A flexible approach with options that work for you
Manufacturing gives us the ability to turn ideas into reality and we do it with an approach that fits your specific needs. We can operate as your CM, OEM, or take a blended approach. Ranging from small batch to full-scale production, from prototype and pilot build to long-term manufacturing, we support complete products, peripheral accessories, and sub-assemblies. We specialize in low-to-medium production volumes, addressing a market often dismissed by larger CMs, but critical to portfolio strategies across multiple sectors. Our development, production, and quality system is flexible enough to deal with the rigors of medical device, while not placing undue burden on commercial and industrial products.
We take on a product with the same dedication as if it were our own
Utilizing our 30+ years of production, our operations teams work with you to ensure that the product you want to make is solving the right problem and becomes a successful business. We work with you on product cost, volume projections, and capital constraints as important design requirements and business considerations to be addressed early in development. Post launch, we perform continuous improvement activities to improve the bottom line and address customer needs.
Whether you’re just getting started, ready to scale up, or a well established industry leader, we have space for you
Healthcare / Life Science / Consumer / Commercial / Industrial
Strong partnerships to support your growth goals, supply security, and a diverse range of design requirements
Our extended team of suppliers and service providers work with us in support of meeting your goals. We manage procurement of various processes including: injection molding, thermoforming, extrusion, multiple casting methods, machining, forming, and material finishing.
Medical Device
Manufacturing for the medical industry from the beginning
Medical device design and manufacturing has been the core of our business since its inception and remains a strong part of our identity. We have experience in orthopedics, neuro, endoscopy, patient care, and other heavily regulated product categories. We work with you to customize your manufacturing strategy across engineering builds, through clinical phases, to full-scale commercialization.
ISO 13485:2016 Certified
FDA Registered
FDA 21 CFR 820 Quality System Regulations
Regulatory Planning and Assessment
IEC 60601-1 and 61010 Electrical Standards
Regular Audits with UL and SGS
Business Scaling
Strategically growing portfolios and launching new businesses
We understand what it takes to strategically grow your portfolio or launch an entirely new business. Specializing in small to medium volumes to get you to the next level, we’ll partner with you to meet your growing customer demands and new market opportunities. We’ll help enhance your current capabilities and build your vision from prototype to full production. We have the experience and resources to accelerate your launch from concept to direct delivery.
End-to-End Development
Full development and commercialization services
Experienced DFM and DFA
Embedded in our process to drive success
Product Testing
In-house development testing and V&V testing partners
Certification Management
Obtain and manage necessary certifications
Wide Range of Build Quantities
Meeting your needs and expectations
Shipping Options
Small parcel direct-drop to bulk truckload distribution
Post Launch Support
Active cost and supply chain monitoring for increased stability
Packaging and Labels
Innovative packaging design and custom labeling
Start-Up Development
Solutions that fit your launch plan and growth goals
We create customer-specific manufacturing solutions to fit your launch plan and growth goals. With a strong design and engineering history of launching polished and innovative solutions, we work side-by-side with you to bring your vision to life. We know how important it is to get to that next big milestone and our decades of manufacturing experience will help you save time and cost in product development. With our end-to-end research, design, engineering, and manufacturing, we can be your turnkey development partner.
Product and Part Testing and Certification
Support from planning through execution
Condensed Design Cycles
To help you efficiently prove out your business plan
Rapid Prototyping
With production intent
Wide Range Quantities
Production of 25-10,000 units
Feasibility Assessment
Quick-turn analysis of manufacturability
Small-Cell Planning
Production planning and development
Component Sourcing
Size appropriate sourcing strategies
We work to reduce risk while improving speed to market
From design, through development, to full-scale production, our process is centered around our robust Quality Management System (QMS). We ensure safety, reliability, and ease of use of every assembly with our focus and drive for quality outcomes. Our system is adaptable, allowing us to execute for full commercialization or design transfer.
Program planning and critical path management reducing time to market
Failure modes effects and criticality analysis (FMECA) for risk analysis and mitigation
Product and process verification and validation
Auditing – internal, supplier, and notified body audits
Supplier qualification, material confirmation, and assembly comply with your requirements and delivery needs
Our distribution system is set up to handle bulk shipments to our customers as well as direct shipments to the end-user. We utilize FIFO controls to ensure accurate costing and optimal product life. We work alongside you to understand not only finished goods costs, but also inbound and outbound freight, warehousing, outside processing, design, quality and regulatory factors, providing you with a detailed total cost. Full lot and serial control traceability are maintained throughout the process, enabling timely and targeted action in the event any issues arise.
Supplier controls focused on compliance and performance
Integration of electronic components and sub-assemblies
Product marking, labeling, and traceability
Components, sub-assemblies, kitting or fully finished devices shipped directly to you or your customers
