The medical and plastics industries have continued to see advancements. As the two converge, plastics have emerged as a critical raw material for manufacturing medical devices, components, and equipment because plastics are lightweight, durable, cost-efficient, sterilizable, and have numerous design possibilities. Injection molding is one plastic manufacturing process that offers numerous advantages to the industry. However, choosing the right medical plastics manufacturer is critical for a successful program launch.
Launching a new product can be a trying adventure if you haven’t formed the right partnerships. The right injection molding partner will reduce your risk, help you achieve early market penetration by reducing your time to market, and minimize the stress of moving to large-scale production. Below are seven questions to help you decide if you are working with the right partner.
While there are countless injection molders, working with a company with experience with product launches in the medical industry is essential. With the industry being highly regulated, critical products, particularly class 1 and 2 devices and vital equipment, must be defect-free and reliable. Injection molders with experience in this market understand the essential nature of the products and take necessary steps to ensure they have a solid quality system in place and can deliver products on time.
They understand that getting your products into the marketplace is much more rigorous than many other industries, so they take your product launch very seriously. It starts with the design phase and follows your journey until you are ready for large-scale molding.
Not all resins are suitable for every device. Some components and devices need specific properties, such as compatibility with high temperatures. But not all molders have the experience or equipment to run engineered plastic such as PEEK, PEI, or PPSU. Your injection molder should be knowledgeable enough to help you find the right material and understand material compatibility.
As medical products advance, the need for more complex molding is needed. Insert molding, molding over a metal component, and overmolding, molding one thermoplastic over another, are two methods used by many medical devices. If you need a plastic handle over a surgical tool or a soft-touch grip on a connector, your injection molder must have these capabilities.
While other certifications can be valuable, medical product manufacturers should seek out an injection molding partner with ISO 13485 certification. ISO 13485 is an international standard for quality specific to medical devices. The FDA has issued a Proposed Rule to amend 21 CFR 820 to align with this international standard. 21 CFR 820 is the US regulation, part of the current good manufacturing practice (cGMP), that ensures medical devices are safe for the US market. With this strong support from the FDA, it is apparent that ISO 13485 is globally recognized as a top standard for medical device quality and safety.
While other standards focus on increasing a customer’s satisfaction by providing quality products, ISO 13485 aims to secure the safety of a medical device at all life stages (i.e., from the initial conception to final decommissioning and disposal). ISO 13485 has more demanding documentation requirements and includes process validation and risk management requirements. Unlike other standards, ISO 13485 has specific requirements for work environments, contamination control, cleanliness of products in production, and sterile products in production.
Not being compliant with FDA regulations is a fast way to derail your product launch. It is critical that your injection molding partner not only understands FDA regulations for medical devices but also is registered with the FDA as a medical device manufacturer.
The FDA maintains a database of registered medical device manufacturers that can be searched to verify their registration. While it is possible for an injection molder to make a component without being registered, they cannot assemble, package, and ship a complete device.
For sensitive medical parts and components, a clean room is non-negotiable. Injection molders that adhere to clean room standards will protect devices and components from dust, chemical vapors, and other contaminants that could compromise product quality, integrity, and safety.
For non-sterile class 1 and 2 device molding and assembly, an ISO 8 (100,000) cleanroom is common. This clean room filters the air through a HEPA filter between 10-25 times an hour to keep particulates within a specific range:
• There can be 3,520,000 particulates greater than or equal to 0.5 micrometers per cubic meter of air.
• There can be 832,000 particulates greater than or equal to 1 micrometer per cubic meter of air.
• There can be 29,300 particulates greater than or equal to 5 micrometers per cubic meter of air.
Getting product design right early reduces the likelihood of added costs and delays. There is a theory to 10 that states that the cost of errors increases tenfold at every stage of product launch. Finding out there is a design issue once the product is in assembly will create a significant setback and exorbitant costs.
A valuable injection molder will offer design for manufacturability (DFM) services. They will evaluate your product using predictive modeling software to verify it can be molded. They will also ensure that the product can be properly assembled after molding. If potential issues are spotted, they can make design change recommendations and keep your project on track. In addition, your molder should be thinking about your growth and ensure your product can be molded when you need higher volumes.
Moving from low-volume injection molding when your product first launches to high volume should be a smooth transition. However, some injection molders are not forthcoming with critical information to assist your new molder. An injection molder that cares about your success will pass on any lessons learned so your new molder doesn’t have delays while trying to figure issues out all over again.
As a low-to-mid volume injection molder specializing in medical products, we are ISO 13485 certified, FDA registered, and offer full validation and qualification. We set you up for success by providing fast turnaround, only the services you need, and through collaboration and transparency of our knowledge. As your bridge to production, we help you transition into full-scale production by providing exceptional manufacturing capabilities and service during the launch phase of your project.
With design assistance (DFM), automated tool manufacturing, broad molding capabilities (overmold, insert molding, engineering plastics), ISO class 8 clean room for molding and assembly, extensive quality assurance and testing capabilities, and value-added secondary operations and assembly, you get everything you need to launch your product under one roof. Even though our customers find value in all we do, we allow them to choose only the services they need to make their product launch successful.
Are you getting ready to launch your product? Contact us for all your injection molding needs.