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The Voyage of Discovery: Blockchain for Pharmaceuticals and Medical Devices

Introduction

We live in a world of increasing sophistication where technology aims to make life easier and joyful. The advent of internet, social media, mobile revolution, and Internet of Things (IoT) has transformed our ways of life. Now is it the turn of blockchain for ushering in an even more profound transformation?

In all our transactions, intermediation is accepted as a necessity for bringing in security, orderliness, and behavioural enforcement. The rapid advancements in Cyber Physical Systems (CPS) are diminishing the need for physical mediation. Such ‘digital twins’ harbingers new waves of automation. Automated cars, Automates Factories, Automated Homes…the list is growing.

Initiatives like Industrie 4.0 are working out possibilities in self-organized logistics, machines that can predict failure and trigger maintenance. In this environment of boundary-less and collaborative enterprises, seamless and real time exchange of information is vitally important while protecting Intellectual Property rights.

Dis-intermediation, CPS/Digital Twins, Automation, and Collaboration: all these are premised on the firm foundations of security, immutability, transparency, and auditability. Can blockchain help bring in such a bedrock foundation?

What’s a Blockchain ?

It was all started by the mysterious Satoshi Nakamoto in the late 2000s. The origins were in enabling monetary processing without involving banks and settlement. The novelty of the approach heralded a refreshing relook at the fundamental questions about how entities and humans transact, and the underlying trust (or lack of it).

The foundational aspect of blockchain is distributed ledgers which contains ‘Facts’ occurring in the ‘Network’. Facts can be patient vitals, medical device log, temperature of medicinal products during shipment, etc. ‘Network’ is the collaborating parties: could be Payer-Regulator-Medical Devices firms; Clinical Trial Site – Pharmaceutical – Logistics Provider. Multitude of ‘Facts’ forms ‘Blocks’; ordered assembly of multiple ‘Blocks’ forms a ‘Chain’ and that is our subject of interest – ‘blockchain’.

Since blockchain can contain any ‘Facts’, the gamut of possibilities is immense. An interesting aspect of Blockchain is the ability to create SmartContracts. A SmartContract can read blockchain ‘Facts’ and execute actions: for instance, a SmartContract can look at date of transaction and determine what should happen.

Blockchain in Pharmaceuticals & Medical Devices Enterprises

Preventive Maintenance of Medical Devices

While the IoT can help connect things, Blockchains can make the medical devices a lot smarter. Consider a surgical medical device whose operational data is fed to a blockchain. Medical Devices enterprises can create SmartContracts on blockchain to understand device health and automatically trigger a preventive maintenance.

Strengthening Manufacturing Process Control

Manufacturing involves several stages like Weighting and Dispensing, Mixing and Blending, Granulation, Compression, Coating, etc. The scale of manufacturing and shipment destination influence the process parameters as well. Manufacturing process control is an area of continued concern. Blockchain can be used to record the parameters and help build auditable trail with automated decisions.

SmartContracts – Distribution Chain

Pharmaceutical products – particularly biological – are highly temperature sensitive. For instance, a vaccine may be allowed to be >25C only for 15min. It is essential to track temperature across shipment, warehouse, and dispensing. IoT-enabled temperature loggers can transmit the temperature excursion to a blockchain; SmartContracts on blockchain can automatically determine the stability of the pharmaceutical product.

Collaboration in Clinical Trials

Pharmaceuticals have a long history of collaboration – an example is engaging with a Contract Research Organizations for clinical trials. The mechanisms of data exchange are rooted in file transfers. A private blockchain can be setup for enabling collaboration with all participants and optionally, the regulator as well. Similar possibilities exist in preclinical research collaborations between Academic institutes and the pharmaceutical.

Disintermediation – Certificate of Medical Necessity (CMN)

A CMN certifies that a treating physician has determined that services or supplies are medically necessary for the patient. For payers, verification of CMN is a laborious and error prone task: intermediation with the physician is necessary. A blockchain network with patients, physicians, and payers as participants can be created. SmartContracts can be created to determine the validity of CMN. Payers can login and verify the CMN avoiding intermediation.

New Digital Processes – Confluence of Blockchain, IoT, and Machine Learning

We believe that blockchain will be one of the key drivers along with IoT and Machine Learning in digitization of business processes. For example, a blockchain based SmartContracts can read patient vitals via an IoT powered continuous glucose monitor and feed to a machine learning algorithm for likely diagnosis.

Patient Centric Initiatives

Payer-Pharma-Provider-Patient world is likely to provide fertile grounds for innovations. Recording irrefutable evidences on performance of a medicine and demonstrating adherence to the prescribed regimen, is a hard challenge. Blockchain’s immutability and democratic approaches can be creatively explored.

What can you do now?

Start Small

Starting small, exploring a few narrowly scoped use cases, understanding industry and technology directions are some of the suggested beginnings. Internal use cases may be explored with Open Source solutions. It will be good to create a Point of View on how to approach this emerging area.

Know the Limitations

Challenges include the irreversible nature of Blockchain, challenges in scalability and interoperability, lack of standards, consensus mechanisms. A keen appreciation of the pitfalls will help in sieving use cases before proceeding for implementation.

Keep a Watch on Regulators

We anticipate regulators will continue struggling to come up with guidance on dealing with blockchain. As the fundamental social notions are challenged and disruptive, keenly watching regulatory developments is essential.

Collaborations (with ecosystem) and Partnerships (with technology providers)

Partnering with technology and solution providers will help accelerate the learning curve, develop deeper insights, and master the art of possible.  Interesting use cases will require working with the eco-system participants hence collaboration with them will be beneficial.

Looking back at how you have prepared for Mobile and Social explosions, how do you plan to get ahead for blockchain? How do you see blockchain influence the Pharmaceutical and Medical Devices enterprises?

About the Author

R. Krishnamurthy

Raghuraman Krishnamurthy works as a Senior Director in Cognizant Technology Solutions. He focuses on emerging technology and its application to pharmaceutical and medical devices enterprises. His areas of interest include Enterprise Architecture, Blockchain, Machine Learning, and IoT. He is a Senior Member of ACM and is the secretary of ACM’s Chennai (India) Chapter. He holds a master’s degree from Indian Institute of Technology, Bombay. He can be reached at Raghuraman.krishnamurthy2@cognizant.com.

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