Michelle Kuei is the Founder and CEO of Mulder, a company transforming medical device traceability through blockchain technology. Trained as an architect, Michelle later transitioned into MedTech, where she has spent over eight years driving innovation and regulatory compliance. Having grown up in a family deeply involved in the industry, she developed an early understanding of its challenges and opportunities. Before founding Mulder, Michelle played a key role in scaling global MedTech firms, leading FDA and EU MDR-compliant product launches, and spearheading strategic growth initiatives.
In a recent interview with Digital First Magazine, Michelle Kuei discussed her experience with blockchain solutions for medical device traceability and supply chain transparency. She shared her views on medical device traceability, improving the security of medical device data, adoption of blockchain in healthcare, and many more.
What led you to focus on its application in medical device traceability and supply chain transparency?
I founded Mulder because I saw an opportunity to transform how medical device manufacturers approach regulatory compliance and traceability. With over seven years of experience scaling global MedTech firms and launching products under US FDA and EU MDR regulations, I’ve seen firsthand the complexity, cost, and inefficiencies companies face in ensuring compliance and patient safety.
My co-founders, Sriya and Prathyusha, and I met while completing our MBAs at Hult International Business School. Over the past two years, we’ve worked together on multiple projects, leading to the creation of Mulder.
With Web3 technology maturing, we recognized a unique opportunity to introduce a more secure, efficient, and cost-effective solution for device traceability. By leveraging blockchain, Mulder empowers medical device manufacturers to seamlessly maintain compliance, improve transparency, and ultimately enhance patient safety.
How does blockchain enhance traceability in the medical device industry, and what are its key advantages over traditional tracking systems?
Blockchain offers a significant leap forward in medical device traceability. Unlike traditional systems, which can be prone to errors and manipulation, blockchain creates a secure and transparent record of a device’s journey, from manufacturing to patient use. With blockchain, every transaction is recorded immutably, meaning the data cannot be altered or deleted, reducing the risk of counterfeits and ensuring data integrity. This shared record provides a single source of truth for all stakeholders, streamlining audits and improving collaboration between manufacturers, regulators, and healthcare providers. Smart contracts automate compliance checks, ensuring that each step in the device’s lifecycle adheres to regulations and triggers alerts for any discrepancies. By replacing manual record-keeping with a secure and efficient digital system, blockchain reduces administrative burdens, lowers costs, and ultimately enhances patient safety.
What are the biggest challenges in ensuring transparency within the medical device supply chain, and how can blockchain help solve them?
Medical device recalls are increasingly common, underscoring systemic flaws in legacy traceability systems. In 2022 alone, the UK recorded 2,754 recall events, spurred by deficiencies ranging from software bugs to equipment malfunctions. Reliance on antiquated paper trails or incomplete digital records has left supply chains opaque, hampering quality control and regulatory oversight. This data integrity gap has direct and tragic consequences – in the UK, faulty medical devices contributed to over 1,000 patient deaths between 2015-2018. Moreover, status quo tracking methods also burden device producers with manual inefficiencies and compliance risks that stifle innovation.
Mulder leverages the security and immutability of blockchain technology to provide the first purpose-built end-to-end traceability solution for small to medium medical device manufacturers. By logging comprehensive supply chain events, Mulder forms a complete, unified data trail of the product’s full lifecycle by storing tamper-proof entries on a permissioned, cloud-based ledger – from raw materials to point-of-care delivery. The system will complement current systems medical device manufacturers often use, to allow for seamless integration within a manufacturer’s existing workflows for rapid adoption. Our permissioned ledger logs tamper-proof data entries across production progression.
How can blockchain solutions support regulatory compliance and improve the security of medical device data?
Blockchain ensures regulatory compliance and data security by recording every transaction in an immutable, decentralized ledger. Each update—whether tracking materials, verifying suppliers, or logging device usage—is encrypted, time-stamped, and permanently stored, preventing tampering or fraud. Smart contracts automate compliance checks, instantly flagging discrepancies and ensuring adherence to EU MDR and FDA standards. This eliminates manual errors, speeds up audits, and enhances transparency, making Mulder Tech’s blockchain solution a secure and efficient compliance tool for medical device manufacturers.
What trends are driving the adoption of blockchain in the healthcare and medical device sector, and what challenges still need to be overcome?
One of the biggest challenges is that the medical device industry is notoriously conservative and slow to adopt new technologies.
However, recent advancements have made blockchain technology scalable and efficient enough for complex applications like medical device manufacturing. The industry, once hesitant, is now more open to blockchain due to increased understanding and regulatory support from agencies like the FDA and ISO. The pandemic further highlighted the need for robust traceability, accelerating the adoption of innovative solutions like blockchain to ensure product safety and integrity. – This confluence of factors makes now the perfect time for Mulder.
Where do you see blockchain technology making the biggest impact in healthcare beyond medical device traceability?
With blockchain, we envision a decentralized health market space. Blockchain makes it possible for patients to control and share their health data securely, whether for research, AI development, or new treatments. Instead of relying on hospitals or tech companies to manage data, individuals can choose who accesses their information and even be compensated for sharing anonymized records. This approach improves AI-driven healthcare, speeds up drug development, and builds trust by ensuring transparency and security in data exchanges.
At the same time, interoperability and unified health records will also benefit from blockchain usage. Healthcare data is often stuck in different systems, making it hard for doctors and patients to get a complete picture. Blockchain helps by creating a secure, patient-owned health record that can be accessed across hospitals, insurers, and even across borders. Patients stay in control of who sees their information, reducing paperwork, preventing errors, and making care more seamless. This kind of system makes it easier to share data while ensuring privacy and compliance with regulations like GDPR and HIPAA.
What advice would you give to healthcare companies looking to implement blockchain solutions in their supply chain operations?
Trust blockchain beyond just cryptocurrency—it’s a powerful tool for security, transparency, and compliance. While crypto is one wing, blockchain’s real strength lies in immutable record-keeping, automated compliance, and real-time traceability. For healthcare, it reduces errors, strengthens audits, and streamlines supply chain operations, making regulatory compliance seamless.
What keeps you passionate about your work in blockchain and healthcare, and what is one lesson or insight you’d like to share with aspiring innovators?
Seeing blockchain drive trust and efficiency in healthcare fuels my passion. If you’re a medical device innovator, we want you to put your best foot forward—focus on innovation and invest in what truly sets you apart. But when it comes to automation and quality management, save your resources—Mulder is tailor-made for innovators and revolutionaries, ensuring compliance and efficiency without the extra burden.