About Alpha Devices
An independent engineering consultancy focused on medical devices.
We investigate medical device performance and failure for legal counsel, manufacturers, and healthcare organizations, from the first technical assessment through reporting and expert testimony.
The firm
Understanding the complete system.
A medical device is a system of interacting parts. Understanding an incident takes more than examining a single component.
We examine mechanics, electronics, fluid flow, heat transfer, sensors, and software to understand how the device behaved. Inspections and controlled experiments test the proposed explanations.
Design and quality records show how requirements and risks were addressed. MAUDE reports and other FDA records let us examine the device’s history alongside the incident evidence.
Based in Philadelphia, we work with clients from the initial technical assessment through reporting and expert testimony. An engagement may involve a specific test, a documentation review, or a broader investigation.
How we work
Three commitments in every engagement.
Opinions follow the evidence
We evaluate possible causes of failure as well as evidence that a device operated normally. Our findings distinguish what is established, what remains uncertain, and which additional tests or records could help.
Test what the records cannot answer
Where documentation leaves a question open, we design experiments that can distinguish between competing explanations, and we report the methods and limitations alongside the results.
Explain it clearly
We explain our methods and results in terms that counsel, clients, and juries can follow, in written reports, demonstratives, deposition, and trial testimony.
Get in touch
Tell us about the device.
Share a brief overview of the device, the question you need answered, and any deadlines. We’ll explain how we can help and recommend the next steps.
info@alphadevices.io