Patrick Malone, Vice President Operations, West Pharmaceutical Services08.24.20
Original equipment manufacturers (OEMs) are increasingly outsourcing their manufacturing requirements as a strategic approach to streamline operations and remain competitive – minimizing infrastructure and overhead expenses and improving efficiencies. It also allows for greater focus on device development and packaging, providing the flexibility needed to succeed in a fast paced, ever-evolving market.
Such outsourcing helps drive forward critical innovation and presents an increased opportunity for contract manufacturing organizations (CMOs) as partners. It also demands that CMOs as partners be adaptable and prepared with advances across manufacturing, regulatory, data and analytics, testing and more.
Whether understanding what to expect from a new CMO partner or an existing partnership, there are a number of key elements to be aware of that are integral to CMOs offering optimal value to customers while fostering a mutually beneficial partnership:
Regulatory Expertise
Regulatory hurdles are a challenge many of our customers face, and to be able to rely on their CMO partner to help manage related processes is imperative. CMOs contribute information and data to their customer’s regulatory filings and are responsible for ensuring all quality requirements are met.
In addition, regulatory requirements vary across different markets and countries, so a CMO must understand the required regulatory landscape(s) in order to properly align to their customer’s product distribution strategy.
An agile quality system is a requirement in meeting a broad set of requirements. Timing and uncertainty around regulatory clearance/approval can also present a challenge to CMOs. Clear communication with the customer around this timing is important as CMOs need to effectively plan their capacity to support their customer launch and market expansion needs.
Risk Mitigation and Issues Management
Risk and challenges must be anticipated and mitigated throughout a product’s lifecycle, in all aspects of development and production. The totality of a product’s quality and safety depends on its various components – from packaging to the delivery of device systems. Through rigorous testing and analysis, CMOs can help ensure that the optimal packaging and delivery systems are selected, and appropriate testing is carried out. Under circumstances where an accelerated timeline must be followed, such as with the current and urgent development of resources to help with management of COVID-19 – safety and quality can become riskier and pose more potential issues. CMOs should be prepared to adapt to differentiated needs, selecting and testing packaging systems faster than usual without compromising any standards, offering both resources and guidance to partners throughout the process.
Cutting-Edge Innovation
To keep up with industry advances, CMOs are similarly preparing for advances in manufacturing to meet partner needs. This includes Industry 4.0, which typically refers to the use of data and automation in manufacturing. Simulation, additive manufacturing, data and analytics, and augmented reality are technologies that are currently being used to create “smart factories” where systems, machines and people work together to more rapidly and seamlessly design or create something while improving efficiencies and eliminating errors. A CMOs automated manufacturing environment with real-time access to manufacturing data allows for optimum process control and performance and enables consistency in product performance for their partners. CMOs are currently focused on improvements in infrastructure – including security, systems and data storage – in addition to building and retaining a high-caliber talent pool, to successfully support and drive value through advanced technologies and market growth.
Comprehensive ‘Full Suite’ Solutions
Strategic partnerships should be not just mutually beneficial but collaborative in nature. Partnering with a CMO that is a leader in its respective market can have myriad benefits, including offering innovative end-to-end strategies and solutions that prioritize quality and safety while minimizing risk, improving time to market, and simplifying processes overall. Further, CMOs with demonstrated leadership have the capacity to support scale up strategies including clinical trials, HF support, regulatory, analytic testing and device manufacturing and live-cycle management.
Due to the cost implications associated with this business and related complex manufacturing requirements, companies may rely even more heavily on CMO partners that can offer an integrated approach to services, across packaging, testing, filing device assembly and final packaging in an effort to help reduce risk and challenges, optimize supply chains and meet time-to-market expectations. For example, the latter – speed-to-market – is becoming even more critical as management of COVID-19 continues. Platform approaches supported by component and system performance data can help position CMOs as better equipped to meet these needs.
High-speed precision automation has become much more common-place because it ensures stability of performance and enables greater levels of productivity and efficiency while providing ability to scale to high volumes. Additionally, as technology continues to revolutionize the health care industry overall, different ways of using data and analytics in manufacturing as well as digital tech and automation will continue to emerge.
Ultimately, strong business practices and processes and the effective use of technology – combined with a long-term strategy – function as important growth drivers and allow CMOs to lead in their sectors. As a result, value and outcomes can be improved for partners while delivering needed therapeutics to patients more effectively and safely.
Patrick Malone, vice president of operations, Contract Manufacturing, West Pharmaceutical Services, Inc., provides strategy, vision, direction and support for West’s six proprietary Contract Manufacturing sites across United States and Ireland. Prior to joining West, Patrick served as the Senior Manufacturing Director and Site Leader of the Medtronic Osteotech Campus, a global leader in the processing of human bone and connective tissue. Patrick also previously held operations and engineering leadership roles focused on the manufacturing and testing of Medtronic implantable electronic medical devices.
Such outsourcing helps drive forward critical innovation and presents an increased opportunity for contract manufacturing organizations (CMOs) as partners. It also demands that CMOs as partners be adaptable and prepared with advances across manufacturing, regulatory, data and analytics, testing and more.
Whether understanding what to expect from a new CMO partner or an existing partnership, there are a number of key elements to be aware of that are integral to CMOs offering optimal value to customers while fostering a mutually beneficial partnership:
Regulatory Expertise
Regulatory hurdles are a challenge many of our customers face, and to be able to rely on their CMO partner to help manage related processes is imperative. CMOs contribute information and data to their customer’s regulatory filings and are responsible for ensuring all quality requirements are met.
In addition, regulatory requirements vary across different markets and countries, so a CMO must understand the required regulatory landscape(s) in order to properly align to their customer’s product distribution strategy.
An agile quality system is a requirement in meeting a broad set of requirements. Timing and uncertainty around regulatory clearance/approval can also present a challenge to CMOs. Clear communication with the customer around this timing is important as CMOs need to effectively plan their capacity to support their customer launch and market expansion needs.
Risk Mitigation and Issues Management
Risk and challenges must be anticipated and mitigated throughout a product’s lifecycle, in all aspects of development and production. The totality of a product’s quality and safety depends on its various components – from packaging to the delivery of device systems. Through rigorous testing and analysis, CMOs can help ensure that the optimal packaging and delivery systems are selected, and appropriate testing is carried out. Under circumstances where an accelerated timeline must be followed, such as with the current and urgent development of resources to help with management of COVID-19 – safety and quality can become riskier and pose more potential issues. CMOs should be prepared to adapt to differentiated needs, selecting and testing packaging systems faster than usual without compromising any standards, offering both resources and guidance to partners throughout the process.
Cutting-Edge Innovation
To keep up with industry advances, CMOs are similarly preparing for advances in manufacturing to meet partner needs. This includes Industry 4.0, which typically refers to the use of data and automation in manufacturing. Simulation, additive manufacturing, data and analytics, and augmented reality are technologies that are currently being used to create “smart factories” where systems, machines and people work together to more rapidly and seamlessly design or create something while improving efficiencies and eliminating errors. A CMOs automated manufacturing environment with real-time access to manufacturing data allows for optimum process control and performance and enables consistency in product performance for their partners. CMOs are currently focused on improvements in infrastructure – including security, systems and data storage – in addition to building and retaining a high-caliber talent pool, to successfully support and drive value through advanced technologies and market growth.
Comprehensive ‘Full Suite’ Solutions
Strategic partnerships should be not just mutually beneficial but collaborative in nature. Partnering with a CMO that is a leader in its respective market can have myriad benefits, including offering innovative end-to-end strategies and solutions that prioritize quality and safety while minimizing risk, improving time to market, and simplifying processes overall. Further, CMOs with demonstrated leadership have the capacity to support scale up strategies including clinical trials, HF support, regulatory, analytic testing and device manufacturing and live-cycle management.
Due to the cost implications associated with this business and related complex manufacturing requirements, companies may rely even more heavily on CMO partners that can offer an integrated approach to services, across packaging, testing, filing device assembly and final packaging in an effort to help reduce risk and challenges, optimize supply chains and meet time-to-market expectations. For example, the latter – speed-to-market – is becoming even more critical as management of COVID-19 continues. Platform approaches supported by component and system performance data can help position CMOs as better equipped to meet these needs.
High-speed precision automation has become much more common-place because it ensures stability of performance and enables greater levels of productivity and efficiency while providing ability to scale to high volumes. Additionally, as technology continues to revolutionize the health care industry overall, different ways of using data and analytics in manufacturing as well as digital tech and automation will continue to emerge.
Ultimately, strong business practices and processes and the effective use of technology – combined with a long-term strategy – function as important growth drivers and allow CMOs to lead in their sectors. As a result, value and outcomes can be improved for partners while delivering needed therapeutics to patients more effectively and safely.
Patrick Malone, vice president of operations, Contract Manufacturing, West Pharmaceutical Services, Inc., provides strategy, vision, direction and support for West’s six proprietary Contract Manufacturing sites across United States and Ireland. Prior to joining West, Patrick served as the Senior Manufacturing Director and Site Leader of the Medtronic Osteotech Campus, a global leader in the processing of human bone and connective tissue. Patrick also previously held operations and engineering leadership roles focused on the manufacturing and testing of Medtronic implantable electronic medical devices.
