Case Study: Diagnostics Kit
August 2, 2024
SMC partnered with an innovative diagnostic company to develop a POC cartridge for sepsis pathogen detection.
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Markets We Serve
Intro
Medical Manufacturing for Diagnostic, Drug Delivery and Medical Device Markets
SMC is a full-service contract manufacturer, providing solutions from concept through completion for single-use and single-patient devices across a range of high-volume to low-volume needs. Dedicated teams work to minimize risk, lower costs and establish a robust process. All manufacturing sites globally are FDA-registered and ISO 13485-certified.
Pharmaceutical
SMC’s experience in manufacturing finished devices from concept to completion includes devices manufactured without the drug or with drug handling under FDA CFR 21 Part 4 compliance for combination products. This includes handling of drugs and biologics in primary packaging for integration into the final device assembly.
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Diagnostics
At SMC, we specialize in flexible manufacturing services for the development, launch, and volume-production of disposable and point-of-care (POC) medical diagnostic kits and devices. These diagnostic consumables can be anything from a self-DNA test kit, to a clinical sepsis test, to an on-the-battlefield blood test kit.
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MedTech
Passion for technology has driven SMC to become a leading partner to medical device OEMs. Execution excellence, in-house tooling, in-house automation, and silicone molding expertise set us apart from other contract manufacturers. Our focus is single-use and single-patient handheld devices.
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What We Do
Strategic capabilities and services for medical manufacturing
Combining in-house engineering, injection molding, and assembly expertise with our global supply chain, we provide end-to-end manufacturing capabilities, from design to distribution. These capabilities allow us to deliver on our core value of speed to market. Our best-in-class facilities around the world provide:
- Design and development through all stages of the product life cycle
- Program management, from design through packaging (including packaging of combination products), labeling and distribution
- Injection molding, including in-house tooling and expertise in silicone, thermoplastics and micro/mini components
- In-house automation and assembly, including
ISO Class 7 and 8 clean rooms - Quality and regulatory capabilities, including extra security and infrastructure for controlled substances
- Sustainable manufacturing and procurement processes
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 manufacturing fall in either Medical Device, Diagnostics or the 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. You Can find all of our certifications here.
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.
