Our Perspective
Our Perspective
By having detailed visibility into the lifecycle of each critical component, healthcare providers can better plan maintenance schedules, manage inventory, and ensure that all parts meet the latest health and safety standards
The push for improved tracking and tracing in the medical device supply chain is intensifying, driven by regulations like the U.S. Food and Drug Administration’s (FDA) Quality Management System Regulation (QMSR). This regulation aims to streamline processes and align with international standards such as ISO 13485:2016, emphasizing the need to document and verify every component’s origin, handling, and distribution. To provide fast, reliable access to quality medical devices, manufacturers must balance these stringent regulation requirements with efficiency and compliance.
Traditional tracking methods, such as supplier self-declarations, must meet increasingly stringent regulations and catch up to previous standards. Digital product passports (DPPs), managed through a shared blockchain solution, offer a practical way for medical device manufacturers to step up their supply chain management to benefit suppliers, patients, and the business.
Enhancing Traceability with Blockchain Technology
While blockchain can be used for various purposes, such as financial transactions or smart contracts, blockchain-based DPPs track the lifecycle of assets or components in a supply chain. Companies can use them to create a detailed, immutable record of each item's history, from production to end-of-life, ensuring transparency and total lifecycle traceability. This specialized use of blockchain is particularly valuable in industries like medical device manufacturing, where verifying components' authenticity and handling history is crucial for safety and compliance.
For example, when a work order is placed for a pacemaker, any component(s)—such as the battery, leads, or circuitry—can be assigned a digital product passport. As these components move from suppliers to manufacturers and finally to healthcare providers as a completed device, each transfer or inspection is recorded as a new transaction on the blockchain, creating a comprehensive, tamper-proof history of each component's journey.
This level of detail is crucial for quality assurance and control; it also enables device manufacturers to identify and resolve issues with specific batches of components quickly, should they arise. In the event of a recall, manufacturers can use the blockchain ledger to swiftly trace the affected components' paths back through the supply chain for a more targeted and efficient response that enhances patient safety and regulatory compliance.
Customizing Traceability: The Role of Buyers in Digital Product Passport Specifications
Another advantage of the digital product passport system is its flexibility, empowering buyers, such as hospitals or other healthcare providers, to specify which medical device components they want to track. This control allows them to start by applying digital product passports only to the most critical parts of a device, which are vital for safety, performance, or compliance. For instance, a hospital might request DPPs for the high-risk components of an MRI scanner, ensuring that any issues can be swiftly identified and traced back to their origins.
This capability also enables proactive maintenance and compliance checks of the medical devices. By having detailed visibility into the lifecycle of each critical component, healthcare providers can better plan maintenance schedules, manage inventory, and ensure that all parts meet the latest health and safety standards.
Incorporating blockchain into supply chain management opens the door to many valuable use cases in medical devices and beyond. In patient-centric care, where treatments like personalized CAR T-cell therapies require meticulous coordination, blockchain's real-time tracking will ensure that each component or device reaches the patient exactly when needed, mirroring the precision seen in advanced pharma logistics. Leveraging AI in conjunction with blockchain solutions can ensure a single source of truth in the pharmaceutical and food supply chains, enhancing compliance and operational excellence by providing real-time data and predictive analytics that streamline processes.
More Robust Performance with an Ecosystem Approach
Traditional supply chain management solutions are often developed to address company-specific issues, leading to various systems within the industry, even though the devices and components being tracked are usually similar. Such fragmentation increases costs and complicates training and operations, leading to potential inconsistencies in how data is handled. These discrepancies can directly impact compliance with safety standards.
Adopting blockchain-based digital product passports shifts the focus from isolated systems to an ecosystem approach that benefits all parties involved. Using a shared ledger managed by a third-party vendor like Wipro Falcon, all stakeholders—component suppliers, device manufacturers, and healthcare providers—are part of a collaborative network. This network allows them to verify the integrity and status of components at any point in the supply chain, promoting accountability and collaboration. This approach eliminates redundant processes and reduces the administrative burden of maintaining multiple systems, cutting costs and enhancing efficiency.
Challenges and Considerations for Adoption
When companies share data on a blockchain platform, there is a valid concern that proprietary information, such as manufacturing processes, component sourcing, and design specifics, could potentially be exposed to competitors and other unauthorized parties. Exposure could undermine competitive advantages and lead to potential IP theft or misuse.
Fortunately, blockchain platforms can be customized to protect sensitive information through advanced encryption techniques that secure data at rest and in transit. Access controls can be configured to define who can view or interact with specific data on the blockchain. These controls ensure that only authorized personnel have access to sensitive information, and that logs of data access and modifications can be audited to maintain accountability. Smart contracts can also automate transactions and enforce confidentiality agreements directly within the blockchain. These contracts execute predefined rules only when certain conditions are met, adding an extra layer of security and ensuring that IP and sensitive data are handled according to strict compliance standards.
A Pathway to Next-Gen Medical Device Management
The successful adoption of blockchain technology in the medical device industry, mainly through digital product passports, hinges on the collaboration among industry leaders to establish standardized protocols for data sharing, passport structures, and security measures. Such standardization would secure and streamline the supply chain and fortify the industry’s commitment to efficient delivery of safe, reliable medical devices.
Although component-level tracking is not yet mandatory, it’s only a matter of time. Consumers and regulators (e.g., the EU’s DPP regulation) are calling for greater transparency and traceability, and advancements in IoT and data analytics are enhancing device monitoring. By proactively adopting blockchain, medical device companies can demonstrate their commitment to quality and patient safety ahead of external pressures.
About the Authors
Jorn Fokkens
Global Change Adoption Lead & Partner liaison – Wipro Falcon
Managing Consultant, Talent & Change, Wipro Consulting
Drawing on more than 25 years of industry experience, Jorn consults with clients on business transformations related to supply chain transition and customer-centricity. His special interest is in advancing game-changing innovations and new business models as global supply chains pursue digitization, automation, transparency, compliancy and sustainability.
Kris Mortier
Senior Digital Transformation Leader
With more than 20 years of experience, Kris specializes in procurement and supply chain operations, with major industry experience in healthcare, wholesale and consumer electronics. His client work has significantly improved operational efficiency and business outcomes by optimizing team dynamics, processes, data usage, and technology advancements.
Henk Smit
Benelux Consulting Head, Wipro
Henk partners with the top management in technology-intensive industries to sharpen strategy, strengthen operations and drive innovation and impact in digital.