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Products from the MPMN Mailbox

PRODUCTS

Products from the MPMN Mailbox

Hybrid Connectors

An experimental miniature hybrid connector system eliminates the need for a separate plastic housing and reduces overall package size and weight. The hybrid connector system from Z-Axis Connector Co. (Warminster, PA; www.zaxisconnector.com) incorporates a heat-activated adhesive to secure the connector. Electrical connection is made as the adhesive is displaced, allowing fine, gold-plated wires to be held in contact with pads on a substrate. The 0.05-mm diam standard wires are bonded to a polyimide substrate with enough strength to be used in repeated mate–demate testing applications. The connector can be reheated and removed for repair or replacement operations.

Subminiature Solenoid Valve

A two-way closed valve is now available with in-line barbed fittings. The Series 58 subminiature solenoid valve offered by Peter Paul Electronics Company, Inc. (New Britain, CT; www.peterpaul.com) comes in 3.5 or 0.9 W units. The valve is suitable for interfacing to circuit boards and miniaturized components with pneumatic outputs. Analytical applications for medical or chemical uses can be operated directly from most programmable controllers. The unit measures 2 × 1 × 5/8 in. and has a maximum operating pressure of 300 psi, with burst pressure of 1500 psi. Temperature range is –5 to 122°F and coil voltage is 6–220 V ac at 50–60 Hz.

Can Stack Step Motor

A can stack step motor is available with unipolar or bipolar construction. Danaher Motion (Wood Dale, IL; www.danahermotion.com) offers its Portescap 42S048 step motor with sintered bronze sleeve bearings. The motor features a 7.5 ° step angle and provides up to 7.2 oz-in. of holding torque. Windings can be optimized to satisfy specific application requirements. The motor is suitable for use in analyzers, pumps, and scanners. Ball bearings are optional.

PCD Rotary Tools

A maker of diamond-tipper tools has introduced a line of PCD rotary tools. The PCD tools from E.C. Kitzel Inc. (Cleveland; www.kitzel.com) replace solid carbide or carbide-tipped tools and offer longer tool life and better size control. Available in all sizes up to 4 in. diam, the tools can be designed with integral shank special connectors. The tools can be used with aluminum, copper, presintered tungsten carbide, and alloys such as silicon-aluminum, brass, bronze, copper, lead, and manganese. In addition to nonferrous metal workpieces, the tools can be used with carbon, ceramics, fiberglass composites, graphite, and plastics.

Insert Molding Design Kit

A design kit discusses the benefits of insert molding. The kit is available from Microplastics Inc. (St. Charles, IL; www.microplasticsinc.com). Each kit comes with a working, practical example of an insert-molded component designed into an everyday item. Also included is a sintered component which is an actual prototype sample from the company’s rapid program development process. A white paper on the insert molding process and a company brochure are also in the kit. Insert molding can be used to produce switches and relays, lighting components, fixtures, connectors, timers, disk and tape drive components, and filters.


Copyright ©2006 Medical Product Manufacturing News

Microchip Technology Used in Low Power Motion Sensor

INDUSTRY NEWS


Microchip Technology Used in Low Power Motion Sensor

Corinne Litchfield

A miniature motion sensor has been built using techniques found in the computer chip industry. The sensor was developed by a team of researchers at the University of Florida (Gainesville, FL; www.ufl.edu).

The sensor measures about 3 mm square and draws a very small amount of electrical power. It has the potential to operate up to one year on a standard watch battery. In addition, the sensor’s extreme sensitivity allows it to register sound as well as motion.

Micro electrical mechanical systems (MEMS) technology has reduced the size and cost of motion sensors in recent years. However, production of the tiny sensors required special manufacturing equipment. The university’s research team set out to solve this problem. The resulting single-chip sensor was made using complementary metal oxide semiconductor (CMOS) technology, which is the industry standard for silicon chip manufacturing.

Possible medical applications for the sensors include blood pressure and glucose monitoring.



Copyright ©2006 Medical Product Manufacturing News

Fluid Connections Firm Opens Design Center


INDUSTRY NEWS


Fluid Connections Firm Opens Design Center

Shana Leonard

A provider of tubing fittings and connectors has unveiled a design center. Value Plastics Inc. (Fort Collins, CO) established the center in order to assist customers with designing fluid management components suited to their specifications.

"It's an expansion of a resource we've been providing to our customers on an informal basis over the years," says Value Plastics technical and design services manager Riley Phipps. "With this new effort, we've dedicated engineering and application development effort to address our customers' increasing needs for application-specific components."

As Phipps points out, customers can't be experts in every area; sometimes they just need a little help from someone in the tubing connector field. "You can't expect every engineer to have a background in plastics or fluid management devices," Phipps states. "So what we do is offer a more specialized service."

The center acts a consultant of sorts, guiding clients through the design process. Unlike most consultants, however, Value Plastics offers its design assistance for free. Drawing on its experience, the firm is able to streamline the design phase for customers, saving them valuable time, according to Phipps. An additional source of pride for the company is its ability to provide accessible custom products.

Among the services provided are free and timely design assistance with technical support, both before and after the sale, in-house testing facilities to validate and qualify design alternatives, and in-house mold fabrication.

In addition to a helping hand, the fluid connections firm also supplies the most up-to-date technologies, materials, and plastics, according to Phipps. Both custom and off-the-shelf products are available.

Copyright ©2006 Medical Product Manufacturing News

Winning Products and Suppliers

MDEA 2006

Critical-Care and Emergency Medicine Products

Rugged Power-Pro XT ambulance cot, manufactured and submitted by Stryker EMS (Portage, MI). See description here.

Supply and design credit: Control Solutions Inc. (Naperville, IL).

Rad-57 portable pulse CO-oximeter, manufactured and submitted by Masimo Corp. (Irvine, CA). The Rad-57 is designed for emergency medicine use. The portable unit rapidly, accurately, and noninvasively measures oxygen saturation, heart rate, and the percentage of carboxyhemoglobin in the bloodstream.

Supply and design credit: Analog Devices (Norwood, MA).

Dental Instruments, Equipment, and Supplies

Image-Guided Implantology system, manufactured and submitted by DenX Advanced Dental Systems Ltd. (Jerusalem, Israel). See description here.

DenLite DP5000 illuminated dental mirror, manufactured and submitted by Welch Allyn Inc. (Skaneateles Falls, NY). See description here.

Supply and design credit: Alliance Precision Plastics (Rochester, NY) and Egli Machine (Sidney, NY).

Finished Packaging

NanoCool controlled-temperature shipping system, manufactured and submitted by NanoCool LLC (Albuquerque). See description here.

General Hospital Devices and Therapeutic Products

CrossJect single-use needle-free injection system, manufactured and submitted by CrossJect SA (Paris). The CrossJect needle-free injection system is a single-use, prefilled device designed to perform subcutaneous, intramuscular, or intradermal injections. Its modular design can be customized for various injection routes and volumes from 0.2 to 1 ml.

Supply and design credit: InterDesign S.A.R.L. (Paris).

Cortrak feeding-tube placement system, manufactured and submitted by Viasys Healthcare/Medsystems (Wheeling, IL). See description here.

Supply and design credit: Designmakers Pty, Ltd. (Adelaide, South Australia, Australia) and Micronix Pty, Ltd. (Parkside, South Australia, Australia).

OmniPod insulin management system, manufactured and submitted by Insulet Corp. (Bedford, MA). See description here.

Supply and design credit: Bay Computer Associates Inc. (Cranston, RI), Design Continuum Inc. (West Newton, MA), and Phillips Plastics (Hudson, WI).

IVantage volumetric ambulatory infusion system, manufactured and submitted by Delphi Medical Systems (Troy, MI). See description here.

Supply and design credit: Debiotech (Lausanne, Switzerland).

Implant and Tissue-Replacement Products

Gynecare Prolift pelvic floor repair system, manufactured and submitted by Ethicon Inc. (Somerville, NJ). Gynecare Prolift total, anterior, and posterior pelvic floor repair systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended.

Supply and design credit: Medi-Line SA (Angleur, Belgium) and Ruetschi Technology AG (Yverdon-les-Bains, Switzerland).

Nucleus Freedom system, manufactured and submitted by Cochlear (Lane Cove, New South Wales, Australia). See description here.

Supply and design credit: Crystalaid (Newstead, Queensland, Australia), Helbling Technik AG (Liebefeld-Bern, Switzerland), Philips Digital Signal Labs (Leuven, Belgium), and Semtech (Neuchâtel, Switzerland).

In Vitro Diagnostics

Afinion AS100 analyzer, manufactured and submitted by Axis-Shield PoC AS (Oslo, Norway). The Afinion AS100 analyzer is a benchtop multiassay analyzer for in vitro diagnostic point-of-care testing. Test cartridges are currently available for glycated hemoglobin and C-reactive protein.

Supply and design credit: Carclo Technical Plastics (Mitcham, Surrey, UK), Epsilon Perspectives Design AB (Göteborg, Sweden), Sortimat (Winnenden, Germany), and Teleca Sweden East AB (Stockholm).

CellTracks Analyzer II, manufactured and submitted by Immunicon Corp. (Huntingdon Valley, PA). The CellTracks Analyzer II is a semiautomated fluorescence microscope used to count and characterize fluorescently labeled cells that are immunomagnetically selected and aligned. It is used with the CellTracks AutoPrep system and specific reagent kits.

Supply and design credit: HS Design Inc. (Gladstone, NJ).

IDI–MRSA assay, manufactured and submitted by BD Diagnostics– GeneOhm (San Diego). See description here.

Over-the-Counter and Self-Care Products

Swing breast pump, manufactured and submitted by Medela Inc. (McHenry, IL). See description here.

Supply and design credit: Milani Design & Consulting SA (Erlenbach, Switzerland).

Radiological and Electromechanical Devices

SureFlex laser lithotripsy fibers, manufactured and submitted by IQinc (Phoenix). SureFlex laser lithotripsy fibers are small-core optical fibers for holmium lasers, offering unimpeded access to lower pole kidney stones without risk to laser optics or ureteroscopes, while permitting the use of full therapeutic laser power.

CereTom mobile computed tomography scanner, manufactured and submitted by NeuroLogica Corp. (Danvers, MA). See description here.

Supply and design credit: A & A Testing Laboratory (Danvers, MA), Altronics Manufacturing Inc. (Hudson, NH), American Design Co. (Bradford, MA), Barco (Edinburgh, UK), Ault Design and Communications Inc. (Bedford, MA), Jaco Electronics (Wilmington, MA), Martek Power (Torrance, CA), Spellman High Voltage Electronics Corp. (Hauppauge, NY), and Varian (Salt Lake City).

HD lower-leg array coil, manufactured and submitted by GE Healthcare, Coils Division (Aurora, OH). The HD lower-leg array coil has been designed to offer minimal or noninvasive high-quality, high-resolution magnetic resonance angiography of the lower leg with minimal risks and side effects, and high diagnostic confidence and patient comfort.

Rehabilitation and Assistive-Technology Products

Impact solar-powered hearing aid battery recharger, manufactured by Project Impact (Berkeley, CA). Entry submitted by Bridge Design (San Francisco). See description here.

Supply and design credit: Bridge Design, Iowa Thin Film Technologies Inc. (Boone, IA), Moonpo Development Ltd. (Shatin, N.T., Hong Kong), Peridot Corp. (Pleasanton, CA), Sector Technology (Cupertino, CA), and Solid Concepts (Poway, CA).

Cleo 90 infusion set, manufactured and submitted by Smiths Medical MD Inc. (St. Paul, MN). The Cleo 90 infusion set connects diabetics to their life-supporting insulin pumps. The set includes a cannula inserter that retracts to store the needle and tubing that delivers insulin from the pump, making insertion and use easy and comfortable.

Supply and design credit: Bridge Design (San Francisco), Modified Polymer Components Inc. (Sunnyvale, CA), and Precision Gasket Co. (Edina, MN).

Inogen One oxygen concentrator system, manufactured and submitted by Inogen Inc. (Goleta, CA). The Inogen One oxygen concentrator system fulfills the duties of stationary, portable-ambulatory, and traveling oxygen devices. It can operate from ac, dc, and battery sources, allowing users to transition easily between power sources as needed.

Supply and design credit: Adsorption Research Inc. (Dublin, OH), Launchpoint LLC (Goleta, CA), Medical Electronic Devices (Torrance, CA), Norgren Inc. (Anaheim, CA), Omnica Inc. (Irvine, CA), and Totex USA Inc. (Torrance, CA).

eFlow electronic nebulizer, manufactured by Pari GmbH (Munich, Germany). Entry submitted by eFlow LLC (Monterey, CA). See description here.

Supply and design credit: Eckstein Product Design (Munich, Germany).

Surgical Equipment, Instruments, and Supplies

Straightshot M4 microdebrider, manufactured by Medtronic ENT (Jacksonville, FL). Entry submitted by Metaphase Design Group Inc. (St. Louis). The Straightshot M4 microdebrider is an ergonomically designed surgical handpiece that improves access to the maxillary sinus, frontal sinus, and vocal folds for the removal of polyps, bone, and mucosa during nasal sinus and laryngeal surgery.

Supply and design credit: Metaphase Design Group.

360° Fascia Closure Device, manufactured by SuturTek Inc. (North Chelmsford, MA). Entry submitted by Bleck Design Group (North Chelmsford, MA). See description here.

Supply and design credit: Bleck Design Group and Lacey Manufacturing Inc. (Bridgeport, CT).

SpineJet MicroResector, manufactured and submitted by HydroCision Inc. (Billerica, MA). The SpineJet MicroResector allows minimally invasive surgical access to the spine using high-velocity water to cut and aspirate the herniated disk. Disk decompressions that had required hospitalization can be performed in an outpatient setting.

Supply and design credit: David M. Fischer Consulting (Waltham, MA), Farm Design (Hollis, NH), LFI Inc. (Smithfield, RI), and Neu-Tool Design Inc. (Wilmington, MA).

PassPort shielded trocar, manufactured by Patton Surgical (Austin, TX). Entry submitted by IncisionTech (Staunton, VA). See description here.

Supply and design credit: Atrion Medical (Arab, AL), BCD (Meridian, TX), and IncisionTech.

Updated ISO Packaging Standard Nears Publication

News Trends

John Spitzley said one goal of updating the standard was to make the terminology clearer.

Revisions to ISO 11607, “Packaging for Terminally Sterilized Medical Devices,” accomplishes what the original 1997 version failed to do. The new standard eliminates the need for the European packaging standard EN 868-1 by incorporating its requirements. The harmonized document covers materials, manufacturing, and package design requirements for terminally sterilized medical device packaging.

The draft of the revised ISO 11607 can currently be viewed online and will be published later this year. According to John Spitzley of Spartan Design Group and JM Hansen & Associates (Tonka Bay, MN), there will be a formal ballot to withdraw EN 868-1. Spitzley spoke at MD&M West.

EN 868-1 is made up of standards that are general requirements for sterile packaging materials. Requirements for specific materials such as sterilization wraps, papers, and Tyvek are included in vertical standards parts 2 through 10 of EN 868. Spitzley, one of the writers of the original and revised versions of ISO 11607, said that the authors of the 1997 version of ISO 11607 thought EN 868-1 would eventually be replaced after ISO 11607 was published. However, European companies and regulatory bodies did not readily accept ISO 11607, and so the standard was not widely recognized or used in Europe. As a result, many U.S. firms assumed they needed to comply with both ISO 11607 and EN 868-1 as separate standards.

Harmonizing the two standards also gave Spitzley and his coauthors an opportunity to revise the formatting of ISO 11607. Spitzley said device manufacturers were having difficulty complying with both standards, in part because neither was easy to read. The documents did not follow the normal packaging development process flow. In addition, EN 868-1 did not cover manufacturing or package design evaluation.

At a meeting of ISO TC 198, WG 7 in Kyoto, Japan, in May 2002, the attendees agreed upon a new format for the harmonized guidelines. The new ISO 11607 is a two-part document. Part I addresses materials (incorporating EN 868-1) and package design and evaluation, and Part II covers package assembly and validation requirements.

Part II is a completely new section. Among the topics it covers are test methods and validation requirements, including installation qualification, operational qualification, and performance qualification.

“One of the biggest changes is that you need to do performance tests of your packaging based on the worst-case scenario,” said Patrick Nolan. Nolan, chief operating officer of DDL Inc. (Eden Prairie, MN), was another of the standard's authors.

This new format also allowed the authors to develop four critical definitions. The goal was to make terminology throughout the document more clear and consistent, Spitzley said. Definitions were developed for sterile barrier systems (SBS), preformed SBS, protective packaging, and package systems.

What U.S. packaging engineers often refer to as primary packaging is now called SBS, says Nolan. All secondary or tertiary packaging is now called protective packaging. In addition, he said, what U.S. engineers refer to as accelerated aging is now called stability testing. And real-time shelf-life testing must begin simultaneously.

The new version also includes two annexes. One provides guidance on medical packaging. The other is an extensive, updated, centralized list of recommended test methods and procedures for packaging materials and preformed SBS.

The new version is expected to be named an FDA consensus standard in the fall of 2006, says Nolan. That should reduce the documentation burden on those who follow it.

Copyright ©2006 Medical Device & Diagnostic Industry

B. Braun Honored as Emerging Leader

News Trends

Frost & Sullivan (San Antonio, TX) has awarded B. Braun Medical Inc. (Bethlehem, PA) its 2005 Medical Devices Emerging Leaders of the Year Award.

The award was given for the quality of the company's products, its strong growth rate, and its efforts to provide educational services and training programs to improve patient and caregiver safety.

“B. Braun Medical Inc. demonstrates true health-sector leadership, producing innovative products that achieve operational excellence and protect patients and health professionals from risks associated with medication errors,” says Sheila Ewing, a Frost & Sullivan research analyst.

Braun is best known for its anesthetic products, but it has also posted growth in infusion therapy, drug delivery, dialysis equipment, and interventional cardiology.
 

Harmful Perception Can Become Hostile Reality

From the Editors

Public relations is not usually a core competency of a medical device company. But public relations influences public perception, and public perception influences public policy. And the truth of the matter is that industry's public perception is at risk of taking a hit, and if it does, resulting public policies could have negative consequences for industry. That means industry must get better about communicating with the public about both good and bad events.

A Harris Poll presented at the AdvaMed annual meeting in March bears this out. It mostly brings good news to industry. More than 70% of consumers say the medical technology industry does a good job serving its customers. This is comparable to hospitals and far superior to the pharmaceutical, health insurance, and managed-care industries. A strong majority of physicians and consumers cited access to the most advanced medical technologies as the greatest strength of the U.S. healthcare system. Medical devices trailed only generic drugs on the basis of how much value respondents believe they offer for the money.

But this does not mean the high approval ratings are guaranteed to stick. In 1997, the pharmaceutical industry received a 79% “good job” rating. By 2005, that had plummeted to 44%. Humphrey Taylor, the Harris Poll's chairman, cited four reasons for the decline. First, growth success made high drug costs visible to the public eye. Second, high profit margins caused resentment from a population concerned with healthcare costs. Third, safety issues and recalls caused a loss of public confidence. Fourth, aggressive and, in some cases, unethical sales practices alienated some caregivers and consumers.

Most of these negatives have not yet crossed over to the device industry, but, Taylor said, there is risk that they will. Last year brought several high-profile recalls that led Congress to question whether industry and FDA were properly addressing postmarket safety concerns.

Elsewhere in the poll are seeds of future discontent, should the device industry hit adversity. Only 26% of the general public believes that the device industry is effective at communicating important healthcare issues. A scant 21% say they would give it the benefit of the doubt if it came under media pressure. And only 20% believe industry accepts accountability for its actions. The numbers were only slightly higher for physicians and so-called engaged citizens.

What that means is that industry is scoring well on product characteristics but not corporate characteristics. Congress, physicians, and consumer groups question its accountability, trustworthiness, reliability, and caring. Nearly half of engaged citizens believe that industry puts profits before people and gives inappropriate marketing incentives to physicians.

With that in mind, Taylor told industry that it needs to “solidify positive impressions to both advance and inoculate” itself. This means communication and public relations are key. More needs to be done to take credit for medical breakthroughs. Shift the debate to topics industry can win, and don't let critics define industry. Emphasis must be placed on the high return on investment medical technology brings, especially in terms of the social and personal rewards reaped when a new device or procedure allows a patient to lead a normal life.

This communication effort must come on many fronts. It must reach opinion leaders, hospital administrators, physicians, patients, financial analysts and investors, and regulators. And the effect on media coverage and attitudes must be measured.

Industry must take Taylor's advice and educate all shareholders of the healthcare system about the value of medical technology. Otherwise, poor public relations will lead to poor public perception, which will lead to hostile public policy.


Erik Swain
for the Editors

Test Evaluates Nanomaterial Hazards

R&D Digest: The monthly review of new technologies and medical device innovations.

In their lab, UCLA's Andre Nel and Tian Xia (left) examine a test method that could determine the health hazards of nanomaterials.

As nanotechnology gains more significance in the device industry, manufacturers may have to deal with the potential health risks of engineered nanomaterials. Now there is a method that could test their safety in the future.

The test, developed at the University of California, Los Angeles (UCLA), is based on a process designed for occupational and air pollution particles, including nanomaterials. The team at UCLA anticipates its work with these particles will provide a framework for application in engineered nanomaterials. Device manufacturers might even be able to apply the method to drug delivery, imaging, and treatments for diseases like cancer.

“Nanotechnology is also likely to evolve into further complexity where you will be able to make nanorobots that consist of many different nanomaterials,” says Andre Nel, professor of medicine at UCLA. He predicts that future nanomaterials could have more complex diagnostic and therapeutic applications that involve sensing out an area in the body that carries disease and then delivering treatment to the region. This could lead to the development of miniaturized robots that treat diseases, but “that's a long way off,” adds Nel.

There are many challenges in nano-technology, because new material properties are constantly being uncovered. According to Nel, the ultimate safety or hazard of a nanomaterial is linked to several principles. These include its properties, biological interaction with the body or the environment, and exposure. The test has chemical instruments that look at size and surface characteristics of nanoparticles, and enzymatic and flow cytometry that observe the generation of oxygen radicals. Humans inhale this form of oxygen, which when activated can interact with and cause harm to tissues, says Nel.

UCLA's test first analyzes a nanomaterial. It examines physical chemical properties, including composition, size, and surface characteristics, such as coatings. After assessing the material, a second string of tests looks at its ability to generate oxygen radicals.

“At the next level, we apply a set of principles called oxidative stress,” says Nel. “This is the group word used for all types of damage that oxygen radical damage causes in cells or tissues.” Each test reflects different levels of damage, the first being the lowest level, the second tissue inflammation, and the third causing cellular death. “Our method takes into consideration a wide web of potential cellular responses and damage, whereas the classical toxicological test often only looks at the third tier. If we find that a material shows hazards in the three steps, then we would classify the material as potentially hazardous and would test it in animal models.”

As the researchers gather information on the ability of nanomaterials to cause damage in an intact animal, they plan to assess the risk in humans. “The latter process is a science that is important for toxicology, but hasn't been developed at all for nanomaterials,” says Nel. It can take years, or even decades, to see problems in humans or the environment that result from exposure to toxins. By testing and classifying nanomaterials in a rapid method, Nel hopes to be able to predict potential hazards before they occur.

However, it's much too early to know whether this testing method could be applied to all nanomaterials. So far, Nel has examined about eight materials that appear most often in consumer products, but declines to name them. “The next step is to test a large number of materials to develop a true predictive method of classifying materials as hazardous or not,” says Nel. Setting up the capabilities to study the materials could take one to two years. In the second to fifth years of work, he foresees the introduction of many more materials into testing.

Miniaturizing the testing system and making it high-throughput will be important modifications, says Nel. “Hopefully by the end of the fifth year, we will have established a predictive high-throughput system to use for analyzing a lot of material simultaneously.”

Nel is hoping to launch a start-up company based on the research that comes from investigating the health effects of nanoparticles. He established Nanosafety Laboratories Inc. in association with UCLA's California NanoSystems Institute. Nel anticipates that the group will help manufacturers test the safety or risks of nanomaterials.

The National Institute of Environmental Health Sciences and the U.S. Environmental Protection Agency funded UCLA's research on air pollution.

Copyright ©2006 Medical Device & Diagnostic Industry

Design Excellence Comes to Small Markets, Too

MDEA 2006

It seems that only a limited number of medical device types—usually those that have big effects on lucrative markets—grab the headlines. In reality, however, those devices that draw media attention are the exceptions to the device development process, not the rule. The vast majority of devices are sold to niche markets.

But developments in those niche devices shouldn't be underplayed. They often represent major quality-of-life improvements to small or neglected patient populations. And they can improve ease-of-use for caregivers to these patients. Nursing-home aides and ambulance workers may not have as much clout as high-profile cardiac surgeons, but they save lives, too.

The products highlighted in this article won Medical Design Excellence Awards because they represent significant advancements for underserved markets and underappreciated patient and caregiver populations. Their benefits may not be as obvious as those of some other winners, but their contributions to healthcare are no less important.

The Cortrak system's electromagnetic sensing device tracks the path of feeding tubes during insertion to ensure proper placement.

The Cortrak System

Feeding-tube placement is a routine but crucial task. Many times, though, it is performed blindly. If the tube is mistakenly lodged in the lung, it can cause aspiration or other pain and discomfort for a patient. Moreover, it necessitates using an x-ray to verify the location of the misplaced tube, exposing patients to extra radiation.

Viasys Healthcare/Medsystems (Wheeling, IL) developed the Cortrak system to improve the feeding-tube placement process and reduce x-ray use. “There has been a need to lessen patient exposure to x-rays during feeding tube placement,” says George Nassif, marketing services manager of Viasys. “We had talked with customers about the difficulty of getting tubes into the small bowel. It often required multiple x-rays to ensure the feeding tube was in the right place. So we decided to apply engineering principles to develop a new system.”

The Cortrak uses an electromagnetic sensing device to track the path of feeding tubes during placement. It is usually used in conjunction with an x-ray, but the x-ray should not be needed more than once. It won an award in the General Hospital Devices and Therapeutic Products category.

The device consists of a monitor unit, a receiver unit, and a transmitting stylet. The stylet, which has a coil winding at its end, is placed within the tube and transmits a signal. The receiver tracks the signal, and the monitor processes and displays it.

One key to the design was making the phase detection circuit very sensitive. This allows the system to pick up even very weak signals. It also enabled the signal to be of very low amplitude. This was important because it would minimize interference with other electronic equipment and allow the current feed to be very low, causing no harm to the patient in the event of current leakage. The design also enables power to be cut in milliseconds should circuit integrity be compromised.

The interface was designed with ease-of-use in mind. Navigation and data entry are done via a touch screen. And the system is portable, making it valuable to a multibed facility like a nursing home.

“This product has the potential to improve patient safety by eliminating the adverse effects associated with misplaced feeding tubes,” says juror Jay Goldberg, director of the Healthcare Technologies Management Program at Marquette University (Milwaukee). “It will also help reduce costs associated with the secondary placement resulting from misplaced tubes.”

Indeed, although Viasys projects savings at $25,000 per year, some jurors thought that was a low estimate.

“If anything, I believe that they were somewhat conservative in their estimates because they did not incorporate any cost differential for a patient who ended up with aspiration pneumonia,” says juror Michael P. Schollmeyer. “I thought it was a very worthwhile and practical product.” Schollmeyer is director of clinical research at CHF Solutions Inc. (Brooklyn Park, MN).

The tracking technology could also eventually be adapted to other applications, says Nassif.

Denlite Illuminated Dental Mirror DP5000

You might not think the dental mirror needed improvement—but then, you probably haven't talked to dentists about it. Welch Allyn Inc. (Skaneateles Falls, NY) did, and the company used their input to design a more-useful and less-cumbersome device, the Denlite Illuminated Dental Mirror DP5000.

The Denlite Illuminated Dental Mirror is cordless, which prevents failure modes associated with corded dental mirrors. It also reduces exam times.

“This is one of those simple, ‘that's a great idea' devices,” says juror Mary Beth Privitera. “The light is extremely bright and the clarity of the mirror is exceptional.” Privitera is assistant professor of biomedical engineering for the University of Cincinnati's Medical Device Innovation & Entrepreneurship Program. The Denlite won an award in the Dental Instruments, Equipment, and Supplies category.

The Denlite is not the first illuminated dental mirror, but it is the first cordless one. “The previous product was corded, and it would snag in the dental chair,” says Richard A. Tamburrino, Welch Allyn's engineering manager. “The number-one failure mode was the cord.” So the Denlite runs on batteries that can be recharged in less than 15 minutes.

The company took the opportunity to make other improvements as well. The previous model had a halogen bulb that would get hot. If a dentist held it long enough, he or she could feel heat on the handle, which could be hazardous for the dentist and could lead to errors affecting the patient. So Welch Allyn replaced it with an LED light cartridge, which does not get hot. Also a plus, its white light provides brighter illumination than halogen's yellow light. It's so bright, in fact, that overhead light is not needed. Since the dentist doesn't have to adjust overhead lights or power cords, the Denlite cuts down exam times.

The company improved the mirror, too. Welch Allyn collaborated with Alliance Precision Plastics (Rochester, NY) to develop an automated in-mold decoration process to produce one-piece mirrors. They were made from K-Resin and a proprietary metal foil. (In-mold decoration had never before been used to make a medical product.) The design enables the mirror to transmit light efficiently and remain strong enough for cheek retraction and tongue depression. It is also compact enough for patient comfort.

The handle was designed to be robust enough to endure thousands of steam sterilizations and flat enough that it wouldn't roll off a tray.
Being cordless, the instrument is portable, so it can be taken outside the dentist's office if necessary.

“This is a very clever design that overcame some technical challenges to bring it to fruition. And it appears to be highly functional,” says juror William Hyman. “A seemingly simple device can be an award winner if it is well designed and well presented.” Hyman is a professor at Texas A&M University's department of biomedical engineering, located in College Station, TX.

The Impact hearing-aid battery recharger works on sunlight alone and can recharge almost any type of hearing-aid battery. Project Impact and industrial design firm Bridge Design worked to make the recharger look like a consumer electronics device.

Impact Solar-Powered Hearing Aid Recharger

In the United States, a hearing aid costs about $1500 per ear. That would seem unaffordable to residents of third-world countries, but that didn't stop the Impact Foundation, a Berkeley, CA–based nonprofit organization that runs a program called Project Impact.

“Poverty and disability go hand in hand,” says Joel Segre, a project manager for Project Impact who came up with a low-cost hearing aid idea while in college. “The more impoverished one is, the harder it is to get medical care; and the harder it is to stay healthy, the harder it is to be able to work. A hearing aid can help break that cycle.”

The organization developed a hearing aid that costs only $50 per ear, and it made them available for little to no cost to those in need. But one obstacle remained: battery technology. Hearing-aid batteries are not cheap, but the recipients of the device may be earning as little as $1 per day. So Project Impact developed a recharger that works on sunlight alone and can recharge almost any type of battery for almost any type of hearing aid.

“It had to be able to withstand extreme heat and extreme rain, so we used UV-absorbable resins,” Segre says.

The initial prototype was rudimentary, since costs had to be kept down. “Our feeling was that the people who would use this would care about price and functionality but not cosmetics,” says Segre, who tested the prototype in India. “That was forcefully disproved. People rejected it, saying it looked like it was low quality.”

So Project Impact hooked up with industrial design firm Bridge Design (San Francisco), which agreed to do most of its design work for free. It reduced the number of parts and made the product look like a consumer electronics device, which is a desirable quality even in the poorest communities. It has just three parts, which combine the functions of case, battery door, battery holder, solar panel, and charging contacts.

“The obstacles of the initial prototype were that people didn't like it and retailers didn't want it shown in their showrooms,” says Segre. “The new instrument can be worn and displayed with pride.”

The recharger is now available in India, Pakistan, Nepal, Sri Lanka, and East Africa. The World Health Organization has expressed interest and may get involved with distribution. That would expand its availability exponentially.

Jurors were impressed with the technology's ability to provide care to the too-often uncared-for. They gave it an award in the Rehabilitation and Assistive Technology Products category.

“For emerging countries, the ability to recharge hearing-aid batteries is an extremely innovative idea to bring people with fewer resources the gift of hearing,” says Tor Alden, a principal at HS Design Inc. (Gladstone, NJ).

“This device brings healthcare to those who are less fortunate and have no alternatives,” says Privitera. “It provides an example of leadership to develop devices with severe cost constraints and supports an environmentally friendly technology. Kudos to those parties involved to make this project a reality and for demonstrating successful development of an ecologically sensitive, accessible device.”

Rugged Power Pro XT Ambulance Cot

There are many ways healthcare workers get injured on the job. One that does not receive much publicity is emergency workers who hurt their backs from lifting cots carrying patients. This has become a more serious problem in recent years with the rise in obesity in the United States. There's already a shortage of paramedics, and early retirements due to back injuries is making the situation worse.

The Rugged Power Pro XT Ambulance Cot is lightweight and battery powered, which helps prevent back injuries in paramedics caused by lifting overweight patients.

In response, Stryker EMS (Portage, MI) developed the first hydraulic cot for the U.S. market. It received an award in the Critical Care and Emergency Medicine Products category.

“This has been a crying need for the past three to five years,” says Jason Kneen, a design engineer at Stryker EMS. “As patients get bigger, operators' backs have had to take on more and more weight. We wanted to design something that would allow paramedics to not have to lift a cot.”

The company had to design a powered lifting device that was lightweight, dual speed, and battery powered. The result, the Rugged Power Pro XT, comes with full manual backup and built-in safety features for both the powered and the manual modes. It was subjected to extreme testing to verify its ability to withstand intense heat, cold, humidity, vibration, and sudden impact.

And the cot's electronics and hydraulics were so robustly designed that it was the first product of its kind to receive certification in IEC 60601 compliance from Underwriters Laboratories. “That guarantees to the medical community that the cot will not interfere with heart monitors or any other devices,” Kneen says.

Of course, getting certification meant overcoming a number of engineering challenges. The cot had to support patients up to 700 lb while weighing less than 130 lb itself. So its base uses dual telescoping X-frame leg technology with a four-bar design to reduce the loads on the base geometry. It had to have sensing technology to know when to accelerate or decelerate the speed of motion. It needed two speeds: fast for grave emergency cases, and slow for less urgent cases to provide better patient comfort. And it needed push-button retraction for when the patient was loaded into the ambulance. (Manual loading takes 10–15 seconds, whereas an automated load can be done in as little as 2.5 seconds.)

The response has been overwhelming, says Kneen. “We met all our financial goals for a year within the first three months after launch,” he says. “The demand is bigger than what we can put out, and that says a lot.”

“This is an excellent product,” says juror Denise M. Korniewicz. “It reduces back injury among EMTs and provides safety for heavyset patients. Patients do not fall off the cot, and they are not uncomfortable and jolted around because of a small cot.” She is professor and senior associate dean for research at the University of Miami (FL) School of Nursing.

The Swing Breast Pump promotes milk ejection and simulates a baby's nursing rhythm, delivering maximum milk flow in a short time.

Swing Breast Pump

In today's hurried society, breast pumps are becoming more of a necessity. This may not be a subject that's discussed in public much, but that doesn't preclude customers from demanding better designs. With its Swing breast pump, Medela Inc. (McHenry, IL) met this demand.

“We needed a single electric pump that met moms' criteria: small, lightweight, battery operated with enough battery life, stylish, and quiet,” says Terry McCloud, Medela's marketing communications manager. Also, he says, there had to be a better method for suction.

Medela developed the first two-phase pumping program for home-use breast pumps. Previously, the technology was found only in hospital pumps. The two phases are stimulation and expression. The former promotes the milk-ejection reflex. The latter simulates a baby's actual nursing rhythm and can deliver maximum milk flow in less time.

The challenge was to develop a small pump that had the power of its bigger competitors without hampering product durability and lifespan. It also had to be lightweight, mobile, and easy to clean. Medela's design is versatile enough to be used on a tabletop, worn around the neck or over the shoulder, or clipped onto a belt.

The initial design was tested by 150 mothers in eight countries. “We received very positive feedback on the product on numerous fields of measure, even from moms who experienced some problems with the initial design,” says McCloud. “After some design modifications, our second field testing, conducted with 80 moms in four countries, garnered the same high marks with better performance in the improved areas. Most moms wanted to keep the product indefinitely because it performed and was designed far better than other single electric pumps they had used. We also received very positive feedback on the look and functionality of the product. Technical and product testing exceeded all performance goals set for the product.” Of particular help was an easy-to-use control panel that allows mothers to make manual adjustments in midpump if they need. The pump also can be used with one hand.

“The designers of this product understood the needs of the potential users of this device and provided features to meet those needs,” says Goldberg.

The pump won an award in the Over-the-Counter and Self-Care Products category. It launched in the European market in the fall of 2005 and is expected to be available in the United States in the summer of 2006. Medela expects to use the two-phase pumping technology on other products.

“This is a user-friendly consumer device that was well thought out,” says juror Gail D. Baura, vice president for research and chief scientist at CardioDynamics (San Diego).

Copyright ©2006 Medical Device & Diagnostic Industry

Wearable and Implantable Sensors Use Less Power

R&D Digest: The monthly review of new technologies and medical device innovations.

Assistant professor Huikai Xie and two graduate students (seated) invented the sensor.

A smaller version of a motion sensor used for navigation control is being tailored for medical applications. The novelty of the sensor isn't its size, but its low power draw and low manufacturing cost. These characteristics, along with a wireless capability, could make the sensors a more suitable and prevalent component in medical devices.

Developed at the University of Florida (Gainesville), the sensors detect motion or vibration of a monitored object. They can tell in what direction an object is moving and can measure acceleration, which can be converted to precision or velocity. Measuring 3 mm2, the unit consists of a wireless chip packed with a battery. It integrates signal processing and wireless transmission.

Xie examines the motion sensor that he helped design. The main benefit of the sensor is its low cost and manufacturability. Photos from the University of Florida.

“Our goal is to have a wearable sensor,” says Huikai Xie, assistant professor in the department of electrical and computer engineering at the university. Xie and the Florida researchers designed the sensor to be manufactured with complementary metal oxide semiconductor technology, which uses less power. The designers estimate that if the component were mass-produced, it could cost less than $10 to manufacture.

Xie envisions two types of sensors—one worn externally, the other implantable. He wants to be able to embed the chip in clothes or wrap it around a particular body part. In this case, the sensors could be used for tracking a person or for rehabilitation purposes. For example, a stroke patient might not remember how to move. The motion sensors could help remind the patient how to move or indicate how well the person is progressing. Athletes could use the sensor to optimize their energy consumption.

Tracking a person involves putting wireless radio-frequency circuits on the chip, an important feature for medical purposes. Instead of having a nurse on constant watch, the sensor could help the nurse monitor the patient from a distance.

Implantable sensors would allow doctors to monitor recovery progress or potential problems inside the body. “Because the whole unit is small, we can implant the sensors into the body, in bones or an organ to study motion,” says Xie. “In that case, it's even more important to have wireless [capability], because you don't want to have a wire coming out of the body.”

Xie says the option of implanting the sensor is imperative to better understand body processes. “If you want to know exactly how the bone moves, it's better to implant the sensor into the bone,” says Xie. To make it implantable, the sensor unit must be encased in a biocompatible material. Putting the chip inside the body also raises issues with power consumption.

“You may want the unit to stay [implanted] a few weeks, months, or a year,” says Xie. “With power management, the lifetime of the battery can be easily extended up to one year.”

It can continuously run for about a month, but it doesn't usually need to be turned on all the time. Data sampling may be a more effective way to save power. To run for a year, the unit would use about 0.001 W of power.

More information about the technology can be found in the December issue of the journal Institute of Electrical and Electronics Engineers Transactions on Circuits and Systems.

Copyright ©2006 Medical Device & Diagnostic Industry