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Judgment Calls

Originally Published MPMN

May 2003

2003 Medical Design Excellence Awards

Judgment Calls

Members of the MDEA judging panel reflect on current and future trends in device design

by Norbert Sparrow

Krista Coleman of Enhanced Mobility Technologies was one of eight jurors participating in the 2003 Medical Design Excellence Awards.

Now in its sixth year, the Medical Design Excellence Awards (MDEA) program recognizes outstanding achievements in medical product and medical packaging design. A multidisciplinary panel of judges evaluated the submissions based 
on a range of criteria including product innovation, design and engineering achievement, user benefit, and cost- effectiveness. Capsule descriptions of the 23 winners in nine product categories begin on page 34.

Following the panel's recent deliberations, MPMN asked some of the judges to share their thoughts on the evolution of medical product design. Their reflections follow.

As nature intended

Device designers and engineers who take a cue from nature were widely applauded by the members of the judging panel. "I'm not sure that it's applicable to all areas, but replicating natural biological functions is certainly a desirable goal for rehabilitation products," notes Krista Coleman. Chief technical officer and vice president for research and development at Enhanced Mobility Technologies, Coleman was an assistant professor of physical medicine and rehabilitation at the University of Minnesota for 12 years and is currently an adjunct faculty member. A device that mimics the original biologic function that it replaces has several advantages, according to Coleman, not the least of which is user acceptance. She cites the UroCycler bladder management system from UroSolutions Inc., which enables the bladder to fill and flush in a near-normal way, as an example.

The system is designed around a magnetic valve that attaches to the external end of an in-dwelling catheter. By allowing the bladder to fill and flush in a quasi-normal manner, the UroCycler can help to prevent urinary tract infections. The product is one of two winners in the Rehabilitation and Assistive Technology Products category.

Implants and prosthetics that substantially improve the user's quality of life were singled out for praise by juror Eliot Lazar, an ophthalmologist and principal in the elCON Medical consultancy. "Strides made in device design and in the use of materials have significantly improved the devices' utility for patients," says Lazar. The two winners in the Implant and Tissue Replacement Products category--a finger joint implant from Ascension Orthopedics and a breast prosthetic from ContourMed--can have a "huge impact on a patient's lifestyle," says Lazar. The anatomical implant is designed to restore functional joint mechanics with minimal bone removal and the preservation of critical soft-tissue structures. The breast prosthetic from ContourMed attaches directly to the chest wall by means of magnets and adhesives to provide a natural and secure breast form.

These products may seem mundane, says Lazar. "But for patients who have not had the benefit of really good prosthetics, such devices represent a substantial advance. The finger joint implant and breast prosthetic, in particular, [are indicative] of an attempt to reengineer the artificial to be more like what nature intended."

User beware

"I never cease to be amazed by how difficult some medical instrumentation is to use," says Coleman. Because of her background in physical therapy, Coleman explains, she is sensitive to the ways in which the human body does and does not function. "Indeed, it may be harmed by performing certain functions, and I do not always hear this issue addressed by the ergonomics folks. In some cases, it just seems like they don't bother to consult the users," says Coleman.

Human factors issues continue to challenge industry, concurs Lazar. He points to miniaturization as one area in which remarkable technological progress has outpaced serious thought on usability.

"We've gotten pretty good at making things smaller, but we haven't necessarily perfected the physician and patient interface. We also need to figure out better ways [to factor in] the patient's anatomy and physiology," says Lazar. "I don't think we're there yet."

In the ergonomics debate, juror Michael Wiklund is more forgiving. Vice president in charge of human factors consulting services at the American Institutes for Research, Wiklund gives industry a fairly good grade in usability. He cites two MDEA winners to illustrate his point: the HeartStart home defibrillator and the Sonos 7500 Live 3-D ultrasound system. (These products received awards, respectively, in the Critical Care and Emergency Products and the Surgical Equipment, Instruments, and Supplies categories.)

"In the case of the defibrillator, a strong effort has been made to accommodate the needs of people who have never used the device and who may be using it under stressful circumstances. There is considerable evidence that human factors were taken into consideration," argues Wiklund. Other MDEA winners he singled out for praise in this regard include the Symphony breast pump, which substantially reduces the amount of time it takes to drain breast milk, and the Joey disposable umbilical cord clamp and cutter, which allows a person to sever the cord safely and sans splashes. These products share a design ethos that goes beyond medical efficacy, according to Wiklund, and successfully address usability issues. Wiklund credits FDA, to some extent, for the progress made toward more-usable devices. "The device industry has been chastised and encouraged by FDA during at least the past five years to invest more in human factors," he says, adding that "things are moving in the right direction."

Trend spotting

All of the jurors agreed that the march toward miniaturization and system integration continues to advance at a steady clip. But there are some bumps in the road.

"Give me a PDA-style device that replaces a big piece of equipment, that's great," says Coleman. "Give me a Palm that supplements or replaces only part of a task and that has limited interface capabilities, not great." Coleman also takes exception to a trend that is partly spawned by the proliferation of these types of devices.

"Medical people, as a whole, are not secretaries. A device that requires the user to key in and format data is, in my opinion, ludicrous." Integration, multifunctionality, and automated data capture should be industry buzzwords, she contends. A winner in the In Vitro Diagnostics category, the Accu-Chek Inform blood glucose meter, which downloads data with minimal human intervention, is an example of the way forward, according to Coleman. 

"A device that does not relieve the documentation load for the healthcare provider will find low acceptance," 
she stresses.

For Lazar, a welcome trend is the seamless integration of software into devices, something that he believes "we will see much more of in the future." One winning product in the Surgical Equipment, Instruments, and Supplies category that caught his attention is the Intralase FS ophthalmological laser. The device applies femtosecond-pulse laser technology to vision correction surgery and comes bundled with sophisticated software that performs lightning-fast readings with each pulse. "This product demonstrates industry's ability to take a developing technology and very quickly translate it into a clinical application," adds Lazar.

What next?

Which raises the question: what technologies now in development would the jurors like to see applied to a medical device in the future? What products would they like to see competing for a MDEA trophy in the next few years?

Coleman places prevention of the inflammatory process at the top of her wish list. "We are beginning to understand how the inflammatory process causes problems throughout the body," she explains. "It's easy to see on the skin. You get a wound, there is a red appearance around it, it heals, and the red appearance goes away. We don't tend to see that in the vascular tree, but it's there and we know it," says Coleman. "When we are able to provide implantable devices that minimize those inflammatory reactions, we will have come a long way."

Wiklund lobbies for smarter devices. "I would like to see medical devices that do a good job of safeguarding the patient; for example, a device that knows what kind of drug is being infused and which dosage might be dangerous, or a defibrillator that knows when an electric shock should not be given." Says Wiklund, "The ultimate solution, I suppose, is some kind of artificial intelligence that protects people from harm caused by user error."
Wiklund would also welcome more widespread harmonization in user interfaces. "There is a disincentive among manufacturers to standardize devices, and it's true that standardization can limit creativity and innovation," he says. "But the harmonization of alarms or the way controls move in association with the increase or decrease of certain parameters would certainly make it easier on the user."

Even minimally invasive procedures are relatively traumatic to both the physician and patient, says Lazar, and at the top of his wish list he places "truly minimally invasive systems that offer diagnostic as well as therapeutic benefits. For example, we are still encountering problems putting a catheter in a patient's aorta. Complication rates are huge; we need 
to do better."

The winners of the 2003 Medical Design Excellence Awards (MDEA) program sponsored by Canon Communications llc are presented beginning on page 34. The products will be displayed during Medical Design & Manufacturing East 2003 at the Jacob K. Javits Convention Center in New York City June 2 to 4. 

For more information about the MDEA program, go to www.mdeawards.com

Copyright ©2003 Medical Product Manufacturing News

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