Potential Uses
Blockchain, a technology that allows computers to share information and exchange assets without a centralized gatekeeper, is ideal for recording transactional data. Once a block is added to the chain, it is nearly impossible to change it. These features have enormous potential for future medical device development.
Blockchain creates a trustless method to transfer value without third parties and creates an auditable, provable, immutable log of transactions. It can also point to data: typically, large data files are stored external to the blockchain, using some context-based location distributed file system and the hashed address of the data file is stored on the blockchain.
The KPMG Medical Devices 2030 Report foresees blockchain disrupting the medical device industry across the product life cycle. They claim, “Companies that are early adopters of this breakthrough technology could potentially enjoy significant first mover advantages in 2030.”
Given the excitement over utilizing this technology, what are some of the potential uses in the medical device industry? The following are provided as examples, but as the adoption of this technology progresses, new uses may be found:
Protecting Patient Data
Many medical devices collect, store and transmit patient-specific data, where data is centrally stored and transmitted to another central data store: there is a risk that the data may be hacked from the device or captured during transmission. Blockchain provides an alternative whereby the data is cryptographically protected, immutable and private that is not possible with traditional data storage and transmission processes.
Medical Devices Maintenance
Through blockchain applications it’s possible for machines to share their operating data with those responsible for maintaining it without violating compliance and privacy issues. Blockchain can also keep service records and ensure tamper-proof device logs. Regulators will have the ability to automate audits of all devices and even conduct real time background audits.
Product Supply Chain
Blockchain can keep permanent records of the development, design, production and distribution of medical devices as well device BOMs. Once the information is submitted to a blockchain it cannot be changed, resulting in permanent traceability for every device.
Logistics
A user could scan their individual device to see if there has been a recall, to access instructions for use, to find various safety and regulatory information, and more. Manufacturers could instantly validate labeling before shipping and track individual products or even entire shipments, as well as prevent use of counterfeit devices.
Transparency and Traceability of consent in Clinical Trials
Informed patient consent involves making the patient aware of each step in the Clinical Trial process including any possible risks posed by the study. Blockchain protocols in clinical trials can provide transparency and traceability of consent.
Managing Internet of Things networks
A blockchain-based application could determine the trustworthiness of devices on a network -- and continuously do so for devices entering and leaving the network, such as smartphones. With the growth of connected devices and the Internet of Things (IoT), existing IT architecture is struggling to keep systems secure. Blockchain solutions have the potential to be the infrastructure that is needed to keep data private and secure while reaping the benefits of connected medical devices.
Blockchain technology can allow greater access to and security of information, which can benefit everyone involved from the manufacturer to the end user. Regulators may embrace blockchain to learn actual medical device effectiveness and to provide faster approvals, while prioritizing patient safety. Blockchain appears to be part of the medical device of the future.