FDA guidance on 'human factors' triggers new medical designs

By: 
February 22, 2013


One of the hot topics at MD&M West last week in Anaheim, CA was recent guidance from the Food & Drug Administration on application of human factors and usability engineering to medical device design.

The FDA says that the recommendations "are intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls. The FDA believes that these recommendations will help control current risks and reduce future risks associated with device use."

Medical design is focusing on ergonomics. (PolyOne)

It's like manna from heaven for producers of thermoplastic elastomers, already one of the strongest growing plastics in the medical market.

In an interview with PlasticsToday, Larry Johnson, global director healthcare marketing at PolyOne Corp., outlined several design ideas under consideration, or in use, to improve ergonomics of medical devices:

Orthotics, such as braces . Styrenic block copolymers can form an entire orthotic device, or may be overmolded on top of a rigid sub-layer to provide comfort and control.

Prosthetics. Used with prosthetic fingers, TPEs provide grip properties and softness. Elastomeric prosthetic sleeves or liners impart a more natural look and feel, says Johnson.

Medical Devices. Soft TPEs overmolded onto rigid thermoplastic substrates can reduce muscle strain for specific activities, such as turning a dial, pressing a lever or pushing a button.

Jeff Somple, president of Mack Molding's Northern Operations, said that there is increasing customer interest in human factors engineering, but said that specific products are still in the approval pipeline and could not be discussed. Mack, once a significant molder of structural business equipment, has significantly stepped up its presence in the medical market.

One of the focal points of the FDA guidance is appropriate design of medical equipment for home use, an increasingly important market for plastics.

The guidelines state: "Medical devices intended for home use should be tested in that environment. This can be especially useful in assessing devices that pose problems associated with space, portability, availability of electrical outlets, lighting, noise, and operational complexity. Lay users should participate if possible."

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