Blockchain technology applications to postmarket surveillance of medical devices

ABSTRACT

Introduction

The amount of mandatory data that needs to be analyzed as part of a medical device postmarket surveillance (PMS) system has grown exponentially in recent times. This is a consequence of increasingly demanding and complex regulatory requirements from Health Authorities, aimed at a better understanding of the medical device safety evaluation. Proactive approaches to PMS processes are becoming more necessary as regulators increase the scrutiny of device safety. New technologies have been explored to address some of the challenges associated with this changing regulatory environment.

Areas covered

This paper focuses on the different technical aspects of blockchain and how this new technology has the potential to support the ongoing efforts to improve the PMS system for medical devices.

Expert opinion

To address these challenges, we suggest to generate a private PMS data permissioned blockchain with a proof-of-authority consensus mechanism, to which only a restricted number of designated and audited participants have authorization to validate transactions and add them to the PMS data blockchain ledger. Blockchain has the potential to support a more efficient approach, which could offer many advantages to the different stakeholders involved in the PMS process, such as supporting with new regulatory initiatives.

KEYWORDS:

• Blockchain
• medical devices
• postmarket surveillance
• safety evaluation
• risk management

Article Highlights

• Proactive approaches topostmarket surveillance are becoming more necessary as regulators increase the scrutiny of medical device safety.

• Blockchain technology has the potential to solve some of the current challenges associated with the safety surveillance of medical devices by supporting device traceability, andefficient safety data exchange while maintaining data privacy, integrity and accessibility.

• Recommendations on how to address identified challenges related to the use of blockchain in the safety surveillance of medical devices are presented with a focus on solutions associated with data privacy, data storage, data exchange and data standardization.

• The suggested private postmarket surveillance data permissioned blockchain with a proof-of-authority consensus mechanism as well as the proposed step-wise implementation process are the foundation of the future blockchain-based safety surveillance system for medical devices.

• A solid knowledge of the current challenges and needs of the medical device industry, and continuous collaboration with blockchain technology experts will ultimately lead to the successful implementation of blockchain in the postmarket surveillance of medical devices.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.