As the buzz of digital transformation builds at a frenetic pace all around us, it’s easy to be distracted from the real challenges that surface.
Ensuring patient safety whilst driving down supply chain costs can both be achieved with a single transformation [or single stroke] in the digital era with intelligent use of master data. The obstacles introduced by connected data-driven systems tend to be less interesting than the bells and whistles of new technological capabilities (at least to outside observers). And yet, these challenges deserve our full attention. Hospitals are a prime example of the opportunity/obstacle disconnect that tech often carries. Adding fuel to the fire, regulatory agencies striving to respond to technological advances, threats to patient and public safety, and demographic shifts often add pressure or confusion as health care providers try to sort it all out. Long story short, in the healthcare arena, digital transformation has raced ahead of controls, integration, and master data management — and now we’re playing catch-up.
In an era of widespread consolidation, large healthcare companies are developing increasingly complex supply chains. Tracking the provenance, quality, and life cycle of medical products has become almost as critical as keeping accurate, accessible patient health records — and managing the data from both has become a profound challenge in terms of cybersecurity, interoperability, and regulatory compliance. While the security and governance of patient data has received an enormous amount of press over the last few years (unfortunately due to widespread hacking and ransomware schemes), hospital supply chain issues are still relatively obscure.
However, those in the data management trenches at medical device manufacturers, GPOs and hospitals have been immersed in solving these challenges and compliance obligations, in large part due to Unique Device Identification (UDI) mandates issued by the FDA starting in 2013. Stated simply, UDI regulation required extensive documentation, labeling, and tracking of medical devices, encompassing everything from bandages to MRI machines. Devices are categorized into three risk classes (III, II and I), with registration requirements staggered by risk class over five years, starting with Class III devices (high risk, e.g., implantables) and followed by Class II devices (less risky, e.g. wheelchairs). Now UDI data submissions for the final and largest category, Class I medical devices (least risky, e.g. bandages and dental floss), are coming due in September 2020.
While manual data entry or Excel spreadsheet upload may have been a viable solution for Class II and III submission deadlines, Class I poses a much greater challenge for manufacturers, labelers, and hospitals. The sheer volume of products in this category makes manual submission methods too slow. High product volume increases the burden of data collection, data cleansing and data entry to the GUDID (Global UDI Database). The risk of failing to meet the FDA’s deadline increases substantially.
At the same time, hospitals are under pressure to automate and streamline data intensive processes and to maintain the highest levels of accuracy in recordkeeping. Many healthcare suppliers approach product information management manually via spreadsheets, small databases or ERP systems, rather than a systematic solution that employs ‘best of breed’ PIM system to fully automate processes end-to-end. The result is laborious, error-prone, ineffective and high risk of non-compliance.
Clearly, developing and maintaining clean master data throughout the supply chain is a must for optimizing manufacturer-to-hospital integration and patient safety. Unfortunately, data governance is an area where almost all stakeholders need to make significant improvements. Manufacturers, in an attempt to meet intensifying demands for data quality, optimized supply chain efficiency, and factory-to-OR traceability, have deployed multiple databases and applications, including ERP, PLM, WMS, SQA, TPL, and more. In most supplier organizations, this has led to silos of information and tedious re-keying of data from one system to another.
As we’ve seen in a host of industries, manual approaches to data governance, risk management, and regulatory compliance are simply insufficient as the complexities of “connected everything” converge with increasing consumer, budgetary, and regulatory demands on an already stretched healthcare system. For medical manufacturers participating in global supply chains, the regulatory environment is getting markedly more complex as the EU, UK, Canada, and China develop their own regimes for tracking and monitoring medical devices.
Now is the opportune time to prioritize solving master data management obstacles. A single source of truth, which delivers trusted data across the supply chain, is imperative to ensuring patient safety, and also to optimizing supply chain efficiency, device traceability, and the integrity of electronic health records. After all, regulations like UDI are not simply about labeling, they are about traceability of products throughout their lifecycle, especially during product recalls. This is virtually impossible to achieve with manually entered or siloed data. And in order to buy and sell in a global market, hospitals and manufacturers need to get their data right once and for all, so it remains compliant with multiple regulatory regimes through ongoing rule changes, emerging technologies, and geopolitical instability (e.g., protectionist trade policies).
One critical step for medical device manufacturers is to plan and implement master data management (MDM) solutions. These systems create, maintain, validate, and distribute product information to comply with government regulations and satisfy the needs of downstream trading partners, such as distributors, GPOs, and healthcare providers. The beneficial results go far beyond more accurate reporting for compliance purposes, including: better supply chain management decisions, optimized billing processes, accurate electronic health records, reduced costs of product recalls, and ultimately, improved patient care.
Failure to meet obligations under the FDA’s UDI program, NHS’s Scan For Safety initiative, or the emerging EUDAMED standards from Europe, could lead to manufacturers being prevented from selling their products in these markets. For smaller supply chain partners, this could be devastating. To be ready for future regulations, the ongoing transformation of the healthcare market, and the disruptive emergence of IoT medical devices, manufacturers have to master their data. It’s best to begin now. In retrospect, this may look like a period of relative calm. Master data management and UDI compliance are major undertakings and will be ongoing for at least the next decade. The market leaders of tomorrow have already started plotting their MDM course to accelerate manufacturer-to hospital integration. It’s time to plan your roadmap.
Bang Chau is the co-founder and VP of Business Development at Innovit, a global master data management solution provider. Innovit supports MDM / PIM implementations worldwide with customers across diverse industries including healthcare, CPG and Automotive Aftermarket.