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MDMA Enlists Partner in Compliance

NEWS TRENDS


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The Medical Device Manufacturers Association (MDMA) and R-Squared Services and Solutions LLC (Princeton Junction, NJ) are joining to help MDMA members navigate compliance regarding payments to physicians. The partnership was announced at MDMA's annual meeting in June.

R-Squared provides compliance and reimbursement software and consulting services to healthcare companies. Its products aim to enhance performance and data analysis for manufacturers, and to illustrate best practices.

MDMA members will have exclusive access to compliance systems from R-Squared, as well as discounts on consulting services and software products. R-Squared will provide evidence-based compliance management programs.

One product being offered to members is Arrangements Keeper, a system for merging internal controls and data to show compliance in financial relationships between doctors and manufacturers. Members can also take advantage of SpendTracker, a program that tracks, sorts, trends, and reports on aggregate spend. R-Squared plans to launch a complete compliance system in the fourth quarter as well.

Copyright ©2008 Medical Device & Diagnostic Industry

Contract Management Software Should Be Specific to Devices

OUTSOURCING NEWS


Many industry-specific and internal drivers compel medical device manufacturers to evaluate enterprise contract management systems. Regulatory pressure on pricing and reimbursement is significant and likely to increase. However, there are considerable opportunities to optimize revenue through better management of revenue leakage, says John Rade, CEO of I-many Inc. (Edison, NJ).

Rade's company is working to provide services to help OEMs realize such revenues. It has expanded its contract management software suite to support the medical device market. The Contract Management Suite for Life Sciences uses the same architecture as I-many's contract management framework, but can specifically address the issues facing medical device firms within the entire contract management continuum.

“The regulatory environment is becoming more stringent and we expect that medical device companies will have to deal with the same complex contracting and compliance issues that challenge pharmaceutical companies today,” Rade explains. “We are working with several customers now on their specific needs and requirements to address these issues.”

According to Rade, to achieve their goals, medical device companies need to implement comprehensive contract management software, not only to remain compliant with heavy and increasing regulatory pressures, but also to realize increasing revenue in a highly competitive industry. He says software should be able to manage hundreds of billions of dollars in corporate contracts, revenue, and pricing agreements. And, he says, it should directly address the concerns specific to the medical device industry.

Copyright ©2008 Medical Device & Diagnostic Industry

AdvaMed Program Honored by FDA

NEWS TRENDS

AdvaMed's Medical Technology Learning Institute (MTLI) received the Leveraging Collaboration Award from FDA in June. It was honored for a program educating small medical device and diagnostics firms about FDA and its regulations.“Helping small businesses better understand the intricacies of FDA regulation is critical to their future and to patient care,” said Thomas Meder, MTLI's director. “Given the level of regulatory oversight of this industry, it's critical for companies and patients that ongoing and continuous education occurs to ensure compliance.”

MTLI is AdvaMed's educational institute that offers regulatory, technical, and professional educational programs.

SCS Acquired by Private Investment Company

OUTSOURCING NEWS


Specialty Coating Systems Inc. (SCS; Indianapolis) was sold to Berwind Corp. (Philadelphia), a private investment management company, in June. SCS was previously owned by Bunker Hill Capital LP for two and a half years, a period in which the company experienced strong growth.

SCS specializes in parylene conformal coating services and materials. In the medical device industry, the coating is used on a range of products including stents, catheters, electronics, electrosurgical tools, and cardiac-
assist devices.

Terry Bush, president and CEO of SCS, called the acquisition a seamless and exciting change. “Our core focus will continue to be an unyielding commitment to the needs of our customers and markets,” Bush said in a company statement.

SCS has nine coating plants worldwide. In addition to parylene coatings, the company also provides liquid coating systems such as spray, spin, and dip coating systems, and ionic contamination test systems.

Copyright ©2008 Medical Device & Diagnostic Industry

MD&DI Wins Award

NEWS TRENDS

MD&DI has won a Gold Azbee award from the American Society of Business Publication Editors.

The article, “Neurotechnology Offers Relief and Recovery,” written by MD&DI editor-in-chief Sherrie Conroy, won in the category of Feature Article. It appeared in the July 2007 issue of MD&DI.

The competition is open to U.S.-based business-to-business, trade, association, and professional magazines; Web and newsletter publications; and their editorial and design staff and contributors.

North American Expansion Drives Global Group

OUTSOURCING NEWS


Medical instrumentation manufacturer BIT Group has expanded into North America. Its United States field service center operates through Source Scientific LLC (Irvine, CA). The facility opened at the end of May and is now fully operational. The service center is part of BIT's global expansion; it was initiated to enhance customer service with field technicians and the firm's BAAN service software. The goal, according to the company, is to provide dedicated field services such as response and support that ensures full traceability and device history records.

BIT Group provides instrument contract product development, manufacturing, and after-sale services to medical and diagnostic OEM clients. As part of the Messer Group, which has representation in more than 100 countries, BIT Group offers its systems with adherence to ISO 13485 and 9001 standards. The firm is an FDA-registered contract service
provider.

Copyright ©2008 Medical Device & Diagnostic Industry

Imaging Diagnoses Patients Just Below the Surface

R&D DIGEST

(click to enlarge)
A snapshot of the voltage in the lattice shows the resonance at the center. The pattern is similar to the waves from the ocean.

A theory on the generation of high-frequency pulses that penetrate a short distance beneath a surface could lead to high-quality imaging technology. Called nonlinear constructive interference, the technique could help detect skin cancer and find flaws below tooth enamel. The method produces powerful microwave radiation without the ionizing damage that is generated by x-rays.

Ehasan Afshari calls his work a new phenomenon. “If you have a non­linear medium—in this case, it's a surface—and you launch two waves, when they hit each other at a certain angle, they could combine in a nonlinear fashion,” he says. “The amplitude of the [new] wave could be more than the summation of the two waves.” At the same time, the frequency content of the waves could increase.

Afshari, an assistant professor of electrical and computer engineering at Cornell University (Ithaca, NY), conducted the work with Harish Bhat, an assistant professor of mathematics with the University of California, Merced.

(click to enlarge)
The interaction between the waves can happen more than once.

The team took lower-frequency signal sources (60 GHz) and showed that it's possible to combine them to generate power at more than 200 GHz. This kind of wave interaction and two-dimensional nonlinear surface is something new, says Afshari.

After publishing a paper on the technique, the researchers tested a prototype at a lower frequency and a lower scale, with good results. Afshari anticipates testing the device at a higher frequency and a higher power soon. He says it's possible that they'll be able to generate signals at frequencies up to around 1.16 THz, and have the first device developed within a year.

The main medical uses for the technology would involve scanning and imaging with a high resolution and a low penetration depth. “Without using anything else, we could detect [skin] cancer,” says Afshari. “In dental applications, we could see beneath the surface of the tooth and scan different layers with very high resolution.”

The method is compatible with a complementary metal oxide silicon chip, so there isn't a need to create a complex device. This means it would be small, cheap, and light. “The technique is compatible with existing technology, which is commercially available on a silicon substrate,” says Afshari. “The other advantage is that several types of digital signal processing can be integrated into the silicon.”

The system could be engineered to control penetration depth, allowing signals to push a couple of millimeters deep while providing fine resolution. The heart of it would be on a silicon chip that measures a few millimeters in size, and the cost for mass production would be a few dollars per chip. To apply it to medical applications, Afshari says the system would need packaging and other changes that would increase the cost, but not in thousands of dollars. “At this point,” says Afshari, “I'm very interested in working with a [medical device] company to further develop this.”

Afshari is working with his students to fabricate the prototype on silicon, which is the main challenge. Because his training is in circuit design and physics, Afshari wants to work with someone who understands the medical applications.

The National Science Foundation supported part of the research. Details about the new technique were published in the May issue of the journal Physical Review E.

Copyright ©2008 Medical Device & Diagnostic Industry

Helix Medical Expands Manufacturing Capabilities

OUTSOURCING NEWS


Helix Medical, which specializes in medical device components, has broadened its capabilities through two acquisitions.

Medical device contract manufacturer Helix Medical LLC (Carpinteria, CA) has expanded its capabilities with the acquisition of two companies specializing in medical device components and subassemblies.

As the result of an acquisition earlier this year, Helix Medical oversees the operations of APEC—a Baldwin Park, CA–based thermoplastic and silicone injection molder. APEC uses Arburg and Toyo presses ranging from 28 to 300 tn. The company's seven silicone liquid injection molding cells enable it to manufacture thermoplastics and silicone in the same Class 100,000 cleanroom. APEC also has a 35,000-sq-ft medical component manufacturing facility in Shenzhen, China.

Another acquisition brought Jenline Industries Ltd. (Gloucester, MA) into Helix's sphere of operations. Jenline is a silicone contract manufacturing company that became a division of Helix last year.

“Through our Gloucester and Baldwin Park operations, Helix Medical now offers its customers combined manufacturing experience of more than 50 years,” says Jorg Schneewind, CEO of Helix Medical. “We are well positioned to meet the needs of our customers with these additional manufacturing operations. [We will] continue our service offerings of extrusion and custom molding of platinum-cured silicone products for the medical device industry.”

Helix Medical is part of the healthcare products division of Freudenberg-NOK (Plymouth, MI).

Copyright ©2008 Medical Device & Diagnostic Industry