Biotech and Medtech - Inventions & Patents

For years the relationship between doctors and the pharmaceutical industry has been under scrutiny.  The same magnifying glass is gradually being applied to surgeons and the medical device industry.  Within the last twelve months this type of scrutiny has intensified on the orthopedic community. This culminated in five leading US orthopedic companies being investigated.  The investigation resulted in the orthopedic companies agreeing to a Deferred Prosecution Agreement in September 2007 (see my Sep 2007 blog).  Although not admitting any liability, they agreed to pay a huge sum money and also agreed to be subject to oversight for 18 months by a US federally appointed monitor, pertaining to past consulting arrangements with healthcare professionals.  Zimmer alone paid the government $170 million.  One of the best attended symposiums at the recent annual meeting of the American Academy of Orthopedic Surgeons is the symposium on doctor-industry relation.  Certainly the situation is changing and advocate groups are getting more insistent and the industry is trying their best to comply with government's initiative (see Associated Press' report). 

For the medical device industry where ideas, innovation and identifying unmet medical needs, traditionally comes from surgeons and doctors.  There is a need to balance reform with judicious management of physician's conflict of interest.  We need to be mindful not to throw out the baby with the bathe water.

1. Determination of a genuine need for consultants.
2. Physicians to disclose their financial engagement to patients and hospitals.
3. Provide a list of names and amount paid of all consultants on their website in a prominent fashion.
   

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?

Jim Larrick, MD PhD runs a private research institute called Panorama Research in Mountain View, California (a stone throw from Google headquarter).  This private research institute competes on equal terms with academic institutions for research grants from NIH and other federal agencies including SBIR grants.  Jim has founded 14 biotech companies out of Panorama Research of which 4 have gone IPO (some through mergers).  This is not a bad record for a private research institute.  Many universities would have love such a track record.

Jim is first and foremost a maverick; not the type that will fit well in an academic institution.  He is not only an entrepreneur but also a consummate scientist with a solid track record of having published over 240 peer review journal articles.  He published one of the first books on oncogene with Ed Liu, currently the Executive Director of the Genome Institute of Singapore.

He was recently in Africa with the Sanofa Center for African Dance & Culture.  The purpose of this trip was to promote AIDS awareness through the medium of dance.  Jim's production company, Slick Production (no kidding), produced a moving documentary in HDTV format about this trip.  You can view a sample of the documentary from here and a new trailer from here.

Twenty years ago CAD programs appeared on the market and forever changed industrial design. Initially these softwares were bulky and their performance was not very good unless you run it on workstations and on a Unix platform. Over the last 10 years PC has become much more powerful and CAD programs like Solidworks has outstanding performance and intuitive interactive interface that allows for object manipulation, mating of parts and collision detection. This allows rapid construction of 3-D models using a combination of extruded objects. The 3-D models can be automatically converted into engineering drawings and if so desired the drawings can be sent to the machine shop for fabrication. Alternatively, the CAD program can export the 3-D model as an STL file which basically represents the surface of the 3-D model as series of triangulated surfaces. This data can be fed into rapid prototyping machines to automatically fabricate solid 3-D objects. Major impending change is on the way that will combine advances in computing power of PC, CAD software and a new class of 3-D printers.....

One of the intent of this Blog is to introduce sources of information which the reader may otherwise not be aware of. For those of us involved in product development for medical devices, we have in the past relied on peer review journals, trade magazines and trade shows for information. In September last year I introduced bmesource.org as one of the best in the industry. I would also like to draw your attention to several other sources which are specific to orthopedics.

This year Time Magazine's Best Inventions 2006 has selected an invention which I felt is very relevant to the holiday season.  TruTouch technology has come up with a really bright idea (pardon the pun) of using near infrared spectroscopy to detect alcohol level transcutaneously.  This non-invasive method reportedly will detect alcohol level in 60 seconds flat.