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Using Short-Run Manufacturing to Solve Design Transfer Challenges

The challenges of design transfer are well known in the medical device industry. The innovation process starts by designing and getting the few prototypes of a new device working. However, if an approach has not anticipated the challenges of volume production, then the struggle really starts when that product is sent to a manufacturing partner, often in another country, asking for it to be made in scale.

There are many complexities to consider beyond the device design itself when dealing with highperformance medical devices such as component cost, performance, assembly, and inspection at the high speeds required for serial production. Designers who develop new products from a clean sheet have many issues to consider, and, often, they rely on a manufacturing engineer to sort out production issues later on.

Unfortunately, ‘sorting it out’ can be a tortuous process because each design change can have many unintended knockon effects. When the practicalities of making a design work on a production line delays the launch of a product, the direct costs and financial damage can be significant. In the field of medical devices, the window of opportunity in which to sell a product while it is still under patent is likely to be curtailed significantly, causing unforeseen harm to a company’s potential income. In these situations, the pressure is on.

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Carl Pullen is a versatile and creative Engineer with extensive experience in a variety of market sectors and a wealth of skills designing components and devices with precision and high quality. He has a strong background of computer-aided drafting design and comprehensive experience of injection-moulding design and manufacture all the way through to commercial production, including process optimisation and validation. Carl focuses on robust production techniques and efficient assembly processes to ensure long-term manufacturing at high-quality standards. He is also an experienced Project Manager and engages fully with all parties in complex projects to ensure cross-functional collaboration.

Wade Tipton has 20 years’ experience in the medical device industry, working in product design and development and process engineering. He has been responsible for gaining and maintaining International Organization for Standardization 13485 accreditation and technical file submissions and gaining Conformité Européenne and 510K approval for several Class 2 medical devices. Wade has led successful projects in new product introduction, high-volume manufacturing scale-up, and Lean Six Sigma. He has complete business process experience, from product design and development through design verification and validation and into process validation, product launch, manufacturing scale-up, and process improvement. Wade has a physics degree, a master’s degree in applied optics, and an MBA.
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Carl Pullen
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Wade Tipton
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