The cloud is an accelerator of innovation across nearly every industry. In fact, one McKinsey and Company study found that an incredible 75% of the cloud’s predicted value comes from boosting innovation.
Manufacturers of drugs and medical devices are only too aware of the potential benefits of harnessing cloud-based technologies:
- Rapid development, testing, and go-to-market times of new products
- Increased scalability
- Reduced hardware and associated maintenance costs
- Access to new business models (e.g. outcome-based pricing and pay-per-use)
But cloud providers are not medical device or pharmaceutical companies and didn’t develop their services to be an exact fit for the industry (or its specific requirements). That means when it comes to actually using the cloud for innovation, many pharma and medtech businesses hit an obstacle: a lack of knowledge or guidance on how to maintain regulatory compliance.
This has cast doubt over when, how, and if the usage of cloud technology within the industry is even possible.
And that’s a big problem. Overcoming key issues facing the industry requires the development of such innovative solutions. Such issues include: the rising complexity of developing healthcare solutions due to increased personalisation requirements, and the growing demand for connected, data-driven products.
This is especially true when it comes to post-market monitoring in a value-based model of care, or virtual trial setting. In such situations, data is constantly fed back to the solution provider to be analysed in near real-time. The solution provider then uses this feedback loop for continuous product or service improvement.
Taken together, it’s clear that businesses need clarity and guidance on how to leverage cloud-based technologies in a way that also ensures regulatory compliance.
Working in partnership, Zühlke and the regulatory experts at the Johner Institut have developed a new framework for that very purpose. Our collective insight is presented in our Medical Clouds: A Case for Continuous Validation in Medtech & Pharma whitepaper – which you can read here.
Below, we explore the key challenges the framework overcomes, provide an overview of how it works, and explain how qualification and validation of cloud-based infrastructures and software can be achieved.