Towards the end of November in 2018, the Guardian published a news article titled: “Revealed: faulty medical implants harm patients around world.” As the article goes on to discuss, an entire world of products are being manufactured for implementation into the human body. The problem? They oftentimes defect, resulting in serious harm to the patients they are implanted within, and sometimes, even death. With the goal of improving human health, providing trust within the the healthcare sector, and creating new business opportunities for enterprises intent on promoting transparency, this article breaks down how AMB-NET is uniquely capable of providing a revolutionary solution for tracking implanted health devices.

Implanting Devices: A Wild West

As health care systems have improved alongside increasingly cost-effective technologies, a number of new solutions have reached the market, with the promise of significantly enhancing human health. One area where this is particularly prevalent is in a fast-developing field known as as ‘Implanting’ valued close to $400 billion USD. In line with the name, ‘Implanting’ is the process by which physical-biological or physical-digital devices or components are inserted into the human body in order to better manage a certain health function. From spinal disks, to pacemakers, to replacement hips, such tools are used to recover from accidents, manage the aging process, and as a real-time monitor and emergency backup to fundamental body processes.

While millions of patients have devices implanted inside of them every year, the crucial concern is on the functionality and safety of such devices. As the Guardian reports, the fast paced nature of the industry, coupled with traditionally lax regulations on testing, and product transparency have resulted in unexpected and dangerous side effects. Since 2015 in the United Kingdom, “regulators received 62,000 ‘adverse incident’ reports, linked to medical devices.” (source) For hospitals in the United States, the problem is equally serious, as an article from 2016 argues that medical device reports, which should be submitted to the FDA (Food and Drug Administration) are very consistently forgotten about.

Unlike clinical test trials of pharmaceutical products, device implants are instead approved on the basis of ‘substantial equivalence’. This standard means that if the product is akin to another product already on the market, then it will also be approved for implementation irrespective of the number of clinical test trials conducted. As The Conversation goes onto explain, the entire process is convoluted, and most especially in the European Union whereby the information about devices remains strictly confidential to the designer and manufacturer.

Overall, as the Guardian reporting astutely points out, three core problems drive the unhealthy market growth of implanted devices, and continues to threaten the health and safety of hundreds of thousands of people every year:

Close relationships exist between doctors and manufacturers within the industry. Certain doctors, are prone to promote a particular product in order to be one of the first industry professionals offering a cutting-edge implant device. If a problem is detected within a product, the manufacturers are responsible for improving it. These same manufacturers can then continuously push for market approval of such products without having to publicly display how many times the product has been rejected for safety or functionality reasons. A lack of regulation, inhibits consistent security auditing, product traceability, and performance management. Patients, incapable of accessing data about their implanted device, are at the mercy of their health care providers for understanding what they are putting in their body for decades at a time.

AMB-NET: A Foundation for Cost-Effective and Secure Product Management

Blockchain technology, as a provider of trusted and immutable information, can undoubtedly improve the management and traceability of implanted devices. From tracing the origin of a product, incorporating its various audits and tests, identifying the doctors and health care providers to first offer such a product, and even integrating consumer experiences, the blockchain functions as a means of securely collecting data about the highly unregulated devices used in health care practices. In what ways, however, is the Ambrosus blockchain and IoT platform — AMB-NET unique? How, unlike any other current blockchain solution on the market, can AMB-NET truly protect and improve the well-being of medical patients?

The real value inherent to the Ambrosus Network, is that it combines a number of sophisticated developer tools, devices, and gateways, with a universal data model, an open-source API, as well as open-sourced SDK’s to collect and store data on a publicly visible distributed network. In simple terms, Ambrosus provides manufacturers with the tools to collect data, organize their data, separate it as either public or private, store all of it on a blockchain, and then integrate the data flows with other IT systems or a web or mobile application.

When applied to the $400 billion USD industry of implanted devices, AMB-NET provides a cost-effective means of protecting patients against the three core challenges previously mentioned:

First, in response to conflicts of interest between doctors and manufacturers, an implanted device can be digitally assigned a unique product identity, corresponding to the manufacturer responsible for the product, as well as the health care or service provider offering the product to a patient. In this way, a new layer of accountability and transparency can be established between the suppliers wishing to profit off of a device, and a consumer in need of an implant. Second, in response to the lack of transparency surrounding the testing, auditing, and tweaking of products by manufacturers, Ambrosus provides the capability of digitally tracing how often problems are detected within a particular product, and how many times a product may have been re-configured in order to gain access to a particular market. If a particular manufacturer is unwilling to provide such information, new market opportunities are thereby created for more honest manufacturers break into new markets, and compete with such manufacturers. Third, in response to the lack of supply chain transparency and consumer feedback mechanisms in place, Ambrosus provides a means of tracing IoT implants from factory to hospital, as well as the capability of creating an interactive user interface between manufacturers and consumers, to bridge communication and feedback about a particular product. More specifically, could involve designing an application whereby consumers can input any defects, unexpected side-effects, or life-threatening product malfunctions directly to manufacturers, health care providers, and insurers via the blockchain.

With AMB-NET patients can ultimately visualize the regulatory requirements and procedures of the devices they wish to implant into their body. Devices can be digitally serialised for the first time, as they come to possess a unique life history that has been tracked to ensure quality and integrity. On an industry level, new market opportunities can also be created for businesses wishing to disrupt conventional implant manufacturing models, by choosing to be as transparent and consumer-oriented as possible. As a result, implanted devices are treated with the seriousness and importance that they deserve: in contrast to a temporary medication, the majority of implanted devices are inserted into a patient for the duration of their life! A faulty product implant, may therefore be directly responsible for a long, painful, and costly future.

Open-Sourcing Blockchain as a Service

While fully capable of designing and offering a large number of solutions across industries in the global economy, Ambrosus has open-sourced the capability of uploading data onto the network via REST API known as the Hermes Masternode. Very concretely, this means that Ambrosus wishes to provide access to the entire Ambrosus Network, for the world of consultants, entrepreneurs, and industry experts capable of designing their own blockchain-cloud and IoT based solutions.

In the context of implanted devices, any motivated entrepreneur, health care provider, or up-and-coming manufacturer therefore possesses the capability of managing their own Hermes Node, integrating it with their own software related to implanted devices, developing unique applications, and offering such services to the $400 billion USD implanted devices industry at a competitive price. Ambrosus in turn, will evaluate entrepreneurs on a case-by-case basis, and provide support where possible. Altogether, such opportunities are meant to demonstrate that the Ambrosus Ecosystem, is much more than a blockchain based network: it is a decentralised platform leveraging blockchain, cloud based, and IoT grounded technologies to better improve human health, safety and transparency.

Call for Entrepreneurs:

Ambrosus is looking for teams passionate about and experienced in their respective niche markets, such as implants, who see a clear problem and opportunity in their sector, and who can use Ambrosus Ecosystem and open-source tool to build solutions for the businesses. Whether we operate as partners (Integrator and Technology Provider) or the team is simply using our technology to develop their own startup, Ambrosus team is able to provide support in various ways, including technical, operational and marketing support. Teams who closely collaborate with Ambrosus and build new verticals can also be available to benefit from the development pool and receive AMB to help them build their startup. Reach out via info[at]ambrosus.com with your project proposal or a startup pitch, and we will be happy to provide our tech to help take you to the next level, while acquiring a new vertical or solution for our ecosystem!