The life sciences industry is up against some intense headwinds: declining market access, patent expirations, rising research and development (R&D) costs, pressure to ensure patient access; reimbursement barriers; and ever-increasing regulatory demands. Countering those challenges, however, are some exciting developments, such as growing global demand for healthcare opportunities in emerging markets alongside advances in medical technology innovations in areas such as genomics that open the path to personalized care, personalized medicine and predictive medicine.
At the same time, life sciences companies must respond to the changing commercial landscape, where consumers are increasingly more savvy and are taking advantage of a digital revolution through social media, mobile devices, and wearables or sensors that analyze and/or monitor adherence.
Given these industry and digital transformation events, the main objective for the industry should therefore be to take advantage of those developments and shift the business model from a quantitative to a qualitative or better-outcomes view, to reap the financial rewards and innovation that it presents. In other words, how can business models and business strategies promote a shift of the profit pools — from more inputs to better outputs?
Responding to digital disruption
This next wave is undergoing major change as it responds to the Internet of Things (IoT), the rise of intelligent software, business process automation (BPA), increased flexibility enabled by cloud, Business as a Service and rapidly advancing mobile capabilities.
These winds of change are sweeping the entire ecosystem in a life sciences organization – from R&D to clinical development to manufacturing to distribution to sales and marketing to post-market surveillance. Because this entire value chain has been operating with an outdated business framework not modernized to take advantage of these recent shifts, and working without a clear and comprehensive end-to-end response, companies must manage the cracks in this value chain as they become more visible.
Thus, companies’ operating models need to be adjusted to meet the digital disruptions across the value chain through greater process flexibility combined with enhanced data security. Knowing how to modernize to take best advantage of new trends is the key to a successful transition. It’s our view that digitizing the life sciences value chain is a transformational event that successful modernization needs to encompass across the business. In particular, steps toward modernization involve:
- Regulatory Business Automation Software
- Regulatory Transformation Services
- Regulatory Business Process Services
Over the coming weeks and months, my colleagues and I will explore these three threads in detail and examine where digital disruption should bring the greatest promise for advancing the business model.
Sharad Khusal is global head of Life Sciences Pre-Sales and Customer Success at CSC.