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Articles from 2011 In November

Oscillator Offers Phase Noise Performance in Compact Package

Despite an industry-wide trend toward miniaturization, medical device designers have often been forced to use larger-sized oscillators in order to achieve the necessary phase noise performance for a given medical application. In response to this limitation, Bliley Technologies has developed the Apollo oven-controlled crystal oscillator (OCXO), which the company claims offers superior phase noise performance in a compact footprint requiring less than half the space of existing designs.

Bliley Apollo OCXO
Suited for use in MRI equipment, Bliley's Apollo OCXO measures just
1 × 1 in.

Suited for use in MRI equipment, conventional OCXOs demonstrate good phase noise, which helps drive optical picture clarity. But as phase noise degrades, image quality is sacrificed, making it more difficult to analyze critical test results, according to Dennis Barrick, Bliley's vice president of marketing and business development. In light of this issue, medical device designers have grappled with how to achieve a smaller form factor without sacrificing phase noise performance.

In development for the past two and a half years, the Apollo OCXO addresses this problem by offering good phase noise performance in a low-profile, 1 × 1-in. package size. This space reduction, Barrick notes, can be attributed to an improved circuit design that reduces component count. "We've been working several years trying to continuously achieve the best phase noise performance in the smallest package," Barrick says. "Other companies provide low phase noise OCXOs, but none have achieved this level of performance in a 1-in. square package."

The close-to-carrier phase noise performance of the Apollo OCXO can be attributed to the use of stress-compensated (SC) cut resonators, according to the company. These SC crystals provide compensation for thermal transient and planar stress effects, in contrast to temperature-compensated or voltage-controlled oscillators, which require a compensation network to bring the frequency back to its center point. But because SC crystals don't function well in ambient temperatures, they are placed in an oven so that temperature changes are never seen on the crystals themselves. "They have extremely good phase noise," Barrick remarks. "Everything is housed inside an oven inside the package."

The company also dedicated its design efforts to ensuring that the crystals are hermetically sealed. Other manufacturers, Barrick states, often put a crystal blank inside a package with other components. "As soon as you do that, you can age the part, contaminating the crystal from other components," he says. "Our hermetically sealed crystal never sees other circuitry."

Available with frequencies ranging from 30 to 130 MHz, the oscillators are customizable and can be provided in RoHS-compliant versions as well.

Bliley Technologies

3-D Printer Builds Bone-Like Material in Custom Shapes

Bone-like materials for orthopedic or dental applications have been made with a variety of manufacturing techniques, and the latest uses a 3-D inkjet printer to create a scaffold for new bone growth that is able to later dissolve. Researchers at Washington State University (Pullman, WA) have been performing in vitro test on rats and rabbits successfully, and believe that in the next few years, the technology has the ability to produce custom replacement bone tissue.

To create the scaffold, a team of engineers spent a year modifying a 3-D printer designed to make metal objects to print with other materials. The inkjet printer sprays a plastic binder in layers 20 microns thick over a bed of powder. Following a CAD file, the printer builds up a channeled cylinder a layer at a time. And by adding zinc and silicon to the main calcium phosphate material, the team discovered that the strength was nearly doubled.

When introducing the scaffold to a medium with immature human bone cells, in just a week a network of new bone cells was supported by the scaffold. Susmita Bose, co-author and professor in WSU's School of Mechanical and Materials Engineering, hopes that with this technology, a doctor could perform a CT scan of a defect, which could be converted to a CAD file to create a custom replacement. The technology could also be used to deliver medicine for treating osteoporosis. The results were reported in the journal Dental Materials

Animal- and Pathogen-Free Hyaluronan Passes the Acid Test

Intrinsically biocompatible, biodegradable, and biologically functional, hyaluronic acid (hyaluronan) is used in a range of medical device applications. However, because it has traditionally been synthesized from either rooster combs or various attenuated strains of Streptococcus, it can incorporate animal-derived contaminants or immunogenic pathogens. Now, in a break with tradition, Novozymes Biopharma offers a grade of hyaluronan that avoids these pitfalls.

Novozymes Hyasis
Made without animal or Streptococcus-derived materials, Hyasis does not expose patients to contaminants or pathogens.

In contrast to standard hyaluronan, Novozymes' Hyasis is produced in a fermentation process involving a nonpathogenic bacterial host called Bacillus subtilis, explains Hans Ole Klingenberg, the company's global marketing director. Because it is not derived from Streptococci, it does not expose patients to toxin-secreting pathogens that can result in hemolysis. In addition, it is processed without organic solvents, ensuring high purity and reducing contamination.

Hyasis's porosity and the reduced size of its spray-dried particles enable it to dissolve up to five times faster than other hyaluronan materials, reducing its filtration time and manufacturing costs, Klingenberg says. Given its purity, the material can also be autoclaved without losing significant molecular weight and viscosity. And because its Bacillus-based fabrication process produces material with a targeted molecular weight and narrow polydispersity, manufacturers can avoid process variability, according to Klingenberg.

"Hyaluronan is a naturally occurring polysaccharide that is distributed widely throughout connective, epithelial, and neural tissues," Klingenberg says. "By providing structure to tissues--including skin and cartilage--it contributes to the optimal functioning of the body, acting as a binding and protecting agent in tissue hydration and lubrication." By supplementing the natural levels of glycosaminoglycan in the human body, Klingenberg adds, hyaluronan is suitable for use in a variety of drug-delivery and medical device applications.

While hyaluronan is often used in osteoarthritis applications to supplement naturally occurring hyaluronan, it also serves as a component in implantable devices or in viscoelastic devices during the removal of the natural lens of the eye. In other applications, Klingenberg notes, it is used as a coating because it exhibits low surface friction. Applied by dip-coating, hyaluronan can be deposited on both the inside and outside surfaces of medical devices and on most commonly used polymers and metals.

"The widening use of hyaluronan in medical device applications can be explained by its moisturization properties and its ability to promote tissue healing," Klingenberg says. "And Hyasis is redefining hyaluronan because it enables customers to improve how the material is processed and formulated, speeding up product development and creating improved therapies."

Novozymes Biopharma
Bagsvaerd, Denmark


Transparent Adhesive Technology Offers Antimicrobial Functionality

Although the incorporation of antimicrobials into wound-care products is helping to address infection concerns, the use of such agents as chlorhexidine gluconate (CHG) has presented new challenges to end-users and industry alike. Products that incorporate CHG currently lack transparency, for example, which can interfere with clinicians' ability to quickly identify signs of potential infection. Manufacturers, on the other hand, have struggled with incorporating CHG within a solvent acrylic adhesive. Addressing these limitations, Avery Dennison Medical Solutions has developed a transparent CHG adhesive delivery system (ADS) that offers antimicrobial functionality while promoting ease of use.

Avery Dennison Adhesive Delivery System
Avery Dennison's CHG adhesive technology is
transparent, enabling clinicians to easily monitor insertion and incision sites for signs of infection.

Current products equipped with CHG protection, such as dressings with a CHG-impregnated hydrogel island and an opaque CHG-impregnated foam disk that is covered with a transparent film dressing, may not adequately meet the needs of end-users, notes Emily Berlin, Avery Dennison Medical Solutions global market segment manager. In vascular-access applications, in particular, nurses prefer to have a clear view of the insertion site to monitor it for redness, inflammation, or blood, which may indicate an infection or other potential problems. "Neither product permits easy visibility and must be removed to check the insertion site, requiring the application of a new dressing," Berlin states.

Taking these unmet needs into consideration, the company sought to optimize its CHG ADS for use in the clinical environment. Suited for use in vascular-access or postoperative-care applications, the technology can be offered in a transparent film dressing, which provides clinicians with a clear view of the insertion or incision site. The adhesive system is capable of absorbing moisture and exudates as well.

In addition to its transparency and ease of use, ADS has demonstrated efficacy against a range of bacteria and yeast. The company reports that the system exhibited a cytotoxicity profile of Grade 0 during testing, compared with two commercial products that each had a Grade 3 cytotoxicity profile. Furthermore, these data indicate that the company was able to successfully incorporate CHG into a solvent acrylic adhesive formulation, which has been historically difficult, according to Berlin.

"We had to do some creative development work," she says. "The CHG molecule is chemically incompatible with the adhesive--one hydrophobic, one hydrophilic--so the challenge [was] in how to get the CHG molecule effectively incorporated." Because of this chemical incompatibility, companies typically opt to impregnate the CHG molecule into a different matrix rather than incorporate it into the adhesive formulation.

Having successfully incorporated the antimicrobial into the adhesive, Avery Dennison Medical Solutions is using the technology developed for the CHG formulation to further explore other combinations of adhesives and antimicrobials that haven't previously been possible. The CHG transparent film dressing is currently pending FDA clearance.

Avery Dennison Medical Solutions


'Home Health Hub' Reference Platform Facilitates Development of Remote-Access Devices

Promoting improved patient outcomes and reduced healthcare costs, telehealth and remote patient monitoring applications are on the rise. Responding to increased interest in these fields, Freescale Semiconductor (Austin, TX) has introduced a home health hub (HHH) reference platform designed to accelerate development of remote-access devices and provide seamless connectivity and data aggregation.

Freescale home health hub
Freescale has introduced the home health hub to help expedite network-enabled devices' time to market.

"The changing dynamics of the aging global population are creating an increased demand for new technologies and tools that can offer peace of mind to the family members of seniors living at home," says Steven Dean, manager of Freescale's Global Healthcare team. "There's also a need to provide access to healthcare in remote and growing regions of the world to improve the quality of life for millions of people. Our new home health hub reference platform is designed to simplify development of connected medical devices and help our customers more easily address these growing needs."

Based on Freescale's low-power i.MX28 applications processor and ZigBee and sub-1 GHz transceivers, the HHH reference platform can serve as a foundation for network-enabled medical devices. It allows for secure WiFi and Ethernet connectivity to remote devices, such as smartphones or tablets, as well as to a variety of medical devices, including blood pressure monitors, glucometers, and pulse oximeters.

Compliant with Continua device profiles, the platform provides hardware and software that facilitates prevalidated, secure connectivity for telehealth and remote monitoring applications.

Florida is walking the walk for medtech

I was invited down to Florida recently to view some of the advances they’ve made in the medical device space. Representatives from that state have been making a lot of noise about the technology that’s being developed there, so I thought it would be a good idea to see if they were just “talking the talk.”

My first stop was at a place called The Nicholson Center, a very high-tech training and education center for minimally invasive surgical techniques. Located in Celebration, Fla., a suburb of Orlando, the 54,000-ft.2 center claims to be the world’s largest facility solely dedicated to physician training. With a goal of bringing together physicians, clinical industry leaders, and researchers, the center is expected to train more than 20,000 people from around the world each year. The center had been housed inside the nearby Florida Hospital until recently. It’s now in its own very high-tech building. The official grand opening occurred last month.

While I was touring the new facility, a physician was being trained on a daVinci robot (one of six that are housed at the facility). I had never seen a live daVinci robot, so it was quite an experience. He was practicing tying sutures.

I was informed that the center is home to more surgical stations and trains more physicians on the daVinci robot than any other location in the world. Other technology that I saw on-site included more than 40 fully-equipped endoscopic surgical stations, two 935-ft.2 team training operating rooms, and a medical simulation and robotics center.

Last year, the Department of Defense awarded the Nicholson Center a $4.2 million Congressional Directed Grant to study ways that tele-medicine technology can be used in military surgery. Imagine a doctor in Florida performing surgery on a soldier in Afghanistan using a daVinci robot. The grant was secured by Congressman Alan Grayson with support from Senator Bill Nelson.

My second stop on the trip was to a hospital in downtown Orlando, aptly named Florida Hospital Orlando. While this is a fully-functional working hospital, it’s also home to the InnovatOR Suite, a live surgical environment for clinicians and medical device designers to innovate and stimulate product development.

The InnovatOR Suite is a 35,000-ft.2 neurosurgical center that features eight operating rooms, each outfitted with the latest intra-operative imaging systems. The imaging technology can be used for both diagnostic and intra-operative purposes. For example, the 3-Tesla MRI system provides real-time information during a surgery, unlike traditional MRI systems, that are generally used before or after surgery is completed. Now a physician can confirm the success of a surgery while the patient is still on the operating table.

That’s just the tip of the iceberg at the InnovatOR Suite. With a host of partners helping to fund the project, there is plenty of innovation still to come.

Richard Nass

The Best (and Worst) Thing About Medtech Jobs—An MD+DI Salary Survey Guide

The Best (and Worst) Thing About Medtech Jobs—An MD+DI Salary Survey Guide

You are the pulse of the Medtech Industry, dear reader. That truth is driven home every December when MD+DI publishes the annual salary survey. This year was a change from the usually upbeat results, and it's not surprising. We're seeing higher levels of dissatisfaction than ever before. Our experts say it's the economy in general, the meager state of start-ups, and perhaps a feeling that positions are simply more precarious. 

It's not about the money, Mir Imran recently told editor Brian Buntz, particularly in the medical device industry.

But it is about how you feel about what you do, because, "When you boil it down to its core, we spend about 40% of our time at our jobs and, according to one expert, about 70% of our time thinking about our jobs. So we darn sure better be happy doing what we’re doing." says Rich Nass, who wrote the salary survey analysis.

So take a look at our salary survey, calculate your approximate salary, and let us know the best and worst things about your job.

Salary Survey: Medtech Employees Can't Get No Satisfaction

Salary Survey Tables

Heather Thompson

U.S. Healthcare Reforms Could Impact Domestic Pacemaker Sales

Increasing incidences of arrhythmia and heart failure will contribute to a predicted growth of the global pacemaker and cardiac resynchronization therapy pacemakers (CRT-P) market from $4.5 billion in 2010 to $5.3 billion by 2017, according to a recent report by industry analysis firm GlobalData. The report, "Pacemakers and Cardiac Resynchronization Therapy Pacemakers (CRT-P): Global Pipeline Analysis, Competitive Landscape, and Market Forecast to 2017," cites advancements in pacemaker technology and growth in emerging markets as key market drivers, but cautions that looming healthcare reform could impact domestic sales.

pacemakerWith a compound annual growth rate (CAGR) of 2.5% forecasted, the pacemaker and CRT-P market is composed of dual-chamber, single-chamber, and CRT pacemakers. Despite their higher price tags, dual-chamber pacemakers accounted for 70% of the market's global revenue in 2010 because of their demonstrated efficacy compared with single-chamber devices. However, single-chamber pacemakers comprised a fair 26% of the market, which is largely attributed to their lower cost and related use in developing areas such as China, India, and Brazil.

Dominating the global pacemaker market in 2010 was Medtronic, boasting 40% of the global market share, according to the report. St. Jude Medical, Biotronik, Boston Scientific, and Sorin Group were identified as major players as well. Most of these companies' pacemaker revenues in 2010 came from the United States and Europe, but that could soon change, the report speculates. "Device consumption rates in these countries have decreased due to effects of the global recession and pacemakers reaching their peak sales. This has resulted in companies shifting their focus towards emerging markets, which is expected to provide the next impetus for growth."

Companies are also looking to emerging markets for pacemaker growth as the United States readies for controversial healthcare reform policies, including the much-contested 2.3% excise tax on domestic sales of medical devices. Furthermore, an increased emphasis on value-based payment programs through Medicare and comparative effectiveness research could impede pacemaker growth in the United States, the report states. "Procurement through Group Purchasing Organizations will help hospitals to negotiate higher discounts from medical device manufacturers but is not expected to increase procedure volumes in a market where sales are already at peak levels. As a result, the profit margins of pacemaker and CRT-P manufacturers will be adversely affected because of such purchase models, resulting in reduced revenues and increased competitive pressure pricing."

Likewise, comparative effectiveness research (CER) may prompt pacemaker manufacturers to increase spending on studies and clinical trials in order to prove that their products are more effective than those of competitors. "This will, in turn, increase overall product cost and affect market revenues by driving up the price of product and lowering the demand," the report says. "CER may also result in a decline in the price of a product, which has been found to be less effective by the government authorized research body, Center for Comparative Effectiveness Research, affecting the manufacturer's revenue and product portfolio. This is also expected to change the product development strategy of device manufacturers with more emphasis on proving superiority in terms of safety, efficacy, and effectiveness, increasing timeline and development costs."

Production System and 3-D Printer Combined

A crossover system combines a 3-D printer and a production system. The Fortus 250mc features Insight Software, which is used to drive the company’s line of production 3-D printers. Operators can control build speed, part accuracy, and feature detail. The system is based on the fused deposition modeling (FDM) process. The system can be used to build functioning manufacturing tools to be used in the production process. It has a 10 × 10 × 12-in. build envelope, with build layers of 0.007, 0.010, or 0.013 in. The machine uses ABSplus thermoplastic to create parts; the thermoplastic comes in ivory, white, blue, fluorescent yellow, black, red, nectarine, olive green, and gray. It uses the company’s SR-30 soluble support material.

Stratasys Inc.
Eden Prairie, MN, 800/937-3010

Optical Microscope Takes 3-D Surface Measurements

BrukerAn optical microscope provides benchtop characterization for R&D, wear measurement, failure analysis, process control, and data monitoring. Utilizing white light interferometry, the Contour GT-K1 takes 3-D surface measurements from nanometer-scale roughness through millimeter-scale steps at subnanometer resolution. It has 64-bit multicore operation and analysis software that features a functional and streamlined graphical user interface, with an extensive library of preprogrammed filters and analyses for medical devices. It features a small footprint and optional 6-in. automated stage. A high-resolution camera increases lateral resolution. It also features dual-source illumination with high-brightness LED.

Bruker AXS Inc.
Madison, WI, 800/234-9729