Combining Human Needs With High Viscosity Formulations
February 14, 2025
Within the injectable drug landscape, the availability and usage of high viscosity (HV) drugs is growing, often driven by developments…
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Medical Diagnostic Device and Equipment Manufacturing
Diagnostics Contract Manufacturing Expertise
Contract Manufacturing Services for Disposable and Point-of-Care Diagnostic Devices
SMC provides flexible contract manufacturing services to support the development, launch, and scale-up of disposable and point-of-care (POC) diagnostic kits and devices. From self-administered DNA test kits to sepsis diagnostics and battlefield-ready blood tests, our expertise spans a wide range of critical applications.
Engineering-driven manufacturing solutions for diagnostic devices
With experienced teams, robust in-house capabilities, and a global supply chain, SMC ensures precision and efficiency at every stage of diagnostic device production. Our expertise in both high- and low-volume manufacturing allows for seamless scale-up, while FDA-registered, ISO 13485-certified facilities worldwide deliver consistent quality. Trusted by leading diagnostics companies, we are a partner in bringing innovative solutions to market quickly and reliably.
Specialized Expertise in Diagnostic Device Manufacturing:
- Point-of-care devices
- Laboratory disposables
- Home testing and sample kits
- In vitro diagnostic (IVD) kits
- Microfluidic cartridges
- POC in vitro diagnostics kits
WHAT WE DO
End-to-end manufacturing solutions for diagnostic devices
Experienced in meeting custom requirements for diagnostic equipment, instruments and devices
SMC is a dedicated contract manufacturer for the medical market, providing custom contract manufacturing tailored to the unique requirements of diagnostics. All of our global facilities are FDA-registered and ISO 13485-certified, ensuring compliance and consistency at every stage.
From design and engineering to molding, assembly, automation, and final packaging, we deliver a seamless path from concept to commercialization. By uniting these capabilities under one roof, we simplify complex production challenges, accelerate time-to-market, and ensure reliable, high-quality outcomes for both new innovations and established diagnostic product lines.
Precision Tooling Capabilities
Specialized in high-precision tooling design and manufacturing for complex applications, ensuring performance and durability.
Injection Molding Expertise
Specialized injection molding capabilities in silicone, thermoplastics , and micro/miniature components, supported by in-house tooling.
Automation and Assembly
In-house automation and ISO Class 7 & 8 clean rooms streamline assembly, reduce risk, and optimize throughput.
Design and Development
Advance your diagnostic innovation from concept through production with our dedicated design center.
WHO WE ARE
Over 35 Years of Diagnostic Device Manufacturing Expertise
As a privately owned, global contract manufacturer, SMC has partnered with many of the world’s leading medtech and diagnostics OEMs for more than three decades. Customers trust us to deliver efficient scale-up and mitigate risk through robust quality management, regulatory compliance, and resource planning systems designed for consistency and reliability.
WHY SMC
Reducing Risk and Accelerating Success in Diagnostic Device Production
The need for medical manufacturing methods that support adaptable, scalable solutions has become more crucial than ever in the diagnostic space. As the technologies associated with creating a lab-on-a-chip become more complex, so does the process of bringing the assay to a fully commercialized product. Our customers rely on us for speed to market with high-quality results.
Dedicated Program Management
A single point of contact ensuring seamless communication, performance, and compliance throughout the project, minimizing risk and meeting cost, volume, and regulatory requirements.
Microfluidic Design Specialists
Specialists in designing and manufacturing microfluidic cartridges and cassettes, ensuring precise execution of complex POC consumables from concept to commercialization.
Global Supply Chain Management
Specialized in optimizing global supply chains, ensuring seamless sourcing, logistics, and inventory management, minimizing risks, reducing costs, and streamlining product flow.
Quality & Regulatory Capabilities
SMC is FDA-registered, MedAccred accredited, and backed by an ISO 13485-certified Quality Management System (QMS) for compliance and reliability.
Faq
Frequently Asked Questions About SMC and Diagnostics
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.
