Michael Phalen, president of Boston Scientific Corp.‘s endoscopy division, began his long tenure at the Natick devices giant in 1988 as a sales rep. After several crossings between the outside sales world and inside marketing positions, he was named president of the endoscopy operation in 2001.*

It was a good time to get into endoscopy, Phalen tells MassDevice, as physicians began using the technology to provide previously unheard of, minimally invasive views of the workings of the human body.

We chatted with Phalen recently to discuss developments in his division, its “patients first” philosophy, what’s on the horizon for endoscopy in general and his views on the biggest challenges facing the medical device industry.

MassDevice: What makes the medical device industry a good fit for you?

Michael Phalen: I got exposed to endoscopy in mid- to late-1980s. It was just a fascinating thing to watch, because physicians were making use of endoscopes to actually see inside the body and make sense of it with a less-invasive intervention. It’s proven to be a very good decision on my part, because the endoscopy business at Boston Scientific has become a very large business and a key component of the corporation.

MassDevice: What’s the biggest leadership lesson you’ve learned?

MP: We have to recognize that we play a role in the healthcare industry. Physicians and nurses rely heavily on our devices to try and help their patients. People have our devices used on them and we have to have the patient first and foremost in mind and focus on what will benefit the patient. That’s a core value of Boston Scientific Endoscopy. We really do try to practice that in all of our teaching and training.

MassDevice: Obviously the FDA’s recent 510(k) approval of the SpyGlass device for cholangioscopy is big news for the division. Can you give us a quick overview of the device?

{IMAGELEFT:http://www.massdevice.com/sites/default/wp-content/uploads/featureArt/SpyGlass_300x200.jpg}MP: This is a device that’s used in what we refer to as “pancreatico-biliary intervention” — that is, interventions involving the gallbladder, common bile duct and pancreas. Pancreatic cancers are really very difficult, challenging diseases for the medical folks to engage. SpyGlass is the latest set of tools we’ve developed. It was commercialized two years ago for the common bile duct. It’s a catheter that has a little imaging component to it that allows physicians to put it through the pancreatic duct and into the pancreas. It can be used to take biopsies or we have a number of accessories they can use to break up a stone or perform other procedures.

Cholangioscopy for 15 or 20 years was not used very often because it takes two doctors to perform the operation. We made it more of a catheter-based procedure with steerability so a single physician can operate it.

MassDevice: What’s on the horizon for the endoscopy division? What do you see as the hottest trends today in the field?

MP: There are a number of areas under investigation today in the space. There’s definitely a trend of having more and more surgeons utilize flexible endoscopy as part of their interventional tool kit. We see an expanding customer call for medical and surgical endoscopy.

There’s been a lot of press in the last couple of years about “natural orifice surgery.” Endoscopy’s beginning to be used more as a surgical tool through natural orifices. That’s an area that’s very interesting and continues to be studied by a lot of companies and researchers.

And there’s also a lot of interest in looking at endoscopy to help treat obese patients in bariatric procedures.

Endoscopy in general is growing throughout the world. We have an aging worldwide population, more and more people are living longer, and obviously the GI tract has a fair amount of challenges.

MassDevice: What’s been the biggest lesson you’ve learned during this recession? What’s the takeaway?

MP: We have to remain competitive in everything we do. We do everything we can as a division to continue to produce high-quality devices that meet clinical needs at a fair and equitable cost. Our business is largely still centered around patients that really have to have interventions. If you have a bleeding ulcer in your colon, it’s not like you can put that treatment off. We haven’t seen a significant impact yet. Certainly it’s gotten more competitive.

MassDevice: How about the future of selling medical devices, which is still very reliant on sales reps visiting doctors. As these opportunities become more difficult with the rising prevalence of gift bans, how will companies adapt their sales processes?

MP: We’re still trying to understand what the rules are. A lot of this centers around conferences and meetings — that’s been throttled back pretty heavily over the last several years. Time will tell what really turns out to be a change, in terms of how healthcare is governed in the U.S.

The thing I worry about the most is innovation. We try to work closely with physicians to identify unmet needs. How we do that going forward is going to meet with substantial change.

MassDevice: Aside from gift bans, are there other rules or regulations that have you concerned?

MP: There are a lot of forces at play that could fundamentally change the dynamics of this industry, in that industry supports a lot of research and innovation. You do worry about it. I understand that there’s a need to be invested in change and we want to do the right thing, but you wonder about unintended consequences.

I worry about the industry as a whole losing its edge. We lead the world in medical device innovation. I worry about it ultimately affecting patient care. We’ll see how that unfolds. It’s a big issue, but the idea of how the industry interacts with healthcare providers is probably the biggest sea change we’ll face for the next decade or so.

*Correction, Aug. 27, 2010: This article originally stated that Phalen was named president of the endoscopy division in 1991. Return to the corrected sentence.