Guest column by Yvan Malépart, Senior Vice President Global Sales and Marketing, Linxens

Telemedicine, or remote medical monitoring, allows a healthcare professional to remotely interpret the data needed to monitor a patient’s health and, if necessary, take action to manage the patient. While this device is already well established in the United States, it is not yet as developed in Europe. After having been the subject of an experiment in France between 2014 and 2021, with the ETAPES program, remote monitoring was to become part of common law and thus be generalized by July 1, 2022 at the latest with the Social Security Financing Bill (LFSS). This decree, which will specify, among other things, the pricing and conditions of patient care, has finally been postponed to a later date.

As the Forum Labo approaches, how do industry experts see the remote monitoring market evolving?

Remote medical monitoring, a growing market…

The world, and the United States in particular, have an appetite for remote monitoring. Indeed, the amount of investments in digital health was 5 times higher in 2021 than in the rest of Medtech, with American investments being particularly active. The validation of a legislative framework should allow Europe to attract more investors. The postponement of the application of this decree is therefore a source of tension because many companies have an economic interest in remote monitoring, but also because it will lead to profound changes in patient care.

While it is true that Covid-19 has facilitated the adoption of these technologies by North American healthcare professionals, it is the long-term trends such as the scarcity of healthcare professionals, particularly specialists (this is likely to continue for another twenty years), the aging of the population and the explosion in the number of pathologies and chronic diseases, that will change the lines in France. Behind the acceleration of the implementation of these measures is the desire to change the healthcare system in order to relieve hospital overcrowding and provide access to care, particularly in medical deserts.

Companies have clearly understood that this is a market of the future and that with the entry into force in common law of the framework for the coverage of remote monitoring for the 4 chronic diseases that have the greatest impact on the healthcare system (diabetes, chronic heart failure, chronic renal failure and chronic respiratory failure), the potential is enormous.

Numerous start-ups are proposing well-developed technological solutions, but they are held back by the legislative lever that does not allow patients to be reimbursed. In addition, the creation of medico-economic data requires significant investments for these small structures.

However, the large groups are not left out. It is true that the latter are more easily attracted to hospital monitoring, but some of them have clearly understood the stakes behind remote home monitoring and are ready to take over the market. Their objective is to buy the most promising startups when the market is mature in order to accelerate the development of technologies. For both parties, this is a win-win agreement as these small structures will then benefit from the large network of the big groups.

At the same time, some large groups already offer their remote medical monitoring solutions without reimbursement codes and generate economic data for years before lobbying the health authorities to obtain them. To embark on such a project today requires a strong backbone.

While this is certainly a sector full of potential, the remote medical monitoring market is not yet structured. The entry of remote monitoring activities into common law will allow for the deployment of remote monitoring devices and therefore a growth in the market. This market will then consolidate and should allow start-ups to attract more investors and, for companies that are ready to market their solutions, to generate profits. However, it is important to remain cautious because this market can also be shaken if the legislative framework changes, as was the case in the United States in 2021 when the reimbursement rates for remote monitoring care were revised downwards.

by Christelle Robelin, Linxens Healthcare Marketing Director

A revolution in the making

The commercialization of continuous glucose monitoring sensors for type 1 diabetics has revolutionized the management of diabetes. Indeed, it has allowed the optimization and personalization of treatments while greatly facilitating the life of diabetics. It is by far the most widespread application of smart patches with no less than 100 million units sold last year.

Another application less known to the general public, marketed in the United States but not yet in Europe, is the detection of cardiac rhythm abnormalities in people presenting symptoms of atrial fibrillation.

A smartpatch is a self-adhesive device that continuously measures one or more physiological parameters. These parameters can be heart rate, respiratory rate, oxygen saturation pressure, body temperature, pH, posture or activity. It sends wireless, via a relay box or a smart phone, data to a database stored on a cloud. An application on a smart phone or on the computer of a healthcare professional then processes the data using an algorithm. The vast majority of smart patches are medical devices. Some manufacturers are taking advantage of the “quantified self” trend to market devices for the general public.

What is a smartpatch?

A smartpatch embeds, on a biocompatible adhesive, a power supply, sensors as well as electronic components to process the sensor signal, record the measurements and transfer them to a cloud.

The miniaturization of electronic components as well as the development of electronics on flexible substrates and connectivity solutions have made the emergence of these devices possible. They must be comfortable to wear, i.e. light, discreet and conformable. They are usually worn on the shoulder or on the chest. They must also be biocompatible and breathable. They are often used for only a few days. Some devices are reusable. Only the adhesive part needs to be changed. Some models are even rechargeable.

 

What challenges does the smartpatch address?

Combined with a telemedicine platform, it allows patients to be monitored postoperatively at home rather than in hospital, thereby freeing up hospital beds and generating de facto savings for the hospital. In addition to the gain in comfort for fragile patients, it reduces the risk of contracting a nosocomial disease or Covid and the risk of postoperative complications. It allows to realize significant health savings on these items as well.

Finally, continuous measurement ensures more reliable monitoring of patients with chronic diseases (diabetes, respiratory diseases, chronic wounds) and better therapeutic effectiveness.

 

How can the smartpatch further revolutionize patient care and the healthcare system?

Transdermal smartpatches, like those used to monitor diabetics, could be extended to monitor other chronic or acute diseases in order to adjust treatments that can have harmful side effects when incorrectly dosed.

Chronic wound management incorporating smart dressings could detect infection earlier and avoid serious complications often leading to amputations or even death.

Finally, in the era of digitalization, there is a growing appetite from medical device manufacturers and the pharmaceutical industry to retrieve patient data in real-life conditions for clinical trials, or for treatment optimization purposes.

 

Linxens is a major player in the smartpatch sector

Few industrial companies have the capacity to mass-produce electronic on a single flexible substrate in reel-to-reel format, in compliance with ISO 13485 standards. Linxens brings these features together.

As a leading provider of smart card solutions, Linxens has had privileged access to major chip manufacturers for 30 years. Linxens assembles electronic chips and RFID antennas on electronic tracks created by deposition of selected metals on a range of flexible materials.

Linxens has developed over the last few years its skills in ink deposition for the realization of ECG, heart rate, skin temperature, effort and displacement sensors as well as the manufacturing of electrodes for the detection of biomarkers in sweat or interstitial fluid. Linxens offers the integration of a wide range of sensors.

Finally, Linxens can rely on its network of partners specialized in the assembly of biocompatible adhesives.