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Regulation & Reimbursement Strategies Should Not Get In the Way of ‘Smart’ Electronic Skin Patches

Recent IDTechEx research in their report: Electronic Skin Patches 2019-2029, has revealed significant opportunities in the development and use of electronic skin patches, with over $7.5bn in revenue made from the technology in 2018 and a growth forecast of over $20bn per year over the next decade.

However, it also shows that reimbursement and regulatory consideration aren’t necessarily keeping pace. James Hayward, Principal Analyst at IDTechEx, highlights the dangers of a closed market driven by regulation and reimbursement strategies which favour devices for simplicity and cost rather than effectiveness; deterring new entrants.

Electronic skin patches are wearable products attached to the skin of a user incorporating sensors, actuators, processors and communication technology, allowing the device to connect to the internet to become ‘smart’. Skin patches are one of the latest waves in health monitoring; their non-intrusive design meaning they are comfortable and discrete. Unsurprisingly, interest in electronic skin patches has soared, driven by significant hype and market growth around wearable devices starting in 2014.

A number of significant applications of electronic skin patches are now having a profound impact on health and quality of life. Some of the foremost use cases center around healthcare and medical applications, while the consumer health market is another early adopter. As such, several product areas, particularly in diabetes management and cardiovascular monitoring, have grown exponentially to create billions of dollars of new revenue each year for the companies at the forefront of this wave.

Cardiovascular monitoring faces reimbursement and competitive roadblocks

Alongside this growth has come the need for forward-thinking regulation and reimbursement, especially given the life-changing medical context of their applications. Following regulatory approval, the funding of medical devices can come from different sources, including government-led reimbursement schemes. These provide funding for medical devices defined within certain categories according to central definitions and understandings of the performance and cost of the device. While systems do vary by country, it is typical for central procedural terminology to be linked to reimbursement amounts for each device.

Take cardiovascular skin patches for example, which exist in a highly competitive landscape alongside consumer wearables such as watches and chest straps (which provide cardiac data but with limited medical usefulness due to a lack of medical approval) as well as cardiac implants which offer a more accurate but less safe approach.

Effectiveness must have a role to play in future developments 

Electronic skin patches for cardiovascular monitoring must strike a compromise between data quality and patient comfort. A patient can remain active while wearing the device, minimizing additional issues caused by remaining in a hospital bed for too long. However, they also typically produce simpler data sets than the full 12-lead standard monitor and offer less control over the quality of the data produced. These competitive landscapes drive positive product development but it is often the central regulatory and funding bodies that have the power to drive change.

Previously, these mobile cardiac telemetry products have benefited from a favorable reimbursement scenario in the US, defined under a Category 3 CPT code for “extended Holter monitoring”. This code entitles them to twice the amount of reimbursement as “event monitoring” and more than eight times the amount afforded to generic “Holter monitoring” (both Category 1 CPT codes). If the reimbursement situation were to change, the entire revenue structure for these devices will change with it. Should reimbursement strategies be allowed to shape developments rather than consumers and effectiveness?

Diabetes management reveals a confusing system

One of the biggest revenue generators in the electronic skin patches market has been continuous glucose monitoring (CGM) for diabetes management, which posted annual revenues of over $2.5bn in 2018. The US Food and Drug Administration (FDA) has given four companies approval to sell CGM products, three of the four companies offer a skin patch with a small needle to test glucose levels in interstitial fluid. Only one organisation offers a subcutaneous implant which is then read using a skin patch as a communication hub. In such a closed market, regulations and reimbursements are shaping its course.

The three large players offering a needle-based skin patch have benefited from multiple geographies now offering partial or full reimbursement for CGM products under national healthcare schemes. Yet each of the three products is treated under a single regulatory category and receive the same reimbursement per device, regardless of performance, longevity or functionality. This opens up the potential for a closed market which favours devices because of simplicity and cost rather than effectiveness.

The fourth player is a new market entrant with lower revenue but offers a much longer-lasting CGM solution with significant differentiation from its rivals, but because of limited regulation and reimbursement, however, it may struggle to break the market stranglehold from larger players with cheaper solutions.

New entrants need to be encouraged

This reimbursement and regulatory environment provide an even bigger barrier to entry for new and innovative electronic skin patches. If the product is to be offered as a medical device, it must go through regulatory approval processes, either showing equal performance to existing equivalents or going through a de novo process to prove its efficacy and safety.

These hurdles often result in new electronic skin patch devices being pushed towards the consumer health market, where regulatory roadblocks aren’t as stringent but offer less long-term returns than in direct healthcare. This is already proving to be the case with the promising area of temperature sensing for fever and fertility monitoring, as well as other patient monitoring devices.

Healthcare Sensors Cambridge Event

This is exactly why IDTechEx has been tracking the emergence of electronic skin patches and the reimbursement and regulatory landscape back to 2010, across 26 application areas and over 100 market players, in its report Electronic Skin Patches 2019-2029. The report forecasts the market through 2019-2029 and aims to help innovative healthcare organisations make more informed business decisions before deciding how to roll-out one of the hottest technologies in patient monitoring.

In addition to detailed reports on this topic, IDTechEx are hosting an event: Healthcare Sensor Innovations 2019, in Cambridge, UK which is a conference and table-top exhibition focusing on the latest developments in the use of wearables and sensors in continuous monitoring of individuals and point-of-care diagnostics.

Register here: www.IDTechEx.com/Cambridge


About the Author

James Hayward, Principal Analyst at IDTechEx. James is a Principal Analyst at IDTechEx. Joining in 2014, he initially developed IDTechEx’s wearable technology platform. He now oversees a team of analysts across varied topic areas, as well as oversight over the wearable technology research efforts.

Featured Image: Peshkova

Source: Regulation and reimbursement strategies should not get in the way of ‘smart’ electronic skin patches – TechNative

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Engineers at the University of California San Diego have developed a flexible wearable sensor that can accurately measure a person’s blood alcohol level from sweat and transmit the data wirelessly to a laptop, smartphone or other mobile device. The device can be worn on the skin and could be used by doctors and police officers for continuous, non-invasive and real-time monitoring of blood alcohol content. The device consists of a temporary tattoo—which sticks to the skin, induces sweat and electrochemically detects the alcohol level—and a portable flexible electronic circuit board, which is connected to the tattoo by a magnet and can communicate the information to a mobile device via Bluetooth. Lots of accidents on the road are caused by drunk driving. This technology provides an accurate, convenient and quick way to monitor alcohol consumption to help prevent people from driving while intoxicated. The device could be integrated with a car’s alcohol ignition interlocks, or friends could use it to check up on each other before handing over the car keys. Blood alcohol concentration is the most accurate indicator of a person’s alcohol level, but measuring it requires pricking a finger. Breathalyzers, which are the most commonly used devices to indirectly estimate blood alcohol concentration, are non-invasive, but they can give false readouts. For example, the alcohol level detected in a person’s breath right after taking a drink would typically appear higher than that person’s actual blood alcohol concentration. A person could also fool a breathalyzer into detecting a lower alcohol level by using mouthwash. Recent research has shown that blood alcohol concentration can also be estimated by measuring alcohol levels in what’s called insensible sweat—perspiration that happens before it’s perceived as moisture on the skin. But this measurement can be up to two hours behind the actual blood alcohol reading. On the other hand, the alcohol level in sensible sweat—the sweat that’s typically seen—is a better real-time indicator of the blood alcohol concentration, but so far the systems that can measure this are neither portable nor fit for wearing on the body. Now, UC San Diego researchers have developed an alcohol sensor that’s wearable, portable and could accurately monitor alcohol level in sweat within 15 minutes. News Source: http://jacobsschool.ucsd.edu/news/new…

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Heart Checks While You Shop: NHS Announces Plan To Have Pharmacies Check Shoppers’ Heart Health In Bid To Cut Deaths

Shoppers will be offered on-the-spot NHS heart checks to detect signs of killer conditions.

High street pharmacies will be overhauled under the national plan to prevent up to 150,000 heart attacks and strokes within a decade.

The country’s most senior doctor said the new approach would be a “game changer,” helping to identify risks far earlier, with advice on lifestyle overhauls as well as targeted medication.

Pilot schemes have seen some types of strokes fall by a quarter.

From October, chemists will begin rolling out the “rapid detection service,” which includes mobile electrocardiograms to spot irregular heartbeats, as well as checks on blood pressure and cholesterol levels.

If successful, the scheme will be rolled out to every pharmacist in the country within three years.

An NHS sign is pictured at St Thomas’ Hospital  Credit: AFP

The plans aim to identify those at risk far earlier, when treatment and lifestyle changes are most likely to be effective.

Pharmacists will be expected to dole out advice on exercise and diet, with results passed directly to GP practices, who can prescribe the right medication.

Professor Stephen Powis, NHS England medical director, said: “Heart disease and strokes dramatically cut short lives, and leave thousands of people disabled every year, so rapid detection of killer conditions through high street heart checks will be a game-changer.”

The plans, launched to coincide with the world’s biggest heart conference, follow proposals to scrap “one size fits all” health MOTs at GP surgeries.  In future, GPs will be expected to increasingly target checks on those thought to be at greatest risk, due to their medical and genetic history, while routine screening tests are offered by pharmacists.

Heart disease is Britain’s biggest killer, with deaths from heart attacks, strokes and circulatory diseases accounting for 160,000 deaths in the UK every year.

More than 7 million people are living with heart and circulatory diseases.

Speaking at the European Society for Cardiology (ESC) conference, in Paris, Professor Bryan Williams, author of its guidelines on disease prevention, said: “This is hugely important. Heart disease and stroke remain the most important cause of premature death and disability and we have the means to prevent the many of them.

“The key is early detection of those at risk and doing this is a way that is convenient for the public, not having to wait for a GP appointment that could be done simply the local pharmacy.”

Chemists will begin rolling out the “rapid detection service,” which includes mobile electrocardiograms to spot irregular heartbeats, as well as checks on blood pressure and cholesterol levels. Credit: Anthony Devlin/PA

Yesterday Dexter Canoy, clinical epidemiologist from the University of Oxford, presented research showing that raised blood pressure at the age of 40 is a clear indicator of the risk of suffering heart attacks and strokes in later life.

He said: “We need to find ways to target the people who aren’t seeing their GP regularly – the middle-aged men who think they are healthy, but haven’t actually been checked.”

“If opening it up to pharmacies and shopping malls means that people are more likely to have their blood pressure checked, that could make a significant difference,” he said, calling for proper evaluation of the measures.

The checks are part of a new £13 billion five year contract for community pharmacists which aims to expand their roles and offer earlier detection of diseases.

More than 100 pharmacies in Cheshire and Merseyside have begun offering blood pressures screening services, under a local initiative, backed by the British Heart Foundation, with plans to recruit more than 200 more chemists to the service as it expands.

Medics said widespread use of the monitors by pharmacies, hospitals and individual patients could cut costs, speed diagnosis and avoid preventable hospital admissions.

Pilot schemes in Lambeth and Southwark in south London identified more than 1,400 patients suffering from atrial fibrillation – an irregular heart rhythm –  who should have been taking blood thinning drugs, but were not. In total, 1,300 of the patients have now been put on the medication, leading to a 25 per cent reduction in the rate of strokes linked to their heart condition.

Keith Ridge, England’s chief pharmaceutical officer, said: “This new contract makes the most of the clinical skills of local pharmacists and establishes pharmacies across England as local health hubs – open in the evenings and at weekends – where people can go for an ever-increasing range of clinical health checks and treatment.”

Simon Gillespie, chief executive of the British Heart Foundation, said: “Millions of people in England are living with conditions such as high blood pressure which, if left untreated, significantly increase the risk of having a potentially deadly heart attack or stroke. Reaching more people and encouraging them to check their blood pressure, working with them to lower it where necessary, will play an absolutely critical role in saving lives in the coming years.”

By:

 

Source: Heart checks while you shop: NHS announces plan to have pharmacies check shoppers’ heart health in bid to cut deaths

Promising Blood Test Could Help to Predict Breast Cancer Recurrence

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Doctors have gotten much better at detecting and treating breast cancer early. Drug and chemotherapy regimens to control tumors have gotten so effective, in fact, that in some cases, surgery is no longer necessary. In up to 30% of cases of early-stage breast cancer treated before surgery, doctors can’t find evidence of cancer cells in postoperative biopsies. The problem, however, is that there is currently no reliable way to tell which cancers have been pushed into remission and which ones have not.

That’s where an easy identifier, like a blood test, could transform the way early stage breast cancer is treated. In a paper published in Science Translational Medicine, researchers led by a team at the Translational Genomics Institute (TGen), an Arizona-based nonprofit, report encouraging results on just such a liquid biopsy. Its test, called Targeted Digital Sequencing (or TARDIS), was up to 100 times more sensitive than other similar liquid-biopsy tests in picking up DNA shed by breast cancer cells into the blood.

Currently available ways of tracking breast cancer cells in the blood are most useful in people with advanced cancer. In those conditions, cancer cells litter the blood with fragments of their DNA as they circulate throughout the body to seed new tumors in other tissues like the bone, liver and brain. But in early-stage breast cancer, these cells are, by definition, scarcer.

To address the problem, the research team, which included scientists at Arizona State University, the City of Hope, Mayo Clinic, and the Cancer Research UK Cambridge Institute, developed a new way to pick up elusive cancer DNA. They genetically sequenced tumor biopsy tissue from 33 women with stage 1, 2, or 3 breast cancer, most of whom received drug or chemotherapy treatment prior to getting surgery to remove their tumors. By comparing the tumor sequence to the sequence from the patients’ normal cells, the scientists isolated potential mutations that distinguished the cancer cells and identified those that were most likely to be so-called “founder mutations”—genetic aberrations present in the original cancer cells and carried into the resulting tumor.

On average, each patient harbored about 66 such founder mutations. For each patient, the scientists combined the founder mutations to form a personalized assay, which could then be used to pick up signs of breast cancer DNA in blood samples. Combining a number of mutations together turned out to be a more sensitive way to detect tumor DNA than trying to pick up a single or a small number of mutations in an already small number of tumor DNA fragments present in the blood.

They combined this approach with a new strategy for amplifying the scarce tumor DNA found in a blood sample by preserving the size of these snippets and attaching unique molecular identifiers to them to make them more easily detectable.

At the start of the study, TARDIS was able to find tumor DNA in the blood samples of all the patients; other liquid biopsies for breast cancer currently in development have reported picking up 50% to 75% of the cancer cases.

After the pre-surgery treatment TARDIS detected circulating tumor DNA in the blood in concentrations as low as 0.003%, or 100-fold more sensitive than other tests being developed.

“This is an important advance,” says Dr. Debu Tripathy, professor and chair of the breast medical oncology department at the University of Texas MD Anderson Cancer Center, who was not involved in the study. “This test can help identify those with early stage breast cancer who may still have residual cancer in their body that may not be detectable with standard scans.”

That could help guide treatment, by, for example, determining which patients require closer monitoring for recurrent growths. Because the sequencing identifies the genetic mutations contributing to the tumor, the test could also help doctors to decide which targeted drug therapies, which are designed to address specific cancer mutations, to prescribe for their patients.

Most importantly, the test could help women whose tumors are effectively eliminated by their pre-surgery treatment to avoid an operation altogether since the blood test would reassure her and her doctor that no residual tumor DNA remained.

“If we could really know with a more accurate degree of certainty that you don’t have residual disease, it would be help in saying that you don’t need any more therapy [including surgery],” says Dorraya El-Ashry, chief scientific officer of the Breast Cancer Research Foundation. ”Conversely, if you still had residual disease, if there is information from the test that can pinpoint the next therapy, that would also be better.”

Muhammed Murtaza, co-director of the center for non-invasive diagnostics at TGen, says TARDIS needs to be tested in a larger group of breast cancer patients before it can be rolled out to doctors’ offices. His team is planning to study the test’s efficacy in about 200 breast cancer patients, in order to clarify exactly what levels of tumor DNA found in the blood are most likely to lead to recurrence. They are also exploring how modified versions of TARDIS could be applied to other cancers, like esophageal, colorectal, pancreatic and prostate.

There’s even encouraging precedent for this sort of a liquid biopsy. Doctors routinely rely on a blood test for chronic myeloid leukemia, for example, to track patients’ response to targeted drugs that treat specific mutations driving the cancer. “Applying this same technology to more common solid cancers like breast cancer is the new frontier,” says Tripathy.

By Alice Park

Source: https://time.com

 

Why Doctors Hate Their Computers – Atul Gawande

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On a sunny afternoon in May, 2015, I joined a dozen other surgeons at a downtown Boston office building to begin sixteen hours of mandatory computer training. We sat in three rows, each of us parked behind a desktop computer. In one month, our daily routines would come to depend upon mastery of Epic, the new medical software system on the screens in front of us. The upgrade from our home-built software would cost the hospital system where we worked, Partners HealthCare, a staggering $1.6 billion, but it aimed to keep us technologically up to date……..

Read more: https://www.newyorker.com/magazine/2018/11/12/why-doctors-hate-their-computers

 

 

 

 

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This Thermometer Tells Your Temperature, Then Tells Firms Where to Advertise – Sapna Maheshwari

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Most of what we do — the websites we visit, the places we go, the TV shows we watch, the products we buy — has become fair game for advertisers. Now, thanks to internet-connected devices in the home like smart thermometers, ads we see may be determined by something even more personal: our health. This flu season, Clorox paid to license information from Kinsa, a tech start-up that sells internet-connected thermometers that are a far cry from the kind once made with mercury and glass……

Read more: https://www.nytimes.com/2018/10/23/business/media/fever-advertisements-medicine-clorox.html

 

 

 

 

Your kindly Donations would be so effective in order to fulfill our future research and endeavors – Thank you

 

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