Life Saving Design - Bionix · PDF fileLife‐Saving Design ... The elegantly designed...

Life‐Saving Design

By Kurt Soller

"Medical device designers need to be in touch with their customers," says Dr. Jay Goldberg, who works as a professor at Marque e University. "You can't design a product si ngin your office ‐‐ you need to go talk with people who will use it."

The good news is, that's star ng to happen. More and more o en, medical device manufacturers are hiring in‐house designers or outside firms whose design teams areconduc ng cri cal user research. That involves gathering input from the medical staff who use the tools, the pa ents whose lives depend on them, and even the families whospend hours in the hospital environment.

Such design research and collabora on has paid off in the following collec on of amazing new medical devices. These products help solve problems from life‐threatening woundsinflicted in Iraq to the prohibi ve cost of hearing aids in developing na ons. From the simple and inexpensive to the complex and costly, the following 10 devices represent therange of today's medical tools ‐‐ and the importance of innova on.


Manufacturer: InsuletDesigner: Bay Computer Associates, Con nuum, Phillips Plas csYear: 2006

Na onally, diabetes rates have more than doubled since 1980, and the Center for Disease Control es mates more than 14.7 million Americans have the disease. Not surprisingly,that has spurred a healthy market for products in which companies must compete on more than price. Enter the OmniPod, which makes insulin injec ons wireless.

Here's how it works: The digitally controlled pod is filled with up to three days' worth of insulin and then a ached to the abdomen by its adhesive border. The pod contains a smallcannula that painlessly enters the skin and delivers the drug on command. Instead of using needles, pa ents can treat themselves with the click of a Omnipod's bu on.

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Manufacturer: Bionix DevelopmentDesigner: Lambda Research and The Tech GroupYear: 2005

Not all innova ons in the medical industry are high‐tech, and the Lighted Ear Cure e stands out as a prime example. For years, doctors have removed ear wax with the help of ahot‐water gun or a disposable swab. The Bionix cure e adds an LED diode to a plas c ear swab, allowing physicians to see inside the ear canal. "It's not high‐tech, nothing earth‐sha ering, just an interes ng idea simply put together," says Dr. Jay Goldberg, director of the health‐care technologies management program at Marque e University. Forpa ents, this means added safety as doctors no longer have to work in the dark.


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Manufacturer: Project ImpactDesigner: Bridge Design, Iowa Thin Film Technologies, Moonpo Development, Peridot, Sector Technology and Solid ConceptsYear: 2006

According to World Health Organiza on es mates, 278 million people in the world suffer from hearing loss, and in developing countries only 1 in 40 individuals who need hearingaids has access to them. It's partly a power issue: Ba eries cost a lot and need weekly replacement. Fortunately, this inexpensive solar‐powered recharger solves the problem. "Itisn't enough for companies to come up with high‐end products that are expensive," says Steve Halasey, an editor at Medical Device & Diagnos c Industry magazine. "They alsoneed to think about how to get these treatments to areas where they otherwise couldn't be afforded."


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Manufacturer and Designer: Smith & NephewYear: 1997, FDA approved in the U.S. in 2006

Each year, more than 200,000 people have a hip replaced. Although rou ne, it remains a serious opera on in which the surgeon cuts the femur to make room for a metalextension that fits into the new plas c hip socket. Pa ents must spend several days in the hospital followed by monthly and annual check‐ups, and not infrequently, the ar ficialhip wears out and needs a replacement.

The Birmingham Hip offers an alterna ve to part of the conven onal procedure: Coat the hip socket and femur with a high carbide cobalt chrome. Not only does the procedureconserve a pa ent's natural bone, it also has been shown to offer 98% more wear resistance than the metal‐on‐plas c‐joint of tradi onal replacements.


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Manufacturer: NeuroLogicaDesigner: A&A Tes ng Laboratory, Altronics Manufacturing, American Design, Ault Design and Communica ons, Barco, Jaco Electronics, Martek Power, Spellman High VoltageElectronics, VarianYear: 2006

Typical CT scanners ‐‐ the torpedo‐like machines used to do CAT scans ‐‐ can weigh as much as 10,000 pounds. They require a high‐voltage power supply, a climate‐controlledlocale, and specialists to operate them. And they cost as much as $1.5 million. In short, the machines remain out of reach for many hospitals. Enter CereTom, the first portable,lightweight (740 pounds), low‐cost ($250,000) CT scanner. The model offers hospitals affordability as well as portability ‐‐ the staff can move it to the OR, ER, ICU, or anywhere elsea need arises. "Having to deliver a pa ent down to where imaging is can be a pain," notes Dr. Gail Baura, a medical researcher. "Now you can bring the smaller scanner to thepa ent."

The CereTom cons tutes less a technology breakthrough than a feat of packaging. The NeuroLogica team shrank the components of a standard scanner (the power system, forinstance, is now roughly the size of a microwave oven) and engineered a rugged case. The so ware partner also designed a simple touch‐screen interface that guidesnonspecialist operators through the steps.



Manufacturer and Designer: Z‐MedicaYear: 2006

The QuikClot Sponge builds upon Z‐Medica's wound‐clo ng crystals ‐‐ powder that can quickly stop bleeding when applied to injuries. It starts the healing process by removingwater from blood and allowing platelets to accumulate. A er soldiers who tested the powder in Iraq reported difficulty handling the crystals in ba leground condi ons, thecompany developed the sponge. QuikClot's core material consists of an absorbent derived from volcanic rock. It a racts the small water molecules in blood, leaving behind thelarger platelets and clo ng factors that stop bleeding and begin the healing process.


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Manufacturer and Designer: Siemens Medical Solu onsYear: 2005

In the category of cu ng‐edge innova on, the Somatom ‐‐ the world's fastest CT scanner ‐‐ can actually freeze a heart in mo on. It also offers doctors unprecedented clarity.Because it works so quickly, it exposes pa ents to fewer X‐rays.


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Manufacturer: SuturTekDesigner: Bleck Design Group and Lacey ManufacturingYear: 2006

Needle pricks sustained during OR suturing are one of the most common hospital injuries. In the age of HIV, they can be deadly. SuturTek's Fascia Closure Device offers a safe, fast,and easy alterna ve to hand‐suturing. The ergonomic stylus holds a single‐use suture cartridge containing a standard curved needle and thread. Physicians control the depth,placement, and spacing of the s tches ‐‐ but manipulate the needle with just a squeeze of the handle. The device not only protects health‐care workers but also limits trauma forpa ents.


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Manufacturer and Designer: ThoratecYear: 2003

Ventricular assist devices (VADs) pump blood and are o en used as a pa ent awaits transplant surgery. There are several VADs on the market, some external, some implantable.Introduced in 2003, the IVAD remains the only FDA‐approved implantable device that can provide cardiac le , right, or biventricular support. Due to their handheld size, twodevices can make bi‐Vad support possible while rendering larger electromechanical models obsolete. And in addi on to its use as a preopera ve stand‐in, the Thoratec IVAD canserve as post‐surgery aid to a heart or chamber as it recovers from trauma. "It's partly replacement [for the heart], but it's also partly support ‐‐ making it a unique product," saysSteve Halasey, an editor at Medical Device & Diagnos c Industry magazine.


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Manufacturer: Organ Recovery SystemsDesigner: IDEOYear: 2003

The elegantly designed LifePort replaces the low‐tech Igloo cooler that for years served as the means of transpor ng donor kidneys to the transplant site. Unlike a lunch cooler,the LifePort supports and monitors an organ throughout transport. The company cites studies showing LifePort kidneys survive at least 17 hours longer than kidneys transportedthe standard way. That doubles viability me. The LifePort can even travel unsupervised in airplane cargo‐holds, simplifying the kidney transplant process. In the future, OrganRecovery Systems hopes to expand its line to include other organ‐delivery devices.


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