The New Digital Pathway For Regulatory

By Brian Curran

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.

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. 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.