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Articles from 2009 In May


Medtech Market Cautious But Optimistic

Markets that address critical, acute care concerns such as cardiology have suffered little damage from the economic crisis, but are nonetheless showing that nothing is isolated from the recession's effects. Not all indicators are negative, however. The company says its exclusive MRG data from its new Medtech Confidence Index (MCI) suggests that there is some reason for optimism. The MCI looks at the general economic outlook of practitioners in medtech. Many market players, based on preliminary 2009 MCI data, are cautiously feeling more bullish about the medtech industry's short-term prospects. Overall, however, MRG says that general sentiment remains highly negative, and thus the relative optimism should only be interpreted as a slight increase in outlook relative to a dismal fourth quarter in 2008.

MEMS Sensor Will Assess Lower-Back Pain

As the leading cause of adult disability, spinal conditions are widespread. An estimated 26 million people per year in the United States report suffering from back pain severe enough to cause them to seek medical care. To address back ailments, a sensor supplier and a device manufacturer are partnering to manufacture a MEMS sensor that will assess and treat mechanical lower-back pain. MEMSCAP (Research Triangle Park, NC), a supplier of MEMS-based products, and OrthoMEMS (Menlo Park, CA), a medical device company that develops biomedical applications for patented MEMS and wireless technologies from the Cleveland Clinic, will develop and commercialize the OrthoChip, a miniature batteryless wireless pressure sensor that will provide an objective measurement of spinal disk pressures. The sensor will detect pressure differences between normal and mechanically unstable spinal segments and communicate the results telemetrically to a readout unit. The technology is expected to provide indications for surgical and nonsurgical treatments. “OrthoMEMS is an attractive partner because of its strong business and scientific team and the significant commercial potential of its spine application," remarks Steven Wilcenski, general manager of the MEMSCAP custom products business unit. "This partnership is in line with our strategic commitment to be the lead manufacturer of MEMS in medicine.” “MEMSCAP has a clear track record of success in developing and manufacturing high-value-added MEMS sensors for medical use," states Douglas Lee, chairman and CEO of OrthoMEMS. "This strategic partnership adds real value across our full product cycle—from the design-in phase to the market launch of our ground-breaking product that changes the way clinicians interact with the human body.”

e-Zassi Secure Online Community Assesses Medical Device Designs

Contract manufacturer Zassi Medical Evolutions (Fernandina Beach, FL) has launched a spin-off, e-Zassi.com, that will function as an online community that enables subscribers to privately and securely market their medical technologies to potential development partners so that intellectual property is not jeopardized. Currently offering three-month trial memberships, as well as free 12-month memberships for students, the program is designed to facilitate connections between investors and venture capitalists with academic researchers, technology-transfer departments, and service providers. The e-Zassi program uses an innovation assessment tool to identify what it calls device network attributes to evaluate critical elements of the device design and use those attributes to match the designer with appropriate investors. The information gathered for the device profile is also used by the system to identify elements of the design that are hindering it from being successfully funded, licensed, developed, or commercialized. Such elements that the system screens for include having a clear regulatory classification and direction, as well as identification of material manufacturing, distribution, and sales concerns, associated clinical endpoints to support the safety and marketing claims to earn market clearances, and potential reimbursement and market landscape issues. The system is currently being used to assess technologies for cardiology, urology, orthopedic, and minimally invasive surgery applications. In light of the recent economic downturn and an overall drop in venture capital the medical device manufacturing industry in the first quarter of 2009, the company hopes that members of industry and students will take advantage of this online community in order to bring together partnerships and get devices to market faster.

Does It Obey the Three Laws of Robotics?

An interview with the head researcher can be found here (the presentation is partly in French). According to the release, the ViRob can navigate and crawl in different spaces within the human body, including blood vessels, the digestive tract, and the respiratory system. In addition, itâEUR(TM)s structure gives it the ability to move in tight spaces and curved passageways as well as the ability to pause within the body. These functions could be harnessed to perform minimally invasive medical procedures. ViRob could also assist in targeted drug delivery to lung tumors, as well as take samples from different areas within the body. Several of these microrobots could simultaneously treat a variety of metastases. Researchers also plan to install additional equipment on the robot, including cameras, miniature tongs, and other equipment. The ViRob prototype measures 1 mm in diameter and 14 mm long. It was developed by the Medical Robotics Laboratory at the Israel Institute of Technology. A basic prototype of the ViRob that can move as fast as 9 mm per second has been developed. The unit for business development at the Israel Institute of Technology is currently in the process of establishing a company for technology commercialization. All in all, it makes me want to rewatch Innerspace and reread Snow Crash.

Australian Firm Has Big Ideas for Medical Microtechnology

MD&M EAST 2009: FIRST-TIME EXHIBITORS

Australian Firm Has Big Ideas for Medical Microtechnology
Shana Leonard

MiniFAB, a specialist in microtechnology and microfluidics, developed the osmolarity test card for the MDEA-winning TearLab system.

When it comes to manufacturing miniature medical devices, design and development challenges can become significantly magnified. Luckily, there is an expanding handful of companies equipped with the niche know-how and capabilities in microtechnology to properly serve the medical industry in this capacity. Among them is MiniFAB (Scoresby, Australia), a company dedicated to the design, development, and manufacture of implants and diagnostic devices that include polymer-based microtechnology and microfluidics solutions.

Since it was established as a spin-off from the Industrial Research Institute Swinburne at Swinburne University of Technology (Melbourne, Australia) in 2002, MiniFAB has applied its core competencies in microtechnology, microfluidics, and nanotechnology to an array of implantable and diagnostic devices. Applications have included stents, catheters, electronic implants, endoscopic surgical implants, combination products, surgical tools and instrumentation, and point-of-care and laboratory-based diagnostic systems, including lab-on-a-chip products. More recently, the company has drawn on its microfluidics knowledge for cell and tissue handling and culturing.

Enabling this project diversity are extensive capabilities for the manufacture of micro-sized components with tolerances of 1% or less. "We found that there are very few, if any, players who are capable of integrating a large number of complex process steps to deliver a product that requires microtechnology and microfluidic features under [an] ISO13485:2003 regulatory umbrella," says Dusan Milojevic, MiniFAB manager, devices. "[The] majority of players specialize in one to two areas. Here, we have a long list of methodologies available." Included on this list are injection molding, electroforming, parylene coating, micromachining, embossing, testing, mask aligning, cleanroom manufacturing, lithography, nanoimprint lithography, and polymer processing.

Polymer processing has become an increasing focus of the company's attention due to the company's belief that silicon-based microtechnology has distinct limitations in medical applications, according to Milojevic. "While MiniFAB still has 'classical' MEMS capabilities, today only 10% of its business is based on silicon processing, with the rest coming from microtechnology processing of polymers," he says.

With its scope and abilities steadily expanding, MiniFAB is looking to become a more prominent figure on the global stage. Although it has collaborated with American medical device manufacturers since its inception, the Australian company is looking to make its mark on the U.S. market by exhibiting for the first time at MD&M East. "It is the biggest medical device and manufacturing fair in the world and a perfect opportunity to launch our company to [the] U.S. market," Milojevic says. "We also recognize the need to educate customers about the potential of micro- and nanotechnology in their applications, which is not necessary always obvious."

The company's involvement with a 2009 Medical Design Excellence Award-winning product, which will be honored at the trade show, provides an added incentive for the company to attend. MiniFAB developed the disposable osmolarity test card for the TearLab osmolarity system, manufactured by TearLab Corp. (San Diego). The card features a 75-µm-wide microfluidic channel designed to collect 50 nl of tears for point-of-care biomarker analysis.

MiniFAB
www.minifab.au
Booth #637


Copyright ©2009 Medical Product Manufacturing News

Guidewires, Screws, and Mandrels are Supplier’s Daily Grind

MD&M EAST 2009: FIRST-TIME EXHIBITORS

Guidewires, Screws, and Mandrels are Supplier's Daily Grind
Bob Michaels

M&S Centerless Grinding offers medical core
pins and other components.

Half a century and counting. That's how long M&S Centerless Grinding Inc. (Hatboro, PA) has been in the business of providing grinding services to a range of industries. Today, with an increasing focus on the medtech industry, the family-run company offers precision centerless and cylindrical grinding services to medical device manufacturers across North America and Europe. Employing an array of precision grinding equipment, the company can achieve tolerances on component diameters, geometries, and features that used to be considered impossible.

"We always did a bit of work for the medical industry--grinding bars for screw machines or grinding device components," recounts Shegda, who joined his brother in acquiring the business from their father in 1990. "Then about 10 years ago, we made a concerted effort to concentrate more on the medical and aerospace industries, since they seemed to fit best with the company's high-end grinding philosophy."

To further that effort, the company acquired flexible grinding equipment in the late 1990s that enabled it to complete several difficult projects in the medical device area, including a locking pin for a heart-valve clip and a critical piece for a blood-testing instrument. Following a plant expansion a few years later, it redoubled its efforts to focus on the medical sector, the only market that Shegda thought could hold up well "even if the general economy went south."

In 2007, a year before Shegda became the company's sole owner, M&S strengthened its medical machine mix by adding a guidewire grinder to perform contract manufacturing services. "We do not design, market, or try to sell guidewires, like many companies in the industry." Shegda emphasizes. "All we want to do is grind."

In addition to guidewires and K-wires, the company grinds screws, hypotubes, core pins, mandrels, microsized parts for implants, and parts for dilators. Using multiaxis CNC OD/ID, Swiss-type centerless, CNC centerless, ultraprecision centerless, and precision centerless grinding methods, M&S can produce multiple part features such as diameters, tapers, radii, flats, and threads in one operation. It can also achieve diameter tolerances to ±0.00005 in., concentricity of ground features to submicron tolerances, diameters as small as 0.002 in., and finishes to 4 Ra.

Highlighting these products and its guidewire grinding capability, the company will also acquaint MD&M East attendees with its core-pin grinding expertise, which enables it to produce core pins with the intricate shapes and tiny diameter sizes required by many medical devices. Shegda comments, "When people visit our booth, we will be trying to change their preconceived idea of what centerless grinding is."

M&S Centerless Grinding Inc.
www.msgrinding.com
Booth #2729


Copyright ©2009 Medical Product Manufacturing News

Georgia Tech has Medical Devices on its Mind

The establishment of the Global Center for Medical Innovation (GCMI; Atlanta) was announced this week at the 2009 BIO International Convention held in Georgia this year. Touted as the first of its kind in the Southeast, the center will serve to accelerate the development and commercialization of next-generation medical devices and technology. Located adjacent to the Georgia Institute of Technology (Georgia Tech; Atlanta), GCMI will combine the resources of the university with those of Saint Joseph's Translational Research Institute (Atlanta), Piedmont Healthcare (Atlanta), and the Georgia Research Alliance (Atlanta). Among the institution's offerings will be a medical device prototyping center, production of evaluation devices according to CGMP guidelines, and the ability to manage, coordinate, and aggregate intellectual property from the parties involved. In addition, Saint Joseph's will make available the opportunity for preclinical studies of new technologies. These combined capabilities will enable the development, testing, and prototyping of new technologies in such focus areas as cardiology, orthopedics, and pediatrics. The center is expected to help device start-ups, as well as established companies, from both Georgia and outside the state alike to actualize their ideas. "Medical device companies in the Southeast have long suffered a disadvantage compared to competitors that have access to long-established support networks," says Nicolas Chronos, president of the Saint Joseph's Translational Research Institute. "The new Georgia center will allow companies to contract with a single entity for comprehensive development activities, create a single location for investors seeking qualified medical device companies, and allow innovations developed by multiple institutions to be combined to create more useful devices."

Molder Keeps Pace with Shrinking Lead Times

MD&M EAST 2009: FIRST-TIME EXHIBITORS

Molder Keeps Pace with Shrinking Lead Times
Stephanie Steward

Dynamic Group offers product development, molding, and assembly services for applications such as syringes.

To be truly dynamic, something must exhibit continuous and productive activity or change. The evolution of Dynamic Group (Minneapolis)--the company that developed Dynamic Engineering Inc. and Dyna-Plast Inc., located in the city's northern suburbs--reflects efforts to do just that.

Dynamic Engineering formed in 1977 with the goal to design and make production injection molds for powder and plastic. Serving several industries, it focused on medical and dental applications. Dyna-Plast began 20 years later, offering customers rapid prototyping and molding services.

"In an effort to apply certain lean principles to the operation of our business, we now operate as one business entity with two physical locations," explains Jay Williams, vice president of sales and marketing.

Today, 70% of the group's business comes from the medical and dental industries. The company offers cradle-to-grave product realization from prototype to production tooling and precision molding services to medical device OEMs. Over the years, it has invested heavily in new equipment and has kept up with customers' requirements by having its facilities certified to ISO 9001 and ISO 13485 standards, as well as being registered with FDA. More and more, customers expect the company to be a one-stop shop that offers an array of secondary operations beyond mold manufacturing, according to Williams. "Our molding facility has grown from a shop that qualifies tools and runs bridge-type production to [one] that includes precision medical molding and assembly in a Class 10,000 cleanroom," he says. In addition to its mold manufacturing and molding operations, Dynamic Group offers inspection services, precision high-speed machining, specialized wire EDM services, design modeling, pad-printing, welding, and other services.

Perhaps more important than maintaining state-of-the-art machining and EDM equipment, the company listens to the needs of its OEM customers. Device assemblies are not only becoming more complex--requiring tolerances on molded plastic that were uncommon a few years ago--but firms like Dynamic Group are being asked to do everything faster. "There is a continuous trend toward less and less time being afforded to our company in the development process," Williams says. "In fact, we are given less time in every phase of a project than we were only a few years ago." But the company is ready to meet those challenges, especially since Williams says they do not expect that trend to cease any time soon.

The Dynamic Group
www.thedynamicgroup.net
Booth #1480


Copyright ©2009 Medical Product Manufacturing News

Recycle Your Sensors!

What do users of electronic medical devices do when they have to replace sensors or batteries? They probably throw the old ones away, jeopardizing the environment. To avoid the harmful effects of placing electronic components in the garbage, Alpha Source Inc. (Milwaukee), a global distributor and manufacturer of new and replacement medical devices and accessories, has teamed with Maxtec (Salt Lake City), an oxygen sensor manufacturer, and Elite Energy Distribution (Milwaukee), a recycling company, to recycle used oxygen sensors and batteries. With the aim of promoting customer savings and protecting the environment, Alpha Source will give customers a free oxygen sensor for every 12 old ones they send in. Upon receiving the spent components, Maxtec will recover the small amounts of platinum and lead they contain and recycle the metals. The goal of Alpha Source's battery recycling program is to provide customers with a safe way to dispose of used batteries. By keeping batteries out of landfills, customers will ensure their compliance with environmental and hazardous-waste transportation regulations and thereby reduce their exposure to liability claims.

Lubricious Coating Provider Maintains Surface Appearances

MD&M EAST 2009: FIRST-TIME EXHIBITORS

Lubricious Coating Provider Maintains Surface Appearances
Bob Michaels

Medi-Solve's offerings include AquaCoat DEB for balloons and AquaCoat hydrophilic lubricious coating, shown here on guidewires and a microcatheter.

In 2005, Ron Sahatjian left Boston Scientific Corp. (Natick, MA) with the goal of retiring to the golf course. Instead of improving his handicap on the green, however, he ended up becoming an expert in other types of surfaces. The result was Medi-Solve Coatings LLC (Natick, MA), a venture that specializes in surface coatings and polymer chemistry solutions for medical devices.

"What really helped to get us established was that Boston Scientific let me acquire part of my lab to take with me," remarks Sahatjian. "Art Madenjian, also of Boston Scientific, later joined me to help set up the new company, and Medi-Solve Coatings was born." With more than 40 years of combined experience, the pair have built a company that offers hydrophilic coatings, fluoropolymers, drug-delivery coatings, and antimicrobial systems. It also provides a range of related services, from process development and customized equipment support to testing expertise and radio-frequency plasma surface treatment.

Sahatjian and Madenjian established Medi-Solve Coatings to provide support to small and mid-sized companies that knew how to design medical devices but required a lubricious, antimicrobial, or thromboresistant coating that could outperform competitive products. "We have been successful at providing coating formulations and processes to several customers that coat their products in their own manufacturing facilities using our formulations," notes Sahatjian. The company's coatings, he adds, have been CE marked as part of a 510(k) submission and are applied to products that are marketed in the United States and abroad. In addition to the more than 100 U.S. patents already held by Sahatjian and his colleagues, the company expects to be awarded another patent soon for its coating technology.

The company's coatings include AquaCoat LC, one of the most lubricious coatings available, according to Sahatjian. It also markets AquaCoat PA, a plasma-activated surface treatment that adheres the coating to the substrate; AquaCoat DEB, a balloon-based drug-release coating for coronary artery restenosis that is used when stents are difficult to insert into the body; and AquaCoat Gel, a coating that the company says remains slippery and moist outside the body after other coatings have become tacky and dry.

In addition to offering device coatings, the company's next objective is to convert its controlled-environment facility to a Class 10,000 cleanroom to coat products for final packaging. It also intends to expand its current testing capabilities, which include friction and trackability testing and thermal analysis techniques such as differential scanning calorimetry and thermogravimetric analysis. It also plans to start an aseptic polymer solutions effort to provide its customers with specialty polymer products.

Medi-Solve Coatings
www.medi-solveassociates.com
Booth #969


Copyright ©2009 Medical Product Manufacturing News