Contract Manufacturing

Bring products
to life
.

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.

Manufacturing Illustration

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.

Manufacturing Group Meeting
Tekna Manufacturing Weekly Planning

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.

Tekna Service Manufacturing Partners

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 606061-1 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
Tekna Manufacturing Quality Assurance

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
 

Tekna strives to provide innovative design solutions, exceptional service, and high quality products to our customers. We ensure our success in part by complying with ISO 13485 and FDA quality system regulations.