Case Study: Lift and Shift to US Facility
August 2, 2024
SMC reduced product cost for an OEM’s mature product using SMC’s lift-and-shift processes.
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Global Supply Chain Management for MedTech
STRATEGIC SOURCING
Contract Manufacturing Supply Chain Management Solutions
A true partner in medical device contract manufacturing has capabilities beyond molding and assembly. At SMC, our professional Supply Chain team qualifies and manages suppliers for non-molded components such as electronic components, machined and stamped specialty metals, converted materials, diagnostic fluids, chemicals and buffers, extrusions and packaging. We create resilient and sustainable global supply chains that mitigate risk, enhance speed to market, boost productivity and reduce complexity and cost.
As your complete contract manufacturing partner, we control the supply chain through the entire device lifecycle, to ensure that your requirements are met. Our supply chain strengths include not only the collective experience of our team, but also the utilization of intelligent digital systems that harness the power of AI and data streams to proactively address disruptions and improve supply chain reliability.
What We Do
Program Management With a Team of Experts and a Single Point of Accountability
Your Program Manager pulls together the resources of SMC into an expert team while providing you with a single point of contact and accountability. While you always have access to all team members, the Program Manager has overall responsibility for your program and its performance, including communication, volume expectations, cost parameters and regulatory requirements. Your team will also always include a Quality Engineer. Quality goes beyond producing your product to specifications; it is a system of compliance that includes processes and documentation through every phase of the project.
A Subject Matter Expert—an engineering leader with highly specialized technology expertise—may provide experience and work alongside the Program Manager and others. This specialized expertise might include:
- Product design and development
- Design for manufacturability
- Tooling design
- Injection molding
- Bonding/joining
- Supply chain sourcing
- Processing
- Automation
- Manufacturing assembly
- Packaging
- Quality engineering
- Drug handling
- Reagent filling
- Formulation
- Electronics for connected devices
- Transfer projects (from external source to SMC)
- Transfer projects (from one SMC site to another SMC site)
HOW WE DO IT
Our Supply Chain Management Solutions Process
At SMC, supply chain management begins as a partnership. We listen, we understand your risks and we can quickly pivot from a reactive to a proactive strategy in anticipation of supply chain disruptions or other issues.
We align ourselves with significant suppliers who have a global footprint. Our strategic sourcing team reviews the financial integrity, manufacturing capabilities and quality systems of suppliers before they are considered viable partners.
Our engineers and supply chain experts continuously monitor supplier metrics to ensure the supply chain is efficient, competitive, on time, and delivers high quality and value. Our controlled process verifies that we receive a uniform product time and time again to meet required standards.
FEATURED CASE STUDY
Contract Manufacturing & Supply Chain Management Solution for A Balloon Kyphoplasty Device
SMC Ltd. helped a large surgical device developer bring a highly complex balloon kyphoplasty device to market quickly, while improving quality. Supply chain management was an integral part of the manufacturing program.
Faq
Frequently Asked Questions about SMC and Medical Contract Manufacturing
Do you have a global footprint?
Yes, SMC is a global organization with 11 locations – United Kingdom, India, Costa Rica and 9 located in the United States (California, Ohio, Wisconsin (4), Massachusetts, North Carolina).
What are the differences between each manufacturing facility?
All SMC facilities are designed to produce high-volume medical devices, but each location has unique specialties. For example: SMC Somerset specializes in silicone manufacturing. North Carolina serves as our dedicated fill-finish location. Our facilities are strategically located to provide convenient access and support to our customers. To determine which facility is best suited for your project, we recommend reaching out to us for personalized guidance. Contact us for more information.
What percentage of your manufacturing is medical?
All of SMC’s manufacturing falls in either the Medical Device, Diagnostics, or Pharmaceutical Markets. We do not manufacture anything in other markets.
What makes SMC different from other CDMOs?
At SMC, we stand out among other CDMOs (Contract Development and Manufacturing Organizations) because of our unique approach and capabilities. Not only are we a privately held company with an actively engaged management team, but we also specialize exclusively in medical manufacturing, serving the medical device, diagnostic, and pharmaceutical markets.
Our end-to-end manufacturing solutions cover everything from design to production, including fill-finish capabilities. With subject matter experts (SMEs) available every step of the way, we ensure a seamless process tailored to your needs.
What truly sets SMC apart is our proprietary auto-injector technologies, which we offer exclusively to our customers.
When does SMC prefer to get involved with a new project?
At SMC, the sooner we can get involved, the better! However, we’re happy to assist at any stage of your project. Whether you’re starting with a simple concept—like a napkin sketch—or transferring a fully developed program through a lift-and-shift process, we’re here to help.
It’s always best to engage your Contract Manufacturer (CM) as early as possible during your program’s planning phase. Early collaboration allows us to partner with you effectively and thoroughly review the manufacturing aspects of your project for optimal success.
Do you have a purchasing organization that manages the supply chain?
At SMC, the collaborative supply chain teams, led by our Chief Supply Chain Officer, employ best-in-class techniques to ensure customer success on a global scale. The SMC-approved supplier list includes multiple alternatives for all major commodities, providing diverse sourcing options to mitigate risk. We collaborate closely with internal stakeholders, including finance, engineering, operations, and legal teams, to ensure alignment and support for procurement strategies tailored to address customer concerns and needs. By building and nurturing strong relationships with key suppliers and partners, we leverage strategic advantages that foster innovation, enhance pricing power, and provide flexibility in production and transportation.
Key performance indicators (KPIs) are utilized to measure the effectiveness of procurement strategies and operations, driving continuous improvement in supply base processes, systems, and practices. Our approach anticipates and mitigates risks by accounting for economic, geopolitical, and environmental events that may impact procurement and supply chain operations. Additionally, we achieve buying power through a combination of concentrated spending with key suppliers, independent pricing and minimum order quantity (MOQ) negotiations, and the use of purchasing data and forecast extrapolations.
How do you manage risk for your customers?
Our success in managing potential supply risk is rooted in our focused approach across several key areas. We maintain a strong core of senior technical and commercial leaders within SMC, ensuring that experienced leadership drives risk management efforts. Identifying supply risk areas and implementing mitigation strategies is a core responsibility of our senior management and their teams. To stay ahead of our customers’ capacity needs, we pre-invest in infrastructure, ensuring preparedness and adaptability. Consistent technology investments enable us to mitigate risks related to both obsolescence and security.
Additionally, we provide safety stock of both raw materials and finished goods to support our customers’ needs. Where applicable, we employ dual sourcing for critical components to enhance supply chain resilience. Lastly, site-specific business continuity plans allow us to respond quickly and effectively to unexpected events, minimizing potential disruptions.
Are you ISO Certified?
Yes, all SMC Facilities are ISO 13485 Certified and FDA registered. Learn more about our certifications.
Thought Leadership
Explore Case Studies, Articles and Other Resources
Our contract manufacturing capabilities, focused on single-use and disposable medical devices, include innovative autoinjector platforms designed for subcutaneous or intramuscular injection. These platforms can be customized to your drug formulation.
