Medical Device Daily National Editor

PALM DESERT, California — When it comes to sharing lessons learned in vascular device development, Amr Salahieh’s your man.

Salahieh, one of the keynote speakers at this year’s Materials and Processes for Medical Devices (MPMD) conference, speaks from plenty of experience, that experience garnered through his involvement in three start-ups in this sector.

After opening with what amounted to career-development tips for the medical device designers and engineers in the audience at the Marriott Desert Springs Resort, the president/CEO of Sadra Medical (Campbell, California) switched horses to apply those tips to the real-life world of product development.

If the opening session of the ASM International- (Materials Park, Ohio) sponsored conference was in a sense a celebration of the role materials and processes-oriented designers and engineers play in the intensely active med-tech arena, Salahieh brought much to the party.

He has been involved in the development of thermal and perfusion angioplasty balloons, minimally-invasive cardiac surgical devices, drug delivery and embolic protection devices, and percutaneous valve repair and replacement products.

In his presentation, Salahieh highlighted some strategies for identifying and pursuing product development opportunities, including collaboration with venture capitalists, industry and clinicians in that exceedingly difficult drive to commercialization.

He said that would-be product developers need to decide which of three roles they will play: “early movers,” “fast followers” or “fast executors.”

“You have to understand what your strengths and weaknesses are,” Salahieh said. “Typically there are many design choices [for the product you are developing], and you have to choose one based on your business model.”

Citing his experience with start-ups, much of it with companies coming out of the Incept incubator, he described first being involved with Embolic Protection (EPI), a company founded in 1999 to, well ... develop an embolic protection device.

A fast follower-type of company, EPI chose to address a potential $200 million market, one in which the product would demand significant clinical studies before weaving its way through the demanding FDA 510(k) clearance process.

The question was simple: How to design a better embolic-protection filter?

The company’s solution, according to Salahieh, was “to make it really simple.”

Answering a simple question with a simple solution usually is plenty complex, though, but EPI kept its focus on the fact that it was developing what amounted to a temporary solution to the debris problems that occur during stent-placement procedures.

“Since the device only needed to work for 30 to 40 minutes during these procedures, we only needed to do acute studies, not chronic studies,” he said.

What resulted was the Filterwire EX, in effect a relatively simple polyurethane filter to keep wayward debris from causing serious negative cardiac events. A second-generation Filterwire EX, built upon the initial iteration to offer what Salahieh termed “a much smaller-profile device.”

EPI was sold to Boston Scientific (Natick, Massachusetts) in 2001 for some $160 million and additional milestone payments.

Next up for Salahieh was Sadra Medical, launched in July 2003 with the goal of developing a percutaneous aortic valve. With a potential addressable market of $1 billion a year and a pre-market application (PMA) regulatory path, the company most definitely fits the “fast follower” model.

“The challenge was to improve on a first-generation device that was already on the market,” he said.

Sadra is developing an aortic valve replacement that can be inserted via minimally-invasive methods, thus differing sharply from the existing standard-of-care, open heart valve replacement.

Sadra’s product is designed to reduce the risks and morbidity associated with open surgical valve replacement, which it says will provide a therapeutic option for patients who are not being treated today.

Clinically speaking, the challenge is to treat patients in a less-invasive procedure. That brings with it a severe downside if placement doesn’t hit what Salahieh described as “a tight landing zone.” If not, he said, “Mistakes are fatal. If you make one, the patient dies on the [operating] table in a few minutes.”

Terming the Sadra program “a very difficult project, with a lot of different solutions possible,” Salahieh called it “a dream come true for materials developers and designers.”

Another Incept-conceived company, SquareOne (also Campbell, California), was founded in 2005 to focus on what Salahieh termed “a rather simple solution” to the problem of inaccurate stent placements.

SquareOne is developing a flared, stainless-steel stent that he said “mimics the human physiology.” The company is “still in the development stage, but is making great progress,” Salahieh said.

Returning to the importance of determining a business model and then acting in accordance with that model, he said that if you’re a fast mover type, you can’t take all the time usually required to develop your own materials — “You have to just grab stuff off the shelf and put it together.”

And if you’re the early mover type?

“You don’t want to move too early — and have others leapfrog you.”