The importance of medical devices is indisputable. But designing a successful product is a complex process taking into account not only the final function of the device but a range of additional factors too, including its interaction with human beings.
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We wouldn’t buy a product and accept the fact it we couldn’t get it out of the box, hold it properly or find it awkward to store. If we invest in an upgraded vacuum cleaner for example, we assume we will be able unwrap it alone, that we can use the product easily and that it actually does what we bought it for – vacuum.
Given the crucial, often life-saving role that medical devices play, it’s not surprising guidance exists on product usability to ensure safe and effective products reach the market. Of course we would expect a medical device to perform the function it has been designed for but other factors also come into play – the testing or manufacture of the product or how easy it is for a healthcare professional to remove the packaging when needed? How easy is the device to transport and does it lend itself to scale-up?
Earlier this year the FDA updated its 2011 guidance on applying human factors engineering (HFE) to medical devices – manufacturers will therefore already be aware of its importance which aims to improve products and reduce errors. It examines how humans interact with devices – how a person’s cognitive and physical functions tie in and what the limitations of device design might be.
Thanks to this FDA guidance medical device manufacturers are encouraged to focus on all points of interaction between the user and the device: “FDA is primarily concerned that devices are safe and effective for the intended users, uses, and use environments. The goal is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible.”
HFE is increasingly becoming a key issue for the sector. At this year’s Pharmapack in Paris, the topic was a key focus – the organiser recognised that for instance where combinations products are concerned, HFE along with design for manufacture (DFM) and design for assembly (DFA) are crucial to the success of this range of products.
Phillips-Medisize has been considering this aspect of medical device production for some time. An integrated product development process combines human-centred ways of thinking with solid design for manufacturing (DFM) and design for assembly (DFA) philosophy, covering design research, industrial design and human factors engineering focussing on product usefulness, usability, desirability and manufacturability.
Likewise product design and development firm Cambridge Consultants has teamed up with medical device start-up WaveGuide Corporation on the development of a portable nuclear magnetic resonance (NMR) scanner to tackle TB.
The new sputum test being developed is affordable and no bigger than a shoebox – so it can be used in mobile clinics, for example. It will give results in less than 30 minutes, with 95% accuracy. And it paves the way for detecting drug-resistant TB. This all means that appropriate treatment can be started promptly – improving patients’ chances of recovery.
“We’re bringing the reliability of expensive, high-tech laboratory equipment to patients in the field, as well as in hospital, in the form of a compact POC device that gives accurate results fast,” said Richard Hall, head of global medical technology at Cambridge Consultants. “Our expertise in fluidics, electronics, mechanical engineering and connected health, together with our human factors skills, is enabling us to help WaveGuide create a truly innovative diagnostic device for emerging markets.”
Ximedica is another business that recognises the value of human-centred engineering. Speaking to EE Times, the company’s Aidan Petrie, outlines how he helps maintain a lead in innovative medical device design using his experience working in medical device development. His aim is to “build a robust but nimble product development process within an FDA-regulated industry with a particular eye to usability and human factors.”
Petrie tells the magazine how the company operates: “Our project teams typically consist of a small core group that travels with a program from start to finish, and then brings resources in and out as defined by the program phase
"In the early stages, for example, user insight, usability, industrial design and technical innovation are the heavy emphasis. Later in the process, engineers take over the heavy lifting. Finally, the rigours of the FDA requirements kick in and so quality assurance and compliance take over there.”
Possibly human factors engineering doesn’t get the column inches it deserves. However its importance and increasingly significant role in the design and manufacture of medical devices cannot be underestimated. With FDA guidance in place now for several years, it will be interesting to see how this affects future device design – it should be very positive indeed.