Medical Device Link.

SPECIAL REPORT

London-based PDD focused on developing a user-friendly interface and foolproof drug-delivery mechanism for the easypod system, marketed by Merck Serono.

What essential items should be in a product design toolbox? We posed that question to several design engineers working in the medical technology industry. We also told them not to feel limited to mentioning only tangible items. The philosophical concepts that may be part of a larger, metaphorical toolbox, we stressed, were as much of interest as next-generation CAD software. Not surprisingly, they came up with some creative tools.

Begin at the beginning. Lewis Carroll had it right. When the White Rabbit asks the king where he should begin reading a letter in Alice in Wonderland, the monarch replies, “Begin at the beginning. Go on until you come to the end, and then stop.” Design projects should follow a similar pattern, according to Stephen Knowles, managing director at Industrial Design Consultancy Ltd. (Datchet, Berks, UK). In particular, design engineers should be acutely aware of a project’s myriad needs right from the start.

“Setting up a plan at the outset, and keeping on top of it, is a crucial aspect of product design that is sometimes overlooked. You wouldn’t begin production without a drawing of the part and an understanding of how it will be made,” says Knowles. Yet, he adds, it is not uncommon for companies to neglect planning the process from design to product launch. “That is one of the key aspects of successful product development,” notes Knowles. Another is knowing when to stop.

You can find ways to improve the design of just about any product, says Knowles. “But it’s churlish to be overly critical, because at some point you have to start making it.” Don’t let perfect be the enemy of good, in other words. “You’ve got to make sensible choices that result in a good product that is ready to launch within the agreed time frame,” he notes.

Industrialization should be part of the debate early in the design process, adds Jim Orkney, managing director at Kinneir Dufort (KD; Bristol, UK). “We define industrialization as the consideration of how a design will meet the cost-of-goods and effectiveness requirements when it goes into production.” To ensure that design for manufacture is front and centre even in a project’s early stages, the KD staff includes someone who comes from a manufacturing background on the product development team.

“Following the initial user and category research, we go into brainstorming ideation,” explains Orkney. “That is when we typically get our industrialization person involved. He comments on our ideas, adding value in the process. For example, he might suggest that polypropylene would be a good material to consider in terms of cost,” says Orkney. And when the design engineers get too carried away, as can be their wont, he can reel everyone back to reality.

Know your user. “You need to do research at the front end of a project to understand who you are designing the product for and the category into which the device is going to fall,” says Orkney. Observing how users interact with competing or similar devices is integral to KD’s product design process.

Sidebar: Medical Design Excellence Awards Programme Announces 2007 Winners

“We have our own research facility on-site, which is a real asset because we can run groups relatively easily. It allows us to construct the research to suit our client’s brief and to extract the kind of knowledge we need,” says Orkney.

It’s not always possible to get professionals or clinicians together in one location at a given time, however. That’s when the design team hits the road and performs its ethnographic study in the users’ natural habitat. “That can be more useful, in fact, than bringing them into our office,” he adds. “It can be more relevant to our objectives because we are talking to them in the context of their working environment and we are seeing where the product will be used.”

Understanding the sometimes-intimate relationship between a user and product was a central concern at PDD (London) when it designed the easypod.

Marketed by Merck Serono (Geneva), the easypod is a drug-delivery device that administers the company’s recombinant growth hormone– deficiency drug. It is described by the manufacturer as the first product of its kind in this therapeutic area. Because this therapy typically involves parents injecting their child with the drug on a daily basis, there were a number of sensitivity issues involved in the product’s design, according to Alun Wilcox, director of medical at PDD.

“We based the design on an understanding of the delicate relationship between the parent and child during this traumatic experience,” says Wilcox. “The parent has to inject the child every night, and this places stress on their relationship.” The designers sought to mitigate this through the product’s shape, its colours, and its tactile qualities. “We wanted to put in features that would help the child to relate to the device as a friendly, nonthreatening product. That’s why we added a picture frame on the back to allow personalization,” explains Wilcox. “The same goes for the electronic interface, which has comfort settings.” The easypod offers patients selectable settings that allow them to fine-tune the injection.

Aim for simplicity. “Medical environments are very complex,” says Raimund Erdmann of Erdmann Design AG (Brugg, Switzerland). Design projects, at least in the early stages, don’t have to be.

The QuikDrive mini surgical screwdriver, designed by Erdmann Design AG for Stryker, has received a red dot award in recognition of its aesthetic and functional qualities.

“A designer should try to simplify things. For example, he can come up with a prototype that brings alive the new feelings that a design may inspire,” says Erdmann. Forget the fancy equipment and the visualization tools, he adds. “You need to retreat and ask yourself some very simple questions.” That’s what he did when he was working on the QuikDrive mini surgical screwdriver for Stryker (Kalamazoo, MI, USA). The device began life, literally, as a simple wooden stick. “We put that in the doctor’s hand to determine what the optimal length should be. Visualization tools, at the end of the day, are simply a screen in front of your eyes. They won’t let you touch the product, feel its heft, and so forth.”

The simple approach worked, at least from a design standpoint. The QuikDrive mini has received a prestigious red dot award recognizing its sophisticated and innovative design.

Drafting a comprehensive plan at the start of a project is crucial to achieving a satisfactory outcome, according to Stephen Knowles, managing director at Industrial Design Consultancy Ltd. The firm designed a personal-use heart monitor (pictured) for Medick Healthcare Ltd. in Milton Keynes, UK.

For James Toleman, an industrial designer based in Puget Ville, France, cardboard or foam-core mock-ups based on volumetric component models are a good, simple way to develop a product’s character. “You can attempt to do this using 3-D design tools,” says Toleman. “But there is no scale and no physical interaction. We can fool ourselves with objects that we cannot handle and place in space and, especially, in situation.”

Toleman’s design work on the Picolo Xpress point-of-care blood chemistry analyzer from Abaxis Inc. (Union City, CA, USA) earned him recognition in the 2007 Medical Design Excellence Awards. (See the accompanying article for more information about this programme.)

The tyranny of electronics. “As soon as you add electronics to a product, you have the option of putting in a whole range of things,” says Wilcox of PDD. Avoid the temptation of adding unnecessary complexity, he stresses.

When the company designed the easypod, it determined that the device needed to deal with two primary issues: allaying the parent’s and child’s concern over the pain that might be inflicted and ensuring that the correct dosage of the drug was being administered, explains Wilcox. “We focused on the creation of a user-friendly interface, because as soon as you put technology into a product people become nervous about not understanding how to use it. And we came up with this ‘traffic-light system,’ a big friendly button on top of the device that walks the user through the process,” says Wilcox.

No risk, no gain. Wilcox is a big believer in risk-managed product development driven by human factors engineering. “US FDA understands this approach, and in fact encourages it,” he notes.

“Risks you have identified are also opportunities,” says Wilcox. “If you can overcome them, then you have raised the bar somewhere.” You have gained something that you can potentially patent and protect, he adds, something that differentiates you in the marketplace.

Play it forward. Feedback? At Erdmann Design, they prefer to talk about feed forward. “We believe the future is more interesting than the past,” says Erdmann. “You can have countless meetings talking about the past—what works, what doesn’t work in the marketplace—but that [thought process] can be a hindrance. We visualize the future and build with that in mind.”