Outsourcing production of medical disposable devices and systems can be a complex process. Sourcing teams are faced with challenging questions. How can the dual requirements of superior quality and continuing cost reduction over time best be satisfied? Is the chosen contract manufacturer as concerned about regulatory requirements as my company? If I source offshore will our company’s intellectual property (IP) be adequately protected? If tooling costs drive single sourcing, how can I ensure the supplier will work on the cost reduction we need over time?
Medical device manufacturers are facing continuing cost pressure. At the same time, regulatory complexity continues to increase. Reducing cost in that environment requires strong focus on working smarter in all phases of the product’s lifecycle. When product development and production is outsourced, this translates to more heavily leveraging your supplier’s ability to add value to every step of the process. In short, the supplier’s processes and expertise should take both measurable and hidden cost out of the overall product commercialization process.
Medical device manufacturers are under continuing pressure to cut cost while delivering superior quality. The amount of identifiable cost that can be taken out of a product through alternative materials and lower cost labor markets is finite, particularly given materials specifications, quality considerations and the fact that disposable medical device assembly typically involves highly automated processes.
Medical device manufacturers face continuing challenges to reduce cost without lowering quality. At the same time, a key benefit of globalization has been the emergence of health care market growth opportunities as the quality of medical care improves in densely populated emerging markets such as China and India. These trends drive many companies to reassess their manufacturing and supply chain choices.
Outsourcing product development can provide a competitive edge in terms of expanding engineering resources, accessing specialized expertise or reducing time and/or overall cost. However, product development partners can vary widely in terms of the value provided. Additionally, while offshore product development firms can provide a cost advantage; careful consideration should be given to the quality of their processes and ability to work well multi-nationally.
Transferring the manufacturing of medical disposables from one part of the world to another poses unique challenges given the combination of a robust regulatory environment, and custom tooling and automation. That said, when done properly, a ‘lift and shift’ strategy can seamlessly achieve its goals.
To some, tooling may appear to be simply one more non-recurring engineering (NRE) cost in a product development process. However, in medical disposables manufacturing, it is also the single most important item in ensuring that quality and cost objectives are met. The quality of the tooling design and fabrication process dictates the amount of secondary processing options needed for the product,the contractor’s ability to control key parameters in the process likely to affect product quality, production throughput and the life of the tool. Is there an advantage in selecting a contractor with in-house tool design capability rather than a utilizing a separate tooling manufacturer? This paper looks at five reasons why the answer to that question should be “yes.”
Keys to Success in Medical Micro Molding
It’s no secret that medical devices are getting smaller. Implants, tubing and drug delivery systems now often require injection molders capable of fabricating parts at a micro level. The smaller the part; the more complex the injection molding process since material behaves differently in smaller shot sizes. Forefront Medical Technology has experience with both standard and micro molded products. This white paper describes the product development and process complexities found in micro molding in greater detail, plus looks at how these capabilities were successfully applied in a recent micro molding project.
Replacing Metal Components with Precision Molded Plastic Parts
Metal parts have been traditionally used for endoscopes because machined metal parts ensure a tight seal at joints in the device. However, use of metal components is costly and drives a need for the product to be sterilized and reused in order to make cost it effective. Since endoscopy is an invasive procedure and the cleaning/sterilization process may not remove all body fluids or tissue contaminants,the reuse of endoscopes can pose a contamination risk to patients. A lower cost, single-‐use precision molded plastics alternative mitigates the risk of patient contamination plus eliminates the need for a washing/autoclave sterilization process following each procedure.
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