How a software engineer invented a breakthrough medical device

http://blogs.zdnet.com/Foremski/?p=760

by acangiano • 17 years ago

207 81 17 years ago

blogs.zdnet.com

acangiano• 17 years ago

Assuming it's effective, this guy deserves the Nobel prize.

Novash11• 17 years ago

True.

akd3• 17 years ago

The Nobel prize is usually awarded for basic science, uncovering the mechanisms of something, rather than engineering applications based on that science.

Mongoose• 17 years ago

Engineers always have the option to settle for a boatload of money.

noss• 17 years ago

That changes over time. Nobel's intention was to give it to people that gave the greatest benefit to mankind during the year. A few prices in the later years have been directed toward less base-research like inventions.

Also... why do people keep refering to the "The Sveriges Riksbank Prize in Economic Sciences in Memory of Alfred Nobel" as a nobel prize in economics? It's not one of the subjects that Nobel himself thought worthy.

catzaa• 17 years ago

A Nobel Prize wasn't even given for the first heart transplant.

ShabbyDoo• 17 years ago

I presume that it works by allowing chemo doses to the tumor that would be fatal if administered globally (or whatever the word is for (in the patient's bloodstream)? I wonder if this would reduce the side effects of chemo in non-terminally ill patients.

alex_stoddard• 17 years ago

The term you are looking for is "systemic".

I think targeted delivery of chemo might be more effective in the non-terminally ill, and very likely would reduce side effects. Chemo is effectively poison, just somewhat more toxic to cancer cells than the rest of the body. (Often because it targets cells that are actively dividing - like in a tumor, or your hair follicles or you gut...)

In terminally ill cases, where cancer has metastasized to multiple locations in the body you might well still need systemic chemo, because you don't know where all the metastatic sites are.

pbhjpbhj• 17 years ago

OT, spelling: shouldn't it be "metastasic sites"?

dantheman• 17 years ago

The video on the bottom of the page: http://www.youtube.com/watch?v=CZlOtFloDQk&eurl=http://b...

Shows how it works and it seems like a great invention. It's truly an uplifting story.

meterplech• 17 years ago

truly amazing. seems seriously unfortunate that it takes the FDA 7 years to approve a device like this. I wonder how much testing they actually spend and how much time is wasted in bureaucratic BS. regardless, the story is amazing and the device seems incredible

windsurfer3• 17 years ago

Considering the worst case situation, if this is unsafe, to be death, and best case is a slightly better treatment, I think thorough testing and a long approval process is certainly in order.

yummyfajitas• 17 years ago

You would be right if it were an asthma or restless leg treatment. This is a cancer treatment. The worst case scenario is a slightly earlier death.

anamax4• 17 years ago

> I think thorough testing and a long approval process is certainly in order.

Huh?

Suppose that it costs $1 and a quick test shows that it seems to help "a bit". Why not let folks skip a Coke for on the chance that the benefit is real while "thorough testing" goes on?

Costs and benefits apply to testing as well as deployment.

jacoblyles• 17 years ago

It has long been the contention of many economists that the incentive structure of the FDA is biased towards killing people through inaction (too strict approval) rather than killing people through too loose of approval standards.

The FDA takes a lot more heat when someone dies from a drug they approve than when 100 people die from not having access to a drug that they drag their feet on.

duncanj• 17 years ago

If it's important to you, why not ask and find out?

akd3• 17 years ago

The FDA, on the whole, is quite reasonable and well-run. For treatments where there isn't an alternative and the disease is fatal, they do accelerate approvals and they allow more people to use the drug experimentally. For things like Rogaine they are very cautious and even then sometimes make fatal mistakes.

gojomo• 17 years ago

Impressive, but also -- in retrospect -- kind of obvious. Why, of course you want to target destructive chemotherapy directly to tumors, via precise physical delivery.

I wonder if outdated assumptions about the limits of manufacturing prevented doctors/researchers/incumbent-companies from more actively pursuing this idea. It may take an outsider on a mission to remind a field of what's possible.

hyperbovine• 17 years ago

Every brilliant idea is obvious in hindsight. That is precisely what makes it brilliant. Nobody saw what was sitting in front of their noses, and then somebody did.

xcombinator• 17 years ago

Agree, think in the Descartes coordinates, it was Descartes looking at the corner. How many corners had people looked at before seeing before?.

bena• 17 years ago

The idea of applying treatment directly to tumors is obvious, true. He didn't patent or invent that. He came up with a delivery method that is safe, reliable, and easy. That was the hard part.

johnohara• 17 years ago

Excellent video production. Understood it immediately. Easy to imagine the nano-machine version of this. Bravo.

I also liked the 'summary version' of the conversation. Short, sweet, to-the-point. Two wins.

marciovm1234• 17 years ago

This article is inspiring but it fails to mention that no studies have shown that the device actually works. The FDA approval process for medical devices is very different then from pharmaceuticals; to oversimplify, efficacy does not need to be demonstrated, only safety (i.e. the device is not toxic). Thus the fact that the device is FDA approved doesn't really mean much (although it sounds great).

As with renewable energy, cancer treatment draws massive attention because it is such a big problem, and potential miracle solutions constantly make headlines.

However, the general audience does not have the background to place these announcements in context, and neither does the typical journalist. It is actually rather easy to come up with an entirely new approach that seems to work under certain conditions (algae make biofuels! solar panels in space! mice cancer cured!) but has no practical value. Having said that, good luck to this guy and I hope the device works well.

(I work in medical devices for cancer diagnosis)

BigZaphod3• 17 years ago

From the article:

"I found a 1987 Italian funded set of clinical studies that showed successful treatment of tumors by the application of chemotherapy directly into the tumors."

It stands to reason that if it is true that directly treating the tumors themselves is effective, then this device will be effective since all it is is a delivery mechanism for the pre-existing drugs. While I guess it's possible that somehow the design of the device itself is defective, it does seem rather unlikely that they'd have come this far without at least testing the mechanics of the process on a pig or cadaver or something.

brfox• 17 years ago

Tumors that you can find don't kill people with cancer, its the millions of metastases all over the body (or a specific organ) which actually cause cancer to be deadly.

There are a fair number of drugs which "treat tumors" (i.e. shrink tumors or stop their growth), but very few drugs actually extend the life of a cancer patient due to the metastatic issue mentioned above.

Novash11• 17 years ago

You sound like the doctors on the article that says that "it wouldn't work anyway". I understand that you have a far greater background than I have and I respect that, but you must keep your mind open. Most of the great anchievements of mankind 'wouldn't work anyway' in the minds of the specialists of the age. And they were wrong. With all due respect, you, giving you background on the matter, can find any technical reason why it wouldn't work? Can any of your colleagues? I am not asking about a real test, just a theorical reason based on everything you know about the field.

marciovm1234• 17 years ago

Very valid points. I'm not saying this kind of work shouldn't be pursued, I just wanted to point out that it is premature to think of this device as a "breakthrough". As I said before, I hope it works, and new approaches are in general a good thing. I just think the way they are reported is more for entertainment purposes then spreading true knowledge.

Technically, the idea of killing a tumor w/ a localized toxin is in fact already widely used, not mechanically with tubes but with things like focused X-rays or molecular targeting (drugs that preferentially bind to cancer cells). While this helps, it rarely cures cancer because 1) by the time it is applied cancer cells have circulated throughout the body and seeded new tumors and 2) it's very difficult to kill 100% of cancer cells, and what winds up happening is you kill 99% of them that are most susceptible to being killed by chemo giving the 1% that is most resistant more room to grow. Hence the recurrence is much more difficult to treat.

nixme2• 17 years ago

> Most of the great anchievements of mankind 'wouldn't work anyway' in the minds of the specialists of the age. And they were wrong.

Really? Care to provide any examples?

joe_the_user2• 17 years ago

I have worked very, very briefly with medical devices...

The main thing to keep in mind is that biology is mind-bogglingly complex. More complex than our human, conscious minds can possible realize. This makes pills, devices and such much less reliable than one would imagine as an engineer inventing things, so the original poster has A point.

But... the very complexity of the biology field also means that the received ideas of experts about what is or isn't possible probably aren't right either. Probably, on the average, no one is right. So the experts could easily be wrong in telling you that a given approach will fail ... but it probably will fail anyway, just because most things fails.

However, it does seem like machines that rely on external tech might be easier than machines that rely on understanding biology - a machine which just finds and kills cancer cells seems more plausible than something tells the body itself to do something since the machine isn't depending the body to do anything.

by• 17 years ago

I have long felt that there is a massive and well funded lobby for curing things, but an impoverished prevention programme. There is no real financial incentive to prevent cancer etc, but lots of money and glory for curing people who have got cancer. This applies right across medicine.

Similarly there is a massive and well funded lobby for power production and very little for power efficiency, which effectively achieves the same result. Instead of spending the money on solar panels in space what about energy efficient fridges? And no, this doesn't shrink the 'economy' it allows us to achieve the same level of wealth with less resource consumption.

anamax4• 17 years ago

> I have long felt that there is a massive and well funded lobby for curing things, but an impoverished prevention programme. There is no real financial incentive to prevent cancer etc, but lots of money and glory for curing people who have got cancer.

I see lots of people spending money on things that they're told will protect them from cancer, so there's clearly a huge financial incentive.

> Similarly there is a massive and well funded lobby for power production and very little for power efficiency, which effectively achieves the same result.

Likewise.

And, I see people buying things to get them better mileage too.

In fact, it's hard to avoid seeing this stuff, at least in mainstream US.

In short, I'm pretty sure that the "there's no real financial incentive" stuff is "why don't the proles see what's obvious to people like me". The only question is whether it comes from cocooning or just not paying attention.

Novash11• 17 years ago

I believe that there is a serious incentive on prevention and efficiency. However, there is a much louder voice for curing and expansion. I can offer you two reasons why.

1) Lack of better knowledge in the past: For a long time people thought smoking was fashionable. Today we know it causes lung cancer, but it is now too late to tell all those people that have been smoking their entire life. This can be said about nearly everything in every other field. I would not say that we have better knowledge about many things now. Science is still not sure if eggs are good or bad for you, neither why many people develop lactose intollerance after their childhood. Because of that, prevention is pretty much a luck guess by now. We look at those who have survived and try to figure out why. Then we tell people to do that and see if it works, but there are so many factors that 'I' feel that prevention is in many cases just a gambling game.

2) Lack of knowledge of economy of scale. When the industrial revolution started, steam was on its heydays, and all that, the idea of recycling and efficiency didn't exist AT ALL. People really thought that Earth could take everything that was thrown at it and its resources would last forever. Only now, with a population of many billions that we are seeing that Earth is panting, trying to catch up with our wasteful ways. The idea of 'reduce, reuse, recycle' to save resources is very new and there is a lot of social and economical mommentum it needs to overcome before it becomes mainstream.

mhb• 17 years ago

Isn't part of the prevention program the billions of dollars which are spent on health research, vitamins, etc.? Sure some of them are bogus, but there is continuing effort on uncovering things which actually might work - calorie restriction, vitamin E, fish oil, resveratrol,...

Some of these aren't represented by a massive lobby, but isn't that a good thing?

joe_the_user2• 17 years ago

I suspect that research isn't the problem...

Consider, if cancer prevention cost as much per person as cancer curing, it would be impossible to implement. So the prevention that makes any sense is cheap prevention.

Moreover, we know of many cheap preventative activities, especially exercise and healthy diet.

Unfortunately, it is hard to get people to engage in healthy activities. Indeed, it is easier to get someone to spend $100 on a bogus cancer prevention pill than it is get them to spend nothing at all and exercise regularly.

So I'm sure research efforts will continue on creating a pill to give people who live unhealthily the effects of a healthy lifestyle... but I'm more than skeptical

tmoertel• 17 years ago

> There is no real financial incentive to prevent cancer etc, but lots of money and glory for curing people who have got cancer.

Prevention is much harder to sell than cures because the effect of prevention is hard for people to see. If you get cancer, are given a treatment, and you live, you assume that without the treatment you would have died (death being the "counter-factual" observation that corresponds to the factual observation of your not dying), and thus that the treatment effect was big and important. But if you take a preventative treatment and don't get cancer, you don't have an obvious counter-factual to which you can compare your present state of well-being. You don't have the opportunity to realize that without the preventative treatment you would have gotten cancer and died: that counter-factual history never had a chance to play out.

nollidge• 17 years ago

> I have long felt that...

Your "feelings" are irrelevant on matters of fact. Show your work.

spoonyg• 17 years ago

Not exactly correct. For an FDA market approval a medical device must be proven to be safe AND effective. This can be proven in several ways: through a trial or as I believe in this case, through similarity to another proven device. And this is not the only bar. If you have a new device you also have to get reimbursement from health insurance. This is not guaranteed just because you have FDA approval.

ynniv• 17 years ago

Mechanically, or clinically? It seems likely that this will work mechanically. I don't think that he is claiming to have cured cancer, just improved the technique for delivering chemotherapy drugs to a certain kind of tumors.

BigZaphod3• 17 years ago

"It’s too late for my sister. She died and suffered terribly."

allenp• 17 years ago

I agree - as much as we all want to make it big, the desperation of trying to save your loved one is heartbreaking.

edw519• 17 years ago

It’s too late for my sister.

But it's not too late to honor her memory. Press on.

BigZaphod3• 17 years ago

I found this gem in the comments on that page:

I appreciate the kind comments. If you or a friend / family member could benefit from the catheter, please do not hesitate to contact us on our website at www.vasculardesigns.com

No one will be turned away if they can not afford the catheter.

Robert Goldman

Novash11• 17 years ago

Unfortunately, they arrived one month too late.

mahmud• 17 years ago

One month too late for whom? is there another product in the market, or is it too late for your own needs?

raquo• 17 years ago

Everyone needs beta testers.

darien• 17 years ago

In the article he claims that he owns the intellectual property. Does that not mean that there should be a patent availble for public study? If so what's the #?

anamax4• 17 years ago

Trade secrets are intellectual property too. (As are copyrights, but I don't see how they'd apply here.)

daeken• 17 years ago

The patent number, as far as I can tell, is 20080208118. http://www.freepatentsonline.com/y2008/0208118.html

biohacker42• 17 years ago

And it has taken the FDA seven years and two months to approve the product for sale.

Even if (or especially if) the device does NOT work, the iterative cycle for any med. tech is far too long.

viggity• 17 years ago

The FDA approval process is downright criminal. 7 years? wtf?

kqr2• 17 years ago

Does anyone know what kind of software he actually worked on previously?

It just says that he sold intellectual property to Intellectual Ventures.

KevinMS• 17 years ago

I have two questions, maybe somebody with expertise could answer them.

1. What is the breakthrough here? Delivery of medicine through feeder vessel? The idea of how to implement it (needle, robots, tube, etc)? Or just the actual design of the rig to do it?

2. In what situations can you target a tumor up through a blood vessel and not have the option of cutting it out? Is this a brain situation?

iag• 17 years ago

Nothing but utmost respect for this guy. I hope he succeeds

Dove• 17 years ago

Seven years. Wow. That really makes me wonder how many folks die while treatments that might save them are still working their way through the FDA. And how many treatments don't exist at all -- just think, this thing could be on the third or fourth iteration by now!

I don't mind information, but that's just silly. People should be able to decide for themselves when to use experimental treatments, based on their own level of risk tolerence.

kuronukurosu• 17 years ago

It looks like an interesting tool that might help against the fight against cancer. My mayor concern comes from the intrusiveness of the catheter, and towards what kind of cancer patients this instrument is oriented to? I really hope Doctors would use this new instrument in the best way possible for the patient, which in my opinion would be to to use it on only patients whose cancer is on the right place and not on patients that have undergone intensive sessions of chemotherapy.

caa09hh• 17 years ago

Now that is an amazing invention. The concept is so simple, but to make a catheter like that must have been such a difficult engineering job. I wonder how they get that wire all the way through blood vessels without puncturing anything. - Now that would be a good invention - a guide wire that automatically finds it way through blood vessels.

How a software engineer invented a breakthrough medical device

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