Dec 05-08: Exploring Diagnostic AI, Regulations, and the Equator

Hi everyone, oli otya! (How are you!)

Beyond learning more luganda, the end of our first week was filled with an exploration of Uganda, innovative AI techniques in screening, regulatory understanding, and more as we journeyed to Mbarara.

Thursday, December 05, 2024

Thursday began with an incredibly insightful meeting with the brilliant Dr. Trasias Mukama at the Guesthouse. Dr. Mukama is a cancer epidemiologist and public health practitioner, who previously worked on an AI mammography screening company known as Vara. We discussed the company's innovative decision referral system in which AI is only used for diagnoses where the model has a high degree of confidence, leaving the more complex cases for radiologists, to promote higher sensitivity and specificity. During our conversation, we conversed about the AI design differences in screening vs diagnostic populations, enabling efficiency vs accuracy, and providing descriptive AI results, to understand how we could adapt this AI methodology to our needs.

Soon after this meeting, we quickly headed over to the beautiful Golf Course Hotel for a meeting the National Drug Authority (NDA) and Ministry of Health (MoH). Our main goal was to further introduce our technology, and gain an understanding of government regulations for our device. During this meeting, we learned that our device would primarily fall under Uganda's software device guidelines, which were in the process of being formalized and would likely be available next year. Additionally, the NDA explained the various regulatory bodies that we would need to seek approval from as we transitioned from a preliminary research stage to pilot study to implementation, including but not limited to the Research and Ethics Committee, National Advisory Committee on Medical Equipment, National Medical Stores, and the Director General Health Services. We are excited to continue building our relationship and keeping them informed as Ekyaalo Diagnostics progresses.

After polished off a delicious meal at Taj Asian Bistro, we ended the day exploring the East African Craft Village on Buganda Road. (Kenny and Sofía tried a grasshopper!!)

1) Meeting with NDA and MoH. 2) Meeting with Dr. Mukama. 3) Eating lunch with Darious. 4) Ava at the East African Craft Village

Friday, December 06, 2024

Due to an emergency, our original meeting was cancelled, giving us some time to synthesize all the information we gathered over the past few day. We spend a lovely morning working (and eating and drinking coffee/tea) at the Kardamom and Koffee shop. Soon after, we scheduled a last-minute interview with one of the pathologists (our ninth of the week!) at Makerere University's pathology department. This patholgist validated many ideas we heard earlier in the week, detailing the importance of multiple magnifications, cellular quality and density as a measure of adequacy, and provided some new cytology resources for us.

Satuday December 07, 2024 - Sunday, December 08, 2024

Our main plan for this weekend was to travel to Mbarara for next week's plans, but our drivers, Samuel and Dennis, were gracious enough to allow us to tour some of Kampala's historic locations first. We visited the Gaddafi Mosque and Kasubi Tombs to learn about Kampala's rich history, culture, and architecture. After our morning exploration, we finished our drive to Mbarara, crossing the equator on the way! On Sunday, we met up with Dan who took us on a small tour of Mbarara Central Market and planned for our first Healthcare IV visit and usability study this week.

1) Arjun at the Equator! 2) Dan's tour to the Mbarara Central Market. 3) An usability study evening.

Our Main Takeaways:

• Avoiding low diagnositic accuracy by AI by training two model: one with high sensativity, one with high specificity, and only presenting AI diagnosis of cases with a high degree of confidence

• Maintaing frequent contact and approval from various regulatory bodies as make progress

• Importance of triple diagnosis as clinicians must factor in 1) clinical patient information, 2) imaging, and 3) cytology, prior to making a diagnosis for patient

Our team is extremely grateful for the opportunity to travel to Healthcare Level IVs, General Hospitals, and Regional Referral Hospitals. We are very excited to learn from lab technicians and medical officers, as for the first time we can extensively interact with our target users and receive some long-awaited answers. Additionally, we will finally meet one of our primary partners, Dr. Mitala. We look forward to another amazing week ahead in Uganda!

Siiba bulungi!

(Have a nice day!)