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

Posted on December 3, 2009 by Steven F. Palter, MD

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.

DITM Podcast Jeff Cohen CEO-complete interview [ 26:09 ] Play Now | Play in Popup | Download

DITM Podcast Jeff Cohen CEO-interview part 1.mp3 [ 12:32 ] Play Now | Play in Popup | Download

DITM Podcast Jeff Cohen CEO-interview part 2.mp3 [ 13:37 ] Play Now | Play in Popup | Download

Meeting Announcement -The Adequacy of Assisted Reproductive Technology Oversight

Posted on November 24, 2009 by Steven F. Palter, MD

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, DrPH, Centers 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.

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

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

Posted on November 20, 2009 by Steven F. Palter, MD

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

Dr David Adamson Endometriosis Fertility Index Podcast with Docinthemachine.com [ 17:12 ] Play Now | Play in Popup | Download

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

Posted on November 12, 2009 by Steven F. Palter, MD

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

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

Posted on November 12, 2009 by Steven F. Palter, MD

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!

Standard Podcast [ 15:35 ] Play Now | Play in Popup | Download

First Ever Surgical Video in 4k Ultra High Def- Hollywood and Doctor Team Up for Revolutionary Projects on Future Visualization in Medicine

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

our digital cinema control room- Sony controls

For the first time ever Hollywood’s digital vanguard has teamed up with a surgeon to use tomorrow’s cinematic tools to revolutionize visualization in the operating room. We successfully filmed produced and played a 4k digital cinema movie of a live human surgery. This was an amazing collaboration between a fertility surgeon, the AAGL endoscopy society, Sony Medical & Broadcast divisions, Red Digital Cinema Camera Company, FotoKem, Vincent Pace films, USC professor Richard Weinberg, and the NBA just to name a few! We also showed the largest medical 3d displays ever.

The AAGL reported on this groundbreaking session today . Further details are here and here.

Dual Sony SXRD 4k projectors in 3D scaffold

New cinematic technologies are transforming the film business today. The two major revolutionary developments are 1) ultrahigh definition “4k” technology – which brings resolution to 4 times that of HD and 2) realistic immersive high definition 3D. I set out to introduce these technologies to the medical world and to see if we could for the first time apply them to surgical practice- setting the goal to once again use technological innovation to improve our patient outcomes.

Virtually all of my surgery is endoscopic- performed through tiny telescopes and viewed on a TV monitor. In 2001 I performed the world’s firs HDTV surgery and demonstrated how increased resolution improved the surgeon’s visualization and performance of procedures. For those interested in the history of HDTV surgery and the details of its development further details of my work are here from the New York Times and here from Science Daily and here from MIT Technology Review. Over the past two years I refined this work with even better performing camera systems and this work was featured on 20/20 and on the National Geographic Channel’s first ever HD medical show – Inside the Living Body.

Hollywood is embracing its digital future by adopting (with $1 billion in financing and a follow-up deal by Sony) planned conversion of 20,000 theaters to ultrahigh definition 4k (4096x 2048) video. The revolutionary Red One camera is one of the few that can natively record this type of file. Having heard about it I went to vegas for NAB in April and saw with my own eyes the amazing realistic movies being made with it. While there I met with Ted Schilowitz, Red’s “Leader of the Rebellion” and was ecstatic with his desire to help with with a proof of concept- to film surgery with a 4k camera. I also partnered with Sony’s Medical and Broadcast Divisions who eagerly helped me set up a 4k and 3dHD digital cinema in an international medical conference hall in the Las Vegas Paris Hotel. The theme of my Keynote lecture was “Film and Medicine: From the Past to the Future- Through the 4th Wall.” In this, I traced how cinematic film technology has transformed the teaching and performance of surgery- and how the future will again have revolutionary changes in physician visualization. Our Hollywood partners allowed me to first show jaw-dropping pro-sports and theatrical demos of the technology.

Sony’s digital cinemas allow the next generation of film to be projected at these previously impossible resolutions. We used dual SXRD 4k projectors with linear polarizing filters for 3D HD then went to a single projector for the 4k. 4k footage has to be played off a dedicated media block digital server and we used an LMT-100 like a movie theater would and FotoKem converted the 4k files into a DCP digital cinema package that can be played. For 3d footage we played off an HD SR tape dual stream deck. I’ll post a follow-up explaination of each of these technologies in detail.

By increasing resolution to this level we allow the surgeon to be actually immersed in images that surpass the live surgical experience. The progress from regular surgical film technology is like comparing sitting in an HD home theater to watching a video on a cell phone.

Ultra high resolution digital cameras are transforming the art of cinema. Leading Hollywood directors such as Peter Jackson and Stephen Soderbergh today have just started filming the next generation of cinema blockbusters using cameras with “4K” resolution, four times the resolution of High Definition (HD) with 4096 lines of resolution to give audiences unprecedented realism. The Red One digital cinema camera is the at the forefront of the revolution. Director Soderberg previously described this technology as “This is the camera I’ve been waiting for my whole career: Red is going to change everything….Shooting with Red is like hearing The Beatles for the first time. Red sees the way I see.”

Amazingly, the surgeons in the conference were able to visualize the surgery they were watching better than if they had been in the operating room live. If it can transform the immersive experience of the movies with unprecedented realism wouldn’t you want that degree of vision in your surgeon’s hands? By combining unprecedented resolution and magnification the surgical images were beyond what a surgeon would have standing live in the operating room. Those in the audience predicted this technology would further revolutionize minimally invasive surgery as it becomes incorporated into the OR of the future.

We then projected the largest high definition (HD) 3d surgical images ever. Wearing glasses reminiscent of today’s 3d Hollywood blockbusters U23D and Journey to the Center of the Earth a standing-room only crowd of 1600 surgeons felt as if they could “reach out and join the operation”. These images were enabled by converting Sony’s ultrahigh definition and 3d theatrical systems to show medical footage in what the AAGL called the “Theater of Tomorrow.” A Vince Pace 3D demo reel showed where Hollywood is going as well with Gwen Stefani concert footage, underwater vistas, and movie clips.

Since laparoscopic surgery is performed by a surgeon watching on a video monitor making the images “better than live” may facilitate teaching and procedures in the future.

The 4K system, manufactured by RED Digital Cinema Camera Company, was used to film Jumper, Crossing the Line, and The Argentine. This recording represents its first use for medicine and biology in the world. In addition to a surgery we showed the first ever 4k microscopy images of single cell organisms ever recorded (from USC).

Stay tuned a for a series of posts coming up this week that will review the session, how we managed the collaborations, the difficulty in executing each of the technologies, and where I predict this is going in surgical visualization.

FDA Update: Ophthalmic Device Panel Meeting To Review LASIK Safety

Posted on April 11, 2008 by Steven F. Palter, MD

eyeball LASIK 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.”

Top Scientists Using Performance Enhancing Drugs

Posted on April 10, 2008 by Steven F. Palter, MD

This is your brain on performance enhancing drugs

Perhaps the top science journal in the world - Nature – reported today on epidemic-like levels of cognitive performance enhancing drug abuse by top academic scientists.

why they began the survey

The survey was triggered by a Commentary by behavioural neuroscientists Barbara Sahakian and Sharon Morein-Zamir of the University of Cambridge, UK, who had surveyed their colleagues on the use of drugs that purportedly enhance focus and attention (Nature 450, 1157–1159 ; 2007). In the article, the two scientists asked readers whether they would consider “boosting their brain power” with drugs. Spurred by the tremendous response, Nature ran its own informal survey. 1,400 people from 60 countries responded to the online poll.

They looked at illegally obtained (no prescription) use of three drugs: methylphenidate (Ritalin), a stimulant normally used to treat attention-deficit hyperactivity disorder but well-known on college campuses as a ‘study aid’; modafinil (Provigil), prescribed to treat sleep disorders but also used off-label to combat general fatigue or overcome jet lag; and beta blockers, drugs prescribed for cardiac arrhythmia that also have an anti-anxiety effect.”

One in five respondents said they had used drugs for non-medical reasons to stimulate their focus, concentration or memory. Use did not differ greatly across age-groups

Favorite drugs of the performance enhancing professor:

For those who choose to use, methylphenidate was the most popular: 62% of users reported taking it. 44% reported taking modafinil, and 15% said they had taken beta blockers such as propanolol, revealing an overlap between drugs. 80 respondents specified other drugs that they were taking. The most common of these was adderall, an amphetamine similar to methylphenidate. But there were also reports of centrophenoxine, piractem, dexedrine and various alternative medicines such as ginkgo and omega-3 fatty acids.

As I have srtten many times before. Prepare for the upcoming epidemic of performance enhancing drug abuse. I predict these drugs will be used at rates surpassing any other illegal drug in history. They have minimal side-effects and are becomming increasing viewed on college campuses as nothing more than a no-doze.

Read my previous posts on this topic here:

Would you use it? My history of working to the limit. I was in an accelerated 6-year combined college and medical school program. Balancing the advantage of being accepted to medical school while still in high school was taking full years of college courses ever summer to catch up on the skipped time. At one point I had medical school 8-5 followed by college classes from 6-10. All was manageable until med school finals hit the same week as college midterms. I remember giving up sleep and filling 2-liter soda bottles with iced coffee to get through the day. We moved onto iced coffee in Captain Crunch next. I stopped at this point (actually at two of these bottles a day= 3000 mg caffeine). I knew others who went the route of amphetamines no-doze and pizza. While an intern my worst shift ever in the hospital was 7AM Friday until 4PM monday= 81 hours. By sunday night I was unwell to say the least. Will drugs help this? I have a good friend who is a leading academic physician. He is a brilliant physician, professor and inventor. He could not believe I had not taken modenifil and raved about how well it worked for him.

Apparently other experts agree with me:

“Neuroscientist Anjan Chatterjee of the University of Pennsylvania in Philadelphia predicts a rise in the use of these drugs and other neuroenhancing products and procedures as they become available (A. Chatterjee Cam. Q. Healthc. Ethics 16, 129–137; 2007). Like the rise in cosmetic surgery, use of cognitive enhancers is likely to increase as bioethical and psychological concerns are overcome and as the products gain cultural acceptance. One difference, Chatterjee says, is that use of cognitive enhancers doesn’t rely on training of medical specialists such as surgeons. Internet availability will also greatly accelerate use, he says.”

New Technique Sees Inside Blood Vessels in a Microsecond

Posted on April 8, 2008 by Steven F. Palter, MD

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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