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By reducing costs and time to launch products on the market, a US Food and Drug Administration (FDA) initiative is set to change the face of the medical device manufacturing and marketing.

By Lucy Brake on Dec 6, 2012

The FDA announced this week that, in collaboration with LifeScience Alley (a biomedical science trade association) it will be supporting advances in medical device regulatory science through the creation of the first ever public-private partnership (PPP) with the sole objective of advancing this field of the health care industry.

The US medical device sector alone is worth around US$136 billion annually and delivers products for approximately 48 million domestic inpatient procedures every year. The newly created Medical Device Innovation Consortium (MIDC), a not-for-profit organisation, will be focusing on increasing the speed of development, assessment and review of new medical devices being made available to medical professionals to help improve efficiencies in this critical healthcare sector.

This initiative has important implications for the pharma industry as it means that there is potential for the cost and time it takes to develop a product and launch it on the US market to be significantly reduced. FDA offers an example where an implant could be tested on a virtual patient using computer technology, prior to a manufacturer investing time and budget in a clinical trial.

The FDA is responsible for assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices in the US. From their perspective this new partnership presents immense opportunity to deliver on this, as Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health explains: “By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost.” 

The industry in the US has increasingly criticized the government for inhibiting the release of new products and innovations on to the market. This has led some companies to launch in Europe in order to avoid restrictions on approvals.

The idea behind the new PPP is that government and scientists will be able to collaborate closely with manufacturers of medical devices. This includes setting up a new industry-backed group which aims to streamline the design and testing of equipment.

One of the research areas that is believed will benefit from the partnership is genetic testing. The plan is to set up a comprehensive database of human genetic variations, which is seen to offer an important source of information to support the development and promotion of clinically-valid genomics-based products.

A report published this week in the Science Translational Magazine, authored by Michelle McMurry-Heath and Margaret Hamburg from the FDA, summarises how the scheme should allow everyone with a stake in the industry to work more closely together to modernize regulatory science: “MDIC will serve as a collaborative freeway to biomedical discovery and development by forming a foundation that makes it easy for industry, academia and government to come together to set research priorities.”