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

Posted on September 27, 2010 by Steven F. Palter, MD

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

New Program for Centers of Excellence in Minimally Invasive Gynecologic Surgery Launched at International Congress of the AAGL

Posted on November 23, 2009 by Steven F. Palter, MD

BREAKING NEWS: First description- full free slideshow with audio of project and podcast

I am honored to share with you on docinthemachine.com my Presidential Report from the CGE of the launch of the Center of Excellence Program of the AAGL CGE. With 38 years leadership in Gyn Minimally Invasive Surgery the AAGL is uniquely qualified to share its educational mission by verifying those Centers that meet these standards.

The AAGL Global Society for Gynecologic Minimally Invasive Surgery Launches Center of Excellence in Minimally Invasive Gynecologic Surgery Program at Annual Meeting November 16-20, 2009 in Orlando, Florida —dedicated to establish and verify standards at surgical facilities and hospitals.

(click green play arrow to hear presentation audio and automatically advance slides)

The primary objective of the AAGL and its professional interest partner the Council of Gynecologic Endoscopy (CGE) is to promote the adoption of minimally invasive gynecologic surgery with its reduced morbidity, shorter post-operative recovery time, less invasiveness, and reduced costs.

Our Analysis of patient and provider needs worldwide showed that there are widely divergent qualities of practice and that patients and providers have difficulty in identifying excellence. There is a lack of national standards to improve outcomes. While payors seek to control costs/outcomes patients lack access to the educational resources to direct them to the appropriate center to meet their needs in many cases. As I stated in my address:

We recognize in the modern era of health care we have a unique opportunity as well as an obligation to use our educational resources and multidisciplinary expertise to help promote those systems and procedure which can improve patient outcomes in women’s health while reducing costs to both patient, payor, and society as a whole.

The CGE has therefore launched two new programs to address these needs.

First is an individual registry of physicians based upon peer review of operative experience and complications. The CGE, founded in 1996 has over 1100 individual gyn surgeons who have meet its standards. The new program integrates an evaluation based on today’s complexity of procedures in minimally invasive surgery. It is a tiered system with 3 levels of practice (based on procedure complexity) and 4 areas of proactive experience and specialization (General Gynecology Procedures, Fertility Enhancement Surgery Procedures, Repair of Pelvic Floor Defects & Urogynecology Procedures, Gynecologic Oncology Procedures)

Second is a Center of Excellence Program In Minimally Invasive Gyn Surgery. This is in recognition of the modern notion that to achieve best-in classs surgical outcomes requires not only an expert surgeon, but an integrated multidisciplinary surgical facility with systems and procedures in place to maximize quality cost effective safe outcomes for patients.

9 Requirements: Areas of Review To Qualify as a COEMIG:

Institutional Commitment to MIGS
Director of Division
Medical Staff Physician Qualifications
-Dedicated Educational Program
-Formalized Credentialing Guidelines & Systems to Introduce New Procedures
-Procedures for Minimizing Complications
Sufficient Experience with Procedures
A Full Complement of required Non-Surgeon Consultative Staff
Ancillary Staff
-Dedicated Team-Based Concept
-Dedicated non-physician Educational Program
Equipment Guidelines
-Availability & maintenance
Treatment pathways
-Linked to Peer reviewed Practice Guidelines
HIPAA Compliant prospective Outcomes Data Tracking

In my presentation launching this program at the AAGL annual meeting I shared

The AAGL is extremely excited and totally committed to the concept of Gynecologic Minimally Invasive Surgery Centers of Excellence. It represents a unified vision for women’s health that integrates our entire educational mission and expertise over the past 38 years.

First Ever Global Opportunity for Standards of Excellence:I was equally excited to present the concept to the Affiliated Societies of the AAGL which is made of representatives of National Minimally Invasive Gyn Societies from around the World. Our dedication to this concept and recognition of its value was shared by representatives of Partner Societies from South America, Europe, and Asia. We agreed to work together collaboratively to establish a shared Global Standard and to establish a shared program to advance Women’s health under the AAGL CGE COEMIGS program in cooperation with each Nation’s Society.

I will share further details of the program with you here as they are released!

Details of the society are are on the website of the AAGL

Information on the CGE

Information and Applications for the COEMIG Program

AAGL CGE COEMIGS Program Launch Information [ 10:57 ] Play Now | Play in Popup | Download

Can Vision Testing Improve Surgical & Athletic Performance?

Posted on April 7, 2008 by Steven F. Palter, MD

Gizmodo is reporting today about how White Sox catcher A.J. Pierzynski said he improved his performance though the daily use of a Nintendo video game. This reminded me of research I did while at Yale on similar visual testing on surgeons. We found back then that for both athletes, and surgeons (especially endoscopic surgeons) visual acuity correlated with performance and both could be improved with exercises.

First the report on the catcher and the video game. Gizmodo writes:

We were just about to stuff Nintendo’s Flash Focus vision game into the snake oil file when White Sox catcher A.J. Pierzynski revealed he actually improved his hitting through daily use of the software. Like many of the White Sox batters last year, Pierzynski stunk, and to come around he played Flash Focus in the off season. Now, one week into the 2008 schedule, the hapless catcher has two home runs, a .529 average and a team-leading seven RBIs.

What is Flash Focus?: Flash Focus is a video game for the Nintendo DS. Basically it is a series of hand eye coordination exercises designed to improve overall visual acuity through vision “exercises”. A review of the game and screen shots are here.

The Concept of Optomeric Testing for Athletes and Surgeons: The idea behind optomic testing is two fold. First, there are innate differences in visual performance between people second, elite athletes perform significantly better on objective tests of visual performance and hand-eye coordination, and third, specific testing and exercises can identify areas of optical performance weakness and improve them- and performance.

A review of optometric testing in general for athletes can be read here:

The basic tests they mention are:

Visual acuity – right and left eye separately without an occluder
Stereopsis at distance – contour and random dot
Ocular dominance – independent of handedness
Letter contrast
Contrast sensitivity – at spatial frequencies known to be related to sport performance
Contrast sensitivity with glare
Reaction time
Reaction time with varying targets

Our experiments with surgeons- Some years ago whenI was at Yale My Partner David Olive and I conducted a lerge study of novice and expert endoscopic surgeons using the validated athletic optometric testing tools. We testing a very large group of trainees as well as experts at an international AAGL conference. We found similar patterns as with the athletes. Namely significant differerences existed between visual ability and eye hand coordination skills and these were related to measures of performance and skill. We also found that with exercise performance could improve.

Top 6 Most Dangerous Medication Abbreviations Now Banned in Hospitals

Posted on March 6, 2008 by Steven F. Palter, MD

Medication errors in the hospital are a major cause of preventable suffering and death. I wanted to share with you the top 6 handwriting errors of doctors in the hospital that have been banned in to prevent these errors.

First some background: You may recall the landmark Institute of Medicine (IOM) study that found medication errors injure 1.5 million people and cost billions of dollars annually. Their report found “the extra medical costs of treating drug-related injuries occurring in hospitals alone conservatively amount to $3.5 billion a year, and this estimate does not take into account lost wages and productivity or additional health care costs.” The press release of the report and summary is here and the enormous full report can be searched and read here.

Every hospital I go to has implemented warning sheets (some in bright yellow with red stop signs on them) of the “Top 6 Forbidden Medication Orders” These are abbreviations so often misread or mistranscribed that they have been banned in the hospital! (not the drug or the order but the abbreviations have been banned!). You all know how awful doctor’s handwriting is!

U for units with heparin insulin and pitocin can be misread as zero or cc’s causing dangerous overdoses
IU for nternational units can be mistaken for IV (intravenous) or 10 (ten)
q.d. means once a day in latin but can be mistaken for qid or qod (four times a day or every other day) if the period is written above the line
.1 must be written as 0.1 else 10 fold dose errors can occur
1.0 should never be written – the decimal can be missed and a 10 fold dose error occur
morphine and magnesium can be mixed up with lethal consequences- the use of MS, MSo4, or MgSO4 have been banned

a fun view of how bad the handsriting is can be read here

Google Finished With Cataloging the Internet Moving on to Your DNA

Posted on March 4, 2008 by Steven F. Palter, MD

It was just reported today that: “A Harvard University scientist backed by Google Inc. and OrbiMed Advisors LLC plans to unlock the secrets of common diseases by decoding the DNA of 100,000 people in the world’s biggest gene sequencing project.”

What nothing better to spend $1Billion on? Why are they doing this you ask….

Harvard’s George Church plans to spend $1 billion to tie DNA information to each person’s health history, creating a database for finding new medicines. The U.S., U.K., China and Sweden this year began working together to decipher the genetic makeup of 1,000 people at a cost of $50 million.

Google, owner of the most popular Internet search engine, is looking for ways to give people greater control over their medical data. Along with the unspecified donation to Church, the Mountain View, California-based company said last week that it would work with the Cleveland Clinic to better organize health records, and last year gave $3.9 million to 23andme Inc., a seller of genomic data to individuals.

Church’s plan “would be the largest human genome sequencing project in the world,” Stephen Elledge, a geneticist at Harvard Medical School in Boston, said in a telephone interview today. “The genetic variations are what make people different, and we need to understand the connections to human disease. They’ll get a tremendous amount of information from this,” said Elledge, who isn’t involved in the project….“If we can expand the project, we’ll probably go for a million genomes,” Church said.

Personalized genetics and genomics are hot topics – Read more about the concepts here. With these two you either look to an individual’s genetics to see how it will impact a disease or a treatment (a single gene) or with genomics “This is the dream of everyone gets a genome sequenced at birth, we assess risk, create prevention plans, identify idosyncratic drug reactions prior to medication therapy”.

The medical and financial impact for the company owning this data in unimaginable. The source of individual variability of response to drugs and individual susceptability to disease could be greatly unlocked – as well as mined for new therapeutics. Google of course is getting into all medical databasing starting with your health record and I predict images of your diseases next.

Second Life for Medicine

Posted on February 14, 2008 by Steven F. Palter, MD

More and more social networking sites, web 2.0 sites, and other initially recreational new internet systems are migrating to work and educational related functionality. The potential for medical uses, online research, education, and patient networking is seemingly endless.

This wiki lists general grid and teen grid educational sites on second life as does this very comprehensive one.

On May 25, 2007, 1300 educators from around the world gathered at the Second Life Best Practices in Education: Teaching, Learning, and Research 2007 International Conference in the virtual world of Second Life. The event was the first 24 hour, international conference ever to take place entirely within a virtual world. Details are here.

My award winning friend-blogger Bertalan Mesko has the most comprehensive blog on web 2.0 medical resources has put together this great list of everything about seond life and medical education.

Check this out. I’ll be writing much more about vitual communities in the future and medical uses.