Blockchain, a tamper-proof ledger of transactions, has been trending in popularity, largely due to Bitcoin. By providing a secure record of transactions accessible exclusively to relevant people, blockchain helps ensure that information does not change unintentionally. Its traceable, transparent, and auditable nature has generated interest in a variety of industries. The medical device supply chain is currently siloed and consequently, proposes a variety of challenges for all people involved. Acting as a decentralized ledger, blockchain would help increase transparency while preventing intellectual property (IP) from being shared with uninvolved parties. It is difficult for the FDA and other regulatory bodies to audit medical device companies, and likewise, it is challenging for Original Equipment Manufacturers (OEMs) to continually monitor their contract manufacturers and suppliers. Here we will show that blockchain is a useful and necessary tool in providing transparency, which can be achieved in a user-friendly manner that will benefit regulatory bodies, manufacturers, clinicians, and patients. Our project is in a previously unoccupied space that industry members argue is needed. Audits are often done physically and requested documentation is provided on paper to prevent revealing unnecessary information.

Audits and Document Control Management via Blockchain

Advisor: Dr. Folarin Erogbogbo

Authors: Michelle To, Hussein Abed, Denice Serna