Originally Published EMDM May/June 2002
SPECIAL REPORT
Design engineers discuss the key elements of a successful product development strategy, as EMDM presents the winners of the Medical Design Excellence Awards.
The key to product success is paradoxically simple, writes Sheila Mello in her recently published book, Customer-Centric Product Definition: The Key to Great Product Development (New York City: AMACOM, 2002). All you have to do is delight the customer by creating a product that fills a specific need in the marketplace better than competing solutions. But the simplicity of this idea belies the complexity of actually carrying it out, she adds.
While product design and development personnel working in the medical sector face a unique set of challenges that include regulatory requirements and reimbursement matters, their products must ultimately delight potential customers if they are to capture market share. In this Special Report, engineers from some of the leading design bureaus with expertise in healthcare products share their insights on developing successful devices.
Many of their techniques were undoubtedly applied to the development of the winning products in this year's Medical Design Excellence Awards, which are profiled in an accompanying article. A multidisciplinary panel of judges evaluated scores of entries, ultimately singling out 28 products for achievements in product innovation, design and engineering features, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery. Or you might simply say they selected products that, in one form or another, delighted them.
Will the Real End-User Please Stand Up?
You wouldn't think of beginning the design process without careful consideration of who will be using the finished product. When the product in question is a medical device, however, that straightforward proposition can take some surprising turns. "Who is the end-user," asks Alun Wilcox, head of medical at PDD Product Innovation Consultants (London). "Is it the doctor, the nurse, the patient?" All three may be considered users of the device, he says, "and you need to understand the needs of all of the stakeholders to design a successful medical product."
Attempting to satisfy both the practitioner and patient may raise some contradictory issues, says Marc Piel, project designer at InterDesign (Paris). "The patient must be reassured and feel psychologically safe and comfortable," says Piel. Medical personnel, on the other hand, may be attracted to a product because it "flatters their professional ego." It's the designer's responsibility to interface with all of the people who will be using the device and to reconcile those contradictions. To put the patient at ease, Glen Polinsky, design director at Modo Inc. (Beaverton, OR, USA), recommends adhering to what he calls a medical aesthetic.
"The patient needs to feel reassured that the product is appropriately medical," says Polinsky, whose firm designs carts and roll stands for many of the world's leading device OEMs. "It should have a clean, warm look . . . not too sterile in appearance or daunting, yet it has to look like medical equipment. The medical aesthetic is hard to define and it can vary from market to market—wood furnishings are popular in US labour and delivery rooms, whereas they are seen as bacteria traps in Europe and are considered wholly inappropriate in a medical setting," says Polinsky. "But you know it when you see it," he adds.
The visual aspect of medical equipment is important not only to the patient but to the secondary users, as well: the patient's family and friends. "The patient's family is consuming the product in the sense that it is providing them with reassurance that the proper level of care is being provided," notes Modo president and CEO Robert Marchant. "That's why, at Modo, we like to say that we are designing experiences and not just things. The focus is on the experience of the people who will interact with the product during its useful life," says Marchant.
In some cases, designers will need to tailor the product to appeal to a purchaser who is neither the practitioner nor the patient. "An administrator may be making the purchasing decision," says Polinsky, "and you have to make sure that the product has functional appeal."
Procurement criteria should not be neglected during product development, agrees Mark Gart, managing director of LumaCare Div., Ci-Tec (Newport Beach, CA, USA), a start-up company that develops photodynamic therapy products. "The focus there is on return on investment," he notes. "Companies need to identify the feature and function sets of their products in the development pipeline and firmly understand the costing required to get there." Be wary of overestimating the market size and adaptation of your product because you've relied simply on the advice of practitioners, he adds.
The Customer Isn't Always Right
It's not uncommon for device OEMs to rely on mistaken assumptions about the core features that users want in a product under development. To illustrate the point, Mello cites a project at Bio-Rad Laboratories (Hercules, CA, USA), a manufacturer of life-science research products, clinical diagnostic equipment, and analytical instrumentation.
When Bio-Rad team members initially defined the critical features of a diagnostic instrument, high throughput was deemed a core factor in the customer's buying decision. "More throughput was considered the Holy Grail for new products by internal company functions," says Mello. The potential purchasers of the instrument thought otherwise, she learned.
A managing partner and principal consultant at Product Development Consulting Inc. (Boston), Mello conducted research for Bio-Rad using what she calls a market-driven product definition process. Her findings revealed that instrument users were, in fact, frustrated by the inability to obtain any test results until the full array of tests had been completed. "Consider the aggravation of completing 98% of a test cycle when the machine stops, and being unable to get those results until the problem has been fixed," says Mello. Most of the instruments on the market operated in this manner. The desire for this feature did not emerge spontaneously during customer interviews, however: it came to light during a contextual analysis of the laboratory environment, says Mello. Bio-Rad subsequently validated this finding with a broad survey of potential users. "It saved the company a fortune in R&D dollars and time to market," says Mello, because increasing throughput would have added cost to the product without substantially adding value.
The Lure of Technology
Advanced technology has enabled remarkable breakthroughs in healthcare, but OEMs should be cautious of indulging in technological innovations simply because they can. "I've seen too many medical products designed by technicians for whom technology is the ultimate thing," says Piel. "The technology is not important—it's what you have to do to get the results you want that matters. The technology can be completely transparent."
"Our approach to development puts technology, markets, and users on the same level," says Mike Pearson of Pearson Matthews Design Partnership (Kingston-Upon-Thames, Surrey, UK). "We try to address them evenly, and this market-focussed approach to the development process seems to have struck a chord," says Pearson. He notes that his firm doubled in size in 2001, while some of the technology-driven consultancies are struggling.
One of the biggest mistakes his customers make, says Pearson, is to present a technology-driven product and simply ask him to package it. This happens less frequently than it used to, he adds, "but just last week we had a client come by who developed this technology but had not thought things through in terms of the market. There's a story about a motorist in Ireland stopping for directions. He asks someone by the side of the road, 'How do I get to that town from here?' The Irishman thinks for a while and finally says, 'Well, I wouldn't start from here.' And that's my point. They've already gone so far with the technology, but they haven't considered the market. You don't want to start there."
An ear wash system from Welch Allyn Inc. (Skaneateles Falls, NY, USA), which was recognized in the 2002 MDEA competition, is one example of a product that gets the technology balance right, according to Dale Bevington, cofounder of Indes Design Consultants (London) and an MDEA juror. "The technology turns a procedure that typically has been performed by a clinician into something that can be done by nontechnical staff," says Bevington. "Products that de-skill the job and make it less likely for something to go wrong while serving the patient in a nonclinical environment are bound to succeed in the marketplace." (See the accompanying article for more information about this product.)
During the design phase, tech envy can take the form of "feature creep," adds Polinsky. "As we go through product development, the customer will want to add this, and this, and this. Over time, that can harm the product because it has become too costly to produce, or it will require a change in architecture."
The Cost of Change
"When you think of the cost of change throughout the development cycle,' says Wilcox, "revising a specification at the project's outset simply means changing some words. If you have to make changes in the tooling because you didn't adequately prototype your product or—worst-case scenario—you're faced with a product recall, the cost and time delays are horrendous." To avoid such setbacks, it's important to have a holistic view of what you want to accomplish at the beginning of the process, he adds.
Well-organized project management is key to bringing it all together. Charles Tavner, head of the drug-delivery devices group at Arthur D. Little Cambridge Consultants (Cambridge, UK), recommends that device design should be driven by specifications arrived at from a risk-based approach that examines regulatory issues at the outset. "A common pitfall," says Tavner, "is that design engineers want to design bits, and they get excited and come up with a thousand brilliant ideas. What you really need, though, is a taut design process that allows you to explain to the regulatory authorities why and how you got to where you are."
DCA Design International (Warwick, UK) stresses the benefits of performing a competitive product analysis early in the process. "What is good about the products that have already been used and why, and what patents do you need to be aware of?" are questions that should be asked, according to Robert Woolston, DCA's director of medical and scientific. "You have to know what direction you're going in, and to continuously measure the risk." Woolston emphasizes the use of a concept failure mode effects analysis (FMEA), which is standard procedure at DCA, to strip away risk from the project before progressing to the development phase. "Spending time with a concept FMEA means you will spot more of the issues early on, when you can do more about them."
Design for manufacturability may be an obvious step, but it is sometimes overlooked during the design process, says Anthony Saunders of Minerva Technology (Horsell, Surrey, UK). "If the company that is spearheading design will not be making the product, it's important that the manufacturer be brought onboard at the earliest stage," he says. "Everybody has their own expertise, and you often end up in a mire when one of the parties tries to think out the expertise of someone else." This often plagues biotechnology companies, according to Saunders. "Many of them don't have firsthand experience in manufacturing, and they will develop products that look great, have a beautiful concept, but you just can't make them," he says. "They may have some impossible undercut or tolerances, or the design may have stopped at the drawing board." Each time a line is put on the drawing board, recommends Saunders, you should ask yourself what that line is going to represent when it comes to manufacturing or assembling the part.
Think Different
The importance of industrial design varies significantly with the type of device that's on the drawing board. "It can have a major bearing on the value of a syringe pump or other device with a hugely important interface," says Bevington. "When it comes to a catheter, you would really have to prove the point that spending a lot of money on design is worth it."
But arguing the case may indeed be worth it, according to Jeremy Watson of Elemental Design (Birkenhead, Merseyside, UK). "Marketing personnel will tell you that a catheter is a catheter is a catheter. My response is, 'Why not try to make yours a bit different?'" he says. "There are some Foley catheters around that are bright green or yellow, and this is something that is going to be hanging out of a very personal part of the body," says Watson. "The designer should at least have a passing thought to the aesthetics of the product, if only to lessen the shock to the patient."
Marchant takes it a step further, saying that "usability or humanity" should be one of the foremost aims in designing a medical product. Designers must heed the fact that "a person is going to have to use this product. They should make sure that they have simplified the interaction and provided the user with an opportunity to tailor the use of the product to meet his unique requirements."
To achieve that objective, one simply has to know how to listen, says Marchant. "In our business, we deal with highly educated, highly trained people. If you frame your questions properly, you can tap into an enormous amount of institutional knowledge," he says. "Unless you probe it out of them, they tend to keep information to themselves."
Extracting meaningful information from the potential users of a product requires asking the right questions, concurs Mello. This is more difficult than it appears, she adds, because customers don't always know what they want. "You have to know how to talk to them, how to ask why a particular feature is important," she says. Avoid telling your potential customers about a product you are developing, showing them the alternatives that are available, and asking them what they think, says Mello. "You won't get any out-of-the-box thinking, because you've already put a box around the feedback." Focus on the problems that the customer encounters with comparable products, she says, and use that information to determine the must-have features of your product.
"Ask them: 'If you had that feature, what problem would it solve?'" says Mello. To get meaningful input, "you have to think differently."
Norbert Sparrow [6]
Copyright ©2002 European Medical Device Manufacturer