A Medical Device Daily

Noting that South Korea is one of the most developed countries in Asia, global consulting firm Frost & Sullivan (F&S) says that South Korea has “a well-established healthcare infrastructure, as well as a strong national healthcare insurance program, which make it a favorable destination for the growth of high-tech medical devices such as advanced wound management products.”

Research Analyst Andrew Wee, a research analyst in Frost & Sullivan’s Singapore office, said, “This demand is likely to raise the penetration of advanced wound management products in both acute and chronic wound care. The use of these products, particularly in acute wound care, is set to increase due to a rise in the number of specialist surgeries performed in South Korea.”

Wee said specialist orthopedic and cardiothoracic surgeons are “a key end-user segment, as they use advanced wound management products more frequently than general surgeons due to higher incidences of acute wound types during such procedures. These products are also considered more applicable for acute rather than chronic wound types.”

The new F&S report, “Advanced Wound Management in South Korea,” notes that as chronic wound management improves and procedural volumes drop, acute wound care procedures are expected to grow at a faster pace than chronic wound care procedures.”

However, a “substantial” population of diabetics in South Korea with a strong potential for having diabetic ulcers “is likely to sustain the market for chronic wound care products.” In 2006, diabetic ulcers accounted for more than 50% of all chronic wound types in the country.

Some restraints to market growth include cost factors and end users’ “traditional mindset,” Wee said. “There still remains a tendency to use low-cost conventional products for the majority of wound care procedures that are not critical,” so manufacturers “face the challenge of demonstrating the value of advanced wound management products for end users to realize their benefits.”

The report says another challenge lies in the increasing levels of competition due to the entry of local manufacturers that have successfully collaborated with pharmaceutical companies and distributed their products by leveraging these companies’ wide coverage.

“As a result, local manufacturers are becoming increasingly dominant in the moist wound dressing market, the largest segment in the advanced wound management product market.”

Wee said manufacturers “have to actively segment their products line to suit the needs of different surgical specialties. This will allow maximum penetration, especially among high-volume end users.”

The F&S report says new technologies and treatment methods are expected to emerge due to increasing efforts to provide better quality patient care. “Specialist surgeons are showing increasing interest in technologies such as negative pressure wound therapy and tissue engineering.”

Biosafety conference set in UAE

The Environment Agency-Abu Dhabi (EAD) is teaming up with the International Council for Life Sciences (ICLS; Washington) to organize the Biosafety and Biosecurity International Conference 2007, a seminar for life science and policy communities in the Gulf region.

The conference, to be held Nov. 12-14 at the Hilton Hotel in Abu Dhabi, United Arab Emirates, will convene experts from around the world to discuss enhancing public health, safety and security against biological risks.

The gathering will feature presentations on best practices, standards and training in biosafety and biosecurity and success stories for national and trans-national disease surveillance networks.

Particular attention will be paid to identifying priority areas for the Gulf and Mideast region and developing an action plan for future work.

“We need to build a global network between governments, international organizations, universities and private companies associated with the life sciences. Through this network, we can develop and share best practices in research and activities,” said Majid Al Mansouri, secretary general of EAD.

Terence Taylor, president and director of the ICLS, said, “I expect that this conference will result in the sustained engagement of experts from the countries involved and will lead to practical improvements in biosafety, biosecurity and enhanced infectious disease surveillance.”

SNP Genetics gets Illumina certificatio

Illumina (San Diego) said that SNP Genetics, which it called “a leading company in the Korean genetics community,” is the first genetics service provider in Asia to receive Illumina Certified Service Provider (CSPro) certification for Infinium Genotyping.

SNP Genetics is a bioventure company applying its discoveries in human genetics to the development of diagnostic markers for common diseases. Using a population approach with the latest technologies and resources, SNP Genetics can efficiently conduct population- and genome-wide scans for the key genetic factors involved in any common disease, Illumina said

“We chose Illumina because their data quality is the best in the industry, and through our genotyping services we want to offer this level of quality to our customers,” said SNP Genetics CEO Hyoung Doo Shin, PhD, DVM. “This achievement underscores [our] commitment to providing the best and most comprehensive genotyping and analytical solutions, speeding the discovery process for our customers.”

PreMed gets questions from FDA

Canadian predictive medicine company PreMD (Toronto) reported that it has received questions from the FDA regarding its 510(k) application for an expanded regulatory claim for its point-of-care skin cholesterol test.

PreMD submitted the 510(k) application to the FDA in June. The submission seeks to obtain broader clearance in the assessment of cardiovascular disease risk in individuals without known disease.

PreMD said it believes the specific matters raised by the FDA are “fully addressable,” and that it plans to submit a response within the allotted 30-day timeline.

“Receiving questions from the FDA is a common part of the regulatory process,” said Brent Norton, president/CEO of the company. “Based on our current information and analysis, we plan to provide the FDA with the information they requested within 30 days. We are confident that we are on the path toward expanded regulatory clearance.”