白皮书

One of the key benefits of using a contract manufacturer for both design and manufacturing is the ability to work with a product design team that is experienced with manufacturing. This can eliminate design errors that could otherwise increase tooling costs and secondary processing costs. However, this option can also result in a design team that limits design choices to in-house production processes. The optimum solution is choosing a contract manufacturer with a broad enough range of capabilities that all design options that would make sense for the product are considered.

From a medical device manufacturer’s standpoint, tooling is often the least focused upon element in a product development process. Yet, tool design often has significant impact on product quality and cost; production scalability; and on-time delivery. A contract manufacturer’s ability to educate its customers on tooling options and trade-offs associated with each option helps ensure optimal decisions are made in product development.

Outsourcing single use medical device manufacturing with the right supplier can add expertise, cut development time and lower total costs while maintaining superior quality. The question becomes: “what capabilities should that supplier have in-house vs. manage through third parties?”

A key challenge when developing new medical single use products is optimizing automation strategy as volumes grow. Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery systems and medical device systems, routinely helps its customers commercialize new products by providing a scalable solution designed to significantly increase capacity and reduce labor cost as volumes grow.

One of the challenges of designing and manufacturing medical devices is the fact that choices made in the product development effort can have significant impact on regulatory approval lead-time, tooling complexity and cost, and production capabilities. When those choices are made by a cross functional team that reviews potential tradeoffs there is generally balance between features and cost. However, when teams work in functional silos, the end result is often a greater number of design spins or products that are costly to manufacture to desired quality standards.

The unfortunate truth about manufacturing offshore is that unit cost is rarely reflective of total cost. Nor is every low cost country (LCC) contract manufacturer equally equipped to provide the support required by highly regulated medical product design and manufacturing. A strategy based on having your team train or continually audit a low cost contract manufacturer into compliance with your systems, typically doesn’t result in real cost savings if your internal costs as well as the supplier’s charges are measured. In short, for offshore contract manufacturing to consistently save money, the contract manufacturer needs to not only have a competitive unit cost. It must offer the same level of systems and processes found in domestic suppliers. The challenge for a supply chain management team becomes finding a contract manufacturer capable of delivering more than unit price reduction. Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, built its business model around examining that equation. This paper looks at the key support elements that are integral to achieving lowest total cost.

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.”

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.

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.