Working with SMC at an early stage in the development lifecycle mitigates the cost, time and risk associated with typical tech transfers. In a collaborative and cohesive partnership, we benefit each other and share knowledge of both the product and the manufacturing processes required to deliver a commercially viable project.
Our teams are experienced in working with a wide variety of formulations and novel therapies. For even the most complex of molecules, our process development teams, and analytical labs ensure a rapid to clinic outcome. The range of formulations we can accommodate include:
Our dedicated teams of engineers have worked on our own proprietary technology platforms as well as other products, culminating in extensive experience and insight into industrial design for human factors and branding, mechanical engineering for functional requirements, electrical engineering for embedded controls and monitoring, and software development. Everything indeed, you need to create a truly differentiating, patient-friendly, adherence-driven device to transform your concepts into successful and reliable products.
Effective, repeatable, successful design balances form, fit, and function with manufacturing feasibility, regulatory considerations, and commercial viability. Our teams work cohesively as a project group compromising of manufacturing, automation, and supply chain management to deliver a product that can stand the test of time, from launch to lifecycle management.
Every successful device development process requires high-quality, production-representative components and assembly prototypes that speed product launch and enable scale-up, while mitigating risk and minimizing cost.
Together we will utilize our combined expertise and experience to expedite the development phase and enable you to de-risk the design system. Our integrated approach delivers Design For Manufacture (DFM) through to high-quality, low-volume samples suitable for clinical trials, process optimization and full scale-up.
At every key stage gate, we deliver a testing protocol to evaluate and verify the technologies at a product and functional level.]
From a product perspective, we offer tensile and compression testing, featuring bespoke software for cycling against load and/or deflection. Our performance testing captures data on a range of characteristics including stress/strain, temperature/time, pressure/flow, actuation force and dispense time/volume.
Our ES2000 chambers operate from 0–70C and 32–96% RH to deliver environmental and accelerated life testing.
Functional performance requirements including testing for dose accuracy, needle length, activation force and cap removal force, featuring:
ISO 11608 – needle based injection systems
With eight manufacturing sites located strategically across the globe, SMC aims to deliver you the duality of care and capacity, wherever you operate from, or market to.
Our commercialization service enables our pharma partners to benefit from economies of scale with a single source, seamless solution – for the entire lifecycle of the product.
Your dedicated team of R&D, engineering and production experts will support you throughout scale up, into full manufacture and onto lifecycle management.
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).
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.
All of SMC manufacturing fallAll of SMC’s manufacturing falls in either the Medical Device, Diagnostics, or Pharmaceutical Markets. We do not manufacture anything in other markets.
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.
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.
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.
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.
Yes, all SMC Facilities are ISO 13485 Certified and FDA registered. Learn more about our certifications.
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.
