Graphene is penetrating many commercial sectors. Despite the higher regulatory barriers enforced within the medical industry, a range of medical devices are being created using graphene for the general public. In this article, we look at how graphene has been innovating both lower-tech and high-tech medical devices, how graphene is opening new medical device applications, and how the commercialization of graphene medical devices has progressed to the point that, in 2022, we are seeing more and more medical devices going to clinical trials and being sold commercially.

Always a need for the ‘lower tech’ medical devices

Even though it’s the high-tech electronic applications that tend to gather a lot of interest in hype, the fundamental lower-tech, material-focused medical devices also play a major role. In this class of medical devices are implants and prostheses, which are very important medical devices from a clinical perspective and impact far more people than some of the “sexier” devices that come out in niche application areas.

Medical implants, from artificial throats to stents and other surgical implants, are all now being innovated with graphene, and there is already a number of implants making their way toward clinical trials. It’s an area that will take some time to be realized on a large commercial/clinical scale because of the regulatory barriers associated with putting graphene-enhanced implants inside the body.

Despite being seen as a lower-tech side, due to most not being electronically active (although there are some “smarter” monitoring implants that do come out from academia), these medical devices have to withstand a lot of biological wear and tear from the body, so they need to be mechanically sound. This is where graphene has been innovating these types of medical devices, because it has been integrated into a range of materials to form graphene-enhanced nanocomposites that are stronger, stretchier, and more resistant to biological erosion than the conventional metal and polymer-based implants that are often used inside the body — which makes them less prone to causing infections, as there’s less bacterial buildup.

So graphene is helping to innovate the lower-tech side and create new types of implants that will last much longer. Because graphene has excellent electronic properties as well, there is the scope to create smarter/electrical-based implants as well for inside the body for different monitoring applications. Beyond being used as a structural material, graphene is also being trialed as an anti-biofouling and antibacterial coating for more conventional implants to protect them from bio-erosion and bacterial buildup.

“Graphene can be used for applications like targeted cancer treatment [and] antibacterial and antifungal coatings that reduce infections associated with medical implants,” said Adrian Nixon, founder and editor-in-chief of the Nixene Journal, a business journal that provides an independent view of academic and commercial developments in the world of graphene and 2D materials. “However, commercializing these transformative developments requires time and investment because these are highly regulated markets.”

The Covid-19 pandemic, and mask mandates in many places around the world, also saw a number of graphene-enhanced face masks hit the global market from a number of different companies, including Haydale, Versarien, Directa Plus, Graphene-X, and Shenzhen Elite Medical Technology Co. Ltd., but this is an application area that might cool off as the pandemic wears out, other than potentially in the Asian markets, where face masks are used a lot more to deal with smog issues (and general mask wearing is higher).

“Graphene’s antibacterial and hydrophobic properties make it a perfect material to elevate the performance of traditional PPE,” said Jorge Barros, CEO of Graphene-X, on the subject of why graphene was chosen for their masks over other materials.

Interesting applications are happening within the high-tech medical device sector

While lower-tech, implant-based, and supportive medical devices are needed for many patients, some of the most interesting and innovative developments happening as far as graphene medical devices are concerned is within the high-tech space. Graphene-based diagnostic platforms and biosensors for health-monitoring applications certainly fit into this category and perhaps have one of the biggest market shares of all graphene medical devices (if not all high-end graphene technologies). However, this area is very vast and has already been covered in another article in more detail, so the whole scope of developments is not covered here.

Even though diagnostic platforms have the most commercial appeal, there is a number of high-tech graphene-enhanced medical devices that are pushing the boundaries in terms of innovation and are gathering a lot of interest. Some of the developments below are biosensors, but they are a bit more interesting in that they are not in the usual applications that many of the other graphene biosensors are (such as in cancer and disease detection or the detection of biomolecules in a patient’s fluid sample).

Speaking with the Nixene Journal’s Nixon, on some of the interesting things he’s seeing in the medical device space, he pointed to Sensfit Technologies: “In Australia, Sensfit Technologies has developed a graphene-enhanced device that can monitor diabetic ulcers and provide information for medical intervention.”

The interesting thing about Sensfit is the applications where the sensors are already being used. While a lot of sensing platforms check for diseases, these graphene sensing platforms have been used in a lot of sports wearables and activity-monitoring applications to provide a real-time data analysis on physical movement, activity, balance, and gait of an athlete. Even in applications that are more medically inclined, the detection of diabetic ulcers mentioned above is rather unique and is done by measuring the pressure points of a person’s feet while walking. It was announced this year that they are partnering with Footwork to bring the world’s first smart orthotics (for the real-time monitoring of diabetic foot ulcers) to market.

It’s also interesting that the devices used to measure how a person walks are also being adapted using AI algorithms to detect if someone has early onset dementia. So while there have been a lot of graphene diagnostic platforms developed to date, the applications coming out this year from Sensfit are some of the most unique and innovative to date in the diagnostic space.

Another company that has developed some interesting developments and continues to innovate is Grapheal. Some of their latest work has focused around Covid biosensors, but Grapheal’s most interesting and innovative product that continues to be popular into 2022 is the WoundLAB. The WoundLAB is a smart medical patch, which uses graphene as a sensing surface to measure wound-healing biomarkers and transmit the data of how well a wound is healing to a smartphone app.

“Graphene is the ideal material for coupling electronics to living tissue, enabling the invite collection of biological data, from vital signs to more complex signals like changes in biomarker concentration,” said Vincent Bouchiat, CEO of Grapheal. “Graphene’s biocompatibility and mechanical flexibility, alongside its conductivity and electron mobility, make it an ideal material for the implementation of integrated and implantable sensors in complex and difficult environments, such as burns or infected wounds.” On the WoundLab device specifically, Bouchiat said that “Grapheal leverages its WoundLAB product, a wound-care connected management platform, by taking advantage of these combined properties and by interfacing them with state-of-the-art RFID.”

While the above areas are interesting extensions of diagnostic/biosensing platforms, one of the most innovative products in the commercial sector comes from INBRAIN Neuroelectronics and is really pushing the boundaries of what is possible with graphene. INBRAIN is building neural interfaces, known as Egnite, that are being used to treat a range of brain disorders, such as Parkinson’s and epilepsy, using neuroelectronic therapies — and is certainly a good example of what can happen when implant technologies go high-tech.

The technology is still relatively new but has already attracted over €14 million funding to trial these therapies on humans (after success in animal trials), is one of the most unique graphene systems in the industry (not just in the medical device sector), and shows how versatile graphene technologies can be. The graphene implants interpret brain signals to provide a therapeutic response — using small electrical pulses — that is specific to the needs of the patient.

Graphene is being utilized by INBRAIN instead of metal electrodes because its electronic properties allow for an effective stimulation of the nervous system with high spatial resolution — reducing the amount of side effects from the therapy. The implants can also record brain signals accurately, which allows for a more tailored neuroelectronic therapy. The brain of the implant therapy is also being driven by AI, as it makes it easier to personalize the therapy through learned behavior of what the patient needs.

Overall outlook

Graphene is innovating many medical devices, be it more material-focused implants, medical masks, or higher-tech electronics. Diagnostic platforms are the main type of medical device being commercialized because of graphene’s sensing capabilities, but there are some very interesting applications emerging that deviate from the usual disease-diagnosis platforms.

“The products on the market show that medical devices made from graphene have more promise because of external devices that are subject to lighter regulatory approval,” said Nixon.

On the other hand, there are also very innovative systems being created, and many more are waiting in the wings in academic research, where creativity isn’t dictated by market demand. We may start to see even more innovative applications and graphene medical devices in the near future, but there is certainly more of an uphill battle in this area compared with other market sectors because of the regulatory barriers that medical devices need to adhere to.

Nevertheless, a lot of different technologies are starting to make it through clinical trials, and as more graphene technologies start to overcome these regulatory barriers, the more likely it is that we will see a wave of new medical devices based around graphene (and its derivatives) in clinical and monitoring settings.

By: DocMemory
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