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So You Think Inhaled Insulin Can't Make It. Wanna Bet?

Despite a lack of confidence from investors, Mann believes his product will succeed and that the product could bring in more than $1 billion annually. One of the advantages of Technosphere is its fast absorption rate. Upon inhalation, the insulin reaches a peak bloodstream level in less than 15 minutes versus injectable products that can take up to 90 minutes. The safety issue will be critical to product approval. According to Mann, Technosphere is different than Pfizer's Exubera inhaled insulin (Six patients involved in the Exubera clinical trial developed lung cancer). He said that following the Pfizer report, an independent safety board found no signs of emerging lung cancer in MannKind's trials. And even if Technosphere is approved by FDA, market acceptance won't be quick or easy. Given past failures with inhaled insulin, investors won't have confidence in the product, and doctors will be faced with explaining a completely new way of taking insulin to patients. UPDATE: Pfizer and Mann collaborate.

Intuitive Surgical and Power Medical Collaborate

According to the company, it is the world's only provider or computer-assisted surgical stapling products. Last year MD&DI named Intuitive Surgical one of its Manufacturers of the Year.

Norman Noble Extends Reach in Implant Manufacturing Market

MD&M MIDWEST 2008: EXHIBITOR NEWS

Norman Noble Extends Reach in Implant Manufacturing Market
The addition of multiple milling machines expands Norman Noble's ability to machine orthopedic products, such as fixation plates.

Norman Noble (Highland Heights, OH), a contract manufacturer serving the medical device industry, has announced that it has expanded its orthopedic implant manufacturing capabilities. The company maintains that the recent addition of eight Willemin-Macodel five-axis contour milling machines establishes it as one of the largest providers of single-operation machining to the orthopedic implant market.

Acting in response to a growing demand in the market, Norman Noble acquired the machining equipment in an effort to secure a position as a leader in the surging implant manufacturing sector. “The U.S. spinal implant market alone is valued at $3 billion with sizable recent and forecasted growth,” says Dan Stefano, vice president of manufacturing, Norman Noble. “This additional technology and capacity fits our experience in manufacturing for this market, which requires tight tolerances, complex geometries, and unique finishing requirements.”

Suited for machining such parts as spinal and extremity implants, the Willemin-Macodel systems can be automated so that milling and turning operations are combined in one cycle. This capability can yield a higher output coupled with greater precision and quality than other implant manufacturing methods, according to the company. Additional investments toward serving the orthopedics market include increased capacity in Swiss turning and milling. Equipment investments have also been made in the quality inspection department.
Strengthening its offerings to implant OEMs is one component of Norman Noble’s ongoing strategy to maintain double-digit growth. During the past several years, the company has doubled the size of its facilities and has invested in its Swiss turning, laser machining, and finishing technologies. The company is also currently undergoing a $1.7 million expansion of its mass finishing operation to support R&D and automated production.

Norman Noble Inc.
www.nnoble.com
Booth #3019

Copyright ©2008 Medical Product Manufacturing News

Supplier Expands Coupling Offerings, Warehouse Seminar at NMW

MD&M MIDWEST 2008: EXHIBITOR NEWS

Supplier Expands Coupling Offerings, Warehouse Seminar at NMW
Qosina now offers more than two dozen series of quick-disconnect couplings provided by Colder Products Co.

Qosina (Edgewood, NY) has expanded its inventory of medical components, as well as its headquarters and warehouse. In addition to a range of stock and custom connectors, valves, syringes, tubing, and related components, the supplier now offers more than two dozen series of quick-disconnect couplings provided by Colder Products Co. (St. Paul, MN). Of the Colder connector series that Qosina is offering, five connectors are made from medical-grade plastic that meets stringent MEM elution, agarose overlay, hemolysis in vitro, and USP Class VI and physicochemical test requirements.

Qosina's hemostasis valves function as seals by preventing air and fluid leakage around wires and instruments.

Qosina continues to maintain and add to a large inventory of its own medical device components. The company has released two hemostasis valves this year that function as seals by preventing air and fluid leakage around wires and instruments. Able to connect to standard catheters, luer-activated valve #33058 features an actuator cap designed to keep the slit septum in optimal condition prior to use. It is suited for high-pressure applications and is self-sealing. Valve #33057 has two channels; the straight primary channel has a silicone gasket and the secondary channel can be used for pressure monitoring and flushing. Using just one hand, a person can click the valve into an open or semi-open position and can also lock it with a thumb lever.

While broadening its product portfolio, the company has also made efforts to increase efficiency in its facilities this year. Designed to enhance workflow, an expansion project that the company undertook significantly increased the capacity of its headquarters-adjacent warehouse. The addition of more than 42,000 sq ft has brought the total area of the plant to 100,000 sq ft.

Qosina
www.qosina.com
Booth #2932

Copyright ©2008 Medical Product Manufacturing News

Company to Present CAD Component Configurator Seminar at NMW

MD&M MIDWEST 2008: EXHIBITOR NEWS

Company to Present CAD Component Configurator Seminar at NMW
Single-axis linear actuator model LX30 is offered with or without a motor bracket, with one or two short blocks, or with one or two long blocks.

Celebrating its 20th anniversary and the launch of its latest actuators, Misumi USA Inc. (Schaumburg, IL) will present a configurable component technical seminar at National Manufacturing Week, which is co-located with MD&M Midwest in Rosemont, IL. The automation component provider will use the seminar and real-world examples to demonstrate what it claims are substantial cost and time savings gained by using the company’s component-configuring program.

The seminar will demonstrate how engineers can use the online CAD configurator, accessible through the company’s Web site, to select part specifications, download native CAD files in dozens of formats, import components into their virtual assembly, and then verify and order the parts.

It will be held on Level 1 of the Donald E. Stephens Convention Center in Conference Center 12, which is opposite Hall A and just north of the lobby. Depending on attendance, the seminar will be presented every hour on the hour with breaks for lunch. Engineers can register for the seminar online or at the company’s booth.

Attendees will also be able to see the company’s new single-axis actuators while at the Misumi booth. The supplier’s line of actuators has been expanded to include more models and sizes of the precision linear motion components. Model LX30 features more options than previous models; it is offered with or without a motor bracket, with one or two short blocks, or with one or two long blocks. Featuring a 15- or 20-mm lead, the LX45 can come with or without a cover or motor bracket in the same block configurations as the LX30. Brackets are available on the LX-series actuators to allow a combination of two units on a different axis. The actuators are offered in a variety of configurations, including covered models that feature a choice of a flat aluminum cover or a protective bellows made from hand-sewn rubber.

In addition to actuators, the company offers linear shafts and guides, locating pins, aluminum extrusions, rollers, and more. Most of the supplier’s components are configurable using the online program and CAD files, and full product specifications can be downloaded from the company’s Web site.

Misumi USA Inc.
www.misumiusa.com
Booth #4315

Copyright ©2008 Medical Product Manufacturing News

CDRH Issues Flutter Device Guidance

The guidance covers background, scope, study design, study endpoints, statistical considerations, sample size, follow-up of study subjects, anticoagulation parameters, investigator selection and training, data collection forms, and study monitoring. -- James G. Dickinson

AdvaMed Growth Council Launches New Web Site

Medtronic Division Recalls AED

Suppliers Partner to Deliver First ECG-on-a-Chip

BREAKTHROUGHS

Suppliers Partner to Deliver First ECG-on-a-Chip
Daniel Grace
The 32-bit ColdFire microcontroller from Freescale can be incorporated with ECG software from Monebo.

Driven by increasing incidences of diabetes and cardiovascular illnesses, home-monitoring, home-therapy, and self-diagnostic equipment are more in demand than ever before. But for medical OEMs considering entering this growing market segment, the costs and risks can be formidable.

With OEM concerns in mind, Freescale Semiconductor Inc., a provider of microprocessors (MPUs) and microcontrollers (MCUs), has partnered with Monebo Technologies, a software developer for medical applications, to develop what the companies bill as the first-ever electrocardiogram (ECG)-on-a-chip. The technology can be configured to meet specific requirements, offering what the companies claim is unmatched flexibility and feasibility.

A trusted staple of hospital cardiology care, ECG systems record the rhythm of the heart over time to detect abnormalities. Software from Monebo, based on the company’s patented Kinetic ECG algorithm, enables an ECG device to produce online beat-by-beat output, to classify beats, to analyze up to 16 beats, and to detect arrhythmias, atrioventricular blocks, and pauses.

Teaming with Freescale allows Monebo to harness its algorithmic technology with hardware suitable for easy-to-use ECG monitoring tools. Freescale offers a range of MCUs and embedded MPUs, including an 8-bit HCSO8, 16-bit digital signal, and 32-bit ColdFire, all of which can be incorporated with any of Monebo’s six configurations of the Kinetic algorithm. “Prior to this offering, a software company wanting to build [an ECG-on-a-chip] would have had to find somebody to build the hardware, or a hardware provider would have had to find somebody to build the software—all of which takes a long time,” says David Niewolny, product marketing manager at Freescale. “With this arrangement, device manufacturers can pair any of our products with the Monebo technology and basically develop an optimized solution.”

In addition to scalability, the partnership could offer faster time to market. “Software validation can be a lengthy process, which is another advantage of using Monebo’s algorithm,” Niewolny says. “It already has FDA 510(k) clearance.” The ECG-on-a-chip technology has also been thoroughly tested and validated, according to the companies.

The firms’ initial targets for the ECG-on-a-chip technology are cardiac-event monitors, heart-rate monitors, and telemonitoring systems.

Freescale Semiconductor Inc., Austin, TX
www.freescale.com

Monebo Technologies, Austin, TX
www.monebo.com

Copyright ©2008 Medical Product Manufacturing News

Some Arthroscopic Knee Surgeries May Be Unnecessary

Two-thirds of study participants who had knee cartilage tears reported no pain or stiffness in the prior month. The authors said the procedure can benefit those with large tears, recent injuries, or milder symptoms. But it should not be performed routinely on osteoarthritis patients. During the procedure, a scope with a miniature camera is inserted through a tiny incision and surgeons operate through other tiny cuts. Surgeons typically smooth damaged cartilage surfaces on the bone's ends and flush out bone chips. Some speculate that the increased use of MRI has led to more diagnoses of knee problems, which has led to more arthroscopic surgeries, some of them being unnecessary.