Insight Briefs

The New Digital Pathway for Regulatory

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Data Sheet 1 Data Sheet Regulatory:New Digital Pathways Capitalizing on Growth According to KPMG's analysis, the medical device industry is poised for steady growth, with global sales forecast to rise by over five percent per year and reach nearly US$800 billion by 2030. 1 Good news, right? That depends on your organization's ability to capitalize on the trends underlying these projections, like increasing demand for innovative new devices (wearables) and services (health data), a highly expanding competitive ecosystem, new digital value chains, and the huge potential in global markets. The truth is, there has never been more opportunity for growth, but capitalizing on those opportunities won't be easy – particularly for organizations that are slow to modernize their approach to new product introduction. More Data, More Harmonization: A surge of change is underway in regulatory information management (RIM) as life sciences companies re-evaluate their global operating capabilities. Less Time, Less Margin for Error: New product introduction has always been a tenuous balance between speed, cost and quality. First to market typically wins, but a race to the finish line that ends with failure to gain market access, or worse – a product that makes it to market only to be recalled – can cost your company everything. • First movers average 40 percent market share 10 years after launch 3 • Yet 44 percent of new product introductions fail to meet quality or commercial success metrics 4 Complexity, Convergence and Change: As medical devices become more complex – mixing both device and drug delivery and/or integrating software, applications or connected sensors – the regulatory environment is becoming more challenging. According to Deloitte, the current landscape of regulatory pressures and internal challenges often leads to poor decision-making, integration and execution. Modernizing compliance using technology, with a focus on efficiency and value creation, can shape the future compliance landscape and transform how the compliance function is viewed. 5 As a result, companies must strategically invest in a strong interoperable digital infrastructure, and harness data to expand their business models and position themselves to compete in a transformed environment. Pressure to operate more efficiently on a global scale is driving companies to focus on implementing technology solutions to accelerate their ability to harmonize processes, improve data quality, and adopt shared global systems. 2

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