Medical Device R&D: Six Challenges to Profitability - ICON plc

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... face more critical challenges during development, achieving mandates for cost efficiency and productivity in the ...
Medical Device R&D: Six Challenges to Profitability As medical device manufacturers face more critical challenges during development, achieving mandates for cost efficiency and productivity in the marketplace is tougher than ever. How are these six major issues affecting your pipeline productivity?

Site Selection & Recruitment

1 in 10

sites fails to enrol even a single patient

Post-marketing Commitments

50% more

U.S. post-marketing studies are conducted by manufacturers today versus a decade ago

Half of all medical device trials that were terminated in 2015 failed due to slow patient accrual.

Post-market study costs are starting to eclipse early product revenues.

Organisational Silos

Staffing Difficulties

Post-market studies experience delays when the clinical team is unable to transfer expertise to new staff members When organisational structures are segmented, best practises developed within one group often do not transcend divisions.

Study Design

4.3

change orders is average for a typical clinical trial High-cost protocol amendments elude detection in current feasibility reviews.

Inconsistent Outsourcing Partnerships

10,000+

CRA positions still need to be filled as of June 2015 Current resourcing models are not flexible enough to address fluctuations in clinical trial talent requirements, causing both understaffing and overstaffing across teams.

$40bn

will be spent by medical device manufacturers on outsourcing by 2018 The lack of standardised vendor qualification processes and centrally-coordinated outsourcing practises precludes opportunities to secure cost savings.

How can you overcome these six critical challenges? Find solutions to maximise your investment capital in our free white paper, ‘Transforming Medical Device Development.’ Learn more at ICONplc.com/device/transforming ICONplc.com/devices