A unique nonprofit company with a legion of volunteers is working to develop medical devices for children.
The tiny company DesignWise Medical was borne out of both necessity and passion. Now it's being fed by active retirees and professionals, as well as college students from local universities.
Mechanical engineer Bradley Slaker spent the better part of two decades building a career in the medical device industry, gaining experience in product development, quality control and research and development. Along the way, he earned an M.B.A. and worked for a start-up firm developing a new product, as well as for a big corporation -- Boston Scientific.
But in August 2008, he cast about his cubicle and wondered: Just who are the actual people who benefit from these technologies? He craved a more immediate connection with patients.
So he started a nonprofit pediatric medical device company with $30,000 of his own savings. "People sort of react with puzzlement," Slaker said with a laugh. "A nonprofit pediatric medical device company? How does that work?"
So far, the Minneapolis-based company has amassed a voluminous roster of volunteers to help, including college students and retired and currently employed professionals in the Twin Cities' medical technology community.
That involvement reinforces Minnesota's unique position nationally as a medical device hotbed. "There are very few communities across the country that could support this kind of business," Slaker said. "We are very med-tech savvy here."
Always in search of the next blockbuster product, most for-profit med-tech companies have passed on pediatric devices because the market is viewed as a small one. "We've never funded one," said Kris Johnson, general partner of the Minneapolis venture capital firm Affinity Capital Management. "The pediatric market may pose a significant clinical need, but it's unusual to have a really large device market related to pediatrics."
Plus, recruiting children to participate in clinical studies testing new devices for safety and effectiveness is challenging.
"Whether it's new equipment or medications, it's always a little bit more difficult to do research on kids than adults simply because of the consent process," said Dr. Rod Tarrago, a pediatrician at Children's Hospitals and Clinics of Minnesota, who has no connection to DesignWise Medical. "There are questions about what age kids have to be before they can give informed consent [to enroll in a study]. As a result, a lot of medical research occurs on adults and then is extrapolated to kids."
But the tide may be changing. In 2007, the Food and Drug Administration (FDA) announced a $2 million annual grant program to spur innovation of pediatric devices. The agency concedes on its website that designing medical devices for tiny bodies poses formidable challenges. "Children are often smaller and more active than adults, body structures and functions change throughout childhood, and children may be long-term device users -- bringing new concerns about device longevity and long-term exposure to implanted materials." The National Institutes of Health is studying new ways to test drugs and devices on children, as well.
With a focus on pediatric devices in mind, Slaker set about finding a device to develop. The opportunity came after a chance meeting at a National Institutes of Health conference, where he struck up a conversation with Ann Gettys, an Oklahoma mom and physiology instructor whose infant son, Grant, suffered from a rare lung disease requiring supplemental oxygen at night.
Traditional oxygen tents didn't work -- the 6-month-old clutched and tore at oxygen masks and nasal tubes. With no solution at hand, Gettys bought a Thomas the Tank Engine tent, cut it in half, propped it over Grant's bed and outfitted it with three oxygen-delivering nozzles. The crude device served its purpose and became the genesis for the first DesignWise medical device, called the Overnight Pediatric Oxygen Delivery (OPOD) system.
Slaker reached out to a senior design class at the University of St. Thomas, which came up with engineering plans for the OPOD device. Then an industrial design class at the University of Wisconsin-Stout worked on building an ergonomically friendly prototype based on the plans -- a ruby-red polka-dotted tent that looks like a ladybug and is outfitted with oxygen-delivery nozzles that sense and adjust to a child's sleep-time movements.
A student in a master's program at St. Cloud State University specializing in FDA medical device regulations crafted a plan for the OPOD to gain regulatory approval. A student at the William Mitchell College of Law's Intellectual Property Clinic filed a provisional patent for the device and is working on a full patent application. "It's kind of cool working with an actual inventor," said Christian Girtz, the William Mitchell student, who will graduate this May. "Careerwise, it's great experience."
Students "are young, energetic, resourceful and talented," Slaker said. "They also get the chance to work on a real-world project that is making an impact."
Slaker says the company's structure, as a nonprofit, helps him recruit students and professionals alike.
Yet Slaker recognizes that there are limitations to student work, and he is gauging support from professionals currently working in the medical-device field, as well as retirees. He'll also turn to foundations and other philanthropic organizations for funding in the future. He says the company's structure, as a nonprofit, helps him recruit students and professionals alike.
In the meantime, he has struck up a relationship with Children's Hospital, asking doctors and staff what sort of devices they need, an effort that includes mechanical and biomedical engineering students from the University of Minnesota. "Brad is able to fill a need in the medical device market where [pediatric] devices aren't typically at the top of the priority list by adult-focused medical device companies," said Jennifer Olson, director of the hospital's Cornerstone Program, which include major initiatives involving research, technology and evidence-based medicine.
Three projects are currently underway in conjunction with Children's -- a nebulizer mask to help deliver a cough-provoking agent to clear kids' lungs, a kid-friendly insulin device, and an oxygen delivery system for premature babies.
Slaker believes DesignWise's nonprofit construct frees the company from the burdens of reaching an expected level of financial return. Any profit made from licensing or selling a product can be funneled back into the business, and to new projects on the drawing board.
"We can focus on problems," he said, "and hopefully solutions."
Janet Moore • 612-673-7752