Biotech and Medtech - Inventions & Patents

In designing medical devices or developing new products in the biotech industry, patent review is part and parcel of the due diligence process prior to committing resources into a project. Increasingly the engineers or scientists either by themselves or in consultation with IP professionals, have to make some kind of freedom-to-operate determination. Often times such decisions are subjective. The recent ruling by the United States Court of Appeals for the Federal Circuit on "willful infringement" could make things a little easier for the engineers and scientists.... 

One key support staff in the operating room is the scrub nurse.  This person manages and hands the surgeon the correct surgical tools at the right time in the course of the surgery.  Ideally, the surgeon keeps his eyes focused constantly on the operative site which may be an open wound or video display.  If the surgeon looks away from the operative site each time he needs a different instrument or re-set the supporting machines, he losses is concentration including slowing the flow of his surgical maneuver and having to refocus at the operative site.  The surgeon communicates with the scrub nurse using hand gestures.  So when a surgeon needs a pair of scissors, he would continue to keep his eyes focused on the operative site and simply put his arm out with the index and middle finger in a V sign configuration.  Then the surgeon would open his hand and the scrub nurse will "slap" the handle of the scissors into his palm.  The "slap" is for the nurse to indicate to the surgeon that as soon as you feel the "slap" I am going to let the instrument go. 

However this is a dying art for two reasons.  Surgeons and scrub nurses are not these days trained to communicate in this fashion.  Particularly, scrub nurses are often times rotated amongst different surgeons and thus there is not sufficient time to establish such "channel of communication".  More importantly with blood borne transmission of infectious disease such as AIDS and Hepatitis, this manner of passing sharp instruments are at high risk of inflicting accidental lacerations.  The current practice of passing sharp instrument between surgeon and scrub nurse is to place the sharp instrument in a "passive dumb" container such as a metal K-basin.  This way the surgeon or scrub nurse will pick up the sharp instrument from the intermediary container.

But hand gestures in the operating room is not dead yet.  In October last year, I wrote a piece on Apple's patent titled "Multi-functional hand-held device".  Apple is coming back with a vengeance and this time it has an even greater implication for the medical device industry.

My bioengineering design class for third year bioengineering students is starting next Monday. I am going to select a series of blog entry I have made in the past which I consider to be of interest to do those in medical device design.

1. A new class of 3-D printers is going to change the design process for medical devices.
2. Websites you need to know.
3. Mother Lode of Health Care Information.
4. Learning from your competitors' mistakes.
5. Looking for medtech info?