Originally Published MPMN March 2005
Every year, MPMN takes a look at some fascinating new developments in the world of medical device manufacturing. These new technologies often prove to be a preview what we’ll be seeing in the next generation of medical devices.
This year’s crop runs the gamut from diagnostic imaging software for osteoporosis screening to a new deposition process for surface treatment of devices. Terahertz radiation can provide imaging in 3-D, and may improve detection rates of diseased tissue. And a new wireless system for hearing aids likely will have hard-of-hearing patients smiling from e2e.
Early Detection of Osteoporosis Made Easier with Computer Diagnostics
|OsteoGram diagnostic software analyzes x-ray images to determine the patient’s risk for osteoporosis.|
According to recent figures from the National Institutes of Health, osteoporosis is a major public health threat for 44 million Americans, more than half of whom are women. Early detection of the bone disorder has usually relied upon dual x-ray absorptiometry (DXA) scans of the hip or spine, scans which may be inconvenient, if not expensive, to obtain.
However, a company specializing in computer-aided diagnostics technology has come up with a plan to provide osteoporosis screening to more women. CompuMed (Los Angeles; www.compumed.net) has filed a patent for the integration and use of its OsteoGram osteoporosis screening and diagnostic software system on digital mammography equipment.
Originally developed for use on standard or digital x-ray equipment, the software gives clinicians a cost-effective method of measuring bone-mineral density (BMD). Using a hand x-ray, the software uses measurements from the middle phalangeal bones of the index, middle, and ring fingers to analyze and produce the BMD report. The company has designed the OsteoGram software with a highly precise radiographic absorptiometry (RA) technique to measure BMD.
By incorporating the software into existing systems, women can be screened for both breast cancer and osteoporosis in one visit. After a routine mammogram, the woman would place her hand on the machine to generate an image suitable for BMD analysis.
In previous years, combining the OsteoGram software with analog-based mammography was not possible because of differences in penetration and inconsistent photon energy levels. “With traditional mammography, the equipment looks only at the tissue, not the bone,” explains CEO Jerry McLaughlin. But digital mammography machines regularly achieve and maintain peak photon energy levels, allowing deeper penetration in order to get clear images of tissue as well as bone.
CompuMed’s success in integrating the software into other platforms bodes well for its integration into digital mammography equipment, says McLaughlin. “It’s merely acquiring the image from another type
of x-ray equipment,” he adds. The company hopes
to make the technology available within six months.
Ear-to-Ear Wireless Technology Doubles Listening Pleasure
e2e wireless technology
allows two independent hearing
instruments to function as one hearing system.
As recently as the mid- to late 1990s, digital chips in hearing instruments contained a few thousand transistors. Less than a decade later, integrated circuit technology has contributed to the dramatic increase in processing power. More than
2 million transmitters can presently be housed
in a 1.3-V chip. Such power translates into additional features for medical products.
For example, gone are the days when hearing-aid users had to wear bulky instruments and tote around battery packs. Even worse, they had to turn down their volume and forego hearing conversations because of annoying feedback. Today’s instruments are powerful microstereo systems. They feature a microphone, amplifier, loud speaker, and battery in a package that may be as small as a cashew.
Siemens Hearing Instrument (Piscataway, NJ; www.usa.siemens.com/hearing) also incorporates a core digital-signal processing paradigm into all of its Acuris models, enabling a dynamic listening environment. With the use of directional microphones, a signal is transmitted that allows each ear to identify whatever it is hearing. Speech, stationary or fluctuating noise, music, or even silence is recognized. Multiple sounds and the direction from which they originate are also detected. For instance, the process makes it possible for a person in a car to hear a companion speak or to enjoy music, while noises entering through an open window are filtered. In other words, the signal processing analyzes the situation, and the rest of the signal is optimized. Additionally, information about the listening environment is continually sent from ear to ear.
Having successfully developed this digital-signal processing, Siemens sought to simplify the wearing process for hearing-aid users. The firm developed ear-to-ear (e2e) wireless technology, a binaural hearing system that permits two independent hearing instruments to function as one for the first time. The technology synchronizes the system’s core advanced digital-signal processing and wearer-operated controls. William Lankenau, president and CEO of Siemens says, “With 74% of hearing instrument fittings being bilateral, this is a huge step forward in terms of moving the industry to the next technological level. First, there was analog, then digital, and now e2e wireless.”
Until now, there was no integration or synchronization of a user’s left and right hearing aids. E2e enables the instruments to “talk to each other,” says Thomas Powers, PhD, chief research officer for Siemens. He notes that this technology restores critical input information that the brain and auditory systems require to make good decisions, and improves the wearer’s ability to hear in difficult listening situations.
Acuris automatically adjusts itself to the listening condition of the wearer, who can also use synchronized controls to adjust the volume or program on one instrument, which changes both simultaneously. Shortening the programming time for hearing instruments should benefit approximately 80% of the hearing-impaired population, who suffer hearing loss in both ears. People with limited arm movements will also find not having to alter two separate instruments advantageous. Powers says, “Only half of [the users’] effort is required to adjust the volume or program. And since the controls may be separated on the two instruments, they can avoid confusion when making adjustments.”
The core digital technology in Acuris is also suitable for monaural amplification. Acuris can easily be adapted for binaural wireless communication with a second hearing instrument at any time in the future.
Advanced Breast Cancer Imaging TechnologyNears Market
|Cambridge Consultants is working with TeraView
to establish the best market entry strategy for its advanced breast cancer imaging technology.
The death rates from breast cancer have declined considerably between 1992 and 1996. However, the American Cancer Society still estimates that 40,410 women will die from, and 211,240 women will be diagnosed with, breast cancer in the United States this year. Additionally, more than 1.2 million new cases
were diagnosed in 2004 worldwide, according to the World Health Organization.
Two Cambridge, UK–based companies, Cambridge Consultants (www.cambridgeconsultants.com) and TeraView Ltd. (www.teraview.co.uk) have joined forces with leading international surgeons to determine the best strategic market entry for an advanced imaging technology for this type of cancer.
Spun out from Toshiba Europe’s Research Laboratory, TeraView is currently performing a series of studies, imaging healthy and cancerous tissues. The firm is devoted to the exploitation of terahertz radiation or t-rays, which lies at frequencies between infrared and microwave bands and is a yet unexplored region of the electromagnetic spectrum. Capable of imaging in
3-D and supplying spectroscopic information, t-rays can differentiate between unhealthy and normal tissue.
The potential benefits of the system include improved detection rates of diseased breast tissue during surgery. The system serves as a guide for the surgeon’s knife, ensuring that too much healthy tissue is not removed. Using this technology could lead to a decrease in the need for repeat surgeries, which have been quite high. While some studies indicate that 10–20% of patients have to reenter an operating room, others statistics point to 30%, according to Gerald Dunstan, PhD, senior business consultant at Cambridge Consultants.
In addition, TeraView’s technology could also translate into substantial worldwide healthcare savings, says Dunstan. He adds, “Lessening the need for a second procedure by using [terahertz] imaging technology in the initial surgery will not only provide considerable health economic benefits, but may also provide improved recovery rates and a reduction in the trauma of treatment for the patient at an already trying time,” he says. “By engaging with surgeons, we can develop, [analyze], and recommend a number of strategies to TeraView in order to help them achieve successful market entry for this exciting technology.”
TeraView’s CEO Don Arnone notes, “Our technology development is at a critical stage, and by performing this research study with Cambridge Consultants, we hope to see TeraView technology introduced into operating theaters within the next three years.”
Material Structures Enhanced with IonicDeposition Process
|Using Ionic Fusion’s plasma deposition process, a polymer’s substrate was infused with silver oxide for added antibacterial properties.|
Surface-treatment processes have made great strides in the last 20 years through ion-based deposition procedures.
The ionic plasma deposition processes combine materials on an atomic level, such as plastics with metal alloys, to create products that retain core properties but have additional qualities such as hardness, corrosion resistance, and lubricity.
Yet there may be limitations with some of these procedures. Chemical vapor deposition (CVD) can only work at extremely high temperatures. Sputtering, another well-known ionic deposition technique, may not have consistent rates of deposition.
Ionic Fusion Corp. (Longmont, CO; www.ionicfusion.com) has developed an ionic plasma deposition (IPD) process for surface treatment. The patented process is performed in a vacuum and uses low temperatures to infuse materials into most material substrates. The high-energy deposition process creates an impregnated surface that has better adhesion and better
|Click to enlarge .|
The process came about as a result of the company’s work
with silver oxide deposition on polypropylene and spunbonded polyolefin. Once the firm began work on refining the ionic deposition process, as
well as finding other metal alloys for the application, “we found remarkable characteristics as a result,” says president Joe Ryan. Tantalum, platinum, and gold are among the metals that can be processed using IPD technology.
The multiple alloy and precious metal combinations can also be stacked in multiple layers to create complete wear- and corrosion-resistant systems. The entire surface of the material substrate is evenly coated to ensure adherence to close-tolerance specifications.
Use of IPD technology in medical devices ranges from imbuing prosthetics with titanium for added strength and wear resistance to tantalum-coated stainless-steel stents for postimplant visibility. Other medical device implants have been impregnated with silver oxide, a metal alloy known for its antibacterial qualities, for use in preventing infection.