The world of regulatory affairs for medical devices and IVDs is a complex one, and few understand it better than Dr. Bassil Akra. A leading authority in the field, Akra has spent years handling various facets of regulatory compliance, aiding manufacturers in their pursuit of achieving compliance to European legislation, and facilitating communications between manufacturers, notified bodies, and authorities. Recently, Dr. Akra joined Michael Kania on his podcast to share some insights into his work and the future of regulatory affairs.
Akra's primary role, as he explains it, is to help guide manufacturers through the intricate maze of regulatory procedures, often stepping in to rescue situations that have gone awry, regardless of whether it’s from the manufacturer, the notified body, or an authority. His expertise is especially crucial today as the industry grapples with the transition to a more digital future.
On the podcast, Dr. Akra and Kania discuss the importance of eTD (Electronic Technical Documentation), Digital Clinical Evaluation, and Clinical Evaluation Assessment reports. Despite the increasing digitization of many industries, Akra notes that many manufacturers are still relying on traditional methods of documentation management, such as Excel sheets, Word files and manual methods.
We are still not there where we should be in 2023
Dr. Bassil Akra
Though some manufacturers have embraced digitalization, Akra observes that the majority are still working in the old way. This is somewhat disheartening, especially considering we are in 2023. The traditional, manual methodologies are being rapidly outpaced by advanced methods that significantly streamline the process of maintaining and updating documents.
The current situation is analogous to businesses that continue to manage their operations using Excel sheets instead of adopting digital tools that offer more efficient data management. Dr. Akra points out that digitalization not only eases the burden of managing data but also allows manufacturers to focus more on reviewing data rather than engaging in unnecessary paperwork.
Limited resources are a significant challenge that manufacturers, consultants, and notified bodies are all grappling with. The global requirements for regulatory affairs are continuously expanding, necessitating more efficient use of the available resources. Some organizations have developed tools to aid in structured literature review and appraisal steps, but a holistic approach like the meddevo eTD is still very rare.
Despite the clear benefits of digitalization, its adoption is still bad across all manufacturers. Many are yet to fully embrace the digital revolution, which has been further highlighted during the COVID-19 pandemic when digital workspaces became the norm.
There's an urgent need for more manufacturers to transition to digital work. The younger generation, who are more familiar with digital systems, are often baffled by the old-fashioned ways of working still prevalent in many organizations. It's time for a change.
In conclusion, Dr. Bassil Akra's insights underscore the need for manufacturers to adapt to the evolving digital landscape. The challenges are significant, but so are the opportunities for efficiency and growth. As we move forward, digitalization is not just an option - it's a necessity. And it's clear that leaders like Dr. Akra will be at the forefront of this transformation, guiding manufacturers through the transition and helping them navigate the complex world of regulatory affairs in the digital era.