How important is human factors engineering in medical device manufacture?

More often than not the end-user look at a medical device and what it’s for. They rarely think about how it got there, the process behind its conception, its design and its manufacture. Even less often do they give time of day to the device post manufacture – how it’s unwrapped from its packaging, the way it’s handled, where the user places it and interacts with it.

Human factors engineering is the latest buzz word for the relationship we have with a product. In the past we’ve bandied about the phrases about ergonomics, human engineering  - the science behind the application of physical and psychological characterstics that relate to the design of a device and the way it’s used.

In the medical device sector, human factors engineering is big news. Of course a product is designed and manufactured but increasingly important is the collection of data and information about its interaction with the individual and the environment. Not only does a company need to ensure its device meets FDA regulations but additional considerations need to be given to design, testing, development. And what about logistics and scale-up? Is the company working with any partners? How do they fit into the process and are they fully equipped to realise the aims of the product and ensure its success?

One company that has given the concept considerable thought is Phillips-Medisize. The company’s integrated product development process combines human-centred design ways of thinking with a solid design for manufacturing (DFM) and design for assembly (DFA) philosophy. The approach covers design research, industrial design and human factors engineering focussing on product usefulness, usability, desirability and manufacturability.

According to Bill Welch, CTO Phillips-Medisize, in an interview with MPN, almost all of the diverse medical sectors such as diabetes, ophthalmology, oncology, gynaecology and cardio-vascular surgical intervention use and benefit from the company’s human centred design principles.

“In the field of medical devices we are involved in the development of ‘knock-your-socks-off technologies and applications – developed all the time – for ever more complex Class III devices, those still requiring pre-market approval. Class III devices are usually those that support or sustain human life,” said Welch.

The approach is clearly important to Phillips-Medisize and like the company there seems no doubt that human factors engineering will be given increased consideration to device manufacturers across the globe. At MD&M East, the company’s CEO, Matt Jennings recently spoke about the trend for evolution not revolution in the medical device space. As more companies look at refining aspects of product design, the concept of human factors engineering looks set to gain ground and set apart those giving it serious thought and consideration in their product development process.