Medtech 2013: Device Companies Go Where The Growth Is
To stave off the sluggish growth in established markets, multinational medtechs not only are finding new business in countries with booming health care industries but they’re also forging new ways to serve customers. Device companies now are pushing into services, such as disease management, and angling to compete more aggressively on pricing.
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Manufacturers are finding it harder to innovate in the vascular interventional devices as market and regulatory pressures take their toll. New coronary drug-eluting stents face a difficult challenge with the high bar now set by existing devices, and there have been several recent disappointments in renal denervation, drug-coated balloons, and renal artery stenting; still there are some promising areas, with bioresorbable stents offering perhaps the best prospect among vascular therapies for future blockbuster status.
Investors and their limited partners really don’t like risk, especially not the kind due to uncertainty. Now, for developers of mobile health applications and their investors, at least one risk has been taken off the table: regulatory uncertainty. On September 23, the FDA published the much-anticipated final guidance on mobile medical apps.
After the two-week shutdown, FDA staff are facing a backlog of fiscal year 2014 device submissions. The agency says it is working on a plan and assessing its ability to meet its MDUFA III commitments. The bigger concern, however, may be the regulatory uncertainty created by the short-term deal in Congress.