Thursday, September 12, 2013

Challenges in Medical Device Design

The product design in medical device is more complicated than other products. Medical device companies need to consider not only customers' needs, cost control, manufacturing materials as companies in other industries, but also regulatory requirements and healthcare concerns. To have better quality and efficiency in supply chain, medical device companies have to face many challenges in product design.
According to a survey in 2012, cost control (51%) is the most concern among medical device companies,followed by reducing inventory (39%), and globalizing supply chain (33%).
In order to save cost, medical device companies prefer to cooperate with contract manufacturers in the product design phase. Cooperation and communication tends to be more and more important with the development of this model.
Regulatory requirement is a special limitation in medical device design. The Food and Drug Administration (FDA) has specific regulations in design control in order to ensure the consistency in quality. For example, Good Manufacturing Practice (GMP) includes requirements in the methods used in, the facilities and controls used for, designing, manufacturing, packaging, labeling, storing and installing of medical devices.  All medical device companies in the US must follow this regulation.
Another interesting challenge in medical device design is material. Because of the public concern about the spread of disease in hospital, medical device manufacturers start to manufacture disposable products instead of glass or metal ones. However, with the increasing attention to environmental protection, hospitals tend to prefer sustainable products with less medical waste. So now, medical device manufacturers are working on producing products with limited number of recyclable materials to facilitating manufacturing and recycling. To solve the conflict between healthcare concern of spreading disease and recyclable products, is there any other ways except optimizing materials?


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