Originally Published MDDI April 2004

Breakthrough Products Could Put Lesser-Known Firms on the Map

Erik Swain

If innovation is the lifeblood of the medical device industry, then small companies are the lifeblood of medical device innovation. That idea was borne out in the 2004 Medical Design Excellence Awards. Many of the most radically innovative products that won awards came from small, new, or relatively unknown companies. 

This is well in keeping with the recent history of medical device development. Many a small device company has been created because of a momentous idea that may seem too risky for a large or established firm to gamble on. A lot of the industry's boldest innovations come from companies with employees in the single digits, kept afloat by the grace of venture capitalists, angel investors, and family and friends of the founders. Those with ideas that pan out may see their product, and maybe even the whole company, acquired by a larger firm. Or at the very least, they may attract enough notice and interest to grow bigger on their own.

“Innovative products, from the perspective of new functions and utility, come from small companies,” said MDEA juror Craig M. Jackson, PhD, president and principal scientist of start-up company HemoSaga Diagnostics Corp. (San Diego). “A company will be founded because it can develop and produce a new product that can outperform existing products, or a new product that doesn't even exist.”

“For example,” added juror Michael E. Wiklund, vice president in charge of the Human Factors Research and Design Group at the American Institutes for Research (AIR; Concord, MA), “a physician may think of a way to improve a surgical procedure, or folks working in a research lab may discover a new material for dressing a wound.”

Indeed, said jury chair Dale Bevington, cofounder of Product Innovation Partners (London), start-ups by their nature may have some inherent advantages in developing breakthrough products and retaining their market leadership. “Start-ups often produce well-balanced outcomes, as the owners often come from larger companies, where they understand that a well-rounded product at the beginning creates real competitive advantages and helps to protect an early market lead, basically because new competitors will have to be at least as good,” he explained. 

Here are the stories of some winning companies that are not household names, and the innovative products that have the potential to make them so.

Bion Microstimulator

The Bion microstimulator is a miniature, self-contained, rechargeable implantable neurostimulator manufactured by Advanced Bionics Corp. (Valencia, CA). Weighing less than 1 g and measuring 27 ¥ 3.2 mm, it is designed to treat a wide range of disorders through direct electrical stimulation of peripheral nerves and muscles. It is a significant departure from traditional implanted neurostimulators, which are much larger and more cumbersome. It won an award in the category of implant and tissue-replacement products. 

Founded in 1993, Advanced Bionics is the brainchild of Alfred E. Mann, a medical technology innovator, entrepreneur, and philanthropist. It develops bionic devices for people with neurological disorders. Its original focus was cochlear implants, and it became recognized for its HiResolution Bionic Ear System, “the most technologically advanced medical device to restore hearing,” said Jeremy Koff, marketing manager for the Bion stimulator. Recently, the firm has leveraged its core competencies and innovative approaches to develop technologically sophisticated implantable devices to treat conditions such as chronic pain and urinary incontinence. The Bion is being tested in clinical trials for the treatment of urinary incontinence and chronic headache, and it may be used for a wide range of other disorders that can be treated with electrical stimulation.

The Bion's small size allows the entire device to be deployed directly next to the target of stimulation. Traditional neurostimulation devices consist of an implantable pulse generator (IPG) and electrode lead. Due to the large size of conventional IPGs, this component must be placed away from the site of stimulation in areas such as the chest, abdomen, or buttocks. The electrode lead and often a lengthy extension must then be tunneled under the skin to reach the stimulation site. Implantation of traditional devices involves extensive surgery, sizable scarring, and the possibility of a prominent bulge under the patient's skin. The Bion implantation is a sutureless procedure that uses a set of custom needlelike insertion tools 4 mm in diameter, leaving no visible scar or bulge.

The origins of the Bion date to 1988 when The Alfred E. Mann Foundation, a nonprofit medical research foundation, and other parties began a research project to develop a miniature implantable stimulation device for impaired neural and muscular functions. The foundation later licensed the initial technology to Advanced Bionics for further development and commercialization. 

“The principal design and engineering challenges were size, hermeticity, and accessibility to many implant locations in the human body,” said Koff. The Bion incorporates sophisticated microelectronics, including a power source, a stimulator, and bidirectional communications, all housed within a cylindrical package only 3.2 mm in diameter. Patented brazing techniques were combined with self-aligning parts to provide a completely sealed device. The novel cylindrical form factor contributes the maximum strength per unit of material while allowing the device to be placed deep in the body through a 4-mm incision.

With its wide range of applications for undertreated conditions, and its less invasive design than traditional IPGs,the bion is “a harbinger of a direction that medicine is going in, which is putting more control in the hands of the patient,” said juror Walter Greenleaf, PhD, president of Greenleaf Medical (Palo Alto, CA). “On top of that, it is a very good-looking product.”

Hand Mentor Rehabilitation System

Applying cutting-edge research about how the brain and body interact, the Hand Mentor rehabilitation system aids in the restoration of hand function to patients disabled by a stroke or other neurological injury. The system, made by Kinetic Muscles Inc. (Tempe, AZ), encourages patients to extend their wrists and fingers on their own as much as possible. It won an award in the rehabilitation and assistive-technology products category. 

“This is a breakthrough concept,” said Greenleaf. “I have not seen anything like it in neural rehab. It's the first step of getting the brain-body connection working.”

Kinetic Muscles is a tiny start-up company founded in 2001 and given a boon in 2002 and 2003 by a Small Business Innovation Research grant and a National Institutes of Health grant. It has based its therapy on the research of Steven L. Wolf, PhD, professor of rehabilitation medicine at the Emory University School of Medicine (Atlanta). Wolf has shown that repetitive practice therapy is effective in regaining function in stroke-affected limbs. In essence, through memories created by the repetition, the brain can be “taught” to tell the limbs what to do, as it did before the injury. 

“This is all based on recent results in neuroscience,” said James B. Koeneman, president of Kinetic Muscles. “It shows that the brain has a lot of ability to ‘rewire' itself, and to find ways around neural pathways, if you do lots of repetition. The research, which was done on a basic science level, overturned a lot of teachings in medicine. Up until 10 years ago, neurologists said that what [functions] you [regain] at the end of six months [are] what you will end up with.” The rest of the functions were expected to remain lost.

The problem is that the therapy is very labor-intensive. “The main way to apply it was with one-on-one sessions with a physical therapist for 6–8 hours a day for weeks on end,” said Koeneman. “That was effective but very costly. So our idea was to have a device that you could take home. It would record what sort of gains you make at home, and print out a report for the therapists, to make their therapy more effective in the clinic.”

Koeneman founded Kinetic Muscles after retiring from Tempe-based OrthoLogic, which made a bone-stimulation device and where he was vice president of engineering. Aside from the government grants, the firm's funding has come from Koeneman's family and friends. “That's given us enough money to manufacture small quantities,” he said. However, the company has been accepted into the Technopolis program, which helps small firms strengthen their business side, at Arizona State University. And it has enlisted several ASU professors and students for help with research and design. 

“This really is from the cutting edge of new technology, way ahead of the curve,” said Greenleaf. “But it's not easy to play in this market because it's conservative and there's not a lot of investment capital. There aren't any big rehab companies. You need to be able to sell the product to early adopters. If this were a neurosurgery product, there would be big bucks pouring in to get it out there.”

HealthWear Weight Loss System

The HealthWear weight loss system, made by BodyMedia Inc. (Pittsburgh) includes a small wearable monitor, an Internet application, and advanced algorithms for a personalized self-care calorie balance system. The user keeps track of calorie intake via an on-line food diary and wears a beltlike device to measure activity. But the algorithms the system uses to show the user how calories have been consumed and burned go far beyond typical biofeedback systems. The system won an award in the category of over-the-counter and self-care products.

BodyMedia, a 30-employee firm that was founded in 1999, “was founded around the principle and intellectual property that an array of sensors, a processor, and memory could be embedded into a well- designed product people would be willing to wear for a long period of time,” said Astro Teller, CEO. “And further, that models of the streams of data from these sensor arrays could …derive, with high accuracy hitherto unavailable, high-value statements about the human body.”

BodyMedia has collaborated on research with the University of Pittsburgh Medical Center, which is one of the firm's largest investors. Its mission is to combat the growing U.S. trend toward obesity, which can lead to diabetes.

The firm is, at its core, a data modeling company, Teller said. “Instead of monitoring individual symptoms that healthcare institutions are used to looking at—blood pressure, pulse oxymetry, cholesterol level—we monitor lower-level vital signs many times a second, and then build sophisticated mathematical models of the data we're collecting,” he said. “These models are built in the context of medical gold-standard equipment such as metabolic carts for energy expenditure or polysomnography for sleep states. That allows us, with very high accuracy, to [make] statements such as ‘you burned 400 calories over the past hour.'”

In particular, the technology has a multisensory design, which counteracts the limits of single sensors that could not differentiate among the different types of physical activity.

BodyMedia's challenge was to convince users that despite the system being both a medical device and a wearable computer, it is not too technologically complex. “To reduce this perception, the team decided to take the best parts of these product categories, accuracy and leading-edge technology, and blend them into a new form and interaction experience that…conveys empowerment and health,” said Chris Kasabach, vice president of design. “A highly ergonomic and body-shaped form factor, integrated and seamless material transitions achieved through over- and insert molding, and soft, light colors help convey this perceptual message.”

“What I thought was great about this product is that it is hard to get a sense of your own activity levels,” said Greenleaf. “They did a great job of doing that, and their algorithms are very sophisticated. In most cases they have a confidence level of 80–90%, and in some cases it's higher, which is very good for this kind of product. There may be a market bias against this type of technology, but there is a substantial amount of medical product behind the peripherals. It's a medical device with embedded systems, software, and algorithms, as opposed to hardware, sensors, and circuitry, but many still conceive of a medical device as having the latter.”

Omega T-Ring CAD Tool

The Omega T-Ring CAD tool, made by Ohio Willow Wood (Mount Sterling, OH) is a new way to fabricate custom-fitted lower-limb prosthetic sockets. It replaces using plaster for capturing the shape of a patient's residual limb. The outfitting process that once took several hospital or clinic visits now takes less than a second. The product won an award in the rehabilitation and assistive-technology products category.

Ohio Willow Wood is under the public radar not because of its age (almost 100 years old), but because of its focus in the rehab/assistive market, which does not attract the publicity or investment that many other device sectors do. The company's mission, to make the lives of amputees easier, derives from its founder, William E. Arbogast, himself an amputee. The firm has never wavered from that, and even retains its location on the same backcountry road where it has been since 1913. But its approach to product development is anything but humble and backward looking.

The company originally conceived the Omega T-Ring as a tool to help orthopedists make cranial helmets for children without causing them as much stress as traditional methods. The software used with it could be applied to lower limb prosthetics, so the firm was able to modify the device for that application. That leap could spell the end of arduous manual plaster casting for amputees. 

“The most amazing feature about the Omega T-Ring is its time-saving capabilities,” said Mark Ford, Ohio Willow Wood's director of marketing. “Combining amazingly accurate shape capture with a simple user interface, practitioners are able to use technology to save incredible amounts of time on mundane tasks and spend more high-quality time working with their patients.”

Juror Dan Haumschild, PhD, group manager for clinicals and development quality assurance at Beckman Coulter Inc. (Chaska, MN), agreed. “Doing 3-D imaging takes hundredths of a second and one visit, as opposed to casting, which takes two or three visits,” he said. “The device is also portable, which means it can be used in the home.” Its accuracy, said Greenleaf, should also dramatically reduce repeat visits for refitting.

The development process included input from hardware engineers, software developers, prosthetic clinicians, and patients. “Throughout the development of the Omega T-Ring, extensive efforts were given to create a device and software that would enable practitioners to capture highly accurate patient shapes in the least amount of time possible,” said Ford. “Our outcome was a lightweight device that captures a shape in less than a second and uses an extremely user-friendly software interface.”

The company was able to keep the T-Ring's weight down to 5 lb by making it from composites and aluminum. It created custom electronics and unique software to capture shapes that are extremely accurate to the true patient shapes. And it developed a “Wizard” format for the software that helps clinicians become experts on the system with just a few hours of use. “This is a great idea,” said jury chair Bevington. “It's a nice marriage of hardware and CAD technology that should make the fitting of artificial limbs faster, cheaper, and less traumatic for the patient.”

Secca Fecal Incontinence Treatment System

The Secca fecal incontinence treatment system provides a solution for the condition that could allow patients to avoid surgery. The radio-frequency-generating control module and disposable handpiece are used to perform a minimally invasive outpatient procedure. The system, made by Curon Medical Inc. (Fremont, CA), won an award in the category of radiological and electromechanical devices. 

Curon, which was founded in 1997, didn't set out to come up with a breakthrough solution for fecal incontinence. Its founders were looking to develop their radio-frequency (RF)-based concept to treat gastroesophogeal reflux disease (GERD). While researching that, the firm's scientists came across a number of patients who also suffered from fecal incontinence. “It became evident that we should develop a second platform,” said Rachel Croft, Curon's vice president of marketing. “This was a huge market with inadequate treatment options. Our technology could be applied to that area in almost exactly the same way it could to GERD. The mechanics of design are similar, and the areas are anatomically and physiologically similar.” The idea was to apply RF energy to the muscles that control the sphincter, to allow the sphincter muscles to better restrain feces. 

“We found that the problem affects up to 8% of the population, or as many as 200 million people worldwide, which was a huge number compared with what we expected,” said John Gaiser, Curon's vice president of research and development. “That's because people don't talk about it. And the treatments are virtually nonexistent because companies don't realize that the market is that big. You have conservative therapy like diet modification and taking things like Immodium. You have biofeedback, but it works no better than changing diet. After that, there's sphincterplasty, a surgical procedure. Only the young and healthy who have a specific defect are candidates for it. And after five years the success rate is only 50%. There is a huge gap between biofeedback and surgery, and those who have failed conservative therapy but are not eligible for surgery have virtually no options.” The Secca system, a minimally invasive outpatient treatment, may now offer an option to some untreatable patients, or to those who want to avoid surgery. 

The disposable portion of the system is a handheld device with retractable needle electrodes. It enters the body through the rectum and administers energy to the necessary sphincter muscle tissues. Specifically, it cools the surface while heating the tissues below. It also has a mechanism that allows the technician to see where exactly the needle electrodes are being applied. There are four needle electrodes, and each has its own power and control system. 

The control module has a graphical user interface that, among other things, displays the temperature information for each needle electrode. An alarm sounds if the temperature exceeds the appropriate level. The module also has a pump that delivers sterile water.
“One thing that stands out is that you can do the procedure with just the device and the control module,” said Croft. “Light, water, and suction are built in. You don't really need anything else.” 

Not surprisingly for such a novel product, it went through a number of iterations during development and Curon made many changes based on patient and clinician feedback, Gaiser said. “One major step was that we originally had the needles on all sides of the disposable, but changed it to one side because it was better to adjust the device to meet different anatomical needs,” he said. “That also allowed us to add the ability to view exactly where the device was going.” 

Juror Denise M. Korniewicz, RN, DNSc, a professor and associate dean for research and doctoral programs at the University of Miami School of Nursing (Miami), praised the device for addressing a major problem. “This will cost much less than surgery, and the recovery period for patients is really reduced,” she said.

Zassi Bowel Management System

The Zassi bowel management system is a catheter and collection bag system that is designed to safely and reliably divert fecal waste produced by bedridden or immobilized patients. Manufactured by Zassi Medical Evolutions Inc. (St Louis), it won an award in the category of general hospital devices and therapeutic products.

Zassi, a small company founded in 1997, focuses on gastrointestinal products but did not originally plan to tackle bowel management issues. The firm was researching technologies to use for ostomy products when its executives met Jae Hwang Kim, MD, PhD, professor of surgery and director of the Anorectal Physiology Lab at the Yeungnam University School of Medicine (Daegu, South Korea). Kim had an idea for a bowel management system and the Zassi team expressed interest in developing it. 

“The more we talked with him about what he was doing, the more it struck back at us that this was an incredible opportunity,” said James Schneider, Zassi's chief technology officer. “Fecal management for patients who can't move to a bathroom or use a bedpan isn't done very often. It's cleaned up after the fact.” If left for too long, feces can cause nosocomial infections, which can be deadly for patients in critical care. 

Existing solutions were inadequate, however. “Fecal pouches have been used. They are stuck to the buttocks and catch the stool. But everyone's buttocks are different, so pouches fit well on some people but not others,” said Schneider. “Their adhesives can also be an irritant, especially because the pouch has to be replaced every day. Some caregivers use rectal catheters off-label. But they weren't made for extended in-dwell use like that, or to divert feces on an ongoing basis.” The Zassi product, however, is a catheter-based system specifically designed to divert gastrointestinal waste and to prevent patients and practitioners from coming in direct contact with it. It consists of a catheter, a retention cuff, and a large-capacity collection bag.

The interface of Kim's original design was made of silicone, but that was not a sufficient odor barrier, so Zassi added a parylene coating to address that issue. The firm also modified the connections to make the device easier to insert and remove. Design decisions were made with the input of nurses and of Zassi's material and component suppliers. One of Zassi's shareholders, a medical distributor, helped conduct product testing and determine price points.

“I like the elegance and simplicity of the solution,” said Greenleaf. “They seem to have taken a difficult problem, boiled it down to what was needed, and come up with something that worked and looked OK. It has good functional design and good aesthetic design.”

Now that a new solution has been devised, the next challenge is “to teach nurses how to conduct fecal management proactively instead of reactively,” Schneider said. “This is a huge problem. Not only does it have implications for infection control, but for time management. Some ICU nurses spend 10–15% of their time cleaning up stool. That is not only not fun, but they could be more productive.” 

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