Case Study: Complex Medical Device
August 2, 2024
SMC Ltd. helped a large surgical device developer bring a highly complex balloon kyphoplasty device to market quickly, while improving quality.
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Contract Manufacturing for the Pharmaceutical and Drug Delivery Device Market
your Pharma partner
The right partner for drug delivery device and pharma contract manufacturing
At SMC, our partnerships with leading pharmaceutical companies have encompassed a wide range of drug delivery solutions. We can manufacture devices 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. All manufacturing facilities are FDA registered and ISO 13485 certified, and select facilities are licensed for drug handling. Our experience includes:
- Subcutaneous injection devices
- Intramuscular injection device
- Transdermal drug delivery devices
- Intravenous drug delivery devices
- Customizable autoinjector platforms for quick commercial launch
What We Do
End-to-end manufacturing with expert oversight for the pharma and drug delivery market
Combining in-house engineering, injection molding and assembly expertise with our global supply chain, our contract manufacturing capabilities extend from exploring the feasibility of your innovative idea through executing flawlessly on manufacturing, packaging and distribution. Devices that utilize a drug or other formulation may demand isolation of some processes, as well as special storage. We will address those requirements and establish the needed protocols to ensure your finished device is fully validated and compliant. Our manufacturing solutions include:
Program Management
- Including the handling of drugs and biologics in their primary packaging, such as aluminum canisters, capsules, glass or plastic cartridges and syringes, or in pill form
Injection Molding Expertise
- In-house tooling capabilities
- Expertise in silicone, thermoplastics and micro/mini components
Automation and Assembly
- In-house capabilities to save time and streamline your supply chain
- ISO Class 7 and 8 clean rooms
Quality and Regulatory Capabilities
- Robust ISO 13485-certified Quality Management System (QMS)
- FDA registered and MedAccred Accredited
- Extra security and infrastructure for controlled substances
WHO WE ARE
More than 35 years of drug delivery device and pharma contract manufacturing
A privately owned, global organization, we have earned the trust of many top pharma and drug delivery OEMs. As strategic partners to our customers, we offer efficient manufacturing and a nuanced understanding of commercialization scale-up while mitigating risk with our robust quality management and resource planning systems. Our highly specialized subject matter experts bring unparalleled experience and understanding to the table, and our best-in-class facilities around the world have been designed for rapid, high-quality manufacturing to meet the highest expectations.
WHY SMC
Driving customer success at every stage of the pharma contract manufacturing process
Product Development and Testing
Our expert capabilities include early involvement assessments and pilot manufacturing development for devices used in:
- Turnkey device design and development
- Device design verification
- Feasibility assessment
- Human factors studies
- Performance testing
- Prototypes, small builds
Rigorous Clinical Manufacturing
Clinical trial devices are manufactured using process validation (IQ/OQ/PQ), with regulatory documentation support providing finalization of:
- Product specifications
- Functional testing
- Design freeze
- Packaging and labeling
Efficient Commercial Manufacturing
With FDA pre-approval inspection, product life cycle is managed with scalable manufacturing:
- Launch with pilot solution
- Increase capacity to forecast
- Implement semi-auto solution
- Implement fully auto solution
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’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.
