Workshop on FDA and TGA Approval with Dr. Sha Pather Empowers Students to Navigate Regulatory Pathways
November 7 | 2024
On Thursday, 11th November, an invaluable workshop on FDA and TGA regulatory approval, led by Dr. Sha Pather of Akunah (COO), took place, equipping students and researchers with critical insights into the regulatory landscape for medical devices. This workshop provided a detailed overview of the requirements and strategies needed to bring medical devices from research to market—an essential skillset for anyone seeking to commercialise medical technology.
Understanding the Importance of Regulatory Approval
Dr. Pather highlighted that understanding the regulatory landscape isn’t just a technical requirement; it’s essential for anyone aiming to connect research with industry, commercialise new technologies, or streamline the translation of academic research into practical solutions. The complexities of regulatory processes, often seen as daunting, can present significant hurdles in device development. Dr. Pather underscored the importance of having a clear roadmap, which not only aids in the commercial viability of medical innovations but also enhances student readiness for industry roles where this knowledge is increasingly valued.
Regulatory Approval as a Risk Management Process
Central to the workshop was the emphasis on regulatory approval as a sophisticated process of risk management. Dr. Pather discussed how regulatory bodies such as the FDA and TGA prioritise the balance of safety and efficacy with inherent device risks. This process doesn’t simply validate the product’s safety but also lays the groundwork for a safe design process, forming the core justification needed for regulatory success. Notably, regulatory approval does not imply absolute safety; instead, it demonstrates that a device is safe enough relative to its potential risks.
The Nuances of Regulatory Strategy: More than Just a Checklist
In a compelling analogy, Dr. Pather described regulatory approval as less of a “checklist” and more of a “dance”—a nuanced balancing act requiring strategic planning and careful risk assessment. He advised against seeking a “quick fix” approach to meeting regulatory requirements and instead encouraged a thoughtful, long-term perspective. Interestingly, Dr. Pather noted that obtaining approval from international bodies such as the FDA can sometimes be a strategic first step before seeking TGA approval in Australia, as overseas authorisation can streamline the domestic process.
Key Elements of a Regulatory Pathway: Device Indication, Equivalence, and Classification
The workshop also explored three key components of regulatory submission:
- Indication for Use: The intended function, conditions, and patient population for a medical device are critical to determining the regulatory pathway. This foundational step ensures a precise alignment of the device’s purpose with regulatory expectations.
- Equivalent Devices: Reviewing comparable devices in the market can inform the regulatory process, as devices that achieve similar outcomes, even with different technologies, provide valuable benchmarks.
- Device Classification: Each medical device falls into a risk-based classification system. Using tools like the TGA’s device classification questionnaire, developers can identify the classification and specific requirements for their device early in the process.
Navigating the Regulatory Pathway: Practical Tools and Resources
Dr. Pather provided guidance on the sequential steps for obtaining approval, from pre-submission planning to leveraging available resources. He pointed participants toward valuable tools, including the TGA device classification tool and external platforms such as Greenlight Guru (Podcast and Website), Easy Medical Device (European Podcast) and Medical Device Academy (Website and YouTube) which offer further guidance on navigating international regulatory standards.
By understanding and applying these foundational principles, participants left with a clearer path forward and a strategic framework for approaching regulatory challenges. This workshop aimed at bridging academia and industry, succeeded in equipping attendees with a practical toolkit for future careers in medical technology and innovation. With Sha’s expertise as Akunah local start-up company COO, the Centre provided its thanks for an expert training opportunity and looks forward to new collaborative opportunities in the future.
