Whether filling a prescription, cracking open a bottle of over–the-counter pain-killers or receiving drugs through an IV infusion, anything less than 100% is simply unacceptable. Manufacturers have long known that when it comes to safety of their drugs and medical devices, errors can add up to more than law suits, damage to the brand or lost profits, but pose significant risks to health and life. As a hedge against risk, pharmaceutical and medical device makers have invested billions in process automation and IT systems in order to streamline their manufacturing processes and ensure the efficacy and safety of their product-lines. However, these systems are primarily designed to support the needs of enterprise business processes, information flows, reporting, and data analytics. They do little in the way to streamline operational workflows across various R&D, clinical trials, manufacturing, approval and marketing phases. Long term, this lack of operational visibility can lead to compromised output quality, increased risk, and lower TCO.
A Bigger and More Complex World
Even though the goal posts haven’t moved, the playing field has gotten bigger. External market forces are exerting more and more pressure on manufacturers to scale growth while maintaining mandated safety standards. But what are these external market forces and how do they complicate matters for manufacturers in the healthcare vertical?
- Demand: Manufacturers are experiencing increased global demand from an aging global population of 7.6 billion, that expected to approach 10 billion people by 2050.6 Every day, advances in medicine drive formation of new products and procedures that improve patient outcomes and healthcare experiences.
- New Industry Alliances & Outsourcing: Manufacturers are entering into complex collaborative stakeholder partnerships where drug constituents or medical components may be sourced from any number of vendors. And these alliances do not only include supply-chain partnerships but extend into demand-chain sales and distribution channels. (In a recent Career and Salary Survey by Pharma Manufacturing, respondents scored “Increased workload due to organizational changes” at the top of the list (61.1%) when asked the biggest challenge they faced in the past year.10)
- Liability and Regulatory Landscape: The medical industry is one of the most highly regulated in the world and subject to very rigorous approval processes from an increasingly global and interconnected group of regulatory bodies. To make matter worse, the medical industry, overall, operates in a highly litigious market climate charged by skeptical consumer sentiment and general distrust of big pharma/biotech.
For many manufacturers, these challenges represent a fast moving target and one that underscores the need for purposeful technology solutions that can offer them end-to-end operational visibility, real-time information processing and streamlined workflows across their value-chains. And the Industrial IoT (IIoT) represents the perfect vehicle for actualizing their goals in a sustainable and value-added way. However, many would argue that the IIoT has already been quietly transforming public and private sector companies in industries as diverse as process-automation, robotic manufacturing, logistics, distribution & transportation, heavy equipment & mining, oil & gas, utilities and healthcare. But to-date, how exactly are these industries being transformed? To what end? Do they leverage the full potential of the IIoT? And which industries stand to benefit the most?
For many early IIoT adopters, transformation has taken the form of enhancing interoperability and data flow between existing PLC, SCADA and MES systems to satisfy back-office scheduling, product lifecycle and material management functions. The focus has been on extending the reach of traditional IT enterprise systems through the use of predictive maintenance in order to gain a better understanding of equipment performance, utilization and prevent manufacturing interruptions. Far from achieving true digital transformation, early IIoT initiatives were simple stop-gaps that ensured short term business continuity. Today the IIoT offers materials management and integrated workflow solutions capable of gathering granular operations data in real-time, from virtually unlimited numbers of IoT-enabled assets on the front-lines of the operation.
Enter Industry 4.0
As a component of Industry 4.0 “smart factory”, the IIoT is actively redefining enterprise operations, business practices and the markets they serve, and few industries stand to benefit more than pharma. This is due, in part, to a highly regulated manufacturing environment and the many economic and legal risks associated with developing of new drugs and devices. In this context and given the technological (albeit IT-centric) maturity of the industry, digital transformation is measured not only in units of efficiency, but increasingly by the ease at which IIoT implementations are capable of uncovering valuable insights that lead to better decision making, lower risk and long term growth. If maximizing productivity was all the rage yesterday, today is about sustained value, through operational visibility, real-time access to granular asset data collaborative relationships between stakeholders across manufacturing supply and demand chains.
But although large-scale pharma, biotech and medical device makers have invested untold billions in industrial automation, discrete manufacturing and cold-chain process manufacturing, the industry has been slow to realize the benefits of fully adopting Industry 4.0 best practices.
The Paperless Organization
One of the largest opportunities is transitioning to paperless operations. Yet dependence on paper record keeping for asset traceability, serialization, and manufacturing workflows persists. This is due, in part, to continued reliance on centralized IT topologies that were never designed to interact with thousands of smart-enabled devices that live in the Operational Technology (OT) domain. Secondly, IT managers saw the IIoT as an obscure and shifting concept which represented needless risk and uncertainty (especially in the fiscally conservative healthcare industry). Paper records were just easier to keep, and ironically, beautifully technology-agnostic. Yet the medical industry’s move to distributed track & trace technology necessitated a digital record keeping solution that documented in real-time, the flow of manufacturing assets, assays and biological samples. Moreover, as few industries are legally required to record every aspect of production for compliance and audit reasons, the benefits of a purpose-built asset management solution are profound.
In a recent interview hosted by Pharmaceutical Technology, Andrew Whytock, Global Business and Solution Development, Siemens Pharma Competence Center, Karlsruhe, Germany, said “Today’s MES, data historian systems, and control systems are proving the basis for collecting and storing the data that are being collected. Closer integration of these systems is essential for the future. Direct communication between objects or via the IIoT is not yet widely seen.”
The industry is also moving towards smaller-scale modularized manufacturing. The new servitization economy is requiring manufacturers to be agile and responsive. This means that asset value-chains must be flexible, transparent and offer track & trace technologies that enable manufacturers to scale growth and better absorb external shocks from shifting market conditions, new regulations or potential recalls. Being able to rapidly re-configure, re-tool and re-calibrate manufacturing line-processes is predicated on an asset management solution capable of providing plant managers real-time granular visibility over materials and workflows.
The benefits of real-time asset tracking are many. First, it enables lab managers to easily determine the location, condition, dwell-time and status of inventory, materials, sub-components and biological assays as they travel from lab to lab. Second, it protects high-value handheld tools from theft or loss. Third, predictive maintenance routines help ensure robotic equipment and other fixed assets are properly calibrated and ready for operation. Forth, it provides big-data analytics unrestricted access to a wealth of IoT edge-data from assets on located in the lab or on the FAB floor. Adopting the garbage-in-garbage-out principle, it’s clear that real-time granular asset data in the OT domain means better actionable intelligence and deeper operational insights.
Pharmaceutical Technology’s interview with Torsten Winkler, Process Solutions, Honeywell Center of Excellence Life Sciences EMEA commented: “IIoT infrastructure allows modular automation for modular pharmaceutical production to scale production up or down according to the market needs. This enables faster time-to-market for pharmaceutical products in accordance with the regulations and required approvals for specific markets and regions.”
Manufacturing in the Decentralized and Distributed OT Domain
Industry 4.0 is also gaining favor with manufacturers looking to digitally transform the operations due to the inherent security offered by the distributed and decentralized computing environments underpinning the IIoT. And with the US Drug Quality and Security Act (DQSA) enacted by Congress on November 27, 2013, manufactures are now required to comply with rules that govern the electronic identification and distributed tracking of prescription drugs in the United States. In IIoT’s bag-of-tricks, blockchain is emerging as a technologically viable and operationally practical solution. Blockchain technologies have the ability to, not only handle cryptocurrency transactions, but securely validate smart-contracts, facilitate collaborative stakeholder agreements, safeguard medical records and perform other records management activities, such as identity management, transaction processing, documenting provenance, or drug traceability.
Case in point: In a recent article Fortune describes how the pharma industry is exploring automated notarized ledger technology beyond simply securing supply-chains. One such initiative is MediLedger, a project funded by drug giants Genentech and Pfizer in which blockchain tools are being used to manage pharmaceutical supply chains. Genentech is utilizing blockchain to assign unique traceable numbers to its pharmaceutical products to satisfy mandated track & trace requirements. If assets go missing between facilities or in-transit, data stored on the common ledger provides a rapid way for all parties determine location, condition and status. Blockchain and other decentralized technologies have the potential to reduce systemic risk, financial fraud and validate the authenticity of products across the entire value-chain from commodity to consumer.
Moving forward, the healthcare industry will continue to evolve and adapt. As the boundaries between stakeholder value-chains continue to blur, supply and demand curve will harmonized. This will enable direct and on-demand access to materials through the formation of collaborative contract manufacturing organizations (CMOs) and other 3rd party stakeholder agreements. Sustainability will be measured by the degree to which the IIoT solutions are able to bridge the digital divide between IT and OT domains.
The Cloudleaf Advantage
Cloudleaf is an end-to-end cloud solution for monitoring, managing and optimizing complex distributed-asset ecosystems. Cloudleaf’s value-proposition represents a paradigm shift in enterprise-grade IoT adoption and usage across internal and 3rd partner facilities. By reducing IoT deployment from months to days and adoption costs to a tenth of typical IT system implementations, Cloudleaf is able to deliver immediate and sustained ROI. Sensor Fabric is our flagship edge-to-cloud solution. It effortlessly gathers, compiles and analyzes streams of live telemetry data from a broad range of diverse enterprise operations across indoor, out-door and in-transit workflows to provide real-time actionable insight. Patented sensors, gateways, location-aware cloud services combine to solve real-world challenges in manufacturing, transportation and pharma by helping managers to easily track, manage and optimize the flow of people, things and processes. Use cases range from simple supply-chain asset monitoring applications to managing complex assemblies, work-cells and works-in-process as they traverse the value-chain.
Edited by Ken Briodagh