Sandra K. Rodriguez, Senior Industry Analyst, Axendia05.03.21
The need for organizational visibility, control, and resilience has never been greater for the life sciences industry. Executives at forward-thinking companies are addressing the need to solve both present and future challenges. The increasing complexity of designing, sourcing, and manufacturing high-quality medical products under stringent regulations requires a digital factory that supports closed loop manufacturing across-the-product lifecycle. In short, a sustainable factory of the future is needed now.
The factory of the future goes beyond traditional factory walls; it requires digital transformation across the entire medical product value network. Axendia research indicates that 76 percent of digital transformation initiatives are being accelerated by “black swan” events. Digital transformation is a journey, not a project. Life science organizations that have embarked on this journey are modernizing manufacturing and reinventing their value networks.
Building the Factory of The Future, Today
Delivering high-quality, next-generation life-science products is not easy. Stakeholders expect high-quality, complex products manufactured sustainably under stringent regulations. The factory of the future supports closed loop manufacturing and workforce optimization by connecting the following technologies across the total product lifecycle:
Facilities designed today must support current and next-generation products. Companies should start with a virtual model to visualize the possibilities. This approach allows for virtual validation of facilities, products and processes, including factory layouts, process plans and value networks, as well as logistics and workforce plans. However, many companies with older facilities are now investing in equipment and robotics that can be more easily moved and reconfigured to accommodate product line changes. Work capacity is also being simulated based on the number of work cells and expected product demand.
The factory of the future requires a workforce that can think strategically. Although technology will not displace cross-functional teams, skill sets will likely change. Thus, workers will need the tools necessary to contextualize and interpret data from intelligent systems and work in virtualized and augmented environments.
The Shift From Supply Chains to Value Networks
The globalization of medical product supply chains has created unique opportunities and demanding challenges for the life sciences industry. Patients worldwide benefit from medical innovations. However, the growing volume of multinational facilities and suppliers, as well as the variety and complexity of globally sourced products from various countries necessitates a new paradigm in supply chain management. Companies must change course and shift from rigid supply chains to integrated value networks.
Historically, life science companies shifted to global supply chains and “single source” suppliers to lower costs. But offshore single-source suppliers greatly reduce supply chain robustness, flexibility, and resilience. Today, black swan events such as a worldwide pandemic once seemed extremely rare and had little or no impact on supply chains. However, geopolitical unrest, natural disasters, COVID-19, and even the Suez Canal blockage have had significant impacts on global supply chains.
While globalization will likely continue, current supply chain disruptions and potential future black swan events are driving organizations to reassess their outsourcing models. These include build, buy, or partner as well as onshoring, nearshoring, offshoring, and outsourcing decisions.
To future proof value networks in the digital world, manufacturers should encourage collaboration among partners to gain a better understanding of critical-to-quality parameters; process capability; product characterization; and sourcing strategy (multiple tiers suppliers).
The ability to leverage integrated APS to model and simulate potentially disruptive scenarios in the digital world allows life science manufacturers to build supply network resilience proactively, instead of reacting to shortages after they occur.
A Digital Formula for Operational Efficiency
Clearly, most companies have launched digital transformation initiatives. Executives are recognizing the value of leveraging advanced technologies including AI and machine learning for decision-making based on actionable intelligence.
The challenge remains that many industry professionals confuse digitization with digital transformation. Simply focusing on digitization can hinder transformation as well as decelerate innovation due to incomplete information. Digitization (paper on glass) also inhibits continuous improvement due to the lack of a feedback loop. Digitizing ineffective legacy processes has negative consequences, as it quickly produces complications.
A leading manufacturer of infusion, transfusion and clinical nutrition products is undergoing a digital transformation to enable decision making based on reliable data. An executive told Axendia that many areas currently rely on inefficient and costly paper-based processes. Digitally transforming manufacturing operations for this company will create paperless, clear work instructions, processes, procedures, and hand-offs that reduce inefficiencies.
Supply chain optimization is also being addressed within the organization. The company aims to respond to future disruptions with real-time visibility and fit disruptions by optimizing production and inventory into its schedules for both finished products and spare parts. Additionally, this manufacturer is updating its APS as part of its vision for a rapid return on its digital transformation investments.
Lastly, life science companies are increasingly measuring time to value, not just cost, when evaluating technology solutions. Improved outcomes can be achieved by creating and connecting feedback loops that enable stakeholders to make fact-based decisions faster. As a whole, the life sciences industry must shift from siloed design and manufacturing data and processes to digitally connected solutions.
Digital Evidence and The Review of the Future
FDA is encouraging the use of “digital evidence” to accelerate product innovation supporting rapid introduction of life-saving technology for patients.
The use of new technologies to support expedited product reviews is also being explored by the agency. For example, the review of the future is not a submission but a review. The intent is to focus on the product life cycle and have it be synchronous.1 Imagine having an FDA reviewer and company representatives don a set of virtual reality goggles and review digital evidence in real time, viewing models, simulations and digital twins of the product and patient, and learning how it all impacts product quality. For this to happen, the process must be based on advanced sources of digital and real-world data, not on static data alone.
Industry executives agree that digital evidence can also support review by exception in manufacturing and identify potential points of failure along a process. In addition, it is expected that by leveraging digital evidence, time to market/time to validation will be shortened too.
Conclusion
The factory of the future goes well beyond traditional factory walls. It is a digital factory that can leverage digital evidence across entire the product lifecycle (R&D, regulatory, manufacturing, logistics, service) to support virtual risk assessments, commissioning, validation and post-market surveillance.
Life science executives are focused on ensuring that today’s facilities can support next-generation medical products. The life sciences industry must consider a change of course and shift from siloed design and manufacturing data and processes to a digitally connected and integrated factory of the future. This approach can significantly enhance an organization’s resilience and its ability to quickly adapt to changes in business, technology, and regulatory conditions.
Innovative life science companies embarking on digital transformation journeys and building the factory of the future today offer the following recommendations:
Reference
Sandra K. Rodriguez is a senior industry analyst at Axendia Inc. She has 19 years of experience working within FDA-regulated industries in various roles including sales, marketing, and as an analyst for the past six years. She has authored numerous articles and white papers on technology and regulatory trends that impact the future of the life sciences industry and has presented primary research findings to FDA officials and staff. Sandra is a U.S. Army Reserve Veteran.
The factory of the future goes beyond traditional factory walls; it requires digital transformation across the entire medical product value network. Axendia research indicates that 76 percent of digital transformation initiatives are being accelerated by “black swan” events. Digital transformation is a journey, not a project. Life science organizations that have embarked on this journey are modernizing manufacturing and reinventing their value networks.
Building the Factory of The Future, Today
Delivering high-quality, next-generation life-science products is not easy. Stakeholders expect high-quality, complex products manufactured sustainably under stringent regulations. The factory of the future supports closed loop manufacturing and workforce optimization by connecting the following technologies across the total product lifecycle:
- Product Lifecycle Management
- Enterprise Resource Planning
- Manufacturing Operations Management (MOM)
- Advanced Planning and Scheduling (APS)
- Modeling and Simulation
Facilities designed today must support current and next-generation products. Companies should start with a virtual model to visualize the possibilities. This approach allows for virtual validation of facilities, products and processes, including factory layouts, process plans and value networks, as well as logistics and workforce plans. However, many companies with older facilities are now investing in equipment and robotics that can be more easily moved and reconfigured to accommodate product line changes. Work capacity is also being simulated based on the number of work cells and expected product demand.
The factory of the future requires a workforce that can think strategically. Although technology will not displace cross-functional teams, skill sets will likely change. Thus, workers will need the tools necessary to contextualize and interpret data from intelligent systems and work in virtualized and augmented environments.
The Shift From Supply Chains to Value Networks
The globalization of medical product supply chains has created unique opportunities and demanding challenges for the life sciences industry. Patients worldwide benefit from medical innovations. However, the growing volume of multinational facilities and suppliers, as well as the variety and complexity of globally sourced products from various countries necessitates a new paradigm in supply chain management. Companies must change course and shift from rigid supply chains to integrated value networks.
Historically, life science companies shifted to global supply chains and “single source” suppliers to lower costs. But offshore single-source suppliers greatly reduce supply chain robustness, flexibility, and resilience. Today, black swan events such as a worldwide pandemic once seemed extremely rare and had little or no impact on supply chains. However, geopolitical unrest, natural disasters, COVID-19, and even the Suez Canal blockage have had significant impacts on global supply chains.
While globalization will likely continue, current supply chain disruptions and potential future black swan events are driving organizations to reassess their outsourcing models. These include build, buy, or partner as well as onshoring, nearshoring, offshoring, and outsourcing decisions.
To future proof value networks in the digital world, manufacturers should encourage collaboration among partners to gain a better understanding of critical-to-quality parameters; process capability; product characterization; and sourcing strategy (multiple tiers suppliers).
The ability to leverage integrated APS to model and simulate potentially disruptive scenarios in the digital world allows life science manufacturers to build supply network resilience proactively, instead of reacting to shortages after they occur.
A Digital Formula for Operational Efficiency
Clearly, most companies have launched digital transformation initiatives. Executives are recognizing the value of leveraging advanced technologies including AI and machine learning for decision-making based on actionable intelligence.
The challenge remains that many industry professionals confuse digitization with digital transformation. Simply focusing on digitization can hinder transformation as well as decelerate innovation due to incomplete information. Digitization (paper on glass) also inhibits continuous improvement due to the lack of a feedback loop. Digitizing ineffective legacy processes has negative consequences, as it quickly produces complications.
A leading manufacturer of infusion, transfusion and clinical nutrition products is undergoing a digital transformation to enable decision making based on reliable data. An executive told Axendia that many areas currently rely on inefficient and costly paper-based processes. Digitally transforming manufacturing operations for this company will create paperless, clear work instructions, processes, procedures, and hand-offs that reduce inefficiencies.
Supply chain optimization is also being addressed within the organization. The company aims to respond to future disruptions with real-time visibility and fit disruptions by optimizing production and inventory into its schedules for both finished products and spare parts. Additionally, this manufacturer is updating its APS as part of its vision for a rapid return on its digital transformation investments.
Lastly, life science companies are increasingly measuring time to value, not just cost, when evaluating technology solutions. Improved outcomes can be achieved by creating and connecting feedback loops that enable stakeholders to make fact-based decisions faster. As a whole, the life sciences industry must shift from siloed design and manufacturing data and processes to digitally connected solutions.
Digital Evidence and The Review of the Future
FDA is encouraging the use of “digital evidence” to accelerate product innovation supporting rapid introduction of life-saving technology for patients.
The use of new technologies to support expedited product reviews is also being explored by the agency. For example, the review of the future is not a submission but a review. The intent is to focus on the product life cycle and have it be synchronous.1 Imagine having an FDA reviewer and company representatives don a set of virtual reality goggles and review digital evidence in real time, viewing models, simulations and digital twins of the product and patient, and learning how it all impacts product quality. For this to happen, the process must be based on advanced sources of digital and real-world data, not on static data alone.
Industry executives agree that digital evidence can also support review by exception in manufacturing and identify potential points of failure along a process. In addition, it is expected that by leveraging digital evidence, time to market/time to validation will be shortened too.
Conclusion
The factory of the future goes well beyond traditional factory walls. It is a digital factory that can leverage digital evidence across entire the product lifecycle (R&D, regulatory, manufacturing, logistics, service) to support virtual risk assessments, commissioning, validation and post-market surveillance.
Life science executives are focused on ensuring that today’s facilities can support next-generation medical products. The life sciences industry must consider a change of course and shift from siloed design and manufacturing data and processes to a digitally connected and integrated factory of the future. This approach can significantly enhance an organization’s resilience and its ability to quickly adapt to changes in business, technology, and regulatory conditions.
Innovative life science companies embarking on digital transformation journeys and building the factory of the future today offer the following recommendations:
- Bring together stakeholders across the entire value network, including internal functional areas (design, manufacturing, suppliers, quality, regulatory, post-market) and external partners (CRO, CMO, suppliers, etc.).
- Shift from a static paper-driven process to one that enables data-driven insights based on actionable intelligence.
- Take a holistic approach to connect processes, systems, and technology across the value network to support digitally transformed, automated, paperless operations.
- Leverage advanced technologies including AI and machine learning for decision-making based on actionable intelligence.
- Use simulation to predict constraints in people, processes and products, while optimize against multiple business, technology and regulatory conditions to drive supply chain optimizations and competitiveness.
- Produce “digital evidence” to accelerate product innovation and support introduction of complex medical technology to improve patient outcomes.
Reference
- Axendia SftS Webinar: FDA Uses Digital Evidence to Accelerate Innovation
Sandra K. Rodriguez is a senior industry analyst at Axendia Inc. She has 19 years of experience working within FDA-regulated industries in various roles including sales, marketing, and as an analyst for the past six years. She has authored numerous articles and white papers on technology and regulatory trends that impact the future of the life sciences industry and has presented primary research findings to FDA officials and staff. Sandra is a U.S. Army Reserve Veteran.
