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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Meeting Announcement -The Adequacy of Assisted Reproductive Technology Oversight

I received this comunication from the American Society for Reproductive Medicine

MEETING ANNOUNCEMENT  —The Adequacy of Assisted Reproductive Technology Oversight

Monday, December 14, 2009

8:30 am – 3:00 pm
Mandarin Oriental Hotel
Washington, DC
Given the rather high profile incidents in infertility therapies that came to light in 2009, the leaders in reproductive medicine are asking questions about how best to prevent such incidents from occurring again.  While little factual information is available on the specific incidents, we can and should assess where general oversight of the field is, and seek ways to improve it, if necessary

Accordingly the American Society for Reproductive Medicine is convening a meeting in Washington, DC to gather input on this important topic. Information will be exchanged between government agencies, patients, physicians, leading academic experts, and others.

 

Featured speakers will include:

Maurizio Macaluso, MD, DrPHCenters for Disease Control and Prevention
James Goldfarb, MD, President, Society for Assisted Reproductive Technology
Jake Mayer, PhD,  the Jones Institute, Eastern Virginia Medical School
Stuart S. Howards, MD, American Board of Urology

Barbara Collura, RESOLVE, The National Infertility Association
Susannah Baruch, JD, Generations Ahead
Liza Mundy, author
Judith Daar, JD, Whittier Law School

For more information or to register send an email to ekramer@asrm-dc.org.

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

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 SurgeryThis 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:

  1. Institutional Commitment to MIGS
  2. Director of Division
  3. Medical Staff Physician Qualifications
    -Dedicated Educational Program
    -Formalized Credentialing Guidelines & Systems to Introduce New Procedures
    -Procedures for Minimizing Complications
  4. Sufficient Experience with Procedures
  5. A Full Complement of required Non-Surgeon Consultative Staff
  6. Ancillary Staff
    -Dedicated Team-Based Concept
    -Dedicated non-physician Educational Program
  7. Equipment Guidelines
    -Availability & maintenance
  8. Treatment pathways
    -Linked to Peer reviewed Practice Guidelines
  9. 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

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New Endometriosis Fertility Scoring System Predicts Fertility: Exclusive Podcast With Author

In a docinthemachine exclusive first I am excited to share with you a new endometriosis scoring staging system that is the first ever to predict a patients chance of getting pregnant without IVF.

The EFI or endometriosis fertility index was just presented by Dr David Adamson, a fertility specialist at the 38th annual Global Congress on Gynecologic Minimally Invasive Surgery– the annual meeting of the AAGL in Florida.  As a fertility specialist and surgeon myself it was starred on my agenda not to miss as a highlight of the entire congress.  Here’s all the details of his presentation and the scoring system.

Here’s my podcast interview with the lead author Dr Adamson just after he gave his talk at the 38th AAGL Global congress in Orlando

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Breaking News: New Recommendations for Women’s Health To Be Released 11/16/2009

I Just received notifiction from the American College of Ob Gyn that new recommendations for women’s health care will be released on Monday, November 16, at 5 pm EST. The recommendations are under embargo until then.  At that time the college will issue a “response” so sounds like we don’t agree with them!  I’ll post the recommendation as soon as it comes out (or sooner if its leaked) — until then here is the office ACOG email

Office of the President
Gerald F. Joseph, Jr., MD, FACOG

Dear Colleague:

The College is providing you with advance notice that new recommendations for women’s health care will be released on Monday, November 16, at 5 pm EST. The recommendations are under embargo until then, but we will share them with you as soon as the embargo expires. Please visit www.acog.org after 5 pm EST Monday, November 16, for the new recommendations and the College’s response.

Sincerely,
Gerald F. Joseph, Jr, MD
President
American College of Obstetricians and Gynecologists

UPDATE here’s the news about new reduced screeing recs for breast cancer

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Docinthemachine is Back!

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Hello again all my friends, supporters, and loyal readers! After far too long of an absence I am back. So much time has passed and so much has happened that I wanted to fill you all in and welcome you back to my regular schedule of postings on all new in medical technology.

So you may ask- what the heck happened to you? We thought you were dead? Here is my free form list of all that has happened to tie me up and take me (temporarily) off-line. Here is a list of just some of things that took my attention in the last few months.

1) First and foremost my wife gave birth to our son the babyinthemachine. Despite being old pros at this a newborn really takes a hit to your free time! Happily she did awesome in pregnancy and labor and all went perfectly. It is always a bit of an event when an Ob Gyn’s wife gives birth we have really seen it all before, but that gets mixed up with the knowledge of every little thing that could go wrong at every step and trying to stay at the correct end of the bed (the head) ! The little guy came home and has been a delight. This led to the quick realization that these kids no way fit in our car we had to buy some new transportation. Thanks to Edmunds – remember never pay over invoice I won’t say what we got but I am sure you can guess…

Here’s the little guy in utero

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2) All of my research of the use of High Definition video for Surgery got picked up by the medical and lay press and I was doing a fair bit of lecturing and speaking. This was a real pleasure for me having worked on the development of these tools since 1999.

3) National Geographic featured footage from my high def surgery on their special Inside the living body. This led to a series of interviews and lectures including the peculiar thing that is morning drive FM radio shock jocks. No need to go any further. I’ll post some excerpts coming soon.

4) 20/20 did a piece on my research on visualization in surgery including high def and future vision autofluorescent laparoscopy. What a delight that was to do. Bob Brown and crew were great to work with and they then invited me back onto ABC News for a show about innovators. I’ll be posting video clips from this too.

5) DITM – this blog- hit its one year anniversary and I celebrated all that the experience has brought to me and allowed me to share.

6) My wifeinthemachine Michele Lang sold and published a major future tech-sci fi-romance Netherwood which included dozens of examples of current and future med tech from the pages of this blog in the Shomi Line from Dorchester Publishing. All this is woven into a story of a technological future world where computers become sentient and the local sheriff must destroy the man set out to destroy the network but learns he is her virtual reality lover who holds the secret to the survival of mankind. The book can be ordered at Amazon now and has gotten amazing reviews. She be posting some updates and interviews here to come!

7) I was honored to be chosen to be a High Definition Visionary Site by Sony Medical. As one of the few MD’d chosen for this distinction I have access to their wealth of electronic knowledge and product engineering. For full disclosure I do not receive any financial payments for this relationship. They are helping me with a demo research project for HD surgery education on the internet and on improving visualization and archiving of surgery. I’ll be posting more from this to come.

8) I was involved in the keynote general session at the 38th Annual International Congress of Gynecologic Endoscopy (The AAGL). A true honor, this was the third time I led a session on new technology in medicine and the second year in a row. This year I focused the session on NOTES – or natural orifice surgery. This amazing new technology still in development is where physicians pass special flexible never before seen endoscopes through natural body openings (mouth, anus, vagina, etc) to reach any part of the body without any incisions at all. Needless the say the audience was in awe of the video of an appendectomy removed without external incisions and pulled out the patient’s mouth! More from this session will be posted with updates and excerpts on this technology.

9) As part of this session I presented new research of mine on the transformation of medical technological research and mathematical modeling that shows we are on the cusp of unparalleled explosive growth in med tech innovation. Of course more to come on this!

10) I was elected vice-president of the ACGE (Council for Gynecologic Endoscopy) – established to elevate standards in operative endoscopic procedures performed by gynecologists. We will be continuing our efforts on surgeon and facility standards and review including the validation of simulator based evaluations. More to come!

11) I was chosen by the AAGL as well on a special ongoing press conference panel on the future of gynecologic endoscopy. I have to say it was a real honor and validation of years of work when The President of the society Dr Charles Miller introduced me as the visionary of the society. Videos and transcripts will be posted.

12) Related to this I began an advisory role for a company developing a gyn NOTES procedure which will likely begin clinical trials for infertility very soon.

13) We had the Annual meeting of the American Society for Reproductive Medicine (ASRM) – the largest infertility meeting where I serve on the program committee and chair the video program. I’ll be posting updates of new research including a dinner I had with the world’s expert on human pheromones.

14) The Society of Reproductive Surgeons (SRS) of the ASRM invited me to chair their postgraduate course on fertility surgery at next year’s meeting. Of course the topic I chose is “New Technology in Fertility and Reproductive Surgery”. I’ll run the course as a lecture and hands on lab and we will include robotic surgery, alternatives to hysterectomy, surgical simulators, Natural Orifice Surgery, Autofluorescence, Office Surgery, High Definition, High Intensity Ultrasound surgey and many others. I’ll post updates as we go along.

15) I continued my usual lecturing, research, publications, and the development of a new innovative DITM podcast series.

16) Had some minor surgery- I am really an expert on edoscopes and the entire GI track as well now.

17) My clinical practice Gold Coast IVF had our busiest and most fertile year ever! Countless pregnancies in my usual mix of complex cases left me grateful and delighted to be a part of this specialty. Using all the tools in my armamentarium (drugs, surgery, IVF, egg and sperm donation, etc) allowed me to help create more families than ever. I treated local patients and those who traveled from around the country and from Nations as distant as Russia, China, and Nigeria.

OK – it has been a busy few months here but I am ready for 2008 to do even more! Welcome back to docinthemachine!

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Future Vision in Surgery: Let the Podcasts Begin!

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Here it is folks, docinthemachine’s first podcast to play on the site.  This piece is near and dear to my heart.  The Topic is “Future Vision” – and it’s about the coming radical transformation of surgery.  I review how endoscopy allowed us to move from invasive to minimaly invasive surgery.  What’s next?  The transformation to microinvasive surgery (miniaturized robotic rovers inside the body) and non-invasive surgery (3D reconstructed diagnostic imaging and therapeutics via powerful computers). 

 

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This podcast was an interiew I did at the 35th annual AAGL conference in Las Vegas.  Coming soon I will post my keynote lecture on this topic with powerpoint and videos along with the entire plenary session on this topic featuring Dr. Chutkin (GI swallowable pill cams), Barish (radiology virtual imaging), and Andy Van Dam (yes the founder of sigggraph on virtual reality data manipulation). 

you can read more of my ideas about the future of surgery including alternative visualization (seeing what the eye cannot) here

I hope you enjoy these as much as I did making them!

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Exclusive New Video of Prize Winning X-Ray Surgery Vision System

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Another exclusive docinthemachine first. Here is a link to view the prize winning video of my research on the development of an autofluorescent endoscopy system. The details of the research can be found here.

This research was honored with awards at the recent annual meetings of the AAGL (American Association of Gynecologic Laparoscopists), ASRM (Americal Society for Reproductive Medicine) , and SLS (Society of Laparoendoscopic Surgeons).

This is yet another example of what I call “Future Vision – The Coming Radical Transformation of Surgery”

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Details of the Project:

The new “keyhole” surgery technique enables surgeons to see tumors and other pathologies, including endometriosis not otherwise visible. In traditional laparoscopy, the telescope provides the same view as would be seen with the naked eye. In the new method, highly specific filters are incorporated into the light system and telescope so that surgeons can see the tiny amounts of fluorescent light that all living human tissues give off when illuminated, a phenomenon called “autofluorescence”.

The system illuminates tissues with short wavelength blue light (380-450 nm). The tissues absorb this light and then release it as longer wavelength green light (>470 nm).

Normal and diseased tissues give off different amounts of light. Areas of disease that block fluorescence are seen as dark indigo areas, whereas those that emit fluorescence glow like a firefly. With this new surgical technique I can see disease that is otherwise invisible and treat the patient more effectively.

My study reported on the use of the autofluorescence system for the diagnosis of endometriosis, a potentially debilitating disease that affects 5.5 million women in the United States, causing infertility and chronic pelvic pain. We found additional disease using the system in 63% of the women with endometriosis examined

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Lifeboat Foundation Begins Blog

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I was excited to see the announcement that the Lifeboat Foundation has started a blog which can be found here.  There frst posts incude some excellent commentary on nanotechnology.

For those unfamiliar with them, their mission statements sums it up:

The Lifeboat Foundation is a nonprofit nongovernmental organization dedicated to encouraging scientific advancements while helping humanity survive existential risks and possible misuse of increasingly powerful technologies, including genetic engineering, nanotechnology, and robotics/AI, as we move towards a technological singularity.
 
Lifeboat Foundation is pursuing a variety of options, including helping to accelerate the development of technologies to defend humanity, including new methods to combat viruses (such as RNA interference and new vaccine methods), effective nanotechnological defensive strategies, and even self-sustaining space colonies in case the other defensive strategies fail.
 
We believe that, in some situations, it might be feasible to relinquish technological capacity in the public interest (for example, we are against the U.S. government posting the recipe for the 1918 flu virus on the internet). We have some of the best minds on the planet working on programs to enable our survival.

They have an impressive Scientific Advisory Board including a large helping of professors and Nobel Laureats (and me).  You can read more about them here.

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Awesome Army Videos-Terminator 2025 Battlefield Surgery Built NOW!

If you thought my post on military technology in the operating room was cool you will not believe the next generation videos here.  James Bond may have Q but the US military has DARPA.  On of their future battlefield medical projects is TraumaPod.  These videos from my friend Richard Satava, MD (Professor of Surgery and Program Manager of Advanced Biomedical Technology at the DARPA show the creation of terminator-style future battlefield surgery made real today.  Part 1 shows the concept video of how the system will work.  Part 2 shows engineering protoype video used to build the system.  Part 3 shows the real-live thing working today. 

What is Trauma Pod?  As Rick wrote of its Heinlein Science Fiction Origins:

Like many revolutionary ideas, science fiction imagines what might be possible and it takes decades for hard science to catch up. Such is the case for Trauma Pod, a new capability and a new challenging research project for pre-hospital or far forward battlefield casualty care. Concepts of Trauma Pod can be traced back to the 1957 science fiction book “Starship Troopers” by Robert Heinlein, in which a self contained casualty “cocoon” was sent automatically from the spaceship directly to the wounded soldier on the battlefield. The casualty was placed inside this cocoon or pod, which was imagined to be a combination intensive care unit (ICU) and operating room (OR), capable of completely rescuing and, if necessary, operating upon a wounded soldier while being returned safely to the spaceship. As fantastic as that might have seemed, we are well over half way there, with systems that are currently deployed in Iraq and Afghanistan (and in clinical trials in select U.S. civilian trauma centers) and future systems to ultimately realize the full potential as so clearly articulated by Heinlein

Part 1 shows the concept video of how the system will work

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Part 2 shows engineering protoype video used to build the system

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Part 3 shows the real-live thing working today

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If you want to read all the details of the Land Warrior System and its potential medical uses read here

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