About
I help bring high-impact diagnostic medical devices to the US market.
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Articles by J. David
Contributions
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What are the key steps to creating a successful supervised learning algorithm?
There are a few common mistakes we see Medical Device startups making when evaluating their algorithm. First, they aren't careful about unintended data leakage. E.g., they use data from the same geographic location in their validation dataset as in their training dataset. This is an FDA no-no. Second, they let their AI/ML engineers have access to their validation dataset. As FDA says in their guidance: "If you would like the FDA to consider the reuse of any test data in your standalone evaluation, you should control the access of your staff ... set up a “firewall” to ensure algorithm developers are completely insulated from knowledge of the test data." Read more: https://innolitics.com/articles/how-to-avoid-k-ai-ml-mistake/
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What are the key steps to creating a successful supervised learning algorithm?
"Bias" isn't always bad. If your model is intended for a specific population, you want it to be biased to work optimally for that population. For example, if your AI/ML-enabled software is intended for pediatric patients, you want it to be "biased" to work with kids. When working on medical-device AI, the first question we ask is: What dimensions does your model need to generalize across? For example, in radiology you may have: (1) Manufacturers, (2) Imaging Machines, (3) Slice Thickness, (4) Sex, (5) Ethnicity/Race, (6) Locations, (7) Image Age, etc. Once you identify your sources of variability, you can define the dataset you need. (FDA often requires 50% of your data to come from the US, and at least 3 geographic locations.)
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What are the key steps to creating a successful supervised learning algorithm?
It is tragic, but too often medtech companies focus too much on their model's performance, and not enough on defining the problem. You don't want to build an AI/ML-enabled device, clear it with FDA, only to find the radiologists hate it. It slows down their workflow. It is more than sensitive enough, but not nearly specific enough. Do you need 95% specificity? 98%? 99%? In the medical-device space, "It's The Workflow, Stupid"! (https://innolitics.com/articles/its-the-workflow-stupid-and-other-ai-lessons/) You need to know the workflow and the value proposition so you can know what to build. Fall in love with the problem, not the solution.
Activity
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In 2024, pancreatic cancer was projected to take an estimated 51,750 American lives. While asymptomatic in its early stages, pancreatic cancer…
In 2024, pancreatic cancer was projected to take an estimated 51,750 American lives. While asymptomatic in its early stages, pancreatic cancer…
Liked by J. David Giese
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ZDNET has spoken. Ozlo Sleepbuds® are the best sleep headphones overall! 🎉 Ready to experience next-level sleep? Read more here:…
ZDNET has spoken. Ozlo Sleepbuds® are the best sleep headphones overall! 🎉 Ready to experience next-level sleep? Read more here:…
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Recently, I'm spending time prototyping and trying out different ideas for products I'm interested in ... so I got some posts about wearable devices…
Recently, I'm spending time prototyping and trying out different ideas for products I'm interested in ... so I got some posts about wearable devices…
Liked by J. David Giese
Experience
Education
Publications
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Fast volumetric phase-gradient imaging in thick samples.
Optics Express
Oblique back-illumination microscopy (OBM) provides high resolution, sub-surface phase-gradient images from arbitrarily thick samples. We present an image formation theory for OBM and demonstrate that OBM lends itself to volumetric imaging because of its capacity for optical sectioning. In particular, OBM can provide extended depth of field (EDOF) images from single exposures, by rapidly scanning the focal plane with an electrically tunable lens. These EDOF images can be further enhanced by…
Oblique back-illumination microscopy (OBM) provides high resolution, sub-surface phase-gradient images from arbitrarily thick samples. We present an image formation theory for OBM and demonstrate that OBM lends itself to volumetric imaging because of its capacity for optical sectioning. In particular, OBM can provide extended depth of field (EDOF) images from single exposures, by rapidly scanning the focal plane with an electrically tunable lens. These EDOF images can be further enhanced by deconvolution. We corroborate our theory with experimental volumetric images obtained from transparent bead samples and mouse cortical brain slices.
Other authorsSee publication -
Snakules: a model-based active contour algorithm for the annotation of spicules on mammography
IEEE Transactions on Medical Imaging 29:1768-1780
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Medical Device SBOMs: Best Practices, FAQs, and Examples
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Practical suggestions and tips for authoring SBOMs for medical devices and for using them to monitor for cybersecurity vulnerabilities.
More activity by J. David
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My God is it easy to find waste, fraud, and abuse in healthcare. But 𝘞𝘩𝘰𝘰𝘱𝘴𝘪𝘦, 𝘮𝘢𝘥𝘦 𝘢𝘯 𝘰𝘰𝘱𝘴𝘪𝘦 we’re amputating the wrong…
My God is it easy to find waste, fraud, and abuse in healthcare. But 𝘞𝘩𝘰𝘰𝘱𝘴𝘪𝘦, 𝘮𝘢𝘥𝘦 𝘢𝘯 𝘰𝘰𝘱𝘴𝘪𝘦 we’re amputating the wrong…
Liked by J. David Giese
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Update Vulnerability Reported in the Popular RadiAnt DICOM Viewer A new CISA alert highlights a vulnerability in Medixant RadiAnt DICOM…
Update Vulnerability Reported in the Popular RadiAnt DICOM Viewer A new CISA alert highlights a vulnerability in Medixant RadiAnt DICOM…
Liked by J. David Giese
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Update Vulnerability Reported in the Popular RadiAnt DICOM Viewer A new CISA alert highlights a vulnerability in Medixant RadiAnt DICOM…
Update Vulnerability Reported in the Popular RadiAnt DICOM Viewer A new CISA alert highlights a vulnerability in Medixant RadiAnt DICOM…
Shared by J. David Giese
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For exquisite, highly accurate, highly reliable and fully automated total body CT segmentations and deriving all organ/tissue measurements without…
For exquisite, highly accurate, highly reliable and fully automated total body CT segmentations and deriving all organ/tissue measurements without…
Liked by J. David Giese
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This Friday’s MDG Premium guest speaker is Stéphan Toupin, will talk about The Business of Foreign Medical Device Distribution – Lessons, Pitfalls…
This Friday’s MDG Premium guest speaker is Stéphan Toupin, will talk about The Business of Foreign Medical Device Distribution – Lessons, Pitfalls…
Liked by J. David Giese
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Exciting news! Loss of Pulse Detection has received US FDA clearance, paving the way for its launch on Google Pixel Watch 3 in the U.S. at the end of…
Exciting news! Loss of Pulse Detection has received US FDA clearance, paving the way for its launch on Google Pixel Watch 3 in the U.S. at the end of…
Liked by J. David Giese
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What is the "Updateability and Patchability View" required for FDA Submissions? It is one of the Cybersecurity Architecture diagrams FDA requires…
What is the "Updateability and Patchability View" required for FDA Submissions? It is one of the Cybersecurity Architecture diagrams FDA requires…
Liked by J. David Giese
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What is the "Updateability and Patchability View" required for FDA Submissions? It is one of the Cybersecurity Architecture diagrams FDA requires…
What is the "Updateability and Patchability View" required for FDA Submissions? It is one of the Cybersecurity Architecture diagrams FDA requires…
Shared by J. David Giese
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