Dr. Wardak, Innovation and the Taliban

If you think it's tough to develop a new orthopedic device under the FDA. Try developing one under the former rulers of Afghanistan, the Taliban.

That's what Lt. Colonel Mohammad Wardak, M.D., did back at the turn of the century in 1999. Dr. Wardak was and continues to be the Chief of Orthopedic Trauma at the National Military Hospital in Kabul, Afghanistan.

Innovation Under the Taliban

By 1999, the Soviets had long ago slunk back to Moscow to disintegrate and the Taliban, then in power in Kabul, was engaged in a civil war with the Northern Alliance.

Under those conditions, Dr. Wardak developed the Afghan External Fixation device for the knee and elbow.

The Afghan External Fixation Device/WardakNecessity being the mother of invention, Dr. Wardak told us that while there were many fixation devices in orthopedics for long bone,

There were no devices for the knee and elbow. We thought about this and decided to make a small fixation device made from other external fixation devices.

It was not easy. Dr. Wardak said there was nothing in the international literature or books for this type of device and his facility didn't have the tools and instruments necessary to develop a new device. "It was very difficult having nothing and trying to do research. Finding X-rays, taking pictures and keeping them was not allowed. There was a lack of instruments. Many things are necessary in orthopedics."

And then there was the Taliban. "The regime didn't care much for officers, " said Dr. Wardak. He had to take pictures secretly and hide them. The Taliban didn't allow photographs of people. There were no digital cameras. "I convinced my young patient, fixed with the device, to go with me to a hidden place where I could take the first pictures of a patient fixed by the device. Actually as they [the Taliban] were not physicians, the science or research was neither important nor interesting for them.”

Still, the consequences of getting caught with photos of humans was to have the camera smashed. Sometimes there were beatings.

Production

To make the device, Dr. Wardak cannibalized parts from a Russian orthopedic device and got other parts from a local bicycle shop.

Bicycle shop parts maker / Wardak"Yeah, I ordered parts from a bicycle shop. He made the parts for me for about $2-$3. The original metal was not very good so the device was only good for one patient and I had to put in more orders."

Dr. Wardak says his device's unique mechanism causes compression of the fracture site through the tensioning of all wires at the same time with simple turns of one nut.

Patient Results

"We tried it on a patient, it worked well and slowly over a few years we changed it and now it's a good device"

"Now I have more than 200 cases of the Afghan device with excellent results. Most orthopedic surgeons in our country are using this device and the old methods are all abandoned here in Afghanistan."

Afghan Device Patients / Wardak

"All of the fractures healed with full recovery in four to six weeks, the mean time of healing or fixation was 34 days with no subsequent surgery or retained hardware. One hundred seventeen patients regained excellent motion and the mean knee score of 98 points. Seven cases had poor motion with less than 0-90 degrees of motion with a mean knee score of 85 points. However, four had contracture antecedent to our treatment. Other complications included: two wire site infections, nine wire site reactions and three cases had temporary synovial fluid leakage. One case of patella osteomeylitis."

Beyond Afghanistan

After seeing the success of the device in his own country, Dr. Wardak began thinking about getting his device beyond Afghanistan.

"One of our Afghans came from Germany and he took my abstract to an international conference in Baden-Baden, Germany in 2004. I represented the device there.

Then I went to the U.S. for a military conference and did a presentation of the device. In 2006 I went to the Brooke Army Medical Center (BAMC) and was helped a lot to write the research paper by Roman Hayda M.D. We then applied for a U.S. patent.”

BAMC Orthopedic Department 2006 / Dr. Wardak in center"I was in training in BAMC San Antonio where I met Kevin Walker, a very kind and smart rep from Smith & Nephew. He arranged my meeting with Randy Wilkinson, the company’s National Director of Military/VA sales.” Wilkinson took the device to the company. Dr. Wardak said the company then decided to try and manufacture it. Smith & Nephew submitted the device to the FDA for clearance. Dr. Wardak hopes to hear soon if the FDA will allow the device to enter the market in the U.S.

We spoke to Smith & Nephew. The company told us that they would not make any comments about the device while any regulatory processes were underway.

Compression FixationThe possibility of having a new medical device named after Afghanistan has made Dr. Wardak very popular with Afghan politicians.

"It was unbelievable for me when Randy [Wilkinson] came last year [2008] to Afghanistan and brought a gold-plated Afghan device with him to Kabul and presented it to our Secretary of Defense and then he gave it to me."

"Mr. Kanony the leader of the Afghan Parliament gave a speech offering us (me and my teacher Dr. Siawsh) the appreciation letter from Parliament. He said, 'Dear Parliament members of Afghanistan. Every day we discuss our problems and try to find solutions. But today I have good news for you. One of our young physicians made a device by the name of Afghan Device, which will one day be available in the world medical market for treating patients.'"

Dr. Wardak says people in his nation are very hopeful in their future, but he has no desire to be involved in politics.

I like my doctor job. When I was in military school they accepted me for medical college. I like my job very much and enjoy working for those people who have nothing.

What he likes best about his experience in trying to get his device to patients outside of Afghanistan is that the word "Afghan" will be the name on the device. "It's the first orthopedic invention from our country."

Taliban to FDA

Gold Plated Afghan DeviceAnother plus of dealing with a western manufacturer is that there will be adequate financing for good marketing and, says Dr. Wardak, “perhaps even some money for the inventor.” What might the inventor do with the money? "Improve the quality of our hospital, " said Dr. Wardak.

While the FDA has not yet granted clearance for the Afghan device, the Afghan's and Dr. Wardak's hopes are riding on Smith & Nephew to wind their way through the FDA. Dr. Wardak got it through the Taliban. It would be a shame if Smith & Nephew couldn't get it past the FDA.

When we met Dr. Wardak for the first time at a SOMOS (Society of Military Orthopaedic Surgeons) meeting in Las Vegas in 2008, he had just arrived from Kabul. We wondered what his impressions were of leaving the behind the sands and culture of Kabul for the sands and culture of Las Vegas.

"Working hard is the key of success and there is no difference between these sands.” Then he added with a grin, "But I found great differences in other things."

To watch a three and a half minute video about Dr. Wardak and his device produced by the NATO Network, click here: http://www.liveleak.com/view?i=729_1237815472

Triumph of Inspiration

At a time when the disruption of industry/surgeon relationships and a dysfunctional FDA seem to be stifling innovation, Dr. Wardak’s story sends a powerful message of inspiration to any physicians looking for a better way to serve their patients.

Postscript

Dr. Wardak informed us, as we were going to press, that Smith & Nephew had just contacted him to let him know the FDA has cleared his device. We’ll provide details when Smith & Nephew makes an official announcement.