Elizabeth Roberts, Currier Plastics, outlines the importance of custom molding from start to finish in the IVD industry.
The In Vitro Diagnostics (IVD) industry has seen tremendous change over the last decade, triggered by many factors including the global financial crisis; the Affordable Care Act, PAMA, and Clinical Lab Fee Schedule reforms. In turn, IVD manufacturers were forced into cutting internal and external costs to make up for slow growth in the US and European markets. During that time many larger companies turned to manufacturing design houses to aid the design process, not just for the devices but the consumables themselves.
Understanding the go-to market strategies, restrictions, and rigors of healthcare companies is important in appreciating the complexities they face on a day to day basis.
When manufacturing medical / IVD plastic consumables, there are many with the processing capabilities for molding these types of products. Engaging at the concept stage can make the difference to how successful you are in the market. You need an organization with the right combination of results-driven talent and technology to help you reach your potential in the shortest time possible.
To be able to serve the medical and IVD community at large demands the molding expertise to be able to properly develop the form, fit and function of the plastic component. Whether it’s a leak-proof bottle and closure, or a multi well tray, the burden must be taken off the OEM by providing a product that meets the specified user requirements and with zero defects. This can be achieved through early concept design review and collaboration, component prototyping followed by quality-driven production molding. Working with a molder who can provide a hassle-free approach includes being in direct contact with expert molding engineers who are responsible for the product from concept throughout the manufacturing lifecycle and who remain engaged throughout the production process, as changes will invariably occur as the project takes life.
The design and build of the production tooling are paramount to a repeatable molding process. It begins in the prototyping stage before any steel is cut. Predicting how the part will perform in and out of the mold is part of Design for Manufacturability (DFM). Maintaining component part aesthetics for the human factors like ease of use and cost effectiveness, other key factors in the manufacturing process need to be evaluated as well. These factors include mold flow, tool design and complexity, draft, and optimal wall thickness for performance by the end user. Material options should be considered that could positively affect performance and reliability.
Early involvement using a DFM process produces better part-to-part consistency and can reduce mold costs significantly. The DFM process includes using tools to develop the user requirements that must be established early in the process:
FEA - Finite Element Analysis-shows whether the product will function as designed, analyzing the effect of vibrations, fatigue and heat transfer.
DFMEA - Design Failure Mode and Effect Analysis – systematic approach to failure analysis
Moldflow - An injection molding simulation tool used for improving both part and mold designs, and the manufacturing processes.
Solidworks - 2D and 3D solid modeling computer-aided design and computer-aided engineering computer program
Automation - During the development phase of the program, full automation may not be required for producing components but will become necessary as the program reaches maturity. This can begin with the hand assembly and grow into hands free automation when in full production.
Packaging method - How the product is handled once it reaches the destination facility is important. There should be a verification tour to examine the filling line automation and ask the qualifying questions. What works for one customer won’t work for another. The goal is to optimize packaging so the product can readily be used.
Sample parts can be provided using a variety of methods including 3D printed models and building single cavity prototype molds.
While your focus is on the approval process by the FDA and other regulatory agencies, your molder should be able to provide the samples to use while qualifying your IVD instrument, filling lines, etc. During the first year, prototype molding and hand assembly may be used for the shorter runs during the qualification process. This pilot manufacturing enables you to design and qualify your production equipment using the sample models for testing. This step allows:
- Get to design approval quicker
- Low volume flexibility
- Qualification processes accurately defined
- Sellable parts
Production
A molder with a broad range of molding machines give you flexibility in component size and annual volume capacity. Injection stretch blow molding (ISBM) using PET material gives your product a glass like appearance. Extrusion blow molding (EBM) with PE material is more opaque. Thin and thick wall designs are possible with a variety of geometries and neck finishes. Your injection molding (IM) partner should have experience processing a full range of specialty-engineered thermoplastics to optimize your components plastic design requirements for medical/IVD instruments.
Over the course of a year, we may speak to several hundred engineering and purchasing teams who are looking to partner with a custom molder who can support their goals. They work with global suppliers who are on different time zones, already have multiple customers they are trying to support, and layers of red tape to get through to make a decision. This can slow down the manufacturing process.
At Currier Plastics, we’ve created a culture of integrity and mutual respect for our co-workers, our customers and our community. Our V² symbol is defined as Value x Velocity. As a business we are driven to provide two elements of outstanding capabilities to our customers; speed or true velocity in everything we do multiplied by superior value that incorporates total quality, operational efficiency and established organizational core values.
The demands of today’s IVD customer does bring challenges to our organization to be able to respond increasingly faster to their requests for custom molded plastics.
There are hundreds of injection and blow molders in the US but there are less than 30 that do both and fewer that offer it from a single location.
At Currier Plastics, we offer molding expertise in ISBM, EBM and IM. We currently have a 128,00 sq ft facility in central New York and have an expansion planned over the next three years to add much needed manufacturing and warehouse space.
The FDA rules and regulations will be changing again in the next few years creating a more stringent environment and possibly a few more reams of documents to be completed before testing and approval are granted for production and release to the scientific and medical communities. his may see IVD consumables taking on different shapes as the form, fit or function is challenged.