06:44 AM

Against All Odds - How A Software Engineer Invented A Breakthrough Medical Device In Bid To Save His Sister

Plato said necessity is the mother of invention. Robert Goldman, a successful software engineer, didn't need to know anything about Plato, he knew that he needed to help his sister, diagnosed with terminal cancer.

In the process, he invented a breakthrough medical device that has the potential of saving the lives of tens of thousands of people. It's an inspirational story that movies are made from and Oscars awarded.

But that's far from Mr Goldman's mind. He's just happy that after more than 7 years, the FDA has given approval for a medical device that has the potential to shrink or kill tumors in people diagnosed with terminal cancer.

But let's start at the beginning. Let's start with Mr Goldman, who was happily retired.

Mr Goldman had made a fortune through his company GetMedia, which had developed a number of breakthrough technologies in the 1990s, that made possible things like the digital download. He sold his intellectual property to Nathan Myhrvold, the former Microsoft CTO, founder of Intellectual Ventures, an IP licensing company.

He now had plenty of money and no longer needed to work. But early retirement was marred by news that his sister had been diagnosed with cancer and the prognosis was terminal.

Here are some notes from our conversation:

- I wanted to help my sister as much as I could. I went to Medline, where there are hundreds of thousands of documents describing clinical studies, to see what I could find.

- There are billions of dollars spent every year on clinical studies. I was surprised to discover that there were sometimes clinical studies of treatments for which there were no clinical applications. The trials would show successful results but no clinical applications.

- 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. But I could find nothing since then.

- Tumors develop a feeder vessel that provides them with blood. I came up with an idea that if you could make a catheter small enough, you could thread it through a patient's blood vessels and directly into the tumor's feeder. You would then be able to direct chemotherapy straight into the tumor.

- I decided to design and make the device. I founded Vascular Designs in 2001.

- Medical device startup companies generally take a lot of money, around $25 million is a fairly typical first round capital requirement.

- I had absolutely no idea what I was doing, or what it would take. But I wanted to make sure I wasn't completely delusional. I thought I would start at Stanford and met with Dr. Michael Dake, professor of cardiothoracic surgery at Stanford University School of Medicine. He told that me if I could produce the device it might very well work.

- But there were many people who told me it couldn't be done, or that the materials wouldn't work, or that I would never get it through the FDA process. I would ask them if this is because they had done the research? They said no, they hadn't, but it wouldn't work anyway.

- I ignored their advice. I was determined to go ahead with it because I wanted to help my sister as much as possible, even though I had absolutely no idea what I was doing.

- I managed to outsource a lot of the work. I found a company in Santa Cruz, through the Internet, that could help me with the design.

- The first catheter we produced we were told it was too big. There was no easy way to scale it down. We had to start again.

- It took us two years to do the engineering. And it has taken the FDA seven years and two months to approve the product for sale. We were able to shorten the FDA process a little by saying that it was similar to other devices that had already been approved.

-Because the FDA is so strict it will be very easy to get approval in other countries.

- We are now just 2 months away from using it in cancer treatments.

- It cost just $1.8 million to develop. I did raise some funding only because some good people I knew wanted to be a part of this and this was how they could participate. They will make a lot of money from this, which is good because they can put it towards the development of other life saving products.

- I'm hoping that if people read about this device they will bring it to the attention of their doctors despite some medical practitioners not believing that it can be done. When you have terminal cancer and you have exhausted all other treatments why wouldn't you want to try this?

- There was no prior intellectual property around this device, we own the IP. The market for this runs into the billions of dollars.

- I'm not interested in the money, I already have enough money. I just want to help people. We want to make sure that this is available to people who can't afford the treatment. Why should this be only for the rich?

- It's too late for my sister. She died and suffered terribly. I can't wait to meet the first person and their family that will benefit from this. I've found my agenda in life and it's about helping people.

- - -

Mr Goldman showed me the catheter, a long very thin teal colored tube that is attached to three plungers. When Inserted into a blood vessel (a clear plastic tube for the demo) the plungers inflate two balloons that produce a tight fit. This blocks blood flow to the tumor. A separate plunger can then deliver chemotherapy directly into the tumor. The device can be used to treat any solid tumor, breast cancer, brain cancer, pancreatic, etc.

Here is a video of how it works:

Here is today's announcement of FDA approval:

Potential Breakthrough Cancer Treatment Now Available from Vascular Designs - The Company Announces FDA 510(k) Marketing Clearance for IsoFlow™ Infusion Catheter, Making Possible the Direct Delivery of Chemotherapy to Cancerous Tumors