PMPS Publication - Spring 2019

The benefits of using short-run manufacturing to solve the challenges of design transfer in medical device development and commercialisation.

By Carl Pullen, senior consultant mechanical engineer and Wade Tipton, partner responsible for quality and manufacturing at Cambridge Design Partnership

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, but if your approach has not anticipated the challenges of volume production then the struggle really starts when you send that product to a manufacturing partner, often in another country, and ask for it to be made in scale.

There are many complexities beyond the device design itself to consider when designing high performance medical devices, such as component cost, performance, assembly and inspection at the high speeds required for serial production.  Product 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 knock-on effects. When the practicalities of making a design work on a production line delays the launch of a product, then 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.

In many cases when a design is handed over to a contract manufacturer there are challenges with the production processes and equipment the manufacturer uses and is familiar with.  To address this, some contract manufacturers offer their own design service so new products are created with the final manufacturing process in mind.

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