School of Engineering and Computer Science News

(December 11, 2008) -

Ted Wulfman, Mechanical Engineering Class of ’86, is a founder of Pathway Medical Technologies centered in Kirkland, Washington. Today, his company has grown to over 200 employees, occupies a 50,000 sq ft manufacturing plant and is rapidly placing his catheter system in top hospitals all over the country. More so, Ted Wulfman and Pathway Medical has raised over $100 million in private and venture funding in order to bring their medical technologies to market, and he credits University of the Pacific with his success.

Wulfman claims that the Bachelors Degree in Mechanical Engineering he received from Pacific has served him very well because it is a tremendously versatile degree and a majority of engineers working in the medical device industry have Mechanical Engineering degrees. In his case, he used his ME degree, which supplied him with AutoCAD, Solid Works, machine shop skills, resourcefulness, and creativity, to develop fixtures, machines, and prototype catheters for the interventional catheter industry. As a result, he currently has19 patents granted and many more pending.

Wulfman started in the Cardiovascular industry in 1988. Paul Muller, a close friend who also earned a Mechanical Engineering Degree from Pacific in 1986, was employed at Advanced Cardiovascular Systems (ACS) in Mountain View, CA. At the time, ACS was the premier angioplasty balloon catheter company in the world. Muller was assigned to work in the Advanced Development Group which made prototype machines and fixtures for the R and D group and developed new balloon catheters and accessories. Muller thought that Wulfman would also be a good fit for the job, so he helped get him get a job there. While at the company, Muller and Wulfman were incredibly busy and often had up to 30 projects at one time. Their projects ranged anywhere from simple tools to logic-controlled robotic machines. They worked on projects for every type of angioplasty product: balloons, catheters, guide wires, guiding catheters, inflators, etc. Wulfman developed a few pretty crazy machines, and he learned a lot about design using AutoCAD, programmable logic controllers, and machine shop skills.

In 1991, Wulfman saw a new, exciting product called the Rotablator at the American Heart Association meeting. He describes Rotablator being like a high speed dermal tool for the heart. It was a small burr coated with fine diamond grit, bonded on the end of a long and very flexible driveshaft and was driven by an air turbine, like a dental drill, and was guided over a fine guide wire. It could remove calcific plaque safely from coronary arteries by rotational ablation, which at the time, no other technology was capable of doing. He saw this new technology and thought it was the coolest new device. This item fuelled his desire to want to work for that company.

 In 1992, he finally landed a job with them. They were located in Bellevue, WA, and he considered it a nice change from the Bay Area. Heart Technology was a terrific company. It was founded by a laser physicist and professor from the University of Washington, David Auth. Wulfman was lucky enough, and brash enough, to push his way into leading the development of the next generation Rotablator, which incorporated a connection system that was able to separate the drive system from the catheter, which Wulfman, himself, invented.

 In 1995, Heart Technology was acquired by Boston Scientific. Tom Clement was the director of engineering at Heart Technology, and he and Wulfman often talked about starting a new company. After several years under Boston Scientific, it was clear that Boston was going to concentrate most of its R and D effort and dollars on stents and just sell the already marketed version of the Rotablator, so in1998 Clement and Wulfman left to start their own company, Pathway Medical Technologies.

At Pathway, they believed in a vertical company structure, so they completed a machine shop, lab space, assembly and clean room for manufacturing all under one roof. With excellent engineers, machinists, and technicians working closely together, he believes that it is more conducive to rapid development, testing, and manufacturing.

Although they looked at several interesting technologies in the first year of Pathway’s existence and collaborated with a company on MRI surface coils, Wulfman and Clement decided to focus on cardiovascular catheters. More specifically, they wanted to create a rotational ablation catheter with suction (aspiration) at the tip. This would allow the catheter to not only treat calcific plaque but also plaque with thrombus (blood clots) and diseased coronary bypass grafts. They felt that there was a distinct need for a catheter like this.

Wulfman and Clement were able to hire some sharp engineers, including Pacific interns and graduates, such as, Casey Torrance (ME class of ’97), who has grown in Pathway to be a key Engineering Manager. Their first catheter was designed specifically for treating diseased coronary bypass grafts. They started a clinical trial in 2002; however, it was very difficult to recruit patients, and took a year to complete just the feasibility study with 35 patients. At that rate, they could not raise enough money to complete the randomized study that would require up to 600 patients, so they decided to switch strategies and got funded to do a feasibility study in patients having heart attacks, using a version of their catheter to remove the culprit blood clot and underlying lesion. Most of the feasibility study was done in Krakow Poland, where the population has a high rate of heart attacks. It was an exciting study, and patients were diagnosed and treated.

Although Wulfman’s and Clement’s results were promising, once again it proved too expensive for a pivotal trial. With funding unavailable, they were forced to shut down Pathway temporarily; however, it soon restarted when funding was granted to specifically develop their technology for treating patients with diseased legs. It appears that this was a winning approach. With the epidemic of diabetic and obese populations, the market’s need was/is rapidly growing for treatment of patients who have severe walking pain, or even potentially needing amputation because of poor circulation. Wulfman and Clement developed the first generation catheter and completed a 172-patient trial in Germany. Then they subsequently received FDA clearance in the fall of 2008 to market the catheter.

Over the past 10 years they have worked with top research physicians and treated patients in Japan, Argentina, Paraguay, Venezuela, Germany, Poland, the Netherlands, Austria, Canada and all over the US. Wulfman has witnessed the coronary and peripheral vascular versions of his technology do wonderful things, from helping save the life of a person having a heart attack to enabling a patient to walk again without pain. They have seen hundreds of cases themselves and have trained most of the physicians using his device in the clinical trials. In 2006, Wulfman went back and forth to Germany over 20 times! It has been quite an international experience, and of course, he says that one of his greatest rewards is the people he meets and works with and creating new friendships around the world.

Wulfman states that the engineering program at University of the Pacific has been a great resource for Pathway. The co-op program has fed them nine great interns over the history of Pathway (including Stephen Morse, ME and Valedictorian, ’06 who also joined the company upon graduation). They like having the longer intern placements that Pacific mandates, as compared to the typically shorter placements of other universities. Pathway is a great company for any talented engineer that wants a rewarding experience.