National Editor

Joseph DeVivo was appointed president of the Orthopaedic Reconstruction business of Smith & Nephew (S&N; London) in July 2007, bringing to that position 18 years of development, marketing, sales, operations and leadership experience.

Before coming to S&N, DeVivo served as president/CEO of RITA Medical Systems, a pioneer in radio frequency ablation technology, acquired by AngioDynamics in 2006. Before that he served as president/COO of medical robotics company Computer Motion, helping to turn around that company's performance ahead of its merger with Intuitive Surgical in 2003.

From 1993 to 2002, he was at United States Surgical, a division of Tyco Healthcare, in a wide variety of roles: VP/general manager of the USS/DG Sutures division, senior director of global marketing and director of product development.

Biomedical Business & Technology discussed with DeVivo issues of leadership and the important new roles emerging for medical technologies.

BB&T: Given the companies you've worked for and their mix of unique technologies, you've had a very interesting career. How did those experiences take you to where you are today?

DeVivo: Looking back, [my career] has given me a lot of tools to work with. Starting off at U.S. Surgical, I learned how to operate in a large business which values technology and understands how technology can move a market. Moving into two small, publically traded, struggling companies definitely helped me build the type of quick decision-making and leadership ability where there is not a lot of room for error. You need to succeed or die. We had two successful exits of those businesses. and I was very fortunate to have had a fruitful career at U.S. Surgical. The experiences prepared me to run a substantial business at a very sensitive time in that company's history.

[That background] allowed me to build a blend of big-company protocol, experience and the ability to communicate across a larger organization, while the same time having the hand-to-hand combat leadership skills of a smaller organization necessary to survive.

In reading the BB&T interview with Roebin Bellas [in the March issue of BB&T], he talks about CEOs having a gearbox, and a CEO can go from 1st and 2nd gear, but sometimes it's difficult to get to 3rd and 4th. I think when you run a large organization you must have a complete gearbox. You don't have the luxury to have some areas of weakness.

I think that my combined experience in a large company, and also to survive in a smaller organization with more risk, much less resource and protection around you, has hardened the metal for the task at hand.

BB&T: As a former newspaper editor, I thought there really wasn't all that much difference — apart from national recognition and clout — between being editor of a small paper, which I once was, and the New York Times, at least not operationally. Can you make that argument about running a smaller device company and a huge part of a big company, such as S&N?

DeVivo: There are similarities ... and differences .... In a smaller company, you don't have the resources you have in a larger company. Especially, if it's a struggling public company, you don't have the accounting talent, you don't have the finance talent, you don't have a lot of the layers that a larger company affords you. In a larger business, you also have a bureaucracy and things that you don't have in a smaller [company], so there are definite differences in the ability to execute.... [E]ach business has a plan, each business has a focus and each business has a need to accomplish a certain target. The real key commonality in the experiences is that it all comes down to people. You need excellent sales leadership, marketing leadership and technology development — all areas where you can develop a high-performance team, to accomplish some significant goals. The quality of that team and the ability to build that team ... whether a small company or a large one.

BB&T: You touched on the development of leaders rather than managers. You haven't used the word "management" yet, but you've used "leaders" a lot. Is the key having people who lead, and is that different than having managers.

DeVivo: Friends tell me I'm a glutton for punishment — I constantly get myself into situations where the business at hand requires a significant amount of leadership. At U.S. Surgical I leaned a lot of new technologies [and] my last three or four years were spent in a struggling suture business, to try to win a group contract and get U.S. Surgical into the contracting game. That was a real fire-fight for many years to try to fix that business.

Computer Motion was a $20 million revenue company burning $12 million in cash, and it was an absolute struggle, but we also were able to get through it. RITA ... was a troubled start-up for 10 years, but finally we were able to build up a critical mass and make some acquisitions.

[W]hen you're always in a favorable situation, you can manage. But when you are faced with significant challenges, it requires both leadership, and the ability to find people who are willing to take on the challenge as a team. And when you can surround yourself with leaders who all focus on a very specific goal, it's a difficult experience, but enjoyable once you see the team pulling in the same direction. When you see the marketplace understanding the strategy and the vision of the business, and you experience the business ultimately succeeding, it's exhilarating and all about building a high-performance team.

BB&T: In a program that you and Charlie Whelan put on at the recent Frost & Sullivan conference, you cited the lack of public information on the topic of personalized medicine and devices. You said your session was probably the first public discussion of this and so "pretty exciting." Is this topic going to get more attention in the future?

DeVivo: In doing my original [research] and asking the team at S&N to do a scan [on the link between] the term "personalized medicine" and "medical device" — this was probably one of the first times it was mentioned. We could find no links in our research.

That said, on reflection, especially after the talk and in conversations, it seems that personalized medicine has been something that the device industry has been doing all along. And it's something very ingrained in the culture of medical devices. Success in surgery of course all revolves around the surgeon. The surgeon, being the one trying to assist the patient, will use the understanding of the anatomy and the physiology of the body in order to repair that body.

I personally have been in hundreds of [surgical] procedures in my early days with U.S. Surgical, and very rarely did two operations look the same, due to what the disease involved did individually to each patient. But it was the surgeon who understood how the anatomy/physiology should work and how to deal with each situation to deliver an operation in a very personalized manner.

I think that the device industry has continued to try to enable surgeons and interventionalists to have the ability to intervene where two hands and a scalpel won't do the trick. The term personalized medicine is something that has come out of the pharmaceutical industry .... I think the device industry is much further ahead when it comes to personalized medicine.

BB&T: The energy of the Q&A following your F&S session was interesting. You gave your example of the Invisalign technology and then people began mentioning hearing aids, dentures, those sorts of things. That underlined the impact of personalized medicine in devices.

DeVivo: It was exciting, and I think the thought process that Charlie and I had gone down was proven out in the Q&A, because much of what I believe personalized medicine will be in the future is a function of data ... and what you can do with that data to automate the ability of the surgeon or interventionalist to provide therapy. We all do clinical trials to validate technology, but ... imagine a world where all the history of all of the patients, and their therapies, what was recommended, and what worked and what didn't work.

If that was all into a massive database, the pure crunching of that data would allow you to find trends ... and discoveries retrospectively almost impossible to do on a prospective, randomized trial due to the mere cost and logistics involved. This ability ... will be an unbelievable part of the future of medicine.

[T]he ability to acquire as much pre-operative data as possible, whether it be imaging, whether it be any of the diagnostics, is a very important part of the planning of a successful operation. And the ability to use that data ... to guide machinery or guide imaging or guide intervention to the specific point of therapy, to allow therapy to be done that could not be done by the human hand, is an area where there is no better personalization of that imaging and that directed therapy ....

The audience [at the conference] certainly brought those examples forth. [For example], Align's Invisalign technology [takes] an image of the exact positioning of a set of teeth, where they are, and calculates where they should be, and progresses from there.

Also mentioned was photorefractive keratectomy, or LASIK surgery — again, it's immediate feedback.... [T]here's an image of the eye, an exact positioning of what needs to be accomplished, a knife blade comes down to open the eye, and a laser to reconstruct and reshape. I think that's an absolute manifestation of personalized medicine.

Another example is Accuray's CyberKnife. The imaging finds a tumor and calculates the delivery of radiation in a specific dose to a specifically-shaped tumor, even which moves as the body breathes. It's delivered in real-time providing the exact therapy for the specific patient.

I believe it is in direct contrast to what women have had to go through, for example, with ... breast radiation, the entire breast gets irradiated for a small tumor. CyberKnife can specifically target that exact anatomy and that exact tumor, hence personalized medicine. I think the device industry has had [personalized medicine] in its culture for many years and maybe it just took this topic to plant the stake in the ground.

BB&T: You talk abut the gathering of data, a relatively recent development. Are quantum steps looming in the near future, or will it be small steps leading to big ones?

DeVivo: It's a convergence of technology, of healthcare policy, of politics and of economy.... [Y]ou can see those benefits occurring today. In more nationalized healthcare systems, such as in the Scandinavian systems and in Australia — systems where they track certain outcomes and behaviors that allow, on a registry basis, a very high quality and very important set of information. If companies had to pay for that, the cost would be astronomical.

I think the limitations in the U.S. are self-imposed — the technology is here [but] the politics and the privacy laws are the greatest barrier. I have high hopes on Google's efforts with the Cleveland Clinic to allow patients to put their records into a centralized warehouse ... I hope that effort picks up momentum and can help the public segregate between the privacy and the necessity for information. Hopefully we'll strike a balance [between] access to data and storing data and [sharing] data in a safe and ethical way.

BB&T: Has the emphasis on privacy thrown up a roadblock.

DeVivo: It has. People of course don't want an ailment to be used against them — for example, for employment. But if you depersonalize the information, take the patient's name off of it, to do a database search to find commonality, to find trends, and to create markers or earlier indications aside from pure diagnostic testing, but earlier trends of diagnosis that might lead to certain ailments, I believe is the future. It truly is the future, but we can get there — and we will get there soon.

BB&T: At the F&S conference you cited the example of one of your competitors, Zimmer, marketing the "Gender knee." Do you see that type of message growing across the industry? Can it be packaged for both broader and more specific audiences?

DeVivo: What I admired about their campaign was how it resonated with patients. It created a call to action for a patient. It mobilized a patient and got them to seek out their technology. [But] the campaign stalled a bit when it reached the clinician. Of course, all implants are made for men and women, and there are multiple sizes and kinematics for patients at certain sizes.

It ultimately didn't have the commercial impact for them as it did initially in creating the awareness and creating the disruption. I admire the disruption, I admire the awareness and I admire the ability to get a patient to take action, which is the sign of an excellent campaign. I applaud them for taking the marketing risk. It was unfortunately not aligned with all clinicians [but] a campaign that resonates with the patient and is perfectly aligned with the clinical thought of the surgeon can have an unbelievable economic impact for a company. I believe it could really move the needle.

What it taught me was to create a message that is more out of the box, that will resonate with patients. We also need to make sure it's not a conflict with the clinical practice of the physician. Patients today rarely go in for an operation without pages and pages of information off the Internet, and playing doctor. While it's good to have an exposure to information, the best clinical outcome will come from the best surgeon and interventionalist, not from a glitzy campaign. That's where the balance must be struck — creating a message that is in perfect concert with the vision and the clinical intent of the physician.

BB&T: At the F&S conference you talked about the "delicate balance" between marketing, consumer knowledge and the clinician. I think you just underlined that point.

DeVivo: The intent is to create clinical awareness, but it's important to always know that the therapy provider is the most important link. That's an essential gut-check that we should all take.

BB&T: Getting back to the point about data in both existing and future uses being the "secret sauce" in the entire healthcare formula — could you elaborate on that?

DeVivo: I think the ability to automate and translate the ability of the interventionalist digitally . . is an excellent example of the future of personalized medicine. To take imaging and translate it into a dataset, to create a set of points in space, is a very important asset for the interventional side of personalized medicine. If you can visualize and place things into a 3-D dataset, you can then use that data to command motions of technology that can mimic or enhance the ability of a surgeon to provide therapy. It is that dataset that can guide technology. It can guide in a robotic procedure. The dataset gives you the ability to automate, the ability to specialize, the ability to target, and to minimize risk in very difficult procedures.

A long time ago I noted that the ability to rely on the hand alone has, to a certain extent, been maximized, especially for minimally invasive operations. The ability to grow medical device markets will be where [in extending] the surgeons' abilities beyond their physical limitations — any way that automation of the data, the automation of those skills, starts to lend to a convergence between the interventional and the biotechnology side. I think merging those datasets together in providing therapy well into the future is a very exciting prospect.

BB&T: Concluding, is there something I haven't asked you about that you wish I had?

DeVivo: Just to go back to the concept of working for a big company and a small company. If I had worked for a big company my whole career, I never would have had the exposure to the venture capital community, to the rigors of being a small public company. I never would have been exposed to so many different markets and have the perspective that I've been able to gain if I stayed in one place.

I would encourage medical device executives to constantly step out of their comfort zone and to consistently challenge themselves and to not be complacent. While it's disruptive to step out of the comfort zone, it creates an enormous professional and personal awareness of what life has to offer.

Challenge yourself, take on the tasks no one else wants. It'll show everyone what kind of impact you can make and teach you much about yourself. I encourage everyone to put as many gears in their gearbox as they can.