Risk mitigation is a key factor in a reliable supply chain--one of which supply-chain managers for OEM companies in the medical device and disposables markets are acutely aware. Yet despite the importance of risk mitigation, many medical device manufacturers fail to carefully consider the risks involved with outsourcing molds for their safety-critical molded components. Below are five common mistakes that medical device OEMs make when outsourcing a medical mold.
Mistake #1: Failure to see the big picture. The sad truth is that many medical device OEMs continue to make purchasing decisions based on short-term thinking. Manufacturers often select the company offering the lowest price or a slightly faster delivery, for example, rather than partnering with a company based on quality and the the total cost of ownership (TCO) of the mold. But that TCO can disguise itself, and can range from the benign to the very severe. It encompasses the frequency of preventive maintenance required, ongoing mold maintenance over the life of the tool, product quality, and robustness of cycle, and potentially even the extreme cost of product recalls or patient-injury lawsuits.
Mistake #2: Failure to procure the optimum mold for the type of part and volume required. It is a fact that plastic components are only as good as the mold from which they are produced. That is to say that the quality of the molded medical device components is largely determined by the quality of the mold that yields those components. High-quality molds come from mold suppliers that understand the demands of the medical device industry with regard to quality. Not all mold manufacturers are alike, even though they may use the same materials and have the same type of equipment--both machine tools and software. Thus, OEMs must be cautious of choosing a low-cost mold supplier without taking into consideration whether or not the mold can meet quality requirements and help reduce overall cost to manufacture, which can potentially increase per-unit costs over the life of the program.
Mistake #3: Failure to select a supplier with an understanding of how design oversights can impact TCO. A good mold supplier to the medical device industry will have the ability to work closely with the OEM to ensure that the best possible part or product is produced. To achieve this goal, knowledgeable vendors will make suggestions along the way and provide direction that will result in a mold designed for manufacturability that will also run at optimal cycle times. All of those factors need to be taken into consideration when outsourcing molds for medical devices and disposable products. A high-quality mold that optimizes cycle time and reduces maintenance issues and mold downtime will quickly pay for itself in production.
Mistake #4: Failure to understand relevant regulatory guidelines. A company that does not fully comprehend the impact that FDA and the many regulations associated with the 510(k) process may have on the mold manufacturer--and ultimately the OEM's TCO--is vulnerable to selecting an unsuitable supplier. FDA's 510(k) process, including standards for mold qualification and validation, has made supplying molds much more challenging for the mold manufacturer in recent years. When Tech Mold built a medical device mold 15 years ago--we call that "the good old days"--the validation process was far less complex. It primarily consisted of a 24-hour continuous mold sample to ensure that the parts met print and that all the critical dimensions were within allowed tolerances. If everything was within spec and the mold functioned automatically, we would ship the mold to the medical device OEM customer or its molder. Today, in many cases, it takes longer to qualify a mold for medical products than it does to build it, and I would guess it costs more money to validate it than to buy it as well.
Mistake #5: Failure to properly qualify the mold manufacturer. Medical Device manufacturers are often not as diligent as they perhaps should be in terms of qualifying the mold manufacturer in terms of its expertise, knowledge, and capability to meet all qualification and validation policies and procedures. These may include operational qualification (OQ), installation qualification (IQ), performance qualification(PQ), FDA regulatory requirements, and quality assurance procedures (QAP) of the OEM. It is also the OEM's responsibility to qualify mold suppliers that can document and verify the mold, all of the critical-to-quality dimensions, and the production molding process parameters. Medical device OEMs must validate their suppliers by performing audits and rate those suppliers based on traceability, document control, corrective action systems, and much more through the OQ, IQ, and PQ processes to mitigate the risk that comes with outsourcing their molds. The OEM not only has to validate the mold, the press, and any auxiliary equipment involved in manufacturing their part, but everything has to be documented, which is an extremely rigorous process.
Much of this new paradigm of mold design, build, qualification, and validation has to do with product liability. An OEM's medical devices are only as good as their supply chain, and there is some responsibility on the part of suppliers to ensure quality. But ultimately, medical device OEMs are responsible for their own products and are liable at the end of the day.
Tech Mold Inc. (Tempe, AZ) manufactures precision molds and molding systems primarily for medical device OEMs, providing mold and process validation in its molding engineering center, Tech Mold East.