Elevating True Quality with Software as a Medical Device for Early Cancer Detection and Treatment

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.

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Some of the Episode highlights 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.
• Koios’ mission is to improve decision making for diagnosing cancer. 
• Reason for Regulations: Quality makes us better.

Links:

Koios Medical

FDA Clears Koios DS Breast 2.0 to Assist Physicians with AI-Based Software

Premarket Notification 510(k)

Center for Devices and Radiological Health (CDRH)

FDA’s Digital Health Software Precertification (Pre-Cert) Program

The Ultimate Guide To Design Controls for Medical Device Companies (waterfall method)

Global Medical Device Podcast

Greenlight Guru True Quality Roadshow 2019 

Greenlight Guru

Memorable Quotes from this Episode:

“The culture of quality piece is non-optional.” Patricia Setti-Laperch

“Help a physician be that second set of eyes to determine if something is suspicious, malignant, or benign.” Chad McClennan

“There isn’t a regulation mandating that physicians adopt our software. That’s a challenge with getting any new technology adopted in MedTech.” Graham Anderson

“You can never budget too much time or too much money to this process.” Graham Anderson

ABOUT MEDTECH TRUE QUALITY STORIES PODCAST

MedTech True Quality Stories Podcast, powered by Greenlight Guru, takes listeners on a storytelling journey through personal narratives of MedTech executives who offer real-world, actionable advice to industry leaders for guidance towards future imagination, implementation, and innovation of True Quality medical devices.

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