The Planet’s Most Innovative Medical Devices
Editor’s note: This report, appearing in the January 2011 print edition, marks the first in a quarterly installment we’re calling 7 to Spot. Every three months we’ll select seven great innovations and/or inventors from disparate industries. In April 2011, we’re celebrating mechanical engineering. Are you or is your company doing something amazing when it comes to mechanical engineering? If so, let us know. Contact [email protected]
By Mike Drummond
The dawn of a new year typically begets gym memberships and half-hearted resolutions to lose all that weight packed on from the holidays.
With fitness and well-being in mind, we set our sights on tackling something seasonal in a new way. For the first time in this magazine’s history, we scoured the globe in search of some of the most innovative medical and health devices coming on to the scene – devices and technologies that will make us live longer, better and presumably happier lives.
During the latter part of 2010, we reviewed nearly 100 existing and emerging technologies from small inventors and large corporations.
In the end we selected seven to showcase, based on overall impact on humanity, accessibility – that is, how realistic it will be for you or me to have access to the treatment or technology – and how innovative the technology is compared with conventional treatments.
We were struck by the diversity of approaches to medical and health advancements. On one extreme we feature a company that’s growing organs for transplant. It’s the stuff of Mary Shelley’s Frankenstein, without the foreboding Gothic science fiction.
On the other, more prosaic side, we found a simple device from an independent inventor that may radically reduce the number of potentially fatal blood clots resulting from intravenous shunts.
Although diverse, these devices had at least one thing in common – market research. Each company and inventor behind the technology featured in these pages had conducted thorough market research. Each demonstrated an identifiable market need and clearly articulated how their device or technology addressed the problem in a cost-efficient way.
It was the sort of business acumen that often goes missing from many inventions pitched to us on a daily basis. It was refreshing to see innovation and inspiration paired with fiscal reality.
The exercise in winnowing the winning medical and health devices helped reinforce one of our main narratives: If you don’t know who your customers and competitors are, then you don’t have an invention. You have an idea. And there’s a huge difference between the two.
But enough finger wagging.
Assembled for your reading pleasure and enlightenment are seven of the most innovative medical and health devices we see emerging in the coming months:
Grow Your Own
Researchers from Spain teamed with Harvard Apparatus to create a device that grows hollow organs such as bronchus, trachea and blood vessels.
InBreath Whole Organ Bioreactor allows surgeons to germinate new tissue from a patient’s own cells or from compatible donors. In development for about three years, the first “3D bioreactor” for regenerated hollow organs recently hit the market.
On average 18 people die every day in the United States while awaiting a lifesaving organ transplant. In 2007, 6,411 Americans – one every 90 minutes – died while waiting for a transplant, according to Golden State Donor Services based in Sacramento, Calif.
Dr. Paolo Macchiarini of Barcelona became the first to transplant a regenerated airway tube into a female patient who was at risk of losing a lung.
The graft immediately provided the recipient with a functional airway, improved her quality of life and had a normal appearance and mechanical properties after four months. The patient had no anti-donor antibodies and was not on immunosuppressive drugs.
“The results show that we can produce a cellular, tissue-engineered airway with mechanical properties that allow normal functioning, and which is free from the risks of rejection,” Macchiarini and others wrote in The Lancet, a global medical journal, following the operation.
“The findings suggest that autologous cells (tissue from a patient’s body) combined with appropriate biomaterials might provide successful treatment for patients with serious clinical disorders.”
Visit www.harvardapparatus.com
Brace for Impact
Dr. Todd Aaron invented the V2 Prototype Concussion Reduction System – a concussion-resistant helmet initially designed for boxing and football – after his daughter suffered a concussion in an equestrian accident.
“I vowed that I would find a way to protect all athletes so they could safely participate in sports,” the Philadelphia doctor says.
About every 21 seconds, someone in the United States has a serious brain injury, including concussions. One of the most common reasons people get concussions is through sports, including football, boxing, hockey and even soccer.
Concussions generally occur when the head either accelerates rapidly and then is stopped, or is spun rapidly. This causes brain cells to become depolarized and fire all their neurotransmitters at once, flooding the brain with chemicals and deadening certain receptors linked to learning and memory. The results often include confusion, blurred vision, memory loss, nausea and, sometimes unconsciousness.
Neurologists say once you suffer a concussion, you are as much as four times more likely to sustain a second one. Moreover, after several concussions, it takes less of a blow to cause the injury and requires more time to recover.
New research is increasingly linking multiple concussions with Alzheimer’s and Lou Gehrig’s Disease or amyotrophic lateral sclerosis, which slowly robs the body of all voluntary muscle movement.
Aaron created a patented one-piece helmet and shoulder pad design that transfers energy away from the head and redistributes the total force. The product was tested at impacts in excess of 100 Gs at Biokinetics and Associates in Ottawa, Canada, and was found to reduce the incidence of concussions.
His V2 Prototype incorporates existing helmet and shoulder pad systems “to keep the standard aesthetic that so many players are unwilling to give up.”
Visit http://revolutionarysportsgear.com
Robo Surgeon
The CyberKnife Robotic Radiosurgery System is a non-invasive alternative to surgery for treating cancerous and non-cancerous tumors anywhere in the body, including the prostate, lung, brain, spine, liver, pancreas and kidney.
The treatment delivers beams of high dose radiation to tumors with extreme accuracy, according to Calvin Maurer Jr., vice president of research at Accuray, who with a team of engineers developed the VSI technology for the CyberKnife System.
Though its name may conjure images of scalpels and surgery, the CyberKnife treatment involves no cutting. The CyberKnife is the world’s first robotic radiosurgery system designed to treat tumors throughout the body non-invasively. It provides a pain-free, non-surgical option for patients who have inoperable or surgically complex tumors, or who may be looking for an alternative to surgery.
Although the device received U.S. Food and Drug Administration clearance a decade ago, it’s taken time for this technology to go mainstream.
In 2010, the CyberKnife notched several significant milestones, including use on breast cancer, and the company’s strategic alliance with Siemens, which will help further expand the global footprint of the CyberKnife System.
Visit www.cyberknife.com
Walking on Air
When it comes to physical therapy, we’ve come a long way from the Gymnasticon, an exercise machine invented by Francis Lowndes in 1796.
To wit, the AlterG Anti-Gravity Treadmill 300. Using NASA-based anti-gravity technology, the AlterG applies a precise and comfortable lifting force to the body that reduces weight on the lower extremities.
Most lower extremity rehab programs stress the importance of becoming mobile as soon as possible. AlterG’s treadmill offers an advanced anti-gravity approach to physical therapy based on “unweighting” technology.
A bladder filled with air lifts you from your mid-section, giving your upper body natural freedom of movement, while keeping most of your body weight off your legs. You can select the percentage of your body weight in increments from 20 to 100 percent, giving you the ability to set the exact point where exercise becomes pain free and provides clinicians a way to accurately measure a patient’s progress.
It’s safe. It’s effective. It’s FDA approved. And it’s covered by many health insurance plans.
Who’s using it? Walter Reed Army Medical Center, U.S. Olympic Training Centers and the Los Angeles Lakers, among others.
Visit www.alter-g.com
Eye Spy
More than 1.7 million Americans over age 50 suffer from some form of age-related macular degeneration or AMD, which results in loss of central vision.
The condition can make it difficult or impossible to read or recognize faces, although those with AMD generally have enough peripheral vision to lead otherwise normal lives.
The number of people with AMD is projected to double in the next 40 years due to the aging population.
To return full sight to the partially blind, VisionCare Ophthalmic Technologies has developed the telescope implant, tiny telescopes implanted in the eyes.
Dr. Isaac Lipshitz invented the technology, which received FDA approval in 2010.
Smaller than a pea, the telescope is implanted in one eye in an outpatient surgical procedure. In the implanted eye, the device renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.
“This is truly a breakthrough technology for AMD patients,” says Dr. Kathryn Colby, ophthalmic surgeon at Massachusetts Eye and Ear Infirmary in Boston and an assistant professor of ophthalmology at Harvard Medical School.
“The clinical results from the pivotal FDA trial have proven we can place this tiny telescope prosthesis inside the eye to help patients see better and, for some, even to levels at which they can recognize people and facial expressions that they could not before.”
Visit www.centrasight.com
This Won’t Hurt a Bit
When Bob Heitkamp walked into the hospital one morning for minor knee surgery, he expected to go home and recuperate.
However, two pulmonary embolisms – blockages of the main artery of the lung – a week later left him critically ill and hospitalized for 17 days. Heitkamp traces the clotting to the taping and un-taping and swelling and bruising associated with the intravenous or IV shunt in his arm.
Heitkamp invented Site Saver, a comfortable, simple, inexpensive and tape-free way to keep IVs in place. Site Saver allows medical professionals to change fluids without disturbing the shunt, one of the leading causes of infection in hospital settings.
After an IV is started, Site Saver is strapped to the top of the patient’s hand. IV tubing is snapped into one of several alignment clips to accommodate numerous IV insertion sites. Site Saver can withstand a jerking force of more than 100 pounds (four times the breaking point of tested IV tubing) and allows for many different IV configurations.
Studies show that up to 48 percent of all tape-secured IVs result in complications. These complications are caused by movement of the IV catheter within the vein and include pain, phlebitis, migration, dislodgment, infiltration, extravasation (fluid seeping into tissue) injuries, non-thrombotic and thrombotic occlusions or clots.
All of these conditions require IV restarts and costly interventions. Heitkamp’s research showed that every IV restart costs about $32 in supplies alone equating to a $6.7 billion problem in the United States.
Visit http://ivsitesaver.com
Surgery-Free Prostate Surgery
Each year, more than 200,000 men in the United States develop prostate cancer and nearly 30,000 die from it, according the Centers for Disease Control.
Prostate cancer tends to develop in men over the age of 50 and although it is one of the most prevalent types of cancer in men, many never have symptoms, undergo no therapy, and eventually die of other causes.
US HIFU’s Sonablate 500 kills tissue with ultrasound waves that rapidly raise the tissue temperature to nearly 195 degrees, destroying the targeted prostatic tissue but leaving surrounding structures outside the gland intact.
The non-surgical system is an improvement on conventional treatment in that it does not trigger two common side-effects, incontinence and impotence.
Dr. Mark Emberton is among U.K. physicians studying the efficacy of the HIFU Sonablate system on targeted cancerous areas of the prostate.
“I believe that focal treatment is the future for early-stage, low-risk cancer,” he says. “Considering the treatments that are currently approved and available worldwide, men with localized prostate cancer may often feel they must choose between active surveillance and radical therapy (surgery or radiation).
“Patients who opt to monitor their cancer run the risk of having the disease spread, while those who choose radical therapy are at increased risk for incontinence and impotence. I see focal therapy as a cost-effective solution that can potentially provide an optimal balance between cancer control and co-morbidity issues.”
The HIFU Sonablate 500 is approved for use in more than 30 countries outside the United States, but was in two FDA clinical trials as this edition went to print.
Visit www.ushifu.com
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