Entities specifying, designing, and manufacturing complex products are increasingly chasing the vision of connecting all product data into an integrated view – a digital thread. A notable difference between medical device companies and digital thread users is that medical devices are under the review and governance of the U.S. Food and Drug Administration (FDA) (CFR Part 820) and European Union (EU) regulations (MDR and ISO 13485.2016). Regulators insist that medical device companies have traceable quality management.
Until recently, at the end of the design process, necessary documentation was gathered from siloed resources into big, clunky, paper-based binders. Large spreadsheets captured design intent, decisions, changes, processes, and results. Due to the iterative nature of design, it was difficult to show the relationships between stakeholder requirements, design inputs and outputs, and design verification and validation. Paper-based documentation methodologies often led to poor decisions, gaps in data quality, and errors in compliance – negatively affecting everything downstream.
Even before COVID-19, medical device companies had been attempting to overcome these disconnects. Manual processes also resulted in a complex and unusually long approval process, stretching into months and years, generating higher costs and slowing time to market. Additionally, the lack of traceability created additional quality, compliance, and overall business risk.
Then the pandemic arrived and brought mainstream attention to the sobering reality that many medical device companies couldn’t meet the increased hospital demands. Most of that attention focused on the lack of personal protective equipment (PPE) and ventilators, but even medical gloves experienced significant increases in the lead-time required to fill orders. Much of the industry suffered from disruptions in the supply chain along with the challenges of meeting regulatory compliance in a new world of closed borders, lockdowns, and social distancing. These issues existed and were understood well before the pandemic, but they were further exposed and exacerbated to a point that they could no longer be ignored.
Medical device companies are now using platform technology with an inherent digital thread from conception through end-of-life (EOL) to manage mechanical, electronic software, and formulated components, as well as the quality and compliance processes that ensure product safety and regulatory compliance.
Medical device companies use the digital thread to create, manage, and automate the documentation for the design history file (DHF), design master record (DMR), and with FDA regulations, the device history record (DHR). These documents describe the life cycle of a medical device from stakeholder requirements through design to hand-off to manufacturing. As the design develops, change management electronically captures the approvals for minor and major changes as well as changes to life cycle state. Companies can keep track of what changed, and why, to fully address regulatory requirements.
Medical device companies also use the digital thread to capture risk assessment and mitigations, such as in a failure mode and effects analysis (FMEA), an iterative approach to identify and avoid possible failures and consequences throughout a product or process life cycle. As the digital thread systematically connects every phase of the life cycle, it works seamlessly in conjunction with FMEA.
Using the digital thread allows users across different domains to see and collaborate securely and in-context in threaded discussions that document the rationales for decisions. This ensures greater collaboration and lowers the cost of quality. Moving away from paper and siloed or individual- or domain-specific computer applications, the digital thread gives users traceability back to requirements, improving quality and time to market.
Medical device companies must comply with regulations, therefore it’s imperative that whatever product lifecycle management (PLM) platform solutions they have to produce regulatory requirements remain intact, regardless of software upgrades. The PLM platform technology must be able to separate any customizations to reports such as DHF, DMR, and DHR as well as any upgrades to the PLM software.
While the pandemic disproportionately affected the medical device industry, it didn’t create the challenges companies face today, it only accelerated their response. Furthermore, it’s self-evident that those companies that focused on building their digital capabilities were more prepared to adapt and face the crisis. Embracing digital transformation is the medical device industry’s answer to quickly developing products and getting them to market faster to better support patients.