Business Details
18 Years
experience
Your Trusted Partner for Custom Manufacturing Solutions
Since 2008, we have specialized in transforming innovative concepts into tangible products through our collaborative manufacturing approach. Our ISO 9001 and ISO 13485 certifications underscore our commitment to quality management systems tailored for medical devices and diverse industries. With over 15 years of experience, we have served 450+ companies, offering end-to-end solutions from ideation to scaled production. Our team collaborates with startups, federal labs, and multinational corporations to develop customized manufacturing strategies that address unique challenges. We maintain a 45,000-square-foot cGMP facility with clean room operations and have designed 45k+ custom parts globally. Our expertise spans medical devices, consumer products, industrial solutions, and rail transportation technologies, including components for the International Space Station. We prioritize client partnerships through non-disclosure agreements, strategic sourcing, and dedicated project management to ensure timely delivery of high-quality products.
Services
Product Development
Contract Manufacturing
Quality Assurance
Strategic Sourcing
Engineering Prototyping
Packaging Design
Inventory Control
Details
- Year established: 2008
Highlights and features
- We offer 15+ years of experience in cross-industry manufacturing solutions
- Our ISO 9001/13485 certifications ensure rigorous quality management systems
- We implement a patented collaborative manufacturing process for customized strategies
- Our team has designed 45k+ unique custom parts across global markets
- We provide end-to-end solutions from prototyping to scaled production
Associations and certifications
- ISO 9001
- ISO 13485
Services
Contract Manufacturing
We provide full-cycle contract manufacturing with ISO-certified quality control, clean room operations, and in-house assembly. Our services include regulatory compliance management, supply chain optimization, and scaled production for medical devices, consumer products, and industrial solutions. With 15+ years of experience, we deliver cost-effective manufacturing strategies tailored to client-specific requirements.
Product Development
Our product development services cover ideation, prototyping, and regulatory compliance for diverse industries. We collaborate with clients to create detailed specifications, optimize designs for manufacturing, and implement quality assurance protocols. Our team has developed 45k+ custom parts and supported innovations ranging from medical devices to rail transportation technologies.
Quality Assurance
We maintain ISO 9001 and ISO 13485 certifications for quality management systems, offering DFMEA analysis, testing, and inspection services. Our quality assurance processes ensure regulatory compliance for medical devices and industrial products, with documentation support for FDA submissions and international standards.
Engineering Prototyping
Our engineering team creates functional prototypes, proof-of-concept models, and minimum viable products. Services include embedded software integration, material selection, and production intent prototyping. We support clients from initial concept validation through to manufacturable designs for diverse applications.
Strategic Sourcing
We optimize supply chain operations through strategic sourcing of high-quality components at competitive prices. Our services include vendor network management, cost reduction analysis, and logistics optimization for both domestic and international manufacturing requirements.
People
Josh Barnes
CEO & Co-Founder
Co-founded Harbor Designs & Manufacturing in 2008 with a vision to revolutionize collaborative manufacturing. Leads strategic direction while maintaining focus on innovation and client partnerships.
Kevin Barnes
COO & Co-Founder
Co-founder responsible for operational excellence since 2008. Oversees day-to-day manufacturing processes and ensures implementation of quality management systems.
Douglas Pemberton
Vice President of Quality in Regulatory Affairs
Manages quality assurance programs and regulatory compliance for medical devices. Implements ISO 13485 standards and ensures adherence to FDA requirements.
Rick Townsley
Vice President in Business Development
Drives business growth strategies and client acquisition. Focuses on expanding collaborative manufacturing partnerships across medical, industrial, and transportation sectors.
Questions
What industries do you serve?
We specialize in medical devices, consumer products, industrial solutions, and rail transportation technologies, including components for Amtrak and the US Postal Service.
Are you ISO certified?
Yes, we hold ISO 9001 for quality management systems and ISO 13485 for medical device manufacturing compliance.
How do you protect intellectual property?
We require mutual non-disclosure agreements (NDAs) before project initiation to ensure complete protection of client intellectual property.
What manufacturing capabilities do you offer?
We provide contract manufacturing, prototyping, quality assurance, strategic sourcing, and end-to-end product development services with global supply chain networks.
Can you handle complex product development?
Our team has developed 45k+ custom parts, including innovations for the International Space Station and advanced energy solutions.