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How a software engineer invented a breakthrough medical device (zdnet.com)
207 points by acangiano on Sept 4, 2009 | hide | past | web | favorite | 81 comments



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)


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.


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.


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.


> 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.


> 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.


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.


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


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?


> I have long felt that...

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


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.


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.


Now I can see your point. Thanks for the reply. However, this treatment is not only about localized toxin. It has a two-fold approach of both blocking the blood path the tumor is feeding of and using a localized chemo treatment. Wouldn't this approach be more effective than the actual ways? I have another question. Since you claim that localized toxin causes the recurrence to be much more difficult to treat because the 1% that survives is resistant to chemo, wouldn't an unlocalized toxin be much worse because not only it would also not kill these 1% that was resistance, but also it would kill less of those 99% susceptible and would also kill some healthy cells, making the body weaker and the recurrence to occur sooner?


sure =). I'm an engineer and not an oncologist so don't quote me on this. The main msg is that treating cancer is really, really hard; as another commenter noted biology is incredibly complicated.

multi-pronged approaches do seem to work best; some variation of that already happens. Large tumors are surgically removed, anti-angiogenesis drugs work by blocking new blood vessels from growing, I mentioned some others. The problem is that even the most aggressive combinations of treatments haven't proved to actually work in practice, and death rates for most cancers have barely budged in the last 30 yrs. A reflection of this is that people will pay $50k+ for a drug that will increase life expectancy by a few weeks (or their insurance will, that's another topic).

People like me do train their entire lives to improve this, and we are working on many new possibilities, for example tracking circulating tumor cells and figuring out what DNA mutations they have to see if you can make a drug that is targeted towards deactivating whatever fraction of them actually lead to metastatic disease. Look up the National Cancer Institute's nanotechnology in cancer program to see more of this kind of stuff.

I don't know what the "unlocalized" side effects are and why things are done that way - I will say any kind of advance in treaments is incredibly difficult to achieve because you have to convince MDs and patients to go with something new when there is a tried and tested method, and it is their lives in the balance.


The problem is that even the most aggressive combinations of treatments haven't proved to actually work in practice, and death rates for most cancers have barely budged in the last 30 yrs.

[citation needed]


I can't help you with a citation for that, but I can give you citations for the opposite claim "A major decline in cancer mortality has been occurring in the United States for the past 50 years, affecting birth cohorts born as long as 80 years ago. [...] These findings suggest that improvements in cancer detection, treatment, and/or prevention have reduced the risk of cancer death across the life span for individuals born in the last three quarters of the 20th century.":

News coverage: http://in.news.yahoo.com/139/20090814/981/tsc-cancer-mortali...

Original article: http://intl-cancerres.aacrjournals.org/cgi/content/abstract/...


Which is what I was fishing for, thanks. :)

The problem with moderation on HN (and other sites) is that all you have to do to be upmodded is to assert something firmly enough. It doesn't have to be even remotely true; people will mod it up regardless. Annoying as hell, and potentially destructive to public discourse when it's as blatantly wrong as the grandparent's post was.


I think comments are good for adding perspective. You shouldn't expect an expert to arrive and give a concise, absolutely true and exhaustive explanation with that perspective. Spurring a community to dig deeper on something previously assumed true is a good thing, right?

The article cited does not claim we've improved cancer treatments - only that mortality from cancer for certain age groups has decreased according to their analysis, which could be from a number of reasons. To my knowledge, one of those reasons is not that a variety of prevalent cancers has been cured to any substantial degree. Also, just because you can find a published article that claims something doesn't mean it's true (although it is a much better chance in the scientific literature versus popular press due to peer review). Especially in an active area like cancer with 10k+ papers, you can basically find a paper that will support any viewpoint.

The NYT is running a great series on cancer treatment that gets into these matters, I should have cited before, here's one of them:

http://www.nytimes.com/2009/09/02/health/research/02cancerdr...


>>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.

Isn't the point of a device like this that it can increase the concentration of chemo in tumors while keeping the concentration as low as possible in non-cancerous tissue?

Which should help that point (that is, manage to kill off enough cancer cells that the immune system or some other treatment can wipe out any surviving).

(As someone else noted, the article referenced some paper supporting doing this method.)

Let us all hope this works really well.


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.


> 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?


Storage and use of electricity, the lightbulb, the personal computer, the telephone, and the cathode ray tube.


Plus radio, navigation, flight, supersonic flight, space flight, sattelites, computers that break the 1 GHz clock barrier (remember that one?). I daresay everything that was invented since the Greeks owned the world.


Not to draw it out much further, but I don't think a majority of domain experts in a field would (or have in the past) completely discounted the possibility of an invention or achievement. It's usually journalists, pseudo-intellectuals, or self-proclaimed experts who make these types of claims. Are you saying that leading physicists and engineers in the mid-20th century didn't think space flight and satellites were achievable?


You're going too little backwards in time. Spaceflight was proposed in the begining of the 20th century.

http://en.wikipedia.org/wiki/Robert_H._Goddard#A_Method_of_R...

And yes, it was very criticized at the time but as you said, mainly by the media, as it seems. I doubt, however, that they did it without any backing.

And I was wrong about satellites, it seems. I was pretty sure that the idea of using them as communications relay was also dissed, but I couldn't find any references about it.

I can, however, give you one solid example of something that was completely discredited by the scientists, which is flight. It was widely believe at the time that no object heavier than the air could fly.


I don't believe that 'people' ('scientists') thought birds could not fly, or were lighter than air.


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.


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.


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


Everyone needs beta testers.


Unfortunately, they arrived one month too late.


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


I have a friend who died of cancer on August 10. Late to him, I meant.


I think he's referring to his sister. Who died of cancer before he finished the catheter.


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.


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.


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


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.


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.


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


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.


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.


There are other treatments for cancer.


And very rarely they result in cure. Sometimes, they give you some years till recurrence kicks in. Mostly, they make your last years very miserable.


And this one does the same, as it's just a more localized version of chemo.


Is that verified? It seems to me that a localized version would be lees likely to cause nausea, hair loss, and the myriad other side effects of chemotherapy.


> 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.


"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?"

You missed the part about the worst case being death. What if using the device provides short term relief but makes 15 percent of patients die within half a year after its usage?


Nope.

I read the response that pointed out that the worst case here was slightly earlier death and realized that in many cases the worst case is exactly what I said it was, someone is out the cost of a Coke.

The fact that some medical "treatments" will kill you is not necessary useful when evaluating a different treatment.

It's important to evaluate things based on their actual costs and benefits, not the costs and benefits of other things.


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.


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.


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


It’s too late for my sister.

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


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.


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?


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.


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.


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

:(


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


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


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 #?


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


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


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.


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.


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.


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.


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


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


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


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


From the article, it sounds like he already had this prior to working on the invention.


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.


Indeed, if you look at the very earliest Nobel prizes they were less focused on basic research. For example, the 1909 Physics prize to Marconi/Braun "in recognition of their contributions to the development of wireless telegraphy" or the 1912 Physics prize to Gustaf Dalen "for his invention of automatic regulators for use in conjunction with gas accumulators for illuminating lighthouses and buoys".


I'd like to see how they apply this 'basic science' rule for the Peace Prize.


They don't, (nor do they for Literature, of course), and often the Peace Prize is used as a political platform for the Nobel Committee. E.g. Al Gore.


I was joking, but thanks for asking anyway.


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


True.


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

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


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




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