More than 2/3 of Americans have a smartphone. We have grown to expect access to information on demand. Apps and wearable devices are increasingly used by people seeking to monitor heart rate, sleep patterns, exercise, water intake and more.
With a perfect storm of patients facing significantly higher deductibles, pressure on medical institutions and physicians to improve efficiency, and the personal empowerment gained from the latest technologies, people on both sides of the exam table are demanding innovation in Point of Care Testing (POCT) solutions.
+ Doctor and patient both get faster test results
+ More convenient for patient and provider
+ Proven increased patient satisfaction
+ Decrease in overall cost of care
The new focus in healthcare is on value rather than test volume, and reimbursement for tests in decreasing. This leaves providers needing to minimize tests to the optimal point where outcomes won't suffer while cost efficiencies are gained.
The world will be short 12.9 million healthcare workers by 2035; today, that figure stands at 7.2 million.
The emerging markets' healthcare industry represents more than $1.3 trillion and is growing at a rate of 6.8%.
WHO Report, 2013
"Healthcare in the Emerging Markets A Compelling Private Equity Opportunity," Siguler Guff, 2014
"Rising and huge incidences of infectious and lifestyle diseases, increasing funding/investment toward the development of POC products, growing focus of both international and domestic players of the Asia-Pacific POC diagnostics market, and large number of R&D activities are propelling the demand for POC testing products in the Asia-Pacific region."
Point-Of-Care Diagnostic Market by Products (Glucose Monitoring & Infectious Diseases Testing Kits, Cardiac & Tumor Markers), by End Users (Self & Professional Monitoring), Over the Counter & Prescrption Based - Global Forecast to 2018 / Markets and Markets
As the number of skilled healthcare workers decreases, there is a shift toward accurate, intuitive tests that can be operated by less skilled personnel and patients.
Costs Vs. Quality of Care
An estimated 25 percent of Americans with Employer-sponsored health coverage are enrolled in HDHPS*, as compared to 4 percent a decade ago.
Health Affairs Blog, 2016
*High deductible plans, where people pay more out of pocket, have created shoppers with high expectations and demand for convenience and satisfaction.
Though POC tests can cost more on a per test basis, cost savings, reduced doctor visits and laboratory overhead costs need to be factored in to understand the overall equation.
Point-of-care testing (POCT) is one of the innovations that can potentially have impact on quality of care, as well as on system redesign and a more patient centered approach to care.
US National Library of Medicine, National Institutes of Health, 2013
Evolution in the POC Business Model
While many solutions are being developed for consumer markets, the bulk of the users that are ready to embrace POC technologies and can consume large volumes of devices and consumables in the next five years are doctors in hospitals and clinics.
-Milos Todorovic, Lux Research
Pharmacists see a patient 10X more than their doctor.
Using the pharmacist as an extension of the doctor makes a lot of sense. The pharmacist can manage and maintain adherence monitoring between doctor visits, something POC diagnostics are particularly useful for.
+ No hassle to get prescribed labs done
+ Many pharmacies are open 24 hours, eliminating expensive and inefficient ER visits
+ Pharmacists are educated to make clinical judgment decisions
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations are passed, and include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent or treat disease.
An estimated 64,000 community pharmacies are operating in the United States; data indicates that 8,856 (14%) of all community pharmacies have a CLIA Certificate of Waiver, enabling them to perform tests like glucose measurement, which are so simple there is little risk of error.
The National Association of Chain Drug Stores (NACDS) announces the expansion and acquisition of a certificate program designed to provide training for pharmacists to administer point-of-care testing and other health assessments in pharmacies.
Current Development Challenges & Opportunities
Sensors and Microsystems
One approach: Google's smart Contact Lens is an 'eye-mountable device' for monitoring glucose levels
The NIH supports the development of sensor and microsystem and low-cost imaging technologies for point-of-care testing. These instruments combine multiple analytical functions into self-contained, portable devices that can be used by non-specialists to detect and diagnose disease, and can enable the selection of optimal therapies through patient screening and monitoring of a patient's response to a chosen treatment.
Non-invasive or minimally invasive devices are the trend throughout medicine, and will be in increasing demand for POC testing.
The University of Vermont Medical Center in Burlington, VT, announced recently that five million medications have been tracked using radio frequency identification technology.
VeriTeQ (which has also been known as VeriChip and PositiveID) was the first to obtain a license from the FDA to implement RFID chips in volunteer patients in 2004.
A vial of the drug Glycopyrrolate with a strength of 1MG/ML became the five-millionth RFID-tagged dose at UVMC tracked by Kit Check.
A Swedish high-tech office complex, Epicenter, is implanting rice-grain sized RFID chips in employees that allow them access to locked doors and the use of company machinery.
Real Time Data
Because real time POCT data is not provider specific, it's not in silos, like our current EHRs (Electronic Health Records), which are not communicated freely or effectively. Provider groups need to start communicating better under new healthcare laws and goals (i.e. value based treatment). The communication of data via POCT is a natural complement to this.
POC devices were used to regularly screen children, a effort led by Dr. Mona Hanna-Attisha, to confirm the impact of Flint water quality issues within hours.
An easy to use, home-use, cloud-based application that enables users to schedule and monitor real-time medication adherence and history.
2/3 of Americans have a smartphone. Thousands of mobile apps are attempting to help people manage their health online. The smartphone can be leveraged in so many ways in POCT solutions.
Improving Patient Care
Alarms and alerts can cause interruption in a patient's sleep. Technologies like Philips CareEvent mobile alert app moves the alert to a doctor/nurse/caregiver's smartphone.
Smartphone "appcessories," devices that connect with a smartphone, are reinventing the availability of POC tests and vastly increasing their functionality.
BHR's CUBE Point of Care Analyser operates on a custom Android app and performs POCT CRP analysis as well as 9 other tests in less than five minutes.
Device + Mobile Phone
Propeller Health's 'smart' inhalers connect to asthma sufferers' smartphones to log their geolocation so a doctor can monitor whether air quality of certain locations or times trigger attacks.
Using the sensors already built in to a smartphone has many advantages.
The First Derm app allows a patient to send a photo of a skin condition to a licensed dermatologist who will reply with a diagnosis.
The traditional paper forms/clip board experience is incredibly frustrating to patients in this day and age where fast, connected communication is the norm... it's even worse than the DMV. There's great potential to improve user experience in many areas for both patients and nurses/doctors in the office.
14% of undiagnosed HIV patients cause 33% of new infections.
Point-of-care testing at retail pharmacies can reduce the number of undiagnosed HIV patients - leading to the reduction in new infections. The 20 minute visit is light-speeds faster than the 2-weeks needed when sending tests to established laboratories.
A simple, disposable self-testing device for detecting Anemia has been described in The Journal of Clinical Investigation. The intent is to put a simple test that does not require power into the hands of patients.
Much opportunity exists to create POC solutions to help minimize the time spent by nurses walking to and from centralized charting and monitoring areas. Additionally, many current systems are inconvenient and time consuming, actually putting patients at risk ("death by million clicks").
OJ-Bio's Xtalline product range measures the biomarker C-Reactive Protein (CRP), a biomarker of inflammatory disease allowing determination of whether an infection is caused by bacteria. The test then can be used to determine whether antibiotics are required immediately at the point-of-use. It's designed to be simple enough for anyone to use.
What environment are you designing for? What does it require?
Third World Countries
Cologuard, manufactured by Exact Sciences Corp enables people to screen for colorectal cancer at home without an invasive colonoscopy.
Fio intelligent devices can rapidly test for Ebola in third world countries. Rather than sending blood samples to the few laboratories that exist in developing countries, a pinprick of blood or sample of saliva provides results immediately.
On Scene/First Responders
The HemoPalm by ChroMedx lets first responders test possible victims of Carbon Monoxide (CO) poisoning immediately, rather than the hospital taking an arterial blood sample, sending it to a central lab, where a bench top unit uses spectroscopy and electrochemical sensor measurements to provide results.
Radisens Diagnostics' Gemini Platform is designed for placement in physicians' offices, pharmacies or medical clinics to instantly test for diseases or medical conditions at the point of care with a fraction of a blood drop.
Avisa is working on a test for respiratory infections that detects bacterial infections in the lung within 10 minutes at the point of care.
Glucose Testing: Largest market segment currently Cardiac Testing: Fastest-Growing Market Segment
In 2015, three of the five largest data breaches were in healthcare. Looking into 2016, healthcare providers need to be prepared for incidents, as this is a prime target for cyber criminals. Devon Bryan, ADP Vice President Global Technical Services, says that he expects cyber insurance adoptions will begin to materialize this year.
Pressure from the FDA and marketplace has encouraged device makers to upgrade the security in older devices. The FDA only requires a new 510(k) clearance if the updates pose new concerns on the safety or effectiveness of the device.
A virtual local area network (VLAN) allows network administrators to partition their networks to match the functional and security requirements of the systems without making major changes to the current network infrastructure.
Network segmentation offers improved security and performance by splitting a computer network into subnetworks.
Software-defined networking (SDN) allows network administrators to manage network services through abstraction of higher-level functionality. This allows network engineers and administrators to respond quickly to changing business requirements.
Stealth Networks allow authorized users to access only certain parts of a network without seeing the entire network, thus increasing security.
User Security Tip
Tech savvy users should test an application or research to see if the application provider has an attestation letter from a security firm before trusting the program.
Sysorex AirPatrol uRTLS provides real time location and analytics for mobile devices, assets and the Internet of Things from a single platform.
Draft Standards for Diabetes Devices
Diabetes Technology Society (DTS) is in the process of developing a standard set of cybersecurity performance and assurance requirements for the diabetes devices that are at risk of cyber attacks, both in terms of loss of data and execution of inappropriate commands.
Security in Action
Open Web Application Security Project (OWASP)
OWASP is a worldwide not-for-profit organization that focuses on improving the security of software. It's free to participate, and all the materials including information on how to address common security issues and security testing tools are provided at no charge.
The study and development of systems and devices that can recognize, interpret, process, and simulate human interaction. It is an interdisciplinary field spanning computer science, psychology, and cognitive science.
Affectiva, a startup spun out of MIT's Media Lab by Rana el Kaliouby, has built an emotion-sensing app with the largest emotion data repository.
VGo's remote telepresence device demonstrated everything needed to have a physical presence in a different location, including camera, microphones, and video display integrated into a remote controlled platform.
Smart Virtual Assistants
Suggestic's app helps people overcome Type 2 diabetes by delivering advanced personalization with their user-friendly "lifestyle GPS."
AiCure is a HIPPA-compliant software that captures evidence of medication ingestion with your mobile device.
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