A Medical Device Daily

European government and industry leaders will meet to evaluate European policy on health product innovation at a June 1-2 regulatory affairs conference, the Regulatory Affairs Professionals Society (RAPS; Rockville, Maryland) European conference in Portugal at the Sana Lisboa Hotel.

RAPS describes its European Conference, first held in 1995, as a venue for health product regulatory affairs professionals to address changes in the European and worldwide regulatory environments, affecting medical devices, IVDs, pharmaceuticals, biologics and combination products. This year's conference topics include the Medical Devices Directive, EU Pharmaceutical Legislation, Pediatric Regulation, EMEA's EU Risk Management Plan and Clinical Investigation.

A key panel at the conference will feature Rui Santos-Ivo, enterprise and industry directorate-general, European Commission ; Maurice Wagner, director general, Eucomed ; Anthony Humphreys, head of sector, RA and organizational support, EMEA ; and Karima Boubekeur, head of external R&D policy, F. Hoffmann-La Roche . The panelists will focus on medical device and medicinal product sector policies that address the European initiative to promote innovation and enhance technology.

These and other experts will also evaluate the role of innovation in growth of research and development and the commission's future policy proposals.

“This is a crucial opportunity for European industry and government leaders to evaluate how health product regulations can continue to advance health,“ said Sherry Keramida, PhD, executive director of RAPS. “It is vital for regulatory professionals from industry, government and research to participate in discussions on the rapid evolution of scientific research, the health product industries and regulation.“

The conference also features Margaret Murphy, of Patients for Patient Safety , part of WHO World Alliance for Patient Safety. Murphy will highlight the role patients and patient advocates must play in interactions with healthcare systems and in partnerships with health professionals and policy makers.

Conference information and registration is available a the RAPS web site, http://www.raps.org/europe.

RAPS – founded in 1976 and with more than 10,000 members – bills itself as creating and upholding standards of ethics, credentialing and education for the regulatory affairs profession within the health product sector.

Eastern Europe monitor market on the rise

Due mainly to unfulfilled demand, eastern Europe represents an upcoming market for patient monitors, driven by unfulfilled demand, according to a new report from Frost & Sullivan (F&S; London). It said that improving economic conditions together with accession to the European Union will further support the expansion of the market in the region. The most exciting growth opportunities will be in the mid-range monitors segment, which is expected to account for nearly half of overall revenues.

F&S finds that the Eastern European patient monitors market earned revenue of $148 million in 2005, and that it is projected to reach $246.0 million in 2012.

“Increased demand for multi-parameter monitors has severely hindered the growth of single-parameter units,“ noted an F&S research analyst. “This development, together with the low preference for refurbished monitors will boost the growth of new high-end devices.“

Sales of single-parameter monitors have reduced significantly with trends favoring mid-range units. End users are exhibiting preference for monitors that measure more than four vital signs, with customer price sensitivity determining their desire to look for consolidated, one-time investments. As a result, demand for new multi-parameter monitors is rising, even as sales for single-parameter and refurbished equipment lag.

Accession to the EU, harmonization of laws with EU legislation and the availability of international funds have improved product accessibility in eastern Europe, with intensifying competition set to drive down product prices.

While declining prices spell good news for end users, price erosion is a growing concern for patient monitors manufacturers, whose revenues and profit margins are being squeezed.

Large market participants are compromising their profits by bundling their products even as small and medium-sized companies are being severely affected. This situation has triggered increasing market fragmentation, which, in turn, is reducing confidence levels among end users.

“To sustain profitability in this increasingly competitive market, manufacturers need to develop cost-effective, high-quality products and provide product packages,“ the analyst said. “Partnering with technology vendors and other equipment manufacturers, together with good after-sales service, holds the key to gaining market share.“

Panomics establishes European unit

Panomics (Fremont, California), a developer of products and technologies for Parallel Quantitative Biology (PQB), and a provider of life sciences research reagents, reported that it has opened a European subsidiary, Panomics SRL , in Milan, Italy.

Luigi Pirovano has been appointed the subsidiary's managing director reporting to George Bers, executive vice president for commercial operations.

“There is substantial customer demand for Panomics' products in Europe,“ said Bers. “By establishing direct sales channels and customer relationships, we are implementing an aggressive plan to extend our PQB strategy globally. This is an important step in our mission to establish Panomics' PQB products on a worldwide basis.“

Panomics, formed in February by the merger of Genospectra (Fremont, California) and Panomics (Redwood City, California), said it is opening the European offices to address a growing customer base throughout Europe. The new subsidiary will extend Panomics' commercial presence in Europe.

Panomics is focused on PQB as a platform of reagents and products enabling the multiplex measurement of molecular events, such as intracellular pathway analysis, cell signaling and gene expression profiling. Panomics has grown on the value of QuantiGene and QuantiGene Plex, its proprietary bDNA technology for gene expression analysis in cell-based assays, as well as signal transduction and transcription factor assays.

The company recently launched Deliver X, a new siRNA delivery reagent for non cytotoxic transfection of RNAi reagents into primary cell lines, the first in a series of biomolecule delivery products.

B-K Medical launches 8814 transducer

B-K Medical, a subsidiary of Analogic (both Copenhagen, Denmark) reported the launch of the 8814, a simultaneous biplane surgical ultrasound transducer designed for interventional procedures. Designed for intraoperative scanning of the liver, pancreas, and stomach, the 8814 is optimized for ultrasound-guided interventional procedures, including radio frequency (RF) ablation, biopsies, and drainage. The 8814 also offers contrast harmonic imaging.

Shaped like a “V,“ the 8814 features two arrays that image in intersecting perpendicular planes; the needle path directly traverses the intersection of the two planes, thus providing a large benefit as a mapping tool. By following the needle in the intersection of the planes, the surgeon can focus on the target in one plane while also keeping an eye on adjacent structures in the second plane.

The 8814 features a needle guide with four different inserts for interventional procedures, offering flexibility for a range of angles, positions, and needle gauges. The needle guide can also be locked for safety to prevent accidental advancement of the needle. For RF ablation procedures, the needle guide and transducer can be removed easily while the needle is left in place.