Digital Transformation in the Life Sciences Industry 

Key Risk Considerations

Digital Transformation is rapidly being recognized in the Life Sciences Industry as an important enabler for innovation and business growth. The value created includes areas like patient community experience, key clinical opinion leader interactions, clinical and research personnel engagement, new models of care and overall operational efficiency for the industry.

Managing risks in the digital era is critical to the ability of the Life Sciences industry to accelerate time to market and create a system of continuous collaboration.

Potential risks

01 - Engaging the digital consumer through the application of the right risk controls: Life Sciences industry is in the wellness business. The objective of the industry has changed from catering to the sick, to helping the consumer prevent illness. As the industry embarks on this journey, new paradigms of care have emerged. Concepts like Connected Health have become mainstream. Many consider this as the healthcare model of the future. Consumers are now using wearable devices and keeping track of key health indicators like blood pressure, heart rate and the number of steps taken. Many wellness programs are being run by the Life Sciences firms leveraging digital platforms. 

02. Derisking process automation through the right controls: Automation has becomes an important driver of operational efficiency. Healthcare companies are trying to find ways of optimizing human interface in an array of operations, and trying to make it more process and system driven. Such an approach minimizes errors and enhances efficiencies.

03 Building a resilient manufacturing construct: Manufacturing is a key area for the Life Sciences Industry. India, today, has one of the largest numbers of FDA approved manufacturing sites outside of the US. This is a testament to the key advances made by the industry in the manufacturing space. Manufacturing also involves adhering to key compliance processes like Good Manufacturing Processes (GMP). 

04 Gearing up for the Digital mind-set: People are key to the success of any digital transformation initiative. Life Sciences organizations have been built on the foundation set by their people including doctors, biologists, virologists, geneticists, molecular biologists, clinical researchers and others. It is often seen that doctors are busy with diagnosis and clinical work and tend to delegate data entry to nurses or support staff.

In this context, there are 3 key considerations:

01. Contextual Risk- Adequate selection of the digital enablers in the transformation program, keeping in mind the business objectives

02. Implementation Risk- Leveraging a Risk based architecture for digital keeping in mind the technology, operations, vendor ecosystem, FDA and other government compliance, security and resilience

03. Governance Risk- Effective governance around digital transformation initiatives to ensure cross functional synergies and eliminate risks from interdependent processes.

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