Medical outsourcing is emerging as a significant competitive lever used by OEMs to improve quality, reduce time to market, trim costs and minimize capital outlays. At first outsourcing focused on contract manufacturing; now the spotlight is on design engineering and supply chain management as well as manufacturing. And manufacturing is no longer shoot and ship of specific parts; it's a totally integrated process starting with tool engineering and ending with assembly and certification of finished medical devices.
Picking the right plastics outsourcing partner can make-or-break a critical project—and even make or break the outsourcing OEM when you consider the enormous liability potential for medical product failures.
For starters, center your search on a partner that has compatible values, cultures and even business processes, if possible. A long track record of unquestioned commitment to quality is number one. Many contract manufacturers are focused on low cost and output—not quality over the lifecycle of the product. Another key principle is development of well-defined objectives, buy-in to those objectives and methods to measure those objectives at critical junctures of the project. Communication must be frequent, easy and bilateral.
Here are checklist issues to review: The only acceptable score is perfect.
Early design involvement. Early supplier involvement in medical product design cuts costs dramatically and improves product performance. If your plastics provider can't provide significant design resources, move on. Molders that actually design the parts can achieve much simpler designs that integrate functionality into fewer parts and reduce secondary operations. Early design involvement also dramatically reduces engineering change orders, a huge cost factor.
Speed-to-market. Integrated services speed products to market. Look for suppliers with a wide range of prototype tooling capabilities, from stereolithography and urethane casting to aluminum tooling. Also look for suppliers that can multitask product development, such as parallel work on materials, tooling, packaging, and assembly systems. On the production tooling side, do not settle for less than high-speed milling capabilities and automated manufacturing cells.
Productive tooling.Best-in-class toolbuilders minimize materials waste through best-in-class technology and processes. You must look at cavity-to-cavity repeatability, part quality, consistent filling and tool life. Look for capabilities in multi-cavitation tooling (two to 32 cavities), hot manifolds, hot gates and well-balanced runner systems. Does your prospective partner offer life-of-program tooling guarantees?
Clean room capabilities.Look for at least Class 100,000 which means that fewer than that number of particles 0.5µm diameter or larger can be detected in a cubic foot of air sampled from the room. Positive pressure keeps particles out. Laminar air flow through the room begins with filtration.
Tolerance capabilities. Not too long ago tolerances to the thousandths (0.001 inch) were the standard. Today, depending on part geometry, technology leaders can achieve tolerances of ±0.0005 inch using micromolding.
Injection molding repeatability.Robustness of the machines and the type of closed-loop control systems being used must be considered. One yardstick is the age of the machines. Replacement cycles of eight to ten years are necessary. Also check the molders' philosophy on use of cavity pressure systems. In-mold sensors take the guesswork out of the process. You know exactly what's happening when the plastics hits the metal. If you're producing 31 parts every 10 seconds, you want to know about problems fast. Another point: don't get bogged down in the electric-vs-hydraulic machinery debate. A case can easily be made that well-maintained hydraulics offer the best performance for medical molding.
Resin capabilities.You expect your molder can mold materials ranging from polyolefins to specialty compounds. Increasingly, however, OEMs are developing sophisticated proprietary compounds for implantable devices. One new player, for example, is bioabsorbable material, which breaks down in the human body to its molecular components. These materials require dedicated screws and barrels to guard against cross-contamination. They also must be shrouded in nitrogen fog when entering the press to ensure there is no oxygen present.
Two-shot molding. Multi-material molding adds functionality to a part with a second resin and also can improve touch-and-feel with a soft elastomeric material covering a more rigid plastic, such as polypropylene. One new twist: integration of O rings into a closure seal through a two-shot process to boost part integrity. Two-shot also allows product branding options.
Automation.Robots and other automated equipment cut costs, improve cleanliness and quality, and increase speed-to-market.
Micro molding. Micro molded parts today range from 0.002 to 0.06 grams for plastic, and 0.013 to 0.375 grams for metal. Look for a supplier that can deliver initial samples in three to five weeks, depending on part geometry and other requirements.
Secondary operations. Expect sophisticated marking and decorating options that will withstand repeated sterilization cycles, exposure to wide temperature swings or abrasive use. Laser etching in raw resin allows improved lot coding and reconciliation because it tracks every part it marks. Assembly and packaging skills capabilities are critical.
Supply chain management.Best-in-class medical manufacturing partners take over the entire supply chain for the outsourced products, from "sharps" to zinc die cast components. That means procurement, supplier qualifications, some manufacturing, all assembly, sterilization, certification and inventory management of all work in process and finished products.
On-demand.Electronic communications allow the medical manufacturer to see products pulled from the OEM's inventory, triggering a re-ordering process through the supply chain that allows new production that re-stocks inventory on-demand. In dock-to-stock, all lot release and testing take place at the outsourcing partner.
Quality programs. Ask if your potential supplier uses online, closed-loop vision systems to check for flaws where appropriate. A human inspector may miss imperfections on a printing operation, for example. A vision system can consistently detect pinholes in a printed surface. Look for internal process control and lot traceability. You can't just say you have HEPA (high-efficiency particulate arrestance) filters and a clean room. Check training for cleanroom practices. Make sure the manufacturer is audited at least annually by a third party.
Protocol development and validation. Protocol is the written plan for a critical process, such as sterilization and validation is the control technique used to detect any data that are inaccurate, incomplete, or scientifically unreasonable.
Registrations. FDA registration ensures traceability on manufacturing processes and establishes systems, such as tool and process validation, that help ensure quality. Also look for ISO registration 9001:2000.
Intellectual property protection.Make sure your partner shares your values and is located where courts will protect your rights.