Tal navigates his “Narrow Straits”

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I was perusing the web after I put away all my special dishes and food required for my holiday. (OK, I was vegging out after stuffing and carrying 8 tubs, with an average weight of 25 kilos down 10 steps and through a narrow hallway, leaving them in storage until next year.) And, I ran across a new device that intrigues me- and I think you will be interested as well.

It seems that Tal Golesworthy had the unfortunate experience to have been born with Marfan Syndrome, a connective tissue disorder, that causes the long bones of the body to “overgrow”. These tall folks, with long arms and legs, develop problems with their lungs and their aorta. And, Tal had a dilated aorta (one that was about 4 cm v. 2.5 cm that is more normal.

The traditional preventative treatment for this condition is a 6 hour open heart surgery, with the body placed on a full heart-lung bypass, and body cooling to about 18 C (compared to the normal 37 C). The goal of the operation is to remove the ascending aotra and the aortic valve, replace it with a Bentall graft, and close the body. With the patient subjected to anti-coagulant drug therapy (here’s one article; you can check for warfarin or Coumadin in my index on the right) for the rest of his life, otherwise a blood clot will probably end it sooner. To say that Tal was not thrilled with this scenario would be an understatement.

Bentall Graft v. ExoVasc

And, like my questions in Narrow Straits, Tal, who is a boiler engineer, had to consider his options, make a plan, involve others, and proceed ‘as if’. Which he did. His assembled team included Drs. Warren Thornton (CAD engineer), Michael Lamperth (mechanical engineer), Bob Anderson (cardiac morphologist), John Pepper and Tom Treasure (cardiac surgeons), plus Raad Mohiaddin (medical radiologist).

What they proceeded to do was to take radiographs and model Tal’s aorta. Completely. From this information, they produced a CAD model. Then, using rapid prototyping (3D printing), they produced a prototype. Which they then employed to make a mesh stent. To insert AROUND the existing aorta. (Normally, a stent is placed within the blood vessel, keeping it open. Since Tal’s aorta was dilated, and in danger of exploding, this stent went around the external circumpherence of the vessel, to render it stable and keep it contained.)

All that is intriguing- and wonderful. But, what made his story really resonate with me was his description of team development and the trials and tribulations of the device development. Because they matched my experiences.

One of the biggest problems when one is developing medical devices is that physicians and engineers employ completely different vocabularies. Their specialized jargons may help them communicate among peers (members of the club), but only serve to confound those who lack the relevant membership card. (I’ll have more to say about this soon.) So, Tal made sure his team developed a common vocabulary-  that the engineers understood the medical jargon and the physicians comprehended the engineering terminology. (The principles of Adjuvancy– to make all the components in the mixture to operate at maximum advantage.)

Another issue that developed was that the first CAD prototypes did not feel or look right. It turns out that the issue was a pretty simple one. Engineers see things by looking down on them (using “first-angle projection”); physicians typically view things by looking up at them. So, given those differences , it’s not surprising that this prototype was the mirror image of what they needed.

And, like as happenned with many a product I’ve designed, prototyped, and tested, they also ran into institutional and attitudinal problems.

In the desire to obtain funding, one prepares proposals. And, most medical research is reviewed and monitored by physicians. That process is supposed to insure patient safety. But, it means that engineering terms, capabilities, and developments are outside the capabilities of the professionals who would review the product/project for funding. Tal’s group solved that problem eventually. (But, as was true for many of our developments, mostly because the required financial assistance was relatively low.)

During the course of the product development, the primary institution was involved in a merger. When we were testing our dialysis product, our client had just acquired a new division, one that was supposed to market (and, perhaps, manufacture) the device. But, like was true for Tal’s device, the division execs repeatedly averred “our product would never work”. In our case, it already was working- it was undergoing clinical trials, which were exceeding the parameters we set as requirements to proceed with approval and market introduction. Just like the replies Tal’s development group received from various entities. (By the way, the day before FDA approval of our product, the division was sold by our client to yet another company. Which is why I ended up starting my own company to market and manufacture the product.)

Like our products, this one needed the approval of an Institutional Review Board (the British version). For each center (we had multiple locations; they only used one) that was to test the device, such a review is required. These panels or committees are required to approve, monitor, and review any research at the institution that involves human trials. The evaluations of scientific, ethical, and regulatory issues must be completed and approved for the research to proceed. Which takes more time.

And, like was true for many of our novel products, there were no medical product definitions for the device. When you are the first to conceive of such a product, it is not surprising that the regulatory bodies have never considered what the device must or must not do. So that others can then make similar products- or products that solve the same issues. In the UK, the National Health Service provides that using the NICE (National institute for Health and Clinical Excellence) guidance model. (The NICE guidance for this product can be found here. )

The end result? Tal got his own stent. As did 19 others. With a shorter surgical effort. And, no need for anticoagulation therapy for the rest of their lives. And, the dangers of aortic blowout removed and a chance at a long, healthy, and fruitful life.  We hope so. So that Tal can continue to help others.

You can find more about Tal’s company, eXstent Limited, and the ExoVasc Aortic Root Support here.
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21 thoughts on “Tal navigates his “Narrow Straits””

  1. I love this story! It is a perfect example of the kind of outside of the box thinking I believe our medical industry could use on a regular basis! It reminds me of the how the anti-angiongenisis class of cancer drugs. He was a cancer surgeon to begin with, and notices after thousands of surgeries that tumor material was always more bloody than normal material. He came up with a theory that some how the cancer was “calling for” and telling the body it needed more blood. Which began the research and development of a new class of chemo that turned off the cancer’s ability to draw blood vessels into itself and start the starvation process. Both examples show that if we begin to look at things in a different way, a way ignored by the standard, we can do some amazing things! I very proud of Tal, as proud of him as I was my husband when he started his phase 1 trial. Thank you Roy! Great Post!

  2. In other words its in the eye of the beholder. The intelligence of people amaze me. I am thankful God put them on this earth with their gifts so they can help other people. My hubby is a CAD/CAM engineer and he would of thought this project was great fun I’m sure.
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  3. All I can say it that is seems unfair that often lots of people have to die before these things are worked through the system. But then there are the things that are rushed through the system that later become the project of some tort king. I’m glad that it worked on in this instance and any amount of longevity these people get is better than without the device. I hope that it stays that way.
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  4. Thanks for the insight Roy. Now I understand the way the differing sciences look at the issues and solutions differently.

  5. I’m just always amazed what’s possible these days in the realms of medicine as well as technology. I love living in this time and age where advances are made so fast. It’s so exciting! Hope Tal is doing well after his op. 🙂
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  6. Cooperation and teamwork instead of competition is the same model the late Laura Ziskin brought into the cancer community through the non-profit she co-founded, Stand Up To Cancer. She let the community know, the non-profit would fund research but that scientists receiving funding must shift to a cooperative model based on what she knew about successful teamwork in filmmaking. Filmmaking requires many different kinds of experts find ways to communicate and work together to bring the vision of the film to life. It does require developing common language, integrating multiple perspectives, creating a 360 approach and the outcome, in this case, can far surpass anything that only one person might accomplish alone…if at all.
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