First Disposable Single Use HD Endocopic System-DITM Exclusive

Docinthemachine first exclusive report!

Olive Medicalhas developed a single use HD endoscopic camera system for surgical applications.  Traditional endoscopic camera systems consist of a camera head with a coupler to attach it to the scope and a camera control unit.  Camera head and control systems typically cost in the $30, 000 range.  olive’s approach is to make the camera had single use and delivered in a sterile peel pack ready for the operating room.  They intend to deliver such a system at under $300 per case — less than 1% of a current cost to purchase a system.  What’s more the system is native HD at up to 1080 resolution.   I had a chance to speak with them about the system and they claim they are using a native HD imaging sensor chip.  if so, they would be the first surgical camera system to do so.  All other HD systems available today do not natively sense in 1080 but rather employ post imaging processing to upscale and modify the image.  Their camera unit also includes integrated still image capture software eliminating the need for yet another $10,000-$30,000 box – although with obviously less features (no video, printer, etc).  Their fulls specs include :

• Full 1080p Video Output
• 2 DVI and 2 HDMI Outputs
• Touch Screen LCD Interface
• Integrated Storage of 40 Images

Following the disposable razor model, they would provide the camera control box to the facility for minimal (or no cost) and camera heads would be purchased per use.  Following the green bandwagon they intend to accept the cameras back after use for reprocessing.  Of course the obvious thought would be for a facility to just buy a few $300 cameras and use them over and over again.  They have addressed this issue with some novel patented software that recognizes if the unit is shut off and watches and limits use until its factory reset.  The team at Olive includes several ex-stryker hardware and software engineers so they know the traditional market well.

The idea of disposable systems is not new.  Over the years I have seen many disposable laparoscopes and hysteroscopes and even limited use imaging systems.   Many years ago I presented at the AAGL conference the first ever fully digital scope with a cmos image sensor and LED illumination.  At that time I predicted that such a set up by eliminated camera control and illumination box requirements would enable the entire thing to become wireless and disposable.  More recently more recently an Italian group wrote about such a disposable system viewed through a PC that achieved only VGA resolution.  Olive has upped the ante by designing something at a fraction of the cost at true HD definition!  They have some video on their website but its not labeled which one is recorded with which camera so I can’t link here yet.

This is a totally logical progression as Moore’s law gets applied to medical imaging in the OR. Chip fabrication follows Moore’s Law with dropping cost and doubling performance every 2 years.  The expensive parts of these systems are now basically computer chips and related hardware.  Therefore as technology accelerates we’ll see exponential advances in performance and miniaturization for lower costs.  Given Imaging and others have produced disposable self-contained pill-cams that have a low cost cmos chip and LED illumination in a swallowable capsule.  Chip CMOS sensors with integrated processing leverages consumer-based electronic technology advances (and economies of scale) as well as trickle-down military imaging technology.  HD (and beyond) sensors are going to get very cheap in the future for these markets- not to mention the demand for real time HD video imaging on cell-phone cameras as wireless bandwidth goes beyonf 3G.  The sensors really are basically the same. 

The unit is not yet FDA approved.  While I have seen videos I have not yet had he unit in a live lab evaluation so the final grading will ultimately rest of real world image quality, resolution, color fIdelity, and light sensitivity.  I know several of the major traditional manufacturers have seen the unit.  I can only imagine them buying to squash it.  Such a low cost device certainly does not fit in with the traditional low volume high cost + service contract scope camera model used today.

What’s the Sensor?–They obviously would not verify to me the sensor inside the unit– no company ever does.  I usually find out once the camera is released and a competitor cuts one open and sends me detailed photos and spec sheets.  I did do some hunting around and was able to verify there are now American company produced CMOS imaging chips natively 1080p60.  They make a standard 2/3 inch chip imaging max at 2112 x 1188.  The ones I saw are 2.1-2.5 megapixel.  The same fabricators also produce a 1/3 inch version.  Researching this i got quite excited about he prospects for using these chips for consumer electronics in ultra-low cost HD camcorder/still devices.  Flipvideo has some competition coming!  

Such a device if the quality and reliability is there could be very attractive to many facilities battling down time service and sterilization issues.  This could enable higher throughput in the OR with less capital outlay and lower manpower.  The other (even larger in my opinion) potential market is office-based facilities which now primarily bag or high level disinfect such systems.  This would be a very attractive alternative for them.  Until now capital equipment requirements have been a barrier to entry for many doctor’s (and vet) offices.   Ob Gyn , urology, orthopedics, ENT, general surgery, ICU’s and the ER  among others are specialties are those where there is currently a significant application for imaging in the non-OR setting.  This low cost idea is not alone- several companies have introduced low cost integrated camera-view- display units based on cmos- such as the tower-free hysteroscopy system with LED LCD screen and CMOS.  The difference with Olive’s approach is single use eliminates the sterilization costs and they are offereing it for less than 10% of the cost of even the ultra-low cost systems coming out.  Just look at the price of computer LCD panels and HD camcorders (10% where they were recently) and you can appreciate the technology price advances pushing this model. 

Don’t underestimate the difficulty of sterilization.  While many current ystems are labelled as autoclavable most facilities have found that significantly reduces the lifespan.  In january the FDA shut down the use of one of the most common OR scope-camera disinfection systems from Steris used in 23,000 sites.  This whole issue is a subject of an upcoming post but basically the FDA said Steris made too many changes since approval of the device– so it not the same device anymore and shut the thing down!  While the issue is being resolved it has been a nightmare for case preparation and opens up the reexamination of sterilization.  Up until now disposable of resposable systems have not been attractive because they were priced at >10% of system costs.  Now Olive is getting to the <1% price point – and that’s a different story. 

I look forward to some hands on testing…

Follow

The post First Disposable Single Use HD Endocopic System-DITM Exclusive appeared first on docinthemachine.