When it comes to little children, medical devices can be a very big problem.

Take Dr. Thomas Tracy, a professor of surgery and pediatrics at Brown University. Virtually every day, Tracy deals with the fallout from the lack of child-sized medical devices.

“It just impacts your life every day, when you turn around and there’s yet another [device] you can’t apply to a kid,” says Tracy, professor of surgery and pediatrics at Brown University and pediatric surgery chief at Hasbro Children’s Hospital in Providence, R.I.

That’s because there is no financial and creative manufacturing focus on children’s medical devices, an ongoing issue in pediatrics.

“Pediatrics was left out of the loop in the majority of product innovations,” Tracy explains. “I’m not sure the country knows that. The implications are very direct on a day-to-day basis.”

Enter the Institute for Pediatric Innovation, a three-year-old nonprofit based in Cambridge, Mass., that is devoted to fostering the development of kid-sized devices and drugs.

{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/headshots/Lombardi_Don_100x100.jpg}Founder and CEO Donald Lombardi, a former intellectual property chief at Boston’s Children’s Hospital, says the institute aims to upgrade the selection of medical devices for infants and children available to hospitals and improve their pharmaceutical choices.

The organization is also looking to make some noise about the yawning gap between the multitude of treatments available for adults and the few sized for children.

“There aren’t many products developed for kids. That’s the failure of the commercial mentality to focus specifically on developing products that are optimized for treating kids,” he says, a condition he first noticed at Children’s. “The lay public is surprised when this is pointed out to them.”

Take the patients Tracy sees with malformed chest walls. There’s a simple device, called a strut, used to reconstruct those mal-developed walls. It’s an effective treatment for an uncommon condition, he notes.

“But one of the companies making them just took them off the market because not enough of them were being used,” he says, visibly frustrated.

Tracy and his colleagues are left to redesign, tweak or almost re-invent the medical devices designed for adults to make them more effective for children. But if doctors experiment with a makeshift apparatus, they open themselves to legal challenges if things go wrong, he says.

“You’re at risk because you’re modifying something,” Tracy notes. “It’s great when it works. But if it fails, imagine the heyday a plaintiff’s attorney could have.”

Demand from a fragmented market

One product under development by the consortium is an adhesive tape used to fasten electrodes and wires to the delicate skin of premature infants in neo-natal ICUs.

“When you pull that tape off, you’ll pull some of the baby’s skin off because that skin is so fragile,” Lombardi says. “They’ll go home with scars and in need of skin care. So [this is] a tape that you can cause to become ‘un-sticky,’ if you will.”

Lombardi started the institute in 2006, recruiting a handful of hospitals across the country for its Consortium of Pediatric Hospitals. The consortium works to research and develop pediatric treatments, donating funds and sharing information to help identify potential needs and bring medical devices and drugs for children to market.

“We work with the consortium and their clinicians and pharmacists to find out what’s needed,” Lombardi explains. “We also determine what type of presentation of the product would be appropriate for their patient population. And we’re pulling together information to quantify what could be sold and at what price.”

IPI taps other financial sources to fuel the research, he adds.

“We take what we call a public/private, or for-profit/non-profit, collaboration, which is fairly unique,” he explains. “Our funding to date has come from places like [Kansas City’s Ewing Marion] Kaufman Foundation. The hospitals we work with help fund us. Their stake in it is to improve patient care. They know they need for these products.”

The issue is complicated by the fact that the pediatric market is extremely fragmented, says Monique Yoakim-Turk, technology development manager at Children’s Hospital. For example, a device designed for newborns is way too small for treating adolescents.

“When we talk to a venture capitalist or someone interested in licensing the technology,” says Yoakim-Turk, “one of their first questions is always, ‘How big is the market?’”

The answer to that question, unfortunately, is often, “Not very.”

Add to that the fragmented nature of pediatrics itself, with its dramatic changes from age group to age group, Yoakim-Turk says.

“If you think about pediatrics, the needs of a child who has just been born are very different from a five-year-old’s or a ten-year-old’s,” she says. “Any new technology impacts only a piece of that small [market]. That’s what is very hard. So when people do the numbers, it ends up being [a product for] a very small market.”

During the year and a half she spent working with Lombardi at Children’s, Yoakim-Turk says she became well-versed in the small market hurdles he faced.

“We could license out technology for diagnostics or therapeutics, but we would have a very hard time for pediatrics. It was hard to get a company to pick it up,” she recalls.

Dr. Joseph Madsen, a neurosurgeon at Children’s Hospital, understands the financial challenges of developing pediatric medical devices specifically and medical devices in general these days.

“It’s difficult to get devices for children off the ground,” Madsen admits, “but I think it’s also hard to get devices off the ground for anything that has a relatively small market. And pediatric devices may be inherently small-market items.”

Like Tracy, Madsen occasionally modifies devices designed for adults for use in pediatrics.

“A surgical instrument can be modified by someone, made a little shorter or the handle a little less heavy — whatever it is you might need,” he says.

Until recently, Madsen says, medical devices were developed with only a single market in mind, rather than to serve markets beyond pediatrics.

“A lot of people don’t necessarily know … what aspect of an invention is going to be applicable to some other markets,” he explains.

That’s why IPI, Children’s and other institutions now develop pediatric devices with an eye on other patient groups. The larger the potential market for a new device, the greater the chance of stimulating interest in investors or manufacturers.

“I’ve learned that in the world of devices, you have to have a number of seeds planted before you can see a good sprout. And we’re trying to actively promote that spirit among our trainees, because I think it will be a real help in medicine,” Madsen says. “One way is to say that the same technological needs for a pediatric device … will have other ramifications in more common disease states.”

The need for pint-sized pharma

The IPI also focuses on pharmaceuticals, very few of which are formulated for children. In fact, at most hospital pharmacies, pint-sized doses are created by crushing pills or cutting syrups “down to size.”

“Even in some world-class pediatric hospitals, they don’t so much better,” Lombardi says. “It’s a very crude way of administering a drug. The pharmaceutical markets are far larger for adults.”

The World Health Organization recently gave the Institute a $500,000 grant to work with UNICEF in conducting research on children’s medicines globally.

Working with children, parents and healthcare providers in Tanzania and two other African countries, the institute will examine the preferred dosages for pediatric medications.

In the United States, IPI is spearheading another research initiative. The institute formed a consortium of about 25 hospitals and research centers and put them to work gathering data to identify the 20 drugs that are most frequently reformulated for children, clocking the expenses, personnel hours and other efforts involved in the process.

“We’ll study the activities in these hospitals’ pharmacies and use this data as a sort of baseline, to make decisions about which drugs should be focused on for development into commercially manufactured products designed for kids,” Lombardi explains.

Some of these drugs are commonly used in adult practices, but little research has been done with their use in pediatrics. Lombardi estimates their sales potential for young patients could be “in the tens of millions.”

“But the major [drug] companies don’t know how to think about products that are less than a billion. So basically they aren’t interested,” he says. “But there are some niche companies that focus on pediatrics that are interested in smaller markets. Typically, though, they don’t have the wherewithal to do product development or to get the capital to finance that development.”

Lombardi hopes that, as the IPI consortium spreads the word, smaller, niche drug makers will show increased interest — especially as much of its research could lessen the financial risk the drug makers would normally have to shoulder.

For example, a pediatric drug might generate annual sales of $40 million, Lombardi estimates. That’s not enough to make a blip on Merck’s radar, but could be a profitable line for a niche pharmaceuticals manufacturer.

“If you learn to think small, you can solve problems,” he says.