Global Digitalisation and the Impact on MedTech and Pharmaceutical Industries
John Darby M.Sc. Executive Director, Lachman Consultants
and Patrick Day M.S. Principal Consultant, Lachman Consultants
The ultimate bearing point of compliance is transforming the reactive to proactive, for both supply and commercial benefit.
As the Pharmaceutical sector continues to catch up with mature data integrity programs, the adoption of technologies such as Artificial Intelligence (AI) and Advanced Analytics (AA) are quickly creating a “data fault line” separating efficient and quality decision making processes. Additionally, the capabilities gap of personnel to manage, deploy, and provide oversight will continue to grow, thus making a move towards proactive data governance and management even more complex and difficult.
In a risk averse environment such as Drug and Device manufacturing, clear identification of AI in GxP regulations is paramount in order to anticipate the successful uptake of technology and acceptance in the view of the regulator. The key to the application of AI is how to integrate the regulations, regulatory thinking, and published thought papers from the drug regulators in relation to a company’s Quality Management System (QMS).
A company’s competitive edge may very well hang on its ability to integrate the technology, processes, and people into an optimised program for unique and actionable insight. This can be best placed into a strategic plan to integrate ongoing data governance maturity into the holistic digital strategy. Just focusing on the technology itself can exacerbate an already known gap with a key function within Pharma and Device companies.
Across the pharmaceutical sector globally, digitalisation is happening and companies not investing in this area will quickly be behind the curve in adoption. Credible areas of successful digitalisation are being implemented in pharma and devices in targeted areas of need such as:
Supply Chain monitoring and resilience
Supplier-Manufacturer digital transfer of information
Supply Chain anti-counterfeit programs
In parallel, regulators are investing in their own systems and capabilities for similar areas such as the EMA strategy to utilise AI to combat supply chain challenges (1) and the FDA’s draft guidance on assessing risks in the supply chain. (2)
In conclusion, the Pharmaceutical and MedTech sectors are progressing towards a comprehensive strategic roadmap for the adoption of AI and advanced analytics, providing individual companies with strategic scientific and commercial advantages. Late adopters will be impeded by a lack of cogent and comprehensive governance, as well as by the challenges involved in ensuring a robust and mature data science workforce is in place.
European Medicines Agency (EMA); “European medicines agencies network strategy”; December 20, 2023; https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/european-medicines-agencies-network-strategy
U.S. Food & Drug Administration (FDA); “Risk Management Plans to Mitigate the Potential for Drug Shortage – Guidance for Industry”; Draft Guidance; May 2022; https://www.fda.gov/media/158487/download
