Medical Devices Outperform Market But Rule Changes Loom

Medical devices are the overlooked step-child of the biopharma industry but the latest MassDevice Weekly shows this sector to be a market performer that investors should not ignore.

The index looks at clusters of device-makers in Massachusetts, Minnesota and California. It shows stocks in all three regions doing better than comparable market indicators. Overall the index has gained 23.7 percent since the compilation started in January 2009. The 10 top gainers and losers are listed.

One reason devices often do better than drugs or biologics is that these therapeutic systems enjoy a faster and easier regulatory environment. But according to a Gray Sheet article previewed in Medical Devices Today, that may be changing:

FDA is pouring more time and money into the field of regulatory science, and device makers would be wide to wonder: how will this affect us?

The Senate Subcommittee on Aging recently held hearings on medical device safety and heard from experts like Boston-based medical expert Frederic S. Resnic.

In his testimony Resnic told investigators that device failures were infrequent but devastating, and the effects of failures were worsened by a lack of timely and adequate systems to centralize problem reports.

No industry wants regulation but consumer confidence is based upon the conviction that oversight protect patients. In the light of well-publicized episodes like widespread failure of one hip-replacement system, device-makers should cooperate where fixes are needed rather than stonewall regulators and risk a loss of confidence and over-regulation later.


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