratories will need a strategy for supporting virtual healthcare providers. (Photo copyright: Healthcare IT News.)
The HIT News/HIMSS Analytics survey findings suggest telehealth will transition as providers aim for “smart-growth” instead of “pandemic-fueled expediency,” Becker’s Hospital Review reported.
Survey respondents expressed positive attitudes about telehealth:
56% of healthcare leaders plan to increase investment in virtual care over the next two years.
80% of respondents noted “very” or “extremely” important telehealth factors are integrating with existing workflows, fast video connections, and reducing administrative burden.
77% called telehealth platform integration with the electronic health record (EHR) “very” or “extremely” important.
80% envision positive clinical outcomes and patient experiences from a fully integrated telemedicine platform.
75% of payers said a single digital platform has potential to streamline member experiences.
“With telehealth visits stabilizing at roughly 10 times pre-pandemic levels, digital transformation initiatives are rising across the field. As a result of the pandemic, 60% of healthcare organizations are adding new digital projects, with telemedicine becoming a higher priority for 75% of executives (vs. 42% in 2019) to improve the patient experience,” the AHA reported.
Medical laboratories and anatomic pathology groups are advised to keep pace with the changing healthcare landscape which increasingly puts a premium on remote and virtual visits. This has become even more critical as healthcare providers and investors infuse more capital into telehealth technology.
As physicians expand telemedicine virtual office visits post-pandemic, a clinical laboratory strategy to reach patients and acquire specimens will be required.
Service uses ‘hub-and-spoke’ routing model to provide rapid delivery of time-and-temperature-sensitive clinical laboratory specimens and supplies
Drone delivery service in healthcare is beginning to take flight both here and abroad, with California-based Matternet launching medical drone delivery networks in Winston-Salem, North Carolina, and Berlin, Germany.
The successful use of unmanned aircraft to deliver patient specimens has major implications for clinical laboratories. When conditions allow them to fly, drones can significantly shorten delivery times of routine patient specimens such as blood and urine.
The drones will fly two routes and carry scheduled deliveries of specialty infusion medicines and personal protective equipment (PPE). Because infusion medicines are patient-specific, high cost, and have a short shelf life, delivery by drone within 10 minutes is an ideal solution, Matternet said in the news release. Individually compounded medicines also will be delivered on-demand for dispensing to patients who need real-time access to treatments.
“This partnership with UPSFF aligns strategically with our mission to improve the health of those in the communities that we serve as well as our Virtual Health sector in iQ Healthtech Labs,” said Jane Shen, PharmD (above), Chief Strategy Officer at the Wake Forest Institute for Regenerative Medicine, and Head of Sector Development for Innovation Quarter, a subsidiary of iQ Healthtech Labs, in the IQ Healthtech Labs news release. “We seek to leverage technology advances to make access to healthcare easier and more effective. Collaborating in innovative ways with a key logistics partner like UPS allows Wake Forest Baptist to deliver care in better and more efficient ways to patients and their families.” (Photo copyright: Triad Business Journal.)
Matternet has been operating in the US since August 2018. In, “WakeMed Uses Drone to Deliver Patient Specimens,” Dark Daily’s sister publication, The Dark Report, reported how—following a two-year trial period using a quadcopter to deliver patients’ samples from a physicians’ office satellite lab/draw station to the WakeMed Medical Center’s central lab—the North Carolina healthcare system, in partnership with UPSFF, completed the first successful revenue-generating commercial transport of lab supplies by drone in the US at WakeMed’s flagship hospital and campus in Raleigh, N.C.
Bala Ganesh, a Vice President of Engineering at UPS, said UPSFF, which was launched in July 2019, is focused on healthcare deliveries. To make drone deliveries commercially viable, both “criticality” and an industry’s “willingness to pay” are important, he said. “We never looked at delivering pizza,” he told Forbes. UPSFF is the first company to receive the FAA’s Part 135 certification (package delivery by drone).
The video above demonstrates Matternet’s “Easy-to-use interface for sending and receiving packages 24/7/365.” The Matternet Station (above) is “integrated with the Matternet Cloud [Matternet’s proprietary software platform for operating Matternet networks] and the M2 Drone for payload and battery exchange, and autonomous take-off and landing. The station “can store up to seven payloads and batteries and hold one Matternet M2 Drone in its hangar.” Hospital-based clinical laboratory managers will appreciate the ease at which the station can be accessed by lab personnel. Click here to watch the full video. (Video and caption copyright: Matternet.)
BVLOS Drone Delivery of Clinical Laboratory Specimens in Europe
Last year, Matternet launched the first beyond-visual-line-of-sight (BVLOS)-operated medical drone network in Europe. Its unmanned aircraft will be flown without the requirement that a pilot always maintain a visual line of sight on the aircraft.
Matternet launched its BVLOS operations at Labor Berlin, Europe’s largest hospital laboratory, which includes facilities in 13 hospitals across Berlin.
“We continue to expand drone delivery operations around the world with a focus on urban environments,” said Andreas Raptopoulos, Matternet Founder and CEO, in a press release. “Hospitals and laboratories in densely populated cities like Berlin need fast and predictable transportation methods that avoid urban congestion. We are thrilled to partner with Labor Berlin and look forward to streamlining their diagnostics work to the benefit of Berlin’s hospitals and residents.”
According to the press release, Matternet’s drone delivery network will transport samples from hospitals to Labor Berlin facilities up to 70% faster than ground courier services, as well as reducing vehicular traffic and emissions in Berlin’s urban core. Currently, more than 15,000 samples are transported daily across Labor Berlin’s healthcare system.
Will Drone Delivery of Clinical Laboratory Specimens Become the New Normal?
“I think that this is the wave of the future,” Atrium Health Senior Vice President Conrad Emmerich, who previously served as Senior Vice President, Business Services, at Wake Forest Baptist Health, told Fox 8 News.
It’s certainly beginning to look as if drone delivery as a viable alternative to traditional transport methods is taking off (pun intended). Since 2017, Dark Daily has published 10 ebriefings on drone delivery systems for healthcare being trailed worldwide.
Since the shortest distance between two points is a straight line, regular transporting of clinical laboratory specimens and supplies by drone could reduce transit times between hospitals and clinical laboratories and lower laboratory specimen transportation costs.
Hospital administrators and medical laboratory executives may want to keep tabs on the expansion of such services into their regions. There may be opportunities to improve clinical outcomes and patient satisfaction.
