Elevating True Quality with SaMD for Early Cancer Detection and Treatment
This is a podcast episode titled, Elevating True Quality with SaMD for Early Cancer Detection and Treatment. The summary for this episode is: In the U.S. alone, over 80% of the 5,000 biopsies conducted daily come back either falsely negative, or falsely positive. More than 350 breast cancer cases evade early detection because of misdiagnosis. Many of those errors can be avoided. There's one company in particular that is leading the charge with a truly innovative solution to this problem, Koios Medical. Koios is proprietary software that has the power to meaningfully elevate the quality of medical care and support accurate decision-making by ‘seeing’ what humans can’t. Koios Medical offers accurate ultrasound results through artificial intelligence (AI) and machine learning (ML) algorithms that patients need and physicians find valuable to support early detection and accurate treatment of breast cancer and other diseases. Today’s episode features three guests from Koios Medical offering valuable insight to listeners on how they've been successful in imagining, implementing and innovating a true quality medical device that aims to redefine cancer diagnosis as we know it today, and how other medical device professionals can follow in their footsteps. Some of the highlights of the show include: ● Word Origin and Why: Koios is Titan God of Wisdom, Foresight, and Intellect. ● Regulatory Success: Koios Medical’s DS Breast 2.0 received FDA clearance to assist physicians with AI-based software. ● Koios engineers started using AI/ML algorithms to do face-recognition work for a U.S. defense contractor, and transitioned to adapt AI/ML to do more global good. ● Why now? AI has existed for decades, but only recently has computing power allowed massive amounts of data to become useable in a practical sense. ● Competitive Edge: Koios is doing everything possible to maintain its market lead by building an efficient and expedient processing engine and software. ● Design and Development Direction: Koios’ path to clearance commercialization involves behavioral, technical, and financial challenges/opportunities. ● Reason for Regulations: Koios’ mission is to improve decision making for diagnosing cancer and Reason for Regulations: Quality makes us better.
Culture of Quality is Non-optional
Budgeting Time and Money
Design and Development Feedback