Minimizing the High Risk of Developing Plastic Medical Products
Product development outsourcing in the United States remains a great option, if you keep the following tips in mind when selecting a partner.
By John P. Beaumont, Beaumont Technologies, Inc.
No one could possibly say it any better. In recent promotions for a Webinar on outsourcing, Medical Product Outsourcing claimed: “For medical device manufacturers, time to market is shrinking, the pressure to reduce the overall product cost is growing and the requirement to maintain the highest levels of quality remains unchanged….”
Because of this, product development outsourcing by med-tech firms has become more prevalent than ever. Naturally, the first thought that comes to mind is to look to overseas companies for their outsourcing needs.
But, by first looking “locally, nationally or continentally” for an outsourcing partner instead of going overseas, designers, purchasing agents and medical device manufacturers can realize several immediate benefits. Domestic outsourcing firms enable you to deal with professionals who speak English and/or Spanish or French, have the same software and business styles and structures, and don’t require personnel from your firm to take expensive and exhaustive overseas plane trips. In addition, just as is the case in your company, the common goal of providers of domestic product development outsourcing is to keep the business here, on North American shores.
The Reasons for Outsourcing Begin With Some Basics
But let’s go back. Other than obvious reasons just stated, why consider outsourcing in the first place? Those of you who haven’t considered this route may be surprised. One of the primary reasons for outsourcing is that most OEMs likely don’t have the newest tools and latest technologies (software, materials knowledge, problem-solving capabilities, process knowledge and troubleshooting) that outsourcing providers have in their portfolios. With these tools and technologies in hand and applied to your product design and molding, outsourcing might very well save you money and time.
That’s the good news. However, as you look beyond your own walls and resources, you soon will discover all outsource providers of product development are not alike. Therefore, to best meet your needs, you must know what to look for in a partnership and what questions to ask.
Success in Outsourcing a Greater Challenge Than It Appears
The first and most important determination that must be made is, does the potential outsourcing partner have the ability, experience and tools to integrate design, process, tooling and materials? And does the company have these along with practical experience and in-depth knowledge of computer-aided engineering (CAE) to minimize what one should consider as the “risk” of development?
The risk of development? To try to explain, successful development of injection-molded plastic parts without risk is one of the greatest challenges faced by designers, engineers and companies today. Many plastic part designers and manufacturers might consider this statement extremely bold, brash or possibly even naive, considering the many significant technical developments that have evolved in recent years—miniaturization, nanotechnology, biodegradable polymers, polymer alloys, etc.
But, when a challenged OEM considers the number and variety of unique plastic parts conceived almost daily, as well as the complexity, cost and risk of development, such a statement is easy to fathom. Then, factor in the rigors to which the part will be subjected after it is produced, and the risk is even greater.
For starters, any new or existing medical part in need of improvement must be designed for optimum manufacturability. This is much easier said than done. Plastic parts can be produced by various methods including injection molding, casting, machining, thermoforming, extrusion, blow molding and rotomolding (among others). There are numerous variations, or combinations, of each of these manufacturing methods and a “right” and “wrong” match to the product to be produced. The selection must consider the start-up versus long-term production cost of each method, as well as the designer’s ability to match the design to the manufacturing method. On top of all this, more than 100,000 varieties of plastic materials are available for selection in matching one to the product, process and tooling for a particular part.
The risk of product development is easier to fathom by simply taking a look at the enormity of the numbers. An OEM can easily pay in excess of $100,000 for a mold to produce injection-molded plastic parts. If the resultant molded part or parts do not satisfy the OEM’s requirements (performance and dimensional), the company may have just purchased a very elaborate boat anchor. Even if the parts can be made to specification, are they being produced at the projected cost, or is the mold underperforming in the production of desired parts? In either case, you lose. Consider also that mold performance, the properties of the plastic materials and the size, shape (warping) and mechanical properties of the parts cannot be fully known until they are produced in the production mold. Prototype molds and computer simulation can reduce the risk—but not eliminate it.
The risk becomes even greater when production volumes are expected to be small. In this case, the relative cost of the tooling to the product is much higher. A failed product requiring extensive redesign and tool rebuild can be a daunting undertaking. This risk is further compounded if the company is small, or an individual inventor is involved, with the clever new product idea that requires plastic parts as a key ingredient. The impact of a failed product, in either case, could very well be catastrophic.
Further, the initial production start-up often is only the beginning of extensive, time-consuming and costly steps or re-steps that may require alterations to the part and the mold, material changes or adaptations and process refinements.
Finally, the part must be produced consistently—and profitably—over an extended timeframe (eg, hundreds of thousands to hundreds of millions of parts). Even then, shortfalls will crop up in the tooling, the process and the plastic material because of the complexities of the interaction between:
• The part design
• The plastic material
• The mold design
• The molding process
• The ultimate application of the part
The outsourcing partner who can overcome these shortfalls with the right tools in hand, and the skill to use them optimally, is, of course, the one to choose.
Solutions and Savings With Outsourcing
“Ah, but as long as we partner with a firm that has software development programs,” you say? Having CAE capabilities isn’t the full answer or the complete solution. While CAE has the potential of minimizing the risks of developing a new plastic product, CAE tools alone do not assure success. In 1990, the Plastics CAE Center at Penn State University was founded to help educate the industry about the benefits and pitfalls of CAE. An important, much-needed resource that came out of this was a book that has become an industry standard and “must read” for anyone engaged in the design and molding of plastic parts: Successful Injection Molding—Process, Design & Simulation. This endeavor resulted from the knowledge that industry was putting too much faith in computer programs while not recognizing the need to blend this technology with practical knowledge in plastic materials, part design, mold design and molding.
Plastics industry professionals are coming to realize that CAE is analogous to them as an X-ray or a computed tomography scan is to a doctor. The resultant pictures and information alone do not solve the problem but, instead, only serve to help provide a doctor information so that he or she can make more informed decisions. (Also, if surgery is required, a patient certainly doesn’t want the X-ray technician to remove the dark spot that appeared on the X-ray from his or her stomach.)
The point to be made here is, be cautioned: CAE technologies can provide a false sense of confidence, as they are only mathematical attempts to simulate reality. Significant weaknesses still exist in these technologies. Success comes from the skill of their use, combined with the cooperative efforts of an experienced team that must physically bring a plastic part through to production. Some firms have gone further and taken steps to address some of the most significant weaknesses of injection-molding simulation and challenges of successfully producing molded parts. The outsourcing firms that have focused on solutions after parts are injection molded make this approach by far the most costly and risky to develop.
For critical high-risk applications, successful multiple interwoven proprietary and patented technologies have evolved that maximize the effectiveness of CAE when combined with an experienced team. These include VeriFlow technology, used to verify mold-filling simulation performance and correct for inaccuracies, and iMARC (in Mold Adjustable Rheological Control), which manages the melt rheology in the mold to influence product formation and performance. These technologies are based on thousands of real-world applications, blended with elements of new scientific understanding of polymers that go beyond current state-of-the-art. These new approaches give designers and molders a powerful combination of tools to minimize development risks and maximize potential of success.
First Part Cost Is No Less Than the Cost of the Mold
The significant challenge in producing an injection-molded part results from the complex interaction between material, part design, mold and process. Recognize that this means one cannot fully evaluate the performance of a part until a mold is built and parts are molded with it. Therefore, the cost of the first plastic part is no less than the cost of the mold. Any company that has gone through the experience of introducing an injection-molded plastic part understands this risk and should be critical in evaluating firms it chooses as outsourcing partners.
However, after years of numbing experiences, many companies and outsourcing firms have adopted a process of rushing through the product design, mold design and mold build to quickly shoot parts, finding out what is wrong and then going through a tedious and costly debugging process.
Somehow the high costs of this methodology are forgotten and then repeated multiple times. Albert Einstein, while not directing this statement toward plastics, summed up this approach nicely by stating, “Insanity is doing the same thing over and over again and expecting a different result.”
Requirements of a Good Product Development Outsourcing Firm
A good product development outsourcing firm can and should tell you, up front, whether a product is badly designed and virtually impossible to mold on an injection-molding machine; this also applies to bad prototypes—and, of course, knowing which thermoplastics or elastomers work best, depending on the application. This, and more, is paramount. The following checklist is provided to help medical device manufacturers find the right outsourcing partner:
• Expert development team comprised of one or more
– Mold designers
– Product designers
– Molding engineers (this is one of the more important but most commonly missed components of the development team)
– Material engineers
(Note: requiring a full team is critical even if the outsourcing company is only being contracted to develop the part design)
• Parametric solids modeling as well as meshing with broad file transfer capabilities
• High-end 3-D and 2.5-D injection-molding simulation software.
– Mold filling, including runner and cavity analysis
– Mold cooling
– Shrink, warp and stress analysis
• Rheological verification molds with in-house molding and testing capabilities
• Intimate knowledge of the interaction of mold design, part design, process and material. This should include an understanding of how process affects the morphology of plastic materials and this relationship to the characteristics of the plastic part
• Computer material databases with search capabilities of properties, manufacturability and cost data
• WebEx or other online meeting software
• Skilled processing engineer(s) capable of supporting the start-up of your new product and mold with advanced scientific methodologies (avoid the finger pointing between your design and manufacturing outsource teams)
• Quick mold commissioning software
The wise decision, of course, is to look for and select a product development outsourcing partner who has the experience, resources, capabilities and willingness to integrate design, process, tooling and materials and becomes an engineering extension of your team. By addressing and understanding every phase of the development cycle, you and your outsourcing partner can achieve quick, outstanding and cost-effective results with your new, or newly enhanced, products.