With over 300 people in attendance, it was a virtual full house for the annual Thomas J. Fogarty, MD Lecture, co-sponsored by the Stanford Byers Center for Biodesign, Fogarty Innovation and the Stanford Department of Surgery. The strong showing underscored the interest in the Silicon Valley and beyond for this acclaimed series, which is now in its 22nd year.
Of course, a major draw was the speaker, Julio Palmaz, MD, inventor of the first FDA-approved balloon-expandablevascular stent. The Palmaz-Schatz stent is on display at the Smithsonian and was recognized in Intellectual Property International Magazine as one of “Ten Patents that Changed the World.” It has been used in nearly 100 million patients worldwide. With 62 issued patents, Julio has been inducted into the National Inventors Hall of Fame and National Academy of Inventors, joining long-time friend Tom Fogarty, MD, as one of the few physicians to receive the honor. Currently Julio is the honorary Ashbel Smith Professor at University of Texas at San Antonio and scientific advisor at Vantronix Scientific where he pursues new approaches and cardiovascular therapies using nanomaterials.
The event, titled “For Big Developments in Cardiovascular Devices, Think Very, Very Small,” was kicked off by Tom Krummel, MD, Fogarty Innovation’s chairman and co-director of Stanford Biodesign. Tom has been the driving force behind the annual Lecture securing a veritable who’s who list of speakers in the past 22 years, including recent headliners Jessica L. Mega, MD, co-founder and chief medical and scientific officer at Verily; John R. Adler, MD, inventor of the CyberKnife; and Brook Byers, founding partner at Kleiner Perkins.
In this fascinating discussion, Julio walked an audience that included academics, entrepreneurs and medtech industry leaders through the evolution of coronary stents and his perspective on the future of implantable devices.
A laborious process, ripe for innovation
Julio started by recounting the current state of stents, which he considers a bit disappointing, given the lack of technological advances over the past years. In particular, he referenced the fact that stents are still made with wire and tubing in a traditional fashion. This lengthy approach can take hundreds of hours, using traditional reductive technology in what is essentially more of a craft than a sophisticated, predictable and speedy process. The approach uses low-cost materials—wire can be acquired for pennies and tubing for dimes— but also requires dozens of workers who assemble parts using needles, sutures, rivets and staples—and of course, a great deal of skill.
Although antiquated, this process is still the mainstay of medical device fabrication, an issue Julio and his team set out to change by analyzing different sizes and types of tubing and identifying the traditional material techniques and standards that have limited development. He was also at the forefront of working with the FDA and the ASTM (formerly known as American Society for Testing and Materials) to establish manufacturing standards and guide efforts to create quality control methods, which was the first step towards systematizing stent manufacturing.
Bringing technology into the 21st century
Driven by the desire to continue moving the field forward, Julio shared his thoughts on several trends in micro-manufacturing that could lead the industry out of its “stagnation phase.” One of these is physical vapor deposition (PVD), which is ideal for cardiovascular stent manufacturing as it achieves efficiency at the nanoscopic scale, simplifies the process and can be largely computer-controlled, which promises to reduce complexity, and increase repeatability and precision in medical device manufacturing.
Wrapping up his presentation, Julio shared his projections for the near future, which include smaller machines and increased computer power, along with high definition manufacturing and augmented validation.
Then for the distant future, as in 20 to 50 years from now, he forsees chemical-based interventions and perhaps structured nanotechnology, which is currently used in health care today in areas such as:
- Drug carrier nanoparticles for cancer therapy
- Nano molecular tags and markers for diagnostic imaging
- Biosensors, primarily in the food and defense industries
- Electronic-neural interface (motor cortex, retina, cochlear)
But despite its promise, it is not yet seen in cardiovascular devices.
As Tom concluded, “The whole purpose of these lectures is to expand the way we view the world, and you have done that,” he said to Julio. “It was a great saga from the beginnings of bare metal stents and reductive manufacturing to nanomaterials additive manufacturing, which leads us all to think very small.” View the Lecture recording here.