Smith & Nephew CEO David Illingworth recently spoke with the Wall Street Journal about the tough regulatory environment in the United States as a result of increased scrutiny by the Food and Drug Administration and the possibility of an overhaul to the device approval process.
Mr. Illingworth said companies will have to enhance the processes for clinical trials and present real clinical data for FDA approval. The tougher regulations mean higher costs and longer waiting periods before the products can go to market, according to the report.
The $12 billion global market for hip and knee replacements has been hurt by the economy, as potential patients are deferring elective surgery. However Smith & Nephew's knee implant sales rose by 6 percent during the third quarter of 2010.
Mr. Illingworth said the current medical device environment has made him cautious about where he spends the company's research and development capital, and he has become more interested in learning about the technology other companies are researching.
Read the Wall Street Journal report on the orthopedic device industry.
Read other coverage on Smith & Nephew:
- Court Rules in Favor of Smith & Nephew in Patent Litigation
- Smith & Nephew, Nanotope Partner in Cartilage Regeneration Project
- Smith & Nephew Introduce TWINFIX Suture Anchor for Rotator Cuff Repair
Mr. Illingworth said companies will have to enhance the processes for clinical trials and present real clinical data for FDA approval. The tougher regulations mean higher costs and longer waiting periods before the products can go to market, according to the report.
The $12 billion global market for hip and knee replacements has been hurt by the economy, as potential patients are deferring elective surgery. However Smith & Nephew's knee implant sales rose by 6 percent during the third quarter of 2010.
Mr. Illingworth said the current medical device environment has made him cautious about where he spends the company's research and development capital, and he has become more interested in learning about the technology other companies are researching.
Read the Wall Street Journal report on the orthopedic device industry.
Read other coverage on Smith & Nephew:
- Court Rules in Favor of Smith & Nephew in Patent Litigation
- Smith & Nephew, Nanotope Partner in Cartilage Regeneration Project
- Smith & Nephew Introduce TWINFIX Suture Anchor for Rotator Cuff Repair