New Quality Regulations for the Global Device Market

Despite a down economy and shaky healthcare environment, the global medical device industry is still expected to gross $312 billion in 2011 and will continue to expand at an annual rate of 4-6%. The FDA recently announced plans to unveil a strategy to combat the challenges caused by rapidly rising imports of FDA-regulated products and a complex supply chain in a report titled “Pathway to Global Product Safety and Quality.”

Highlights of the report include partnerships with the FDA’s “counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.”

Over the years, our clinical team here at HCB Health has noticed scores of smaller, independent device companies entering the market. Whether our clients see them as a healthy dose of competition or a thorn in their sides, we’ve encountered some companies that fly under the radar when it comes to adhering to product safety regulations and specifications. This isn’t a good situation for us, our clients, the industry or patients.

The FDA solution relies on consensus among multiple countries. As such, it isn’t considered a quick solution. In the long run, we believe that this move will help:

• streamline product development,
• cut costs across the board and
• improve the consistency of positive patient outcomes

In the meantime, we’ll keep working with clients that take the high road and do everything they can to put patient safety first.