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Friday, February 27, 2009
MTC: Life science innovation stats dipped in 2007
By Lynette F. Cornell, Mass High Tech Intern
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The Massachusetts medical devices pipeline shrank noticeably in 2007, sparking what could be a trend for the sector. The number of 510(k) submissions to the U.S. Food and Drug Administration was the second lowest since 1996, according to the recently released 2008 Index of the Massachusetts Innovation Economy.
The Massachusetts Technology Collaborative produces the index, which is used to gauge the progress of innovation in various tech sectors of Massachusetts against other benchmark states, such as California, Illinois and Minnesota.
Looking just at medical devices, Massachusetts companies had only 241 510(k) submissions, which are applications necessary for marketing a medical device that poses a moderate risk to the user, such as condoms or inflatable blood pressure cuffs. The number, a drop from 264 in 2006, reflected a national decline in submissions. Although Massachusetts had fewer submissions than in 2006, its percentage share of the national total actually increased slightly between the two years from 15 percent to 16 percent, the highest it has been since 2003.
“241 is still an impressive number for any state,” said Thomas J. Sommer, president of the Massachusetts Medical Device Industry Council. Sommer attributes the low number of 510(k) submissions to normal yearly fluctuations and said it was not a sign of an impending downturn.
The index also revealed that the FDA granted no premarket approvals to Massachusetts companies in 2007. PMAs are approvals from the FDA that are required for any medical device that requires significant safety and effectiveness data before going to market. The national total was only 13 PMAs, a sharp drop from the 30 approvals in 2006. As the national economy tanked in 2008, California more than doubled its PMAs from 6 to 13, helping to bolster the national total from 13 to 20. In contrast, Massachusetts had only one PMA.
“2008 looks just like 2007,” said Beth Ashman, a MTC research manager who worked on the report. “I would characterize this as an early warning sign that the pipeline has slowed down.”
The research also showed that while 2008 saw a total increase in the number of biotechnology drugs in development from 2006, Massachusetts had a decrease from 82 in 2006 to 76 in 2008 during approximately the first half of each year.
Looking to the future, Ashman noted that there is no way to know when things will get better. MTC’s director of innovation policy, Carlos Martinez-Vela, added, “Nobody really knows what’s going to happen.”
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