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Pacific Biolabs predicts regulation-driven surge in medical device outsourcing

By Gareth Macdonald , 10-Jul-2012

CROs can expect more business from medical device makers as regulations become more complex according to Pacific Biolabs.

The global medical device CRO market was worth $3.2bn (€2.6bn) in 2011 and is growing at a rate of 12.5 per cent a year according to business intelligence group GlobalData, which predicted the sector will be worth $7.4bn a year by 2018 in a recent survey.

This prediction fits with observations by Aaron Burke, business development director at Pacific Biolabs, who told Outsourcing-pharma.com that so far this year the San Francisco firm has seen a 20 per cent increase in requests from device firms compared with the same period in 2011.

Much of this business is in response to specific regulatory changes by the FDA mandating additional testing not only for new devices, but classes of devices already on the market - specifically, reusable medical devices,” he said.

Burke went on to suggest that although the device sector’s use of contract research organisations (CRO) lags behind the drug industry, this is a product of regulations rather than a lack of interest in outsourcing.

I think that this lag is a natural extension of a milder and less intensive regulatory environment for medical devices as compared to pharmaceuticals. As the regulatory environment becomes more complexfor medical devices, which it appears is gradually happening in the US, device makers willout of necessityturn to CROs more frequently.”

CRO sector capacity?

While growing demand would obviously be good news for CROs it is important the sector realizes device firms looking to outsource will want different things than pharmaceutical companies and less experienced contractors consider their limitations according to Burke.

The CRO market is broad and deep, with specialization being the norm rather than the exception. The CRO market as whole is very well equipped to handle medical device testing."

He also cautioned that device manufacturers unfamiliar with the outsourcing market should be diligent in their research into companies.

Pacific BioLabs is in strong position - in terms of knowledge, experience, and capacity – to handle many, but not all, aspects of medical device testing. With respect to medical devices, we specialize in biocompatibility, reusable device studies, sterility testing and validation studies.”

He also suggested that some larger “one stop shop” CROs usually geared towards the pharmacueitcal industry may not have these device-specific capabilities.

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