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The Silicon Hospital and a New Way to Make Medical Devices

Devcon | Bangkok | Nov 14 2024

Dr. Mary Lou Jepsen

Founder, CEO & Chairman - Openwater.health

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Let me introduce myself first.

I’m a Serial Entrepreneur of Moonshot efforts for decades now

I’ve delivered multiple billion dollar products to production

Former MIT Professor, Brown University PhD in Physics

I Left Meta/Facebook where I was exec director of engineering..8 years ago To try this.

In labs like these first

Exploring a principle – IR light, ultrasound, EM penetrate our bodies and could perhaps leapfrog other healthcare solutions - even drugs - to treat many diseases with a single device.

How: using new semiconductor manufacturing processes + consumer electronics and phase modulation - Enabling us to steer, to interfere and selectively excite different kinds of cells

Could leapfrog - healthcare solutions - even drugs - treat with a single device.

How: semi + CEO andphase modulation

steer, to interfere and selectively excite different kinds of cells

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Why - this should make new disease treatments faster and affordable to all

As averaged in a recent paper compiling costs of all novel therapeutic medical devices approved over the last 30 years.

The average capitalized cost is now a whooping $658M in 2024 dollars and it takes an average of 13 years for a De Novo approval.

Its shockingly expensive to do something new in healthcare. The vast vast majority of approvals are called 510ks - they show “substantial equivalence” to something already approved. Thus the slow progress in new treatments.

The same paper showed the main cost isn’t the clinical trials - it’s the device - 85% of the cost is the device development. Safety is approximately another 7 percent.

Based on this data it’s possible with an open source device and shared safety data to get a De Novo regulatory approval with $5M and sub-3 years.

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