While this application is medical, not metallurgical,  the technology is worth a few seconds of your time…

Add a smart phone and you can do lab tests anywhere...

Being a techie, I am  always delighted by new technologies. So imagine when I found out about a $1.50 lensless microscope being demonstrated at Caltech.
As we implement new technologies in our shops we eliminate waste and become both more capable and more efficient.
This Caltech developed microfluidic microscope promises to improve efficiency, capability, and improve medical diagnostics in the third world where cost of detection is often a showstopper.
How do we currently diagnose diseases like  malaria or cancer? A skilled technician examines blood samples brought to the lab using a conventional optical microscope.
Laboratory, sample preservation, preparation, and transportation all add “loss” to the process.
With this Caltech device, a system of microscopic channels called microfluidics lead a sample across the light-sensing chip. Samples flow through the channel because of a tiny difference in pressure from one end of the chip to the other. The chip ‘snaps’ images in rapid succession as the sample passes across.
 Cells tend to roll end over end as they pass through a microfluidic channel allowing the device create an  image of the cell from every angle. This allows the technician to determine its volume and type   by viewing the video made by the device. No lenses, no slides, no expensive transportation or sample prep, just in situ testing.
So what do we call this approach? How about ” Subpixel Resolving Opto-Fluidic Microscopy” or “SROFM.”
This $1.50 lendless laboratory, when coupled with the growing ubiquity of cellular phones around the world,  could just make a difference in developing world medical diagnostics and outcomes. REAL quality of life benefits from technology.
Full story at MIT Technology Review
We can see this type of application being developed for microtaggants on critical precision machined components for aerospace, medical or security applications where provenance and identity of the component are crucial to the mission…

The FDA is  not only the regulating agency  for this market, it is also a storehouse of information. FDA_general
Today’s post is short on text, but packed with authoritative links to the materials available on the FDA website.

  1. Small Business Guide to FDA This .pdf document was last updated on 10/7/2008 and provides contact information as well as an overview of the Federal Register / publication  of proposed regulations process.
  2. Design Control Guidance for Medical Manufacturers Because design controls must apply to a wide variety of devices, the regulation establishes a framework that manufacturers must use when developing and implementing design controls.
  3. Current Good Manufacturing Practices (cGMP) Rule links (on FDA website).
  4. An easier to read and understand   Introduction Presentation.
  5. The October 7 1996 Federal Register (as .pdf).
  6. Is your product a device?
  7. Definition of a device  see section (h) here.
  8. Class II  medical device exemptions 510(k).
  9. Class III device.

What informative links or references have you identified to help you navigate the medical device regulations?