Top 10 Tips: Contract Manufacturing
September 2, 2024
Collaborating with the right Contract Manufacturer (CM) can have many benefits. The right CM provides program management, which anticipates the needs of…
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Single-Use Medical Device & Autoinjector Manufacturing
Intro
Proven Expertise in Medical & Pharma Device Manufacturing
SMC’s commitment extends beyond product excellence, offering comprehensive solutions that span the entire life cycle of device development, from conceptualization to manufacturing. SMC is a global manufacturer of single-use and disposable medical devices, SMC creates complex products from concept to completion. All manufacturing facilities are FDA-registered and ISO 13485-certified.
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.
What We Do
Experienced in meeting custom requirements for single-use medical devices
SMC focuses exclusively on custom contract manufacturing for the healthcare market. In the medical device category, 15 of the top 30 medtech companies partner with SMC. Our experience with single-patient and single-use medical devices includes:
- Surgical devices – electronic integration or mechanical function
- Highly contoured silicone masks for hospital or home use
- Biopsy devices
- Laparoscopic and endoscopic devices
- Specialty syringes/auto syringes
- Air management
FROM FEASIBILITY TO MASS PRODUCTION
A Holistic Approach to Pharma Device Manufacturing
Our customers rely on us for speed to market with high-quality products. Extensive experience in both high-volume and low-volume manufacturing informs a nuanced understanding of commercialization scale-up.
01. Feasibility
We’ll assist you in creating concepts that are viable for mass production while identifying and meeting your product expectations.
02. Development
From concept development to product design, cross-functional teams engineer a reliable product.
03. Design Verification and Testing:
We manage the tooling, planning and assembly of your DV units to ensure your DV testing and submission to the FDA is efficient. We ensure an effective design that balances form, fit and function with manufacturing feasibility, regulatory considerations and commercial viability.
04. Regulatory Submission:
Gate review between each phase provides confidence in the regulatory submission process for applicable FDA and international compliance requirements. We create and manage our development process backed up with comprehensive DHFs and DMRs.
05. Manufacturing Systems Development:
As an experienced contract manufacturer with in-house tooling and prototyping, this is an SMC specialty. From custom test fixtures to world-class molds and tools, we manage the entire capital asset development for your program.
06. Pilot (Limited Market Release) & Mass Production:
Our design and development center will manufacture a low volume to meet limited-release and early-stage clinical testing needs. Once the production processes are streamlined, we can seamlessly transfer to a high-volume SMC manufacturing location. Our In-house global manufacturing and continuous quality support creates a seamless bridge with reliable program management throughout.
Faq
Frequently Asked Questions about SMC and Pharmaceutical Device 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.
