The Next Revolution in Medical Devices: Self-Design and Prototyping

have just returned from the Maker Faire and have seen the future of medical device innovation, invention, and design– Self-design and rapid home prototyping.  For those unfamiliar with the jargon basically technology now exists that can allow the creation of a working prototype of a device from idea to an actual working hand-held version in a physician-inventor’s own home.  This has the potential to democratize the process and eliminate previous massive cost and technological barriers that kept the process inaccessible except to large industry or those with substantial capital resources.

One person I spoke with was calling this the Next Industrial Revolution.  To me this is clearly the inevitable technological evolution of design and device innovation following in the exact path blazed by desktop publishing, digital video and computer based editing for movie creation to name just two examples.  –And once again it is fueled by the exponential progress in computer power –here married to a fanatical base of innovators driving the creation of the raw tools that will be the assembly line of the future.

What is Maker Faire? Maker Fair just had its first NY exhibit and is an offshoot of Make magazine.  MAKE brings the do-it-yourself mindset to all the technology in your life. Think of it as technology-hackers.  Its like wood-shop for the 21st century hacker who is building his own radio controlled spy drone or augmented reality device instead of oven mitts and hotplate coasters.  AS they write “this is a magazine that celebrates your right to tweak, hack, and bend any technology to your own will. For example, in our first volume, we show you how to get involved in Kite Aerial Photography, how to make a cheap but effective video camera stabilizer, and how to build a device that reads the hidden information stored on the magnetic stripes on all your credit cards.”

Homelab laser engraver/cutter.  can carve any substance with laser power and precision.  cuts out 3D models too.

But that’s just the beginning.  The sophistication of the home creation kits is mind-blowing.

This is a beagleboard.  It contains all the power of an entire computer.  It was running what looked like a normal desktop with a video capture and object recognition on a version of linux.  It costs less than $500 and can be the basis for home-made computer intelligent devices.  All open source as well.

At the Faire take thousands of people with this mindset, demos, kits, and lessons to “celebrate arts, crafts, engineering, science projects and the Do-It-Yourself (DIY) mindset.”  And as usual for my tech crossovers— add one doctor to the group.

What’s The Medical Significance? As usual I search out emerging technologies not yet used in medicine that have the potential to right now change how we do things.  What’s struck me with all I saw was the common theme that anything that was a high tech machine now today can be imagined, designed, researched, 3D modeled, and turned into working prototype all in a home workshop on an inventor’s budget.  What’s more this now applies to the physical aspects (ie plastic casing and movable parts) and to the electronics being them embedded operating systems or any myriad of sensors.  The theme of the day was that you yourself can see these projects through to this stage and there is a thriving community and ground-swell of momentum to build a grass roots infrastructure to help.

Examples of 3D Prototyping/Desktop Manufacturing:

The left image is a makerbot — you build this machine and then it produces 3d models out of plastic from 3D images on you computer.  You can anything from an action figure to a device handle to well– the middle images was made on a higher end system like that shown on the right.  here the machine first modeled the bones then applied a tissue layer over it.  The system right now can take any 3D dataset from an ultrasound MRI or CT scan and reconstruct 3D tissue or organ models.  I’ll follow up in a later post how scientists are using such technologies to literally build artificial organs in the lab– they build the structure then seed it with living cells that create the organ.  The maker bot replaces a $100,000 fabricator from a decade ago and costs under $1500– and its all open source.

Could You Cure a Disease With a Device Invention?  Does Your Child Think He or She Could?  You’d be Surprised?  The New Inventor’s Mindset for the 21st Century. You probably grew up thinking devices of all sorts and especially electronics were otherworldly gizmos of incomprehensible complexity of design.  The workings of a TV, video camera, or electronic medical diagnostic device where the stuff that only  biomedical engineer with a pocket protector and a degree from MIT could have created.  Your kids think otherwise.  They are comfortable with technology and with programming computers when presented with understandable languages.  They can make a webpage.  They can edit video and retouch photos.  They have a myspace page.  They may tinker with remote control toys.  Many of them with some practice can create 3D computer graphics.  Just recently A Russian amateur filmmaker called Alexander Semenov produced this 2.5 minute bootleg Transformers short with a couple of sub-$1,000 cameras, two hours’ of footage and a month in the home desktop editing suite that many think rivals the effects of a million dollar Hollywood blockbuster.

Understand that the next generation of design and creation tools will use these same sorts of visual programming language and are just as accessible. I walked through the exhibits with a 6 and 9 year old. By the end of the day the 6 year old had soldered an LED lit circuit board to make an electronic toy (parts cost $1), both had piloted radio controlled robots complete with sensors, and had begun to design autonomous robotic creatures– and they had never done this before.  I was recently asked to give a talk to a group of 4th graders working on the Lego First competition.  This is a robotics competition for kids to build working devices.  There are more than 10,000 teams competing this year.  This year’s theme is biomedical research.  They kids were instructed that they have the tools to invent a device that could solve a medical problem.  They don’t believe only MIT engineers solve problems.  They expect to.  Remember who invented youtube and facebook.


home kit for sensor based mobile search and rescue bot.  The same sophistication as a military robot and the same technology as in implantable body rovers being developed.

robotic arm prototype- could model prosthetics

home made kit for scanning tunneling microscope for research uses.  A scanning tunneling microscope (STM) is a powerful instrument for imaging surfaces at the atomic level. Its development in 1981 earned its inventors the Nobel Prize in Physics in 1986. For an STM, good resolution is considered to be 0.1 nm lateral resolution and 0.01 nm depth resolution. With this resolution, individual atoms within materials are routinely imaged and manipulated.  This is now a do-it-yourself kits for under $200 all open source design and technology

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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…

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Free DITM Podcast With Jeff Cohen-CEO Halt Medical on Medical Device Invention Process

I’m so excited to share with you my latest docinthemachine podcast with Jeff Cohen — serial entrepreneur and current CEO of Halt Medical (a gyn fibroid treatment statup), Voyage Air Guitar (the world’s best foldable guitar),  and Nashville publishers Savannah Music Group just recorded live at the 38th Global Congress of Minimally Invasive Gynecolog in Orlando Florida.

You might recognize Jeff who was recently featured on ABC’s Shark Tank where he turned down the shark’s offer of $500,000 for his guitar idea.  In the podcast we discussed the unique opportunities and challenges of medical device development- and innovation in general.

I was immediately struck by Jeff’s unique perspective and vision when I met him.  He has innovated in so many different areas and has successfully partnered with physician inventors for blockbuster devices.

Topics We Cover in the Podcast:

  • What’s unique about medical device development and how the potential returns differ from other industries
  • Advice for the physician/inventor where to go with your idea–pitfalls, how to protect your intellectual property and how to partner and start a company
  • Is your idea good enough to form a company?
  • The dangers of big companies and the opportunities of start-ups
  • All you need is a fantastic idea and where to go from there
  • What to look for in a business partner
  • What’s similar between innovation in any industry-medical,  music publishing, and internet?
  • What is the unique opportunity in today economic climate?

Hope you enjoy and get inspired…  All you need is a great idea– and as Jeff says- I believe everyone has one.

You can listen to the podcast below or download it in 3 versions — a single file or split into part 1 and 2.

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DITM Podcast on Future of Video for Entertainment & Medicine With Sony Exec

I have been getting great feedback on my DITM medical technology podcast which starts the podcast series I’ll be doing regularly.  Several people wrote to ask if I could post a version with just the interview since they loved it so much and wanted to share that segment.  The original podcast starts with FDA approvals then has an interview with Sony Exec Bob Ott on the future of video technology in entertainment and medicine that we did a the NAB broadcast meeting in Vegas.

Here’s an edit version with just the interview enjoy and share with your friends!

 

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OLED: The Future of Display Technology- NAB 2008 Update

oled sony front displayThis is my second post in a series of updates of exciting new media technology I saw at the 2008 National Association of Broadcasters (NAB) meeting just finishing up in Las Vegas. My intro to the meeting can be found here.

In this post I want to review the most exciting new display technology I saw on multiple fronts at the meeting- and share with you my predictions of how it will be used in medicine in the future. This technology is OLED

OLED represents the next step in the future of video display technology. I have previously written about what the technology is and how it works here. The technology was introduced commercially by Sony at the 2007 CES meeting also in Vegas (the home of all new media conventions). Currently flat panel technology is dominated by LCD’s and plasma displays – the limitations of which have been extensively reviewed elsewhere,

The Importance of Display Technology and its Market:

The display used to watch video is the final link that determines ultimate picture quality. The size of the current consumer flat panel TV market is estimated at $80-$100 Billion. I don’t have to say that number twice to convince you why consumer electronics giants will push the limit of display technologies creating the raw materials for medical displays in the process. This happened with CRT’s, LCD’s , and plasmas in the OR.

Let me be the first to predict- OLED will 100% dominate OR surgical displays as the technology matures. Not to mention the potential for their use in head mounted displays (HMD’s) and alternate display technologies.

I was enormously impressed by several features of the first OLED displays I laid my hands on. – my favorites are highlighted below

  1. Fantastic brightness and contrast ratio. This 11″ model i looked at had a contrast ration greater than 1,000,000:1 (not a typo).
  2. Excellent grayscale
  3. Full-motion video without ghosting
  4. Wide viewing angles from all directions
  5. A wide range of pixel sizes
  6. Low power consumption
  7. Low operating voltages
  8. Wide operating temperature range
  9. Long operating lifetime
  10. A thin and lightweight form factor
  11. Cost-effective manufacturability

oled side viewHere is an an example of the unbelievable wide viewing angle of OLED displays. When you look at standard LCD displays the brightness and ultimately entire image falls off as you start to look from the side angle. This has been a big problem for me with LCD displays in the OR for endoscopic surgery. When we operate as a team often the assistant or nurse need their own separate monitors since they are unable to get a bright clear image viewing my image from a tangential angle.

The OLED looked even better than this since there is a bit of a glare reflection from my camera’s flash.

thin oled display

Here is a view of just how thin these displays are. The screens themselves can be made 0.3 mm thick in current implementations.

sony pro oled

This was Sony’s implementation of OLED for the broadcast pros demo’d at NAB 2008. The HDVF-EL100 is an OLED viewfinder for pro video TV cameras. The same wide viewing angle, incredibly thin dimensions and low heat that will benefit it in the OR went into choosing it for this use as well.

As Engadget HD said- you can see these OLED displays from a mile away.

I had an opportunity to chat with the engineers about OLED and what is delaying its dominance of the market. They said that currently maufacturing becomes problematic as sizes increase leading also to cost escalations.  In addition they are produced in totally new types of production factories which are currently being built- such as the Samsung 8G LCD factory.  There is no doubt these issues will be overcome with current development.

Update:  for those interested in truely amazing future potential for OLED read here about a version that is on a flexible material that can simply be rolled up in testing now by the US Army.

Also – it appears mainstream OLEDs will hit the consumer markets in large number in 2009-2011.  Samsung predicts 2008/2009 while LG predicts a 32 inch version in 2011.  Details are here.

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The Future of Medical Video: DITM Reports From NAB 2008

I had the distinct pleasure of attending the 2008 National Association of Broadcasters (NAB) meeting last week in Las Vegas. As the foremost event for the TV, broadcast, and media industries this is the venue to see and explore the future of all things video and media.

The Floor of the Meeting and a Sea of Humanity- Why I Went

the floor of the nab 2008 meetingBeing probably the only physician in a sea of 105,000 TV and media folks raises the inevitable question- why did I go?

Endoscopic surgery (laparoscopy hysteroscopy arthroscopy etc) all share the common use of video equipment. Since the late 70′s these procedures are performed as remote surgery looking through a thin telescope inserted into a body cavity and observed on a TV monitor.

The progress we make in medical video surgery is a direct trickle down of innovations from the broadcast arena. From the first CCD camera hooked to a laparoscope and suspended from the ceiling via a jerry-rigged boom to the first use of HDTV in the OR – broadcast and TV technology drives innovation in surgical video.

I thrive on researching new technology and then extrapolating new solutions to medical problems using these developments. This meeting provides the raw material for my creative process.

I was honored to accept invitations from several major broadcast, video, computer, and even surgical companies to attend the meeting, walk the floor with them, brainstorm new ways of helping patients with new devices and predict future needs and uses for technology in medicine.

Everybody kept asking me: What was the most important development I saw at the show? What future technology do I predict is poised to transform medicine?

Beyond the entire rooms filled with the latest newschoppers and remote satellite trucks

I was most impressed with the following technologies which have the potential to transform both consumer entertainment and medical devices- I will be posting further about each of these and what I saw (including a series of interviews):

  1. Beyond HDTV- “ultra HD” 4k cameras and displays
  2. 3D video technology in SD and HD
  3. OLED display technology
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FDA Update: Ophthalmic Device Panel Meeting To Review LASIK Safety

eyeballLASIK Safety Review

On April 25, 2008, the committee will discuss general issues concerning the experience and quality of life of patients who have had LASIK.

How Serious is the Problem?  Are the Patients Going Blind?

Dr. Daniel Schultz, director of FDA’s Center for Devices and Radiological Health, said a number of concerns have been raised concerning patient satisfaction with LASIK.

Companies that could be affected by such a meeting include LASIK device makers such as Advanced Medical Optics Inc, as well as LASIK providers such as TLC Vision Corp and LCA-Vision Inc.

Obviously, it’s a technology that has caught on and is used very, very widely. And there have been questions raised in terms of … quality of life and what does it actually do for the patient as opposed to the technology itself,” Schultz told reporters.  Shultz said the meeting will focus on the quality of patients’ lives after surgery.

Known complications from the procedure can include dry eyes, glare, double vision, an increased risk of corneal inflammation or infection, and blindness.

Patients Call for Ban: In July 2007, the FDA responded to petitions from an individual asking for a halt to the procedures and a withdrawal of their approval. The agency said the devices were safe and effective but advisory panel discussions “could complement” its other safety monitoring.

The Boston Globes writes on the adverse effect of the current economic downturn on Lasik numbers and the potential adverse effect of this meeting on Lasik businesses.

But the declining U.S. economy continues to impact the number of laser vision correction surgeries, and Biegelsen cautioned investors that the outcome of the upcoming FDA Lasik advisory committee meeting on April 25 will likely be neutral at best.

“A best case scenario is little-to-no negative headlines in the media and the panel endorses the long safety of Lasik and encourages further use of femtosecond lasers,” he wrote in a note to clients. “On the downside, negative media coverage of unhappy Lasik patients and a panel recommendation to narrow the indications could drive volume down further. We think the most important variable is the media coverage which tends to be negative.”

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FDA Update: Ophthalmic Device Panel Meeting To Review Implantable Eye Telescope

The FDA Ophthalmic Devices Panel will meet Apr 24, 08 8:30 AM – 5:00 PM & Apr 25, 08 8:30 AM – 5:00 PM in the Gaithersburg Holiday Inn, Ballroom – 2 Montgomery Village Ave. Gaithersburg , MD

On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT™). The IMT™, a visual prosthetic device, is indicated for monocular implant in patients with stable, moderate to profound central vision impairment due to bilateral central scotomas associated with end-stage macular degeneration with geographic atrophy or disciform scar, foveal involvement and cataract.

Since these diseases lead to central dysfunction of the retina the implantable telescope spreads the visual image over a larger area of normal retina.

The prosthetic telescope, together with the cornea, acts as a telephoto system to enlarge images 3X or 2.2X, depending on the device model used. The telephoto effect allows images in the central visual field (‘straight ahead vision’) to not be focused directly on the damaged macula, but over other healthy areas of the central and peripheral retina. This generally helps reduce the ‘blind spot’ impairing vision in patients with AMD

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Pills That Monitor If You Took Them

Compliance with taking medications is a huge problem in medicine. Studies show more than half of all prescriptions are either not filled or not taken. Everyone is familiar with how easy it is to forget to take medications. This problem becomes overwhelming in complex diseases such as cancer or HIV where patients are on rigorous schedules throughout the day. Even worse is the situation where the
patient may have compromised cognitive abilities.

A new development is a chip containing networked pill that reports back on medication taking and the dissolution of the pill as reported by MIT technology review.

The company behind the technology, Proteus Biomedical, of Redwood City, CA, calls its technology the Raisin system.

In the Raisin system, each pill contains an “ingestible event marker” (IEM). The IEM consists of a sand-grain-size microchip with a thin-film battery that is activated on ingestion, as it is exposed to water. The battery, Proteus says, is nontoxic because it is made from materials similar to those in a vitamin pill. Once swallowed, the IEM sends through the body’s tissues a high-frequency electrical current that’s modulated in such a way that it provides a unique marker of the pill. It’s not an RFID technology: it uses the conductive tissues of the body to conduct the signal, rather than a radio, and the signal is confined within the body.

I previously wrote about about the development of swallowable RFID chips- a technology I like better.

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New Technique Sees Inside Blood Vessels in a Microsecond

Technology Review is reporting on a new technology to look inside the tiniest spaces such as blood vessels in a microsecond. Up until now endoscopic surgery has been limited as engineers tried to shrink telescopes to ever smaller diameters shifting from glass lenses to fiberoptic scopes to newer technologies. You can read my brief history and overview of microendoscopy here.

The new scope is based on optical coherence tomography but now uses new mathematical image analysis. Read the full article if you are interested in the heavy technical foundations of the system.

Suffice it to say, the system is a sort of “ultrahigh resolution optical ultrasound” and the new modification allows it to process the signal so fast that it could be used inside blood vessels without needing to interrupt blood flow and flush out the blood. The players in this development are two compnaies – LightLab and CardioSpectra of Austin, TX. The latter company was recently purchased by Volcano, one of the leading manufacturers of IVUS products for $25M.

Example of an OCT image of a fingertip (standard old OCT system)

Basic Explanation of How the Foundation Technology of OCT Works from wiki

“OCT is a technique for obtaining sub-surface images of materials at a resolution equivalent to a low-power microscope. It is effectively ‘optical ultrasound’, imaging reflections from within tissue to provide cross-sectional images. It is attracting a great deal of interest in the medical community, because of its potential to provide images at a far higher resolution (better than 10 µm) than is possible with other imaging modalities such as MRI or ultrasound.”

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