The Saudi Food and Drug Authority (SFDA) and the Center of Excellence for Smart Health (KCSH) at King Abdullah University of Science and Technology (KAUST) held a joint workshop today, bringing together leading scientists and leaders from both organizations. The workshop focused on discussing the regulation and innovation of medical devices supported by artificial intelligence and biotechnology. 

The workshop featured a leadership panel discussion titled "Partnership between SFDA and KAUST: Leveraging Expertise to Accelerate Impact on the Healthcare System." Participants included His Excellency Dr. Hisham bin Saad Al-Jadhey, CEO of SFDA; Professor Edward Byrne, President of KAUST; Engr. Ali Al-Dalaan Deputy CEO for Medical Devices and Products Sector at SFDA; and Professor Pierre Magistretti, Vice President for Research at KAUST. The session, moderated by Prof. Imed Gallouzi, Chair of KCSH, explored the steps being taken and implemented in the field of health technologies. 

Dr. Al-Jadhey opened the workshop by emphasizing the Kingdom's historic step in adopting the National Biotechnology Strategy. This strategy aims to strengthen Saudi Arabia's position as a leader in the biotechnology sector, focusing on improving quality of life across multiple sectors, including medical products, pharmaceuticals, medical devices, agriculture, food and industrial applications. 

He pointed out that SFDA's regulations and legislation have kept pace with developments in medical devices based on biotechnology and emerging technologies like AI. This is achieved through a comprehensive regulatory framework specifically designed for biotechnology and new technologies, such as requirements for biotechnology-based medical devices. Furthermore, specialized departments and committees have been established, such as the Clinical Trials and Biotechnology Department and the Modern Technology and Digital Health Department. SFDA also maintains an active presence in international bodies and organizations, enabling it to stay abreast of the latest medical innovations and technologies. 

Dr. Al-Jadhey also stressed the importance of collaboration with relevant government and private agencies to achieve the objectives of the National Biotechnology Strategy. He highlighted SFDA's work and partnership with the Ministry of Health to regulate biotechnology in healthcare, the Ministry of Investment to attract investors, and the Ministry of Education and research institutions to adopt innovations. This workshop, he noted, aims to explore the relationship between biotechnology and artificial intelligence, their transformative applications in the field of medical devices, and innovation and collaboration in this domain. 

KAUST President Professor Byrne stated that this workshop comes at a crucial time and expressed his delight in hosting the accompanying panel discussions and interactive presentations on the latest devices and technologies developed by faculty members at the KCSH. He further emphasized the vital role that SFDA plays in supporting innovation in the field of medical devices. "Utilizing platforms like this workshop, in collaboration with SFDA, can have a tangible positive impact in the Kingdom," he added. 

During the workshop, SFDA presented the "Innovative Medical Devices and Supplies Track" initiative and its role in supporting local manufacturing and innovation in this field. KAUST's experience with regulatory frameworks during the development of a PCR diagnostic toolkit during the COVID-19 pandemic was also shared. Research on sensors and next-generation diagnostic tools, as well as the latest developments in the development of wearable biosensors, were presented. 

One of the workshop sessions focused onAI, specifically the skin diagnostic tool (SkinGPT-4) launched in 2023, and devices developed to support AI. Additionally, the experience of training AI on patient data in Saudi hospitals was reviewed, and an overview of advancements in the development of biotechnology-based medical technology was provided. 

These innovations, and the discussions around their associated regulations, align with the goals of both KAUST and SFDA to find solutions and develop innovative technologies that enhance public health, increase life expectancy in Saudi Arabia, and limit the spread of infectious and chronic diseases. These efforts also support Saudi Vision 2030 and the Health Sector Transformation Program.