Leadership Perspective
Patients first; Intuitive’s new head of quality has a clear vision for the future

When Ian Purdy thinks about his job, he thinks about patients. As Intuitive’s new senior vice president for regulatory affairs and quality assurance, he works primarily with researchers, engineers, and regulators. But it’s patients who are always in the back of his mind.

“In our business, not getting it right has such a huge impact on people,” he says. “We have an obligation to get it right, to do the very best we can. And I feel lucky that I can have an impact on that.”

Prior to coming to Intuitive last year, Purdy had been at several other medtech companies, working to foster and raise quality. He has shepherded dozens of products through a wide range of regulatory processes, both in the U.S. and around the world.

Of course, Intuitive already has a solid record in this area. The company’s robotic surgery systems, which include da Vinci, are very reliable, with better than 98 percent “up time,” meaning that they are almost always available when surgeons and care teams need them.

Purdy says the health care environment has grown increasingly complex in recent years. When he started his career, for instance, some countries had no regulatory requirements at all for certain classes of products; now, nearly every government he works with has at least some level of medtech oversight. On top of that, Purdy says, the pandemic has put extra strain on supply chains across the industry—including at Intuitive. This challenge has added another obstacle to achieving a high level of product quality.

Moreover, the pace of technological change has increased, creating new categories for healthcare companies and regulators. In recent years, there has been a marked increase in products that blur the boundary between a medical device and digital technology. Intuitive has developed several innovations in this space, which use digital intelligence (machine learning and artificial intelligence), mobile phone apps, and data storage and capture technology. Purdy says he and his team are working closely with regulators so that all stakeholders have clarity on these new approaches.

A new initiative designed to boost quality

With this increasingly complex terrain, it is critical for Intuitive to modernize and streamline its approach. To help achieve this objective, Purdy has brought in people from outside of healthcare, notably from automotive and aerospace companies. These sectors have a reputation for having the most advanced quality and safety standards of any industry. He notes that aircraft safety involves the lives of hundreds of people at a time, and large automotive companies sell hundreds of thousands or even millions of vehicles annually. “We can definitely learn from these sectors,” Purdy says.

And earlier this year, Purdy launched an initiative to develop new ways to strengthen Intuitive’s approach to quality. So far, the project has generated more than 2,000 suggestions from employees. The goals of the project, which will last until the end of 2024, are to find areas that can be improved rapidly and to develop innovative longer-term strategies that will more broadly advance the company’s approach to safety and quality.

It’s too soon to know what these changes will be, but Purdy is excited. “I'm a big fan of experiments,” he says. “To get better, we have to continue to try things out. There are a lot of opportunities—reducing bureaucracy, simplifying procedures, training our staff differently, or using machine learning in new ways. It almost certainly will be a combination of these.”

Purdy, who grew up in Scunthorpe, a small industrial city in the north of England, was the first person in his family to go to college. He earned a bachelor’s degree in biology, and then a PhD in human physiology. From there, he began working in clinical research, regulatory affairs, quality, and safety at a series of healthcare companies, first in Europe and for the last 14 years in the U.S. Over his career, Purdy has collaborated with researchers and regulators all over the world—at one point he was taking between 150 and 200 flights a year—so he is not only familiar with the expectations and regulations of the FDA, but those of many other regulatory agencies in Europe, Asia, South America and elsewhere.

In his current role, he works closely with regulators, and says their input is crucial to the process of developing products that help care teams do their work. “We’re all part of the same ecosystem,” he says. “In the end, we’ve got the same goal, furthering patients’ health.” Input from surgeons and clinicians is also crucial, he says, because it provides Intuitive with important insights into how its systems are actually used, and how they can be improved.

Creating an environment where the focus is quality

But this cooperative approach doesn’t remove all obstacles; over his three-decade career, Purdy has had to deal with a wide variety of serious problems, including recalled products, unexpected breakdowns, and muddled product rollouts. When things get tense, he makes it a point to stay calm, a trait he says he inherited from his mother.

“You find yourself in these positions where you have to deal with really tough things,” he says. “You have to have the ability to look at it somewhat dispassionately. I’m naturally like that, which is maybe why I’ve found myself in this role.” To recharge, he goes running, or takes walks on the beach with his dog. He, his wife, daughter and dog (a rescue mutt) live in the mountains near Santa Cruz. His three older children are all in Dublin, attending college.

Despite these demands, Purdy loves what he does. In fact, he says this pressure is part of why he finds his job meaningful. For him, it comes back to the patients.

“I’m not a doctor, I’m not a surgeon,” he says. “But what I do is try to create an environment where people are committed to the mission, empowered to do their best work, and make the best products they can. And then the surgeons can go and use these great products to do what they do for their patients.”