Medical Device Contract Packaging
You may not have thought about packaging services as an important element in the development of a successful medical device. However, the right packaging solution is critical to protect your product through sterilization, shipping and finally delivery to the end patient.
Pro-Tech Design & Manufacturing, Inc. has over 40 years of experience creating packaging that meets the unique requirements of our customers.
We provide medical device contract manufacturing and packaging services and have the expertise and market understanding to design solutions that balance quality, Food and Drug Administration (FDA) requirements, and cost.
Contract Packaging Services
For most medical device companies, packaging is not a core capability. At Pro-Tech Design & Manufacturing, Inc., we can fill that gap.
We are solely focused on providing packaging services for the medical device market. And because we work with a broad range of customers and packaging, we bring detailed knowledge of the industry, packaging requirements, diverse components, and cost-effective solutions.
We take the burden of this specialized area off our customer’s plates so that they can focus on what they do best – designing great medical devices.
The process of packaging development starts with understanding the needs of the customer. From the largest medical device companies in the industry to small startups, we seek to understand the unique requirements of each so that we can create a packaging solution that is tailored to their situation.
That process starts immediately with a Packaging Consult where our experienced sales engineers determine the key components of a customer’s situation.
This is usually a combination of the device itself (size, materials, complexity, design), quality considerations, sterilization requirements, specific needs for the packaging, and cost. Because this is what we focus on, we leverage all these elements to develop packaging solutions specifically designed for that customer.
Our team of engineers use the latest design software to create packaging designs that blend technical and regulatory requirements with cost-effective designs.
They are experienced at developing tailored packaging solutions that not only provide quality and critical sterile protection, but also take into account important production and cost elements.
Understanding the link between initial design to full-scale production is a valuable part of the services that we provide.
Custom or Pre-Validated?
One important decision early on in the packaging consult is whether to design fully custom packaging or to use our portfolio of pre-validated packages.
In consultation with customers, we determine cost and timing considerations and provide them with a recommendation on how best to solve their requirements. Pre-Validated packaging has been pre-tested and qualified to meet regulatory requirements and aging studies for up to 5 years.
Often pre-validated pouches and trays can get customers to market more quickly and cost effectively with no sacrifice in quality.
Packaging Materials Expertise
We processed over 8,000 orders last year and work with packaging products for nearly all sectors of the medical device market. We are experienced in a wide range of packaging materials and configurations, including pouches, form-fill-seal trays, and even sewn items.
Production runs ranging from a few to thousands are routinely managed through our dedicated ISO 13485 registered facilities and our equipment can be set up to handle unique sizes and quantities.
Different materials require different sterilization and shipping solutions, and because we work with a broad array of medical devices every day and have been doing this for over 40 years, we bring a depth of experience and solutions to your business unmatched in the industry.
Medical Device Packaging Capabilities & Services
Pro-Tech Design & Manufacturing, Inc. provides full-service medical device packaging solutions.
Here are some examples:
- Sterile Barrier Form-Fill-Seal
- Pouching – 6 High-Speed Pouching Lines
- Trays – 5 Rigid Tray Lines
- Product Assembly
- Vacuum/Inert Packaging
- Liquid Filling – Syringes, Vials, and Tubes
- Chemical Compounding and QC Services
- Custom Boxes, Foam, and Inserts
- Heat-Sealed Carding
- Automated Bagging
- Shrink Wrapping
We are ISO 13485 certified and FDA registered. We have been developing packaging for the medical device industry for 40 years and have expertise in all areas of packaging design, development and production.
We have facilities in Santa Fe Springs, CA; Arlington, TX; and St. Paul, MN, with redundant capabilities to protect your supply chain.
Please contact us for a free Packaging Consult to kick off your next project.
Frequently Asked Questions
Q: What is the benefit of working with a Medical Device Contract Packaging company?
A: A medical device contract packaging company like Pro-Tech Design & Manufacturing, Inc. is specifically focused on developing packaging solutions for medical device customers.
We have expertise in developing sterile and non-sterile packaging that protects medical devices from design to shipment to the end patient.
We understand the unique regulatory and sterilization requirements for medical device packages. We also understand the benefits of different sterilization methods and how they interact with different packaging materials and product densities.
Plus, when you use a medical device contractor you only pay for the time machines are running and people are working.
Q: What services do you provide?
A: We offer a full range of contract packaging services, including packaging consultation, design, cleanroom assembly, sterilization coordination, labeling, warehousing, and shipping.
Our ultimate service is to provide protective packaging so that your medical device is safely delivered to the end user.
Q: Do you provide packaging sterilization in-house?
A: We provide in-house steam sterilization and are an ISO 17665 registered contract steam sterilizer.
For Ethylene Oxide (EtO) and Gamma sterilization, we work with licensed third-party sterilizers and manage coordination and consultation for our customers.
Q: How do we get started?
A: Complete the
A detail quotation will follow that includes production costs and any validation recommendations.