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The balance is swinging from high tech to the human touch for medical technology companies, as the emphasis in product development shifts from functionality to regulatory compliance, cost-effectiveness and usability.

The demand for innovation has never been greater, as industry is driven to design products that differentiate themselves for a specific functionality while demonstrating cost-effectiveness in the context of a larger healthcare system.

“All western countries are short of cash with budgets that are tight,” says Keith Turner at Cambridge Design Partnership. Those companies turning to emerging markets to find double-digit growth discover another form of cost pressure, with customers seeking basic functions in low-cost devices.

“We have to innovate in a way that does both. If you are not innovative, you are selling commodities, and you cannot grow a business on commodities,” says Turner.

Usability and acceptance make or break products
A critical concern for Turner and his team at Cambridge Design is found at the other end of the device, where patients input data.

“Increasingly we are putting medicine in the hands of consumers,” says Turner. “In terms of future engineering challenges, this is big. The dynamic is changing — medical instruments are being operated by lay users at home and [the data are] interpreted by professionals in a clinic.”

Design challenges include ease of use, device safety and how resistant the product is to user error.

“US FDA is about to issue a new requirement that all submissions for new devices include a usability engineering report,” says Turner. “What is different is that FDA now wants to see that you’ve done it properly from the outset. This requires a whole new set of skills. These studies are not necessarily going to be done by engineers but by people who understand people, who know how to ask the right questions and can interpret user emotions and actions to identify where they find difficulties. Then we will need someone who can interpret this information and engineer a solution,” adds Turner.

Read the full article on the EMDT website at

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