Medical Device Assembly & Packaging Services
Turnkey Medical Device Packaging
We are a leader in complete packaged, single-use, sterile medical devices. Our turnkey medical device sterile packaging services are ideal for 3D, multicomponent products such as suture anchors, pin plates, spine screws, and sterilized instrument and implant kits used in orthopedic and sports medicine applications.
We provide industry-leading medical device assembly and packaging services, including:
- Package design, development, and testing
- Tooling design and fabrication
- Packaging process development and validation
- Cleanroom thermoforming to provide medical grade trays
- Sterile delivery techniques
- Manual and automated assembly to match volume and cost objectives
- Supply chain management
- Secondary packaging flow, including GS-1 labeling to meet global requirements
- Medical device packaging sterilization process validation and routine processing through strategic partners
A medical device and its sterile packaging go hand-in-hand, yet complex packaging design and validation is sometimes left forgotten until the end. Today’s FDA and ISO regulations require more than 25 separate protocols and test reports to validate that a package protects its device and stays sterile from factory, storage, distribution, and even aseptic transfer to the end-user. The regulations are complex and are often confusing, leading to compliance problems, recalls, and, in the worst cases, patient harm.
J-Pac’s package design and validation services include:
We know sterile packaging and have dealt with hundreds of unique packaging formats. Smart design starts with understanding what package formats achieve the desired levels of cleanliness and sterility. User needs also come into play because the standards require that any sterile package be designed to accommodate aseptic transfer. Because we do our own thermoforming, we can create unique packaging designs optimized for your unique products. We balance protection, ease of use, and material costs. Product family designs are also configured to minimize validation costs by using one thermoform for several components.
Virtual package photos
Even rapid prototyping can take days or weeks. Why wait? We can give you a photorealistic rendering that is indistinguishable from the real thing and much quicker. Also, in most cases, several design iterations are required before you want to spend money on a prototype. A picture is worth a thousand words!
When you need a physical sample of a real tool, J-Pac can respond quickly. Our prototype tools serve a double purpose because they are acceptable for small lot production often required for clinical trials. 3D printed packaging is usually not of the surface quality that customers expect – so instead, J-Pac uses rapid prototyping processes and quick change thermoforming equipment.
Both ISO 11607 and FDA regulations require that the package be designed to maintain device sterility until the point of use. This means you need to demonstrate that the contents of the package can be aseptically transferred into the sterile field. This greatly impacts package design. Who better to give you feedback than our sterile field experts that actually use medical devices in the real world?
ISO 11607 includes the carton as part of the packaging system. It has to be designed to maintain sterility during distribution and storage. How are the devices shipped to sterilization? How are they shipped to the customer? These factors have to be taken into consideration. We can do this with an eye toward minimizing material and transportation costs.
Device History Record (DHR) ready validation protocols and reports.
Package design is collaborative starting with J-Pac understanding your product FMEA. A packaging validation can involve more than 25 unique protocols and reports. We provide these to you for your technical and regulatory files. There is no need for you to write protocols.
Simulated distribution testing
We work closely with accredited testing labs for final testing. Having J-Pac work with them directly saves you time, money, and headaches. We know what questions to ask. We understand what testing is required. Prior to conducting a simulated distribution study, we conduct internal feasibility tests to make sure the package passes the test the first time.
Shelf life stability studies
We find that many customers misinterpret the ISO guidelines for stability and shelf life. They often request protocols that unnecessarily extend the development cycle. We will design and execute studies that meet the standards in the fastest possible time.
Before developing the assembly process, we conduct a DFM review of the product to determine the most efficient way to assemble it. The assembly process is then developed according to the commercialization requirements of the customer.
Assembly and packaging processes are validated based on the established critical specifications. Assembly processes undergo a formal process including Installation Qualification, Operational Qualification, and Performance Qualification. Our Performance Qualification process involves running multiple separate lots over multiple production operators, shifts, and raw material lots to ensure all processes are capable.
A new program is transitioned into manufacturing using a formal process that includes a cross-functional team of representatives from Quality, Manufacturing, Engineering, and Purchasing. The team follows a strict process to ensure all the documentation, routers, procedures, and validations are successfully completed prior to transition.
Assembly and packaging production is conducted using Lean Manufacturing processes that ensure efficiency, quality, and accountability. Small teams of trained employees with an accountable group leader ensure the manufacturing processes are followed. Each area maintains visual metrics to monitor performance.
J-Pac has preferred partnerships with several outsourced sterilization companies. These companies ensure your medical device undergoes proper sterilization validation and is compliant with all regulation. J-Pac helps your business be successful through matching the right sterilization partner with your specific needs. We work with you to determine the factors that best fit your current needs as well as future growth.
Considerations we take into account when selecting the right sterilization company for a project:
We work with 3rd party consultants that are experts in the field to help you determine the appropriate sterilization method for your device.
Sometimes the selection of the sterilizer can be sensitive to location due to the number of loads required and transportation costs. A high-quality sterilization supplier located the closest to our facility or yours is one consideration.
Since we work with many customers and products, we have keen insight into which sterilization supplier can meet your lead-time requirements. We consider several factors such as chamber size, capacity, and logistics, as well as the sterilization process capability itself.
J-Pac can recommend sterilization companies that can provide chamber equivalency. This reduces your risk for product reliability by enabling additional capacity and back-up capability.
There are differences in validation costs from one sterilizer to the next. We can provide guidance to best balance your budget with capabilities.
J-Pac performs sterilizer supplier audits so you don’t have to. We treat the contract sterilizer as any other supplier that has to be qualified. We prefer sterilization suppliers with adequate process controls for product segregation.
Some sterilization companies are a better fit for your needs than others. J-Pac can help you navigate this important part of your process.
Supply Chain Management
J-Pac believes that excellent supply chain management is much more than coordinating raw materials suppliers. The medical device industry lags behind other cutting edge industries in regards to using supply chain innovation and excellence as a competitive advantage. J-Pac regularly sees the opportunity to improve performance in inventory, total supply chain cost, and on-time service.
Many of the challenges in managing a good medical device supply chain are related to the high levels of regulation. A survey by the consulting firm A.T. Kearney reports that 81% of medical device supply chain executives cite regulatory requirements as their primary concern.
Additionally, the second most cited challenge (51%) was “supplier issues,” with many companies struggling to find suppliers that have the right mix of compliant processes, quality, and reliable availability.
J-Pac can help.
We give you resources
We see it all the time - customers don’t always have all the resources to focus on their supply chain. This is especially a challenge given all the mergers and acquisitions where large device companies often take years to integrate larger, more complex supply chains with fewer people.
Our lifeblood is our supply chain – your supply chain. J-Pac is a metric driven company and we use on-time delivery and quality as our two most important measures to gauge performance. We measure and review this at all levels every week. By having J-Pac manage your supply chain, you get the benefit of our purchasing, engineering, quality, and management resources focused and - coordinated all under one roof - on our collective suppliers.
We sweat the details
We are properly capitalized and will purchase raw materials on your behalf. We audit suppliers through our ISO 13485:2016 compliant procedures. We track your specialized tooling and molds and will coordinate with you when changes are needed. We handle the day-to-day issues so you don’t have to worry about it.
You become more nimble
When J-Pac manages your supply chain, you become more agile and can change production requirements much easier than you can with in-house manufacturing. It’s done with a phone call, not with endless meetings and coordinating functional silos.
We minimize risk
Our ISO 13485:2016 compliant quality system becomes yours. From tracking suppliers’ service performance to handling NCRs, ECO implementation, and SCARs, we manage variables that could cause compliance and delivery problems.
As the waves of consolidation continue in the industry, there is one troubling trend we see – as contract manufacturers become larger, their ability to react becomes slower. J-Pac is different. We’re big enough to meet your needs and we’re small enough to respond lightning fast.
We know which suppliers are best for your product.
We know you have pressure to reduce suppliers, but that’s not always the best solution. Some suppliers are better than others and the best supplier may depend on your specific component. With J-Pac you don’t have to be limited. When we handle supply chain management, you only deal with us as a single supplier, yet we have the flexibility to use multiple suppliers that are best for your product.
The Latest Updates in Medical Device Assembly & Packaging
J-Pac Medical has the expertise and industry knowledge to be your go-to manufacturing partner.
Let’s Get Started.
J-Pac is ready to simplify your supply chain by manufacturing and packaging your single-use medical devices.