Top 10 Tips: Silicone Molding
August 2, 2024
Liquid Silicone Rubbers (LSRs) are well-suited to the unique needs of the medical product industry. Silicone materials are biocompatible, inert and stable,…
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Medical Device Design & Development
TURNKEY CAPABILITIES
SMC’s Proven Design and Development Process for Medical Devices
SMC’s unique combination of contract manufacturing expertise with design and development engineering services allows us to take a holistic approach to your innovative medical device idea. We’re a company of thinkers and problem solvers, dedicated to making sure your concept can be designed, developed and validated to reach its full potential and scale up into an efficiently executed manufacturing program.
FROM FEASIBILITY TO MASS PRODUCTION
Our Medical Device Design and Development Process
Our experienced engineers leverage a unique array of in-house resources to design and develop your medical device. For example, the SMC Design Center in Ohio, our dedicated design and development facility, has a cleanroom for small-batch manufacturing for design verification, FDA Clearance, clinical builds and limited market release production before scaling up volumes at one of SMC’s production facilities. Our due diligence includes regular gate reviews, with design and process FMEAs, to identify and address concerns early to ensure your device is on the right path for regulatory approval and eventual manufacturing at scale. Throughout the process, our program management team facilitates clear, transparent communication and a seamless transition from the design phase to volume production.
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 create a seamless bridge with reliable program management throughout.
Markets
Design & Development Areas of Specialty
SMC provides full-service medical manufacturing for the pharmaceutical, medtech and diagnostics markets. Our focus is on single-use and single-patient finished devices. With our long history of quality and our partnerships with leading companies in all three markets, we understand the complex medical manufacturing ecosystem.
Medical Devices
Our medical device design and development experience encompasses everything from simple surgical tools to complex electro-mechanical systems. As manufacturing experts, we understand the importance of design to achieve a robust, cost-effective, manufacturable device.
Medical Diagnostics
Comprehensive services for compact laboratory and POC diagnostic devices form a distinctive specialty within our medical device design and development expertise. In-house design specialists for POC cassette or cartridge design have specific experience in microfluidics design and disposable/single-use products.
Electronics Integration
As a medical device development company working on products that incorporate electronics, we make sure our engineers understand user needs, available technology and technical limitations, and the complicated maze of regulations surrounding electro-mechanical medical devices.
Auto-Injectors
Our range of advanced autoinjector platform technologies combines patient-friendly designs with the ability to deliver a wide range of drug formulations for both subcutaneous and intramuscular injections. Our knowledgeable team will customize the technology for your formulation.
WHY SMC?
We Measure Our Success By Your Success
As strategic partners for customers like you, our purpose is to make sure that your innovations are manufactured efficiently, at scale, and that they go to market rapidly, in full compliance with quality and regulatory standards. To make sure that plans are executable and execution goes as planned, we maintain close control over manufacturing with our extensive in-house capabilities. Our best-in-class facilities are ISO 13485, FDA registered, Part 4 compliant, Bio Level 2 certified and CGMP/QSR compliant. As a privately owned, global company, we pride ourselves on the ability to pivot quickly to meet your needs.
Design
Efficiency and risk reduction start here, with detailed planning and DFM expertise.
Manufacture
In-house capabilities include injection molding and tool design and build.
Assemble
In-house assembly and automation expertise sets us apart from other manufacturers.
Package
Complete capabilities include labeling, kitting, boxing and shipping.
Faq
Frequently Asked Questions About SMC and Design & Development
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.
