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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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Motorola Razr 2019: Prepare To Be Disappointed

2019 RAZR

The buzz around the new Motorola Razr is electric. It’s taken off well beyond Lenovo’s ability to control it and the result is that we are all going to be disappointed. To understand why it’s necessary to understand how the original Razr came into being. I was a Director at Motorola in Chicago at the time, and while many of my colleagues, even those who opposed the project, now have LinkedIN profiles claiming to have been involved in its creation I’m happy to say I was only an observer.

But I was close to the people, the super smart people, who did make it happen, and the way it was done means that there is no hope that the forthcoming folding screen Razr can be any bit as good as the original.

It’s not the fault of today’s Motorola, the Lenovo owned company is just a victim of circumstance. My job here is to explain why the circumstances are different. Perhaps the most important difference is that there had never been a Razr before, but it’s also about how that came to be.

Razr was a skunkworks, produced by a bunch of engineers in their spare time and time stolen from other projects. Indeed the Motorola Aura which was to have been the follow-up was codenamed GD2 for “Go Dark 2”, the second project from the same skunkworks, but under the glare of Razr publicity GD2 failed to stay dark and suffered the development malaise that saw a nine month project take the best part of three years so the best ever 2G phone was launched into a 3G world and it failed. The existance of new Razr is already out and that’s the first thing which means this year’s model won’t be as good. The original Razr had no input from mobile operators, no customer requirements, no research or focus groups. And most importantly no sales targets. The development team just built what they thought was cool. Without needing to meet targets they didn’t need to ensure component supply. The keypad came from a manufacturer who could only do limited quantities. It was an enthusiasm. A hobby for some of the most gifted engineers the mobile industry has ever seen who enjoyed what they did. Bo, who looked at screens knew everything there was to know about screen manufacture, where the bodies where hidden, what manufacturing processes where giving what yields, and which technologies were likely to fail despite being promoted by their companies. Joel loved audio, he spent all day worrying about sound quality in phones and then went home to work out what he needed to do to improve the audio on his hi-fi. Roger knew and loved hinges. And most of all Moto had the very best radio engineers. The project was led by Roger Jellicoe a fantastically talented engineer who was protected from the rest of the business by Tracy and her boss Rob. It was a very special team building a very special phone without any commercial pressure.

The new Razr is being built by Lenovo. I don’t know much about the company and I assume that the internal processes and politics are very much better than those of the Motorola I worked for, but I’m just as sure that the environment in which the new Razr is being built is much more commercial and less indulgent. The RF will be on an established platform, the design will be dictated by component availability and there as a commercial project there will not be the passion and engineering flair.

Into this mix you need to add the renderings and anticipation. The concept models flying around the ‘net haven’t come from Lenovo they are people who are great at 3D modelling pleasuring themselves. They don’t have to worry about drop tests and SAR. They don’t have to consider the optical path for the camera, the rf occlusion from someone holding the device or the antenna packaging. All you see in a rendering is what someone thinks looks cool. It’s as though a car geek showed the next generation Ferrari as a flying carpet without stopping to think about where he engine would go.

It makes me sad for Lenovo because it is a great engineering company, but not as great as the fantasies of the 3D modellers. The modelers in turn have been fuelled by the way the original Razr was so radically different from anything before.

That was a perfect storm. Razr only happened because there was a very special team of people, protected from company politics by Geoffrey Frost. So when the new Razr comes out, and it’s a bit thicker than you were hoping, there isn’t a nice snap to the hinge, the screen isn’t as good as you were expecting and it’s not quite as polished as you’d hoped, don’t blame Lenovo, blame the fantasists.

 

Simon Rockman is the publisher of CW Journal read by the wireless and associated communities. 

I wrote my first published games review in 1978 and have been writing about technology ever since. I was the Editor of Personal Computer World and left to found What Mob…

Source: Motorola Razr 2019: Prepare To Be Disappointed

Restaurant POS Lightspeed Announces iOS Integrations – Michael Guta

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Lightspeed has announced it is integrating Intuit QuickBooks Online and Planday so retailers and restaurateurs can efficiently manage their finances and workforce within the iOS ecosystem.

Lightspeed iOS Integration

Intuit is going to bring its payroll solution, while Planday will provide a workforce management platform. Together with Lightspeed’s cloud-based point-of-sale systems, the collaboration will give independent businesses in both industries a fully integrated finance and employee scheduling capability.

All three companies are Apple Mobility Partners, which will ensure a “compatibility issue free” integration. For many independent retailers and restaurant owners, who are in the small business segment, having the technology they choose work out of the box is extremely important. And the relationship between the three companies plays a role in this.

Julian Teixeira, VP of Sales, Lightspeed, explained the significance of the relationship in the press release. He said, “This relationship ushers in a new era of ease and innovation for our customers. With this integration, we are delivering one experience to retail and restaurant customers to help them save time, make more money, and improve data accuracy through automatic syncing of all systems.”

Benefits of the Integration

The applications of all three companies are going to be integrated into the iOS platform to deliver a seamless user experience. According to Lightspeed, this will save businesses time and money while being able to engage with their employees more effectively.

When Lightspeed users get on their iPhone or iPad, they will be able to deliver a better customer experience because they will be able to see a comprehensive picture of their business. Owners will have a centralized location where they can manage and report on their entire inventory.

Anytime there is a sale, the information automatically goes from Lightspeed into the correct ledger in Intuit QuickBooks Online.  And when it comes to scheduling your workforce, Planday lets owners plan shifts based on expected revenue while managing individual or group communications.

While these functions are taking place, the three platforms are communicating with each other. So the information on sales, worker times and attendance will go from Planday and Lightspeed into Intuit QuickBooks Online to run payroll.

What this means for the small business operator is no more wasted time creating reports for each task because they will be consolidated.

Christian Broendum, CEO, Planday, said it best as to how retailers and restauranteurs will benefit from this integration, “Ensuring the right employees are in position and with the right team size during busy or quiet periods is key to success, but this has been a real admin challenge for operators. The combined solution represents a significant step in solving this equation with the minimum of effort.

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