Originally Published MDDI April 2004
|The BiteStrip disposable bruxism test, manufactured by SLP Ltd. (Tel Aviv, Israel), is a disposable electronic home test for teeth grinding.|
A number of factors make it difficult to achieve outstanding design and groundbreaking innovation simultaneously. The inherent nature of the medical product development process presents many hurdles.
The companies behind the products featured below all figured out how to balance significant innovation with exquisite design. Some are small companies that paid as great attention to design principles as to patient-need principles. Some are large companies that thought outside the box. All were able to develop a product that achieved excellence in multiple fashions.
BiteStrip Disposable Bruxism Test
The BiteStrip, manufactured by SLP Ltd. (Tel Aviv, Israel), is a disposable home electronic test for sleep bruxism, the clenching and grinding of teeth. It won an award in the category of dental instruments, equipment, and supplies.
“Bruxism is very common, but until now there were no objective means to measure its existence and severity except relatively large EMG (electromyogram) recorders, which were used almost exclusively for research purposes,” said Noam Hadas, SLP's CEO. “Although all researchers agree that EMG monitoring is the only scientific way to monitor bruxism, this practice was not accepted by the medical or dental community since it involves running an operation very much like ECG (electrocardiogram) holsters. No dentist, TMJ (tempomandibular joint) specialist, or pain expert will ever agree to so much hassle. We believed that if we could make a small, disposable, stand-alone EMG recorder, then the device would be accepted by these medical disciplines. The recorder also interprets the signal in real time so that the results readout will be literally just that—simply reading the display.”
The significance of the advancement was immediately apparent to the juror panel. “This device is really revolutionary,” said juror Dan Haumschild, PhD, group manager for clinicals and development quality assurance at Beckman Coulter Inc. (Chaska, MN). “Previously, you had to be hooked up to and monitored by a large machine, which was expensive and inconvenient. Here, you can have it done at home or in the hospital.”
Jury chair Dale Bevington, cofounder of Product Innovation Partners (London), noted the device “innovatively addressed the problem on a cost basis much cheaper than a sleep lab, provided a permanent record of the test, and was conceptually elegant. It would not make the patient apprehensive.”
Juror Michael E. Wiklund, vice president in charge of the Human Factors Research and Design Group at the American Institutes for Research (Concord, MA), noted the product's design could play a major role in its success. “Rather than looking awkward and uncomfortable, the product looks at least innocuous and maybe even fashionable, strange as that may sound,” he said. “The product is a classic case of simple being better. A diagnostic device of this sort need not be fashionable, but it doesn't have to look like a torture device either. It is nice that the manufacturer was able to find a way to produce a functional device that was also visually pleasing.”
Hadas said the design goals were to make the device as small, inexpensive, easy to use, and clinically efficient as possible. “The main challenge was cost. It is not easy to design a full EMG front-end, analog-to-digital converter and real-time analysis hardware and software that will be sufficiently low cost to be disposable,” he said. “We designed an amplifier that also acts as a simple pulse width modulation A/D converter, so we could use a cpu [central processing unit] without an A/D converter to lower costs.”
Once that was accomplished, it was time to test the device on patients in sleep studies. “We developed the algorithm to arrive at the best correlation with the scoring of EMG bursts by a trained sleep technician, and indeed reach correlations in the 85–90% range and better,” Hadas said.
With all its promise, the device could very well become a mainstay in the dental clinic—maybe even as common as an x-ray, Hadas suggests. “It allows the dentist to better plan any restorative treatment, evaluate the need for a nighttime splint, or help with the alignment of the teeth surfaces,” he said. “We hope the BiteStrip will also help pain experts in making the differential diagnosis for migraine and nonspecific orofacial pain, and many more applications.”
MicroTargeting Platform System
The MicroTargeting Platform System is a software-based tool that allows neurosurgeons to rapidly, accurately design and fabricate a stereotactic fixture for use in cranial neurosurgery. Manufactured by FHC Inc. (Bowdoinham, ME), it represents a significant leap in ease of use, patient comfort, and fixture accuracy. It won an award in the category of surgical equipment, instruments, and supplies.
During research into technologies that could be used with stereotactic frame systems, FHC discerned that “the available stereotactic systems were based on technology that was nearly a century old,” said Ronald Franklin, FHC's stereotactic technology development manager. “Even modernized systems using image-guided and sensor-tracked computer planning are built on stereotactic frames using older mechanical technology. We saw an opportunity to improve the underlying concept.”
FHC began looking to design a device that was more comfortable for the patient, and more accurate. It patented and licensed one that was an improvement but still relied on mechanical adjustments and registration to the patient. After that, the company hit on the idea of customization.
“We looked at emerging technologies and found in one a way to design intelligent customized structures, and in another the ability to manufacture them rapidly,” Franklin said. “The combination of these things with state-of-the-art medical imaging and surgical planning software resulted in…a customized interface technology. The FHC microTargeting platform is one example of its application.”
The jurors were especially impressed by how much simpler a device produced by the microTargeting system appeared in comparison with the older stereotactic frames.
“It is designed to replace a large, complex-looking device that appears to be from an earlier age,” Wiklund said. “The mounting brackets appear to provide an extremely accurate means for stabilizing brain surgery devices. They look like they could be a significant advancement from the perspective of the people performing the surgery.”
|The MicroTargeting Platform System from FHC Inc. (Bowdoinham, ME) enables neurosurgeons to rapidly and accurately design and fabricate a customized mounting interface and navigational tool for a particular patient and stereotactic procedure.|
FHC's primary design goal was to make the interface “something that the surgeon did not have to worry about beyond the regular tasks of using a surgical planning system,” Franklin said. “For this reason, we chose an existing surgical platform system and designed a way that the fixture creation would be very much in the background, requiring only a few new choices and final verification of the design.” The chosen platform system was VoXim from IVS Solutions AG (Chemnitz, Germany).
The achievement of design goals has led to a surgical procedure becoming an option for some who previously could not have undergone one. “Several patients who had had bad initial experiences with a traditional stereotactic frame were surprised by how much less of an ordeal it was, and were enthusiastic about the procedure,” said Franklin.
The customized approach allowing surgeons to design a procedure- and patient-specific mounting interface and navigational tool for the instrument they are using could have applications in a number of other areas. “Things as various as biopsies, electrode placement, drug infusion, brachytherapy, or radiosurgery can be accommodated using a library of template designs that can be user-modified and customized,” said Franklin.
Award juror Walter Greenleaf, PhD, president of Greenleaf Medical (Palo Alto, CA), said the product is “indicative of where medicine is going: customizing a treatment for the individual person. It's nice to see this trend show up in the device sector, too.”
Partner Rhythm Assistant
The Partner Rhythm Assistant, made by Guidant Corp. (Indianapolis), gives the patient control of when to activate atrial defibrillation. It is a handheld device used with Guidant's Vitality AVT implanted defibrillator. It won an award in the category of radiological and electromechanical devices.
|The Partner Rhythm Assistant, made by Guidant Corp. (Indianapolis), enables the patient to activate atrial defibrillation. It is a handheld device used with Guidant's Vitality AVT implanted defibrillator.|
It was commended by the jurors for giving patients more power over their own treatment and for having an interface that leaves no questions as to how the device should be used. A voice chip tells the user when a shock should be administered. “This particular product is one that combines a really good design and user interface with a very innovative concept,” said juror Stephen B. Wilcox, PhD, founder and principal of Design Science Consulting Inc. (Philadelphia).
The idea came when Guidant recognized a major patient need that was not being served well. “Atrial fibrillation is a debilitating heart disease that results in a compromised life-style. So we felt there was a huge portion of the population that would remain conscious during it and would need to treat their own problem,” said Richard Stein, principal systems engineer for Guidant. “This is especially true for the younger, more active people who want to go from feeling crummy to feeling good immediately. So this device communicates with the implanted device and indicates to patients what their heart is doing.” Guidant's surveys of patients with atrial fibrillation found that although a device existed based on a similar idea, patients found it intimidating and confusing to use.
Guidant brought in design firm Worrell Inc. (Eden Prairie, MN) to help define the product. “We brainstormed solutions from what we perceived the problems to be,” said Bob Worrell, president of Worrell. “We took the concepts to the end-users and asked them what must a concept do to be comfortable for them. We captured all the data and put ‘importance ratings' on it. We also incorporated ethnography and observations from viewing patients in a controlled environment. We took all of this information and put it into a ‘computer hopper.'” The end result of the process, Stein said, is that the results it generated made common sense.
One thing that came through clearly, Stein said, is that patients wanted a device that could talk to them and tell them what was wrong—literally. Following the initial importance ratings, a voice chip feature ranked 18th out of 30 suggested features. But after computer analysis that applied additional factors, such as how the suggested features would interact, the voice chip ranked second.
“This was an innovative solution that clearly separated us from what was out there, and clearly benefited patients,” Stein said. “Our concern was to do it in a way that was not annoying. When automatic voice chips first came out, people were annoyed at them. We needed to use clearly understandable, comforting, leading phrases. And we needed to find voice talent that could convey urgency, but with calm, clear direction.” It seems to have paid off. “The product is received well by patients who use it because they understand how to use it with very little training,” said Stein.
Guidant realized the device would take a lot of wear, tear, and abuse, so the designers made it as rugged as possible. The product, Stein said, fits in with one of the most important healthcare trends of recent years. “People want greater control over their own health than in the past,” he said. “And ultimately, more patient control will lead to a cheaper healthcare delivery system.”
Storm Series TDX5 Power Wheelchair
|The TDX5 wheelchair from Invacare Inc. (Elyria, OH) provides mobility for pediatric to geriatric individuals. The design includes five technologies: center-wheel drive, SureStep, stability lock, TrueTrack, and MK5 electronics.|
The wheelchair is one of the most familiar medical devices and not an expected field for significant innovation. But the jurors thought otherwise about the Storm Series TDX5 power wheelchair, manufactured by Invacare Inc. (Elyria, OH). It won an award in the category of rehabilitation and assistive-technology products.
The wheelchair includes a number of cutting-edge technologies and is the first to combine them all into a single product. The most significant of those are center-wheel drive, SureStep, and stability lock.
“Center-wheel drive allows the chair to pivot on an axis that reduces the amount of space needed to maneuver,” said Mark Sullivan, vice president of rehab for Invacare. “It's a big consumer need. Wheelchairs traditionally have been rear-wheel drive.”
SureStep is a technology that allows the wheelchair to climb over thresholds up to 3 in. This allows it to go over sidewalk curbs, for example.
Stability lock solved a common problem of center-wheel-drive chairs; they are prone to tipping forward when moving downhill, said Barb Riles, Invacare's product manager for custom power wheelchairs. “It took our engineers several iterations to get to that,” she said.
“It was not our first thought to use center-wheel drive with SureStep because it was either not flexible enough to climb obstacles, or too tippy,” Sullivan said. “Stability lock is what allowed the concept to go. It's a mechanical ratchet system in the back of the chair. As soon as it starts to come off the ground, the system latches and keeps the chair from moving forward.”
The jurors were impressed not only with the breakthroughs represented by the key features, but also with how they were integrated into an outstanding design.
“I have seen a lot of wheelchairs, and this one seems to really offer enhanced performance,” said Wiklund. “It looks highly refined from a design and engineering standpoint. The product's most impressive characteristic appears to be its ability to traverse challenging terrain, such as street curbs, while providing the user with a comfortable and stable ride.”
“This product had great detail and design features. They thought everything through pretty well,” said Greenleaf. “This would be a great product for children with disabilities who do not have experience navigating themselves. I am also impressed that they are showing commitment to a new generation of wheelchairs.” Invacare plans to phase out older models within 1–2 years to focus on the Storm Series.
ThinPrep Imaging System
The ThinPrep Imaging System is a fully integrated, interactive computer system that helps cytotechnologists and cytopathologists screen and diagnose ThinPrep Pap test slides. Its significant innovation is that it presents to the cytotechnologists only those portions of each slide that contain the most meaningful data for review. This permits rapid resolution of the vast majority (typically 98%) of slides that show negative results, so the cytotechnologists can focus on the slides that show potentially suspicious cells. The product, made by Cytyc Corp. (Boxborough, MA), won an award in the in vitro diagnostics category.
“The cytotechnologists can see immediately which cells have been identified, and apply their expertise to analyzing those,” said juror Craig M. Jackson, PhD, president and principal scientist of HemoSaga Diagnostics Corp. (San Diego). “[The product] makes the cytotechnologists' job easier. It's good use of computer and imaging technologies, and algorithms.”
Cytyc decided in the late 1980s to develop an automated computer image analysis system for screening Pap smears. The first step was to create the ThinPrep System to replace traditional Pap smears. The product was a major improvement in clarity and readability over pap smear slides, and became a huge success. The next logical step, the firm decided, was to realize its goal of creating a more efficient cervical cytology image-screening system.
|Manufactured by Cytyc Corp. (Boxborough, MA), the ThinPrep imaging system is a fully integrated, interactive computer system that assists cytotechnologists in the primary screening and diagnosis of ThinPrep pap test slides.|
A cytotechnologist can typically manually review 50–80 slides per day. “The ThinPrep Imaging System permits the cytotechnologist to focus on only the most important areas of each slide, which results in substantially increased productivity while maintaining screening accuracy at a level equal to that of manual screening,” said Mark Girardi, Cytyc's director of marketing for the imaging system. “[It] is the first imaging-based system designed to augment the human screening process instead of replacing it. The intent is to be fully integrated into the screening process from the moment the sample enters the laboratory through staining, imaging, data recording, cytotechnologist review on the ThinPrep Review Scope, automated marking of the slide, and final review by a pathologist of the marked slides.”
For design and development, Cytyc enlisted the help of Battelle Healthcare Products (Columbus, OH). Cytyc provided strategic design direction, sample staining and imaging expertise, and overall product vision. Battelle provided the project management, statistical analysis, engineering, industrial design, and manufacturing transition resources. Cytyc then took the program in-house to perform clinical trial builds and full-scale production.
“A key technical challenge was generating enough light to image the slide in a reasonable amount of time,” said Matthew Zelinski, director of operations at Battelle's Product Development Solutions Group. “While Cytyc developed a custom stain that combined the visual characteristics of a traditional pap smear with the spectral characteristics and reproducibility needed for monochromatic imaging of cell nuclei, Battelle worked to develop a high-efficiency, high-intensity custom LED module for the light source. The solution is a fractional-watt LED, the size of a dime with low-cost optics, that eliminates heat dissipation issues and facilitates packaging.” The result, said Zelinski, was an innovative imager that is fast, compact, and affordable.
As innovative as the Imager is, the real success of the ThinPrep Imaging System can be attributed to the substantial increase in laboratory throughput it provides and the user acceptance of the Review Scope. The Review Scope had to have smooth motion control and reduce the need for the cytotechnologists to take their eyes away from the lenses. No manual number entry is necessary, as patient identifiers on each slide are read automatically. The scope's ergonomics are one of the product's best innovations. “The user requirements for the scope were painstakingly generated after numerous consultations with users, lab managers, teaching hospitals, and pathologists. We have a hard time getting our demo units back,” said Girardi.
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