Best Practices for Implementing a Rock Star KOL Program - Medsider

In today?s world of commoditized medical devices, differentiating your products is extremely challenging. In fact, the only difference between your company and the next might be how effectively you collaborate with KOLs and other medical device stakeholders.

The end goal for any KOL program is increased sales. But how do you manage growth in the face of a heightened compliance and regulatory environment? To answer that question, we?ve enlisted the help of OpenQ cofounders, Jim Zuffoletti and Otavio Freire. So who exactly are these guys? Simply put, they?re experts when it comes to KOL programs. More specifically?

Jim Zuffoletti is the President of OpenQ. He has been a founder of start-up organizations as both an entrepreneur and an intrapreneur and has served life science companies for the past 15 years. Prior to founding OpenQ, Zuffoletti was a founder of FreeMarkets, Inc., a pioneering e-business company.

Before FreeMarkets, Jim started his career at GE in a variety of positions in finance and business development. Zuffoletti holds a Bachelor of Arts in Economics from Amherst College and holds an MBA from the Darden Graduate School of Business Administration.

Otavio Freire is the Chief Technology Officer of OpenQ. Prior to cofounding OpenQ, Freire was the Director of Technology at a software company serving the pharmaceutical industry where he created innovative technology products that are currently live at eight of the ten largest global pharmaceutical companies, including Merck and GlaxoSmithKline. Otavio?s career has also spanned work at Oracle and InterWorld. Freire holds a Bachelors of Science in Civil Engineering, a Masters of Science in Management Information Systems, and an MBA from the Darden Graduate School of Business
Administration.

In this interview with Jim Zuffoletti and Otavio Freire, we learn the keys to implementing and managing a successful KOL program.

1) You can listen to the interview with Jim Zuffoletti and Otavio Freire right now:

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In today?s world of commoditized medical devices, differentiating your products is extremely challenging. ?In fact, the only difference between your company and the next might be how effectively you collaborate with KOLs and other medical device stakeholders.

?

The end goal for any KOL program is increased sales. ?But how do you manage growth in the face of a heightened compliance and regulatory environment? ?To answer that question, we?ve enlisted the help of OpenQ cofounders,?Jim Zuffoletti and?Otavio Freire. ?So you might be wondering who these guys are?

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Jim Zuffoletti is the President of OpenQ. ?He has been a founder of start-up organizations as both an entrepreneur and an intrapreneur and has?served life science companies for the past fifteen years.

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Otavio Freire is the Chief Technology Officer of OpenQ. ?Prior to co-founding OpenQ, Freire was the Director of Technology at a software company?serving the pharmaceutical industry where he created innovative technology products that are currently live at eight?of the ten largest global pharmaceutical companies, including Merck and GlaxoSmithKline.

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In this interview with Jim and Otavio, we learn the keys to implementing and managing a successful KOL program.

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More specifically, here are some of the points we?ll cover:

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• The 5 major functions of an effective KOL program: Identification, Engagement Planning, Coordination & Tracking, Sharing of Content, and Measure/Monitor.

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• 4 common challenges that medical device companies face when collaborating with KOLs and outside physician experts.

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• Is it really that hard to find KOLs? ?Who should you include and who should you exclude? ?Can technology help with this?

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• Tribal data vs. objective data: Is your ?in-house? list of KOLs really that good? ?You may be surprised.

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• Think about the various facets of KOLs and stakeholder management. ?Medical affairs, speaker programs, grant funding, etc. Is everyone at your company on the same page? ?If not, learn how they could be.

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• Do you have control over the content that your KOLs are presenting and sharing? ?What other regulatory guidelines must be considered?

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• How will the world of mobile and social media change the KOL landscape?

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Of course, there?s a lot more valuable info we?re going to uncover in this interview.??But before we dig in, you need to listen to these brief messages from our sponsors.??And by the way, if you?re interested in becoming a Medsider sponsor, go to Medsider.com/sponsor.??Again, that?s Medsider.com/sponsor.? Now listen up?

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Okay, for you ambitious medical device and medtech doers, here?s your program?

Scott Nelson:??? Hello, everyone.? It?s Scott Nelson, and welcome to another edition of Medsider, and for those of you who are familiar with the program, I?m not going to explain it.? You know what this show?s all about.? But for those of you who are catching this episode for maybe the first or second time, it?s an interview sort of show where I bring on medical device/med tech stakeholders who are doing dynamic and interesting things in this space and the goal would be that we would glean a few insights, learn from their experiences, hopefully pick up on a few major takeaways that we can learn in an effort to become sort of the linchpin on our end so we can make a difference within our certain careers or with whatever we?re doing within the device space.? And so that?s the goal with Medsider, and on today?s program we have two guests, Jim Zuffoletti and Otavio Freire.? And Otavio, I know I may have butchered that, but I certainly apologize.

Otavio Freire:? No, no, that?s great, Scott.

Scott Nelson:??? [Laughs] You?ll correct me here.? But Jim is the President of OpenQ and Otavio is the Chief Technology Officer of OpenQ as well, and correct me if I?m wrong guys, but you guys are both the cofounders, right, of OpenQ?

Jim Zuffoletti: We are indeed.

Scott Nelson:??? Very good.

Jim Zuffoletti: Okay, Scott.

Scott Nelson:??? Okay, so first of all, thanks for taking about 30 minutes out of your scheduled to do the show.? Really looking forward to this.? It?s going to be an interesting topic involving KOLs, speaker programs, study management grant funding, how that?s all impacted by social media, regulatory issues such as the Sunshine Act, and that kind of thing.? We?re going to learn a little bit more about your platform OpenQ and how you guys solve some of these challenges that medical device companies and pharmaceutical companies are having when it comes to these sorts of issues.

So welcome to the show, and I?ll have you guys provide a little bit of kind of a 30,000-foot aerial snapshot of OpenQ just so the audience, for those listening, can get a feel for what we?re talking about in regards to OpenQ, and then maybe just a brief little bio of yourselves so we can get a better understanding of where your experience lies prior to OpenQ.

Jim Zuffoletti: Sure, Scott.? This is Jim.? I?ll start and then I?ll turn it over to Otavio.? OpenQ provides compliant collaboration solutions for life sciences companies.? We are acutely aware that in the medical device and in the pharmaceutical space both sides of the industry rely incredibly on collaboration in a clinical setting, in an advisory capacity, in a consulting capacity, and then ultimately in a promotional capacity on effective collaboration with outside professionals.? It?s a source of great advantage for the company who collaborates effectively.? It?s also a source of big exposure associated with regulatory and compliance risks.? So we sit at that intersection between the company and the outside professional as kind of the glue that brings it together.

Just as a background, the company is about 7 years old at this point, and prior to OpenQ I had been involved in another startup venture for the previous eight years, a company call FreeMarkets in Pittsburgh, Pennsylvania that was serving a variety of industries including the life sciences and other manufacturing industries.

Scott Nelson:??? Very good.? We?ll pass the baton over to Otavio.

Otavio Freire:? Thanks, Scott.? My name is Otavio Freire.? I?m the Chief Technology Officer of OpenQ.? I am responsible for the creation of the OpenQ products and platform.? I am an engineer and my background is really within life sciences.? Since my first day on the job, I?ve been serving the pharmaceutical and medical device industry and enjoyed every step of the way.

Scott Nelson:??? Very good.? Very good.? And Jim, I liked your description, the glue sort of at the intersection between the KOLs, the influencers and the companies.? So that?s a great description.? It sounds like you?ve given that description, that elevator pitch, a couple of times in the past, it?s probably safe to say.? So let?s go to our imaginary whiteboard here.? We?re going to discuss a few topics as I mentioned before, but let?s start out with kind of the common strategies, maybe the common tactics that most medical device or pharmaceutical companies, I mean our focus will tend to be more in the medical device space just because that?s where most of our audience is at, but the common strategies that most device companies use when connecting with those outside influencers, those outside expects, the KOLs, because in my experience, granted I?ve never totally played the role of like a physician education, sort of been on that side, but I?ve definitely been involved in that and it seems kind of a little bit like a cluster a lot of times, a lot of exchanges happening between email and whatnot, and so I?ll hand that over to you.? What are the common tactics that device companies employ when it comes to these sorts of issues?

Jim Zuffoletti: Sure.? So Scott, one of the things that we do when we think about this with respect to medical device companies is that kind of outside engagement has a continuum of activities or tactics that companies have to think about, and the first perspective that you have to start from is that nobody puts Key Opinion Leader on their business card.? So the active engagement actually has to start before many people even think about it, which is the process of identifying.? So as you think about the concept of, ?Gosh, what I really want to do is I want to find the people who are the leading minds in the space who are going to give me the best advice,? or ?I want to work with the leading minds from a promotional or educational perspective,? the first thing I have to do is I have to identify them, so that one of the first common tactics having to do with kind of successful engagement is to take a real scientific perspective associated with identification.? And this might be a situation where people are thinking about, ?I need to find four or five advisers.?? We?ve also worked with medical device companies who wanted to try to identify their top thousand or multiple thousands in terms of the individuals who are going to literally [00:06:41] successful collaboration will drive their business.

The second major tactic that we see people apply is once I?ve identified the best practices out there is to conduct engagement planning.? So you have to think about it from the context of medical device companies have very specific educational needs, educational objectives.? They might have some very specific product objectives.? And key opinion leaders have objectives, so to speak, in terms of what they?re trying to achieve with their research and with their patients, and so the engagement planning has to be that ability to intersect between the objectives of the key opinion leader and the objectives of the company.? And so we?ve seen the best companies in the device world be the companies who are kind of open and direct with some of those discussions in terms of engagement planning.

The third step along the way is actually the one that you made reference to.? You used the polite word ?cluster? to describe that kind of relationship, multifaceted relationship engagement.? Maybe I?ve watched too much Percy Jackson but I think of it as a many-headed hydra problem, which is that you?ve got an organization where there are 10 different people intersecting with that same key opinion leader or outside expert.? They?re all drawing on them with the same or different needs and they?re not coordinating with one another, so a third major tactic is that kind of coordination and tracking.

And the fourth area, and we?ll get to this in a few minutes, I?m sure, when we talk about regulatory aspects, is the interface in collaboration isn?t just about a dialogue that takes place back and forth.? It also involves often the sharing of sometimes very compliance-sensitive or intellectual-property-sensitive content.? So sharing of content is something that?s becoming increasingly critical to create that kind of collaborative dialogue if you will.

And then the last component is measure and monitor.? So, companies who do key opinion leader engagement as a strong discipline, they?re not doing it out of the kindness of their heart.? They?re really doing it because they start with the patient in mind at the end and believe that the right way to get the message out about their products, the right way to target the right patients, the right way to work with the right surgeons, is through key opinion leader engagement.? So it really runs that whole spectrum in terms of kind of the arch of tactics that companies need to think about from an engagement perspective.? Otavio, anything you want to add to that?

Otavio Freire:? Yeah, Scott.? You mentioned a few elements of the types of collaboration that this takes place, through speaker bureaus, advisory settings or grants or investigator-initiated studies.? We think of those as specific work flows in this overall process, so a coordinated engagement plan does account for the fact that ultimately, regardless of the tactics that you?re using to engage your key opinion leader, you have to [00:09:55] think of the overall plan and tying it back to the regulatory.? The PPSA has really given industry a mandate.? This is not [00:10:08] anymore.? It?s really a mandate to make sure that you have a complete view, 360, of the relationship of your firm with those individuals.

Scott Nelson:??? Very good.? No, that?s good stuff.? And Jim, I really like the breakdown of those five different really steps, because most folks, I think, they?re familiar with the speaker bureaus, as you mentioned Otavio, the one-off physician dinners, the podium guys, the guys that go to the conferences and do the talks and whatnot, but to put together kind of these five different sort of strategies or steps that kind of encompass the whole process, that?s a good way.? So just as a review, first step, identification, kind of the search and discover those proper KOLs; two would be engagement planning, trying to find, trying to discover the objectives of both the KOL and the company; coordination and tracking, kind of that cluster idea that we referenced; and then the fourth step would be the sharing of content, more the regulation aspect; and then five, the measure and monitor strategy as well.? And those last three I think are, not that the first two aren?t important, but those last three really ring true for me.

And so looking at kind of those five different areas, guys, when you?re working with your clients, your medical device clients, your pharmaceutical clients, your bio tech clients, maybe more if we can kind of bias this towards the medical device space, when looking at those five different steps, are there common problems that you see and that you?re seeing with certain companies when they try to approach these different strategies, these different tactics?

Jim Zuffoletti: Absolutely, and let me characterize this in terms of, let?s call it common problems as well as emerging problems.? So, Scott, you rightly hit on the concept of the cluster, the many-headed hydra.? This tracking issue is endemic to every organization.? And that?s a common issue, it?s also something that from a best practices approach we have seen companies who have been very effective at assembling that 360-degree view and using that to drive kind of a streamlining and a more kind of, let?s say, call it compliant-engagement model.

Another common area that we?ve seen is the whole concept of identification, and let me turn it around and have you think about it in terms of what I call qualified selection.? So, one of the things that we?ve seen in a lot of companies, and this is true for device and pharma, is this concept of our top individuals that we interact with are the ones that we?ve chosen through what we?ll call politely ?tribal knowledge.?? They?re the top individuals because they?ve always been viewed as the top individuals.? And I think that that becomes a challenge for organizations because the science changes over the years.? Peoples?, individuals?, surgeons? dedication to the science and to research shifts over the years, and so the process of doing identification as a best practice really is built around making sure that you are continuously challenging the selection of the people that you?re working with, that you?re able to point to objective third-party evidence about why you selected those individuals.

And then the third element is that you really need to think about exclusion as part of your selection criteria.? With the Physician Payment Sunshine Act, all relationships that are paid relationships are going to be subject to disclosure, and one of the things we?ve seen in the early days of disclosure through organizations like Propublica is the last thing that a medical device company wants to do is to be working with an individual who?s been subject to discipline from their state medical board in the past.? And so identification has to be thought of as an inclusion as well as an exclusion decision.

So those are some of the kind of best practices areas.? Let me cite one more just as an emerging one and I?ll turn it over to Otavio, which is this issue about sharing of content.? We?re really seeing a shift within the industry, within medical device, about how companies think about the content that they share and how much control they need to exert over that.? Otavio, do you want to speak a little bit to locking content?

Otavio Freire:? Yeah, we?ve seen the content challenge growing as the amount of treatment and devices that the company puts out in the marketplace has grown.? The information gap, both sides of the fence, both for the surgeon or the healthcare professional, is increasing, and the onus to keep them up-to-date on the med tech side or pharma side is also increasing.? So, to compound the problem, there?s the issue of the compliance.? So every content that you distribute is often not static.? It?s changing.? Labels are changing, new indications are coming to the marketplace, and now you have this issue where you just don?t know the content about your firm and about your products out there in the marketplace.? So this is a business process challenge but is a technological challenge at the same time because we all live in the world of Microsoft documents, file types, PowerPoint, Excel, Word, and PDF.

And what we found was, those technologies are ultimately not smart technologies, meaning PowerPoint doesn?t know what?s inside of it.? PowerPoint doesn?t know who owns it.? PowerPoint doesn?t really know where it is.? So we had to create best practices in terms of how you handle it, and that was the easy part.? But the harder part was building these technologies that we did that, effectively, no matter where the content is we?re able to make sure it?s up-to-date.? So the file will open itself, it looks like PowerPoint, smells like PowerPoint or Word; however, now it?s smart, so it knows, ?Gosh, am I the latest?? Has anything changed?? Oops, it?s changed.? I really shouldn?t open.? I need to update myself.?? Think of it almost like Mission Impossible, Scott?

Scott Nelson:??? Yup.

Otavio Freire:? ?where the file might actually autodestruct because now it exposes the company to liability.? So, we feel the nature of the regulatory environment in medical device is such that we really needed a breakthrough content platform that addresses the need of no matter where you are that your content is safe and you know where it is and you know it?s up-to-date.

Scott Nelson:??? Gotcha.

Otavio Freire:? So it?s a big challenge but there is a technological solution and there are some things you can do in the process to mitigate that risk, but ultimately both combined close the full gap.

Scott Nelson:??? Yup.? No, very good.? Those are some great issues.? And again, just to review, and as I look through kind of these four different points that you made, Jim, and then kind of the add-ons that you just mentioned there, Otavio, that cluster idea, we spoke a little bit about that, kind of the coordination tracking idea where files are being emailed back and forth, it turns into that many-headed hydra, that?s a great example, or kind of that notorious cluster.? And we?ll be friendly to the iTunes folks, we don?t want to cuss too much, but that cluster, you know that extra word [laughs], and that?s really probably a great description for those listening that operate on a daily basis within this world, that?s probably a really accurate description.

And then the second point, the search and discover, the inclusion/exclusion idea where we?ve got the tribal idea.? And initially, when I?m hearing you describe that, I?m thinking, ?Is that that big of an issue for the device companies to identify the right KOL??? If you take a step back it?s like it probably is a bigger issue than one would think because you kind of know who the main podium guys are and who the traditional KOLs, but are they a good fit?? Are they even still doing that many cases?? Because I can speak to that, for example.? On various companies that I?ve worked for, we?ll have KOLs that are on the podium that are so unfamiliar with a particular device that it?s almost laughable that they?re even talking about it.? And so that?s an interesting point.

And then the whole disclosure principle as well as the content, Sunshine Act being a huge sort of issue when it comes to disclosure, and then the whole content thing.? And Otavio, listening to you mention about having a file opened up, I?ve been there, done that, when the guy at the dinner program or the event begins to talk about the disease state, how this device works in certain areas and whatnot, and all of a sudden he begins to go into this whole off-label unapproved-use stuff, and then the regulatory folks begin to cringe and it?s just like a big deal.

Otavio Freire:? Absolutely.

Scott Nelson:??? And so I can see that being a huge issue.? So let?s dig right in.? And obviously, you folks run this show at OpenQ, you have a platform for this, and so those in the audience that are listening, you obviously understand there?s a little bit of a bias here, but we want to hear from the experts that are creating solutions to these problems, and so obviously you?re going to come from the aspect of what OpenQ can provide and how you guys can help solve some of these issues.? So let?s dig right in.? Let?s start with some of these problems that you just mentioned.? How can companies solve some of these issues?

Jim Zuffoletti: Sure.? We could break it down, Scott, a little bit in terms of kind of back to the concepts of identify, plan, tracking, sharing, and monitoring and measuring.

Scott Nelson:??? Right.

Jim Zuffoletti: You know, from an identification perspective, again, the best practice that we see a lot is the concept behind getting data, objective third-party data, to support your selection criteria.? So, for example, we had a company that we worked with.? They had identified a thousand individual surgeons that they believed were the top thousand that they should be working with, and this was a list, again, it was kind of from a tribal knowledge perspective.? And we worked with them to identify a thousand top individuals who were based on objective criteria, and quite frankly criteria that the customer was deeply involved in selecting, but we built a criteria, then did all the research to gather the information on the top individuals who met that criteria.? The big aha that we had associated with that selection process was when you set those two lists of a thousand side by side, there was only 20% overlap.

Scott Nelson:??? Wow.

Jim Zuffoletti: And so we said, gosh, you walk away from this and you say getting the third-party data is the best practice, because on one hand you?ve got a compliance protection, because you really want to be able to show that the reason you?re working with an individual is because they?re the most qualified, they?re the most applicable for it.? But the other thing is from a performance perspective, if I?m using and working with and collaborating with the right top thousand, I?m going to get my products to market faster than anybody who?s out there.? So, getting that access to third-party data is definitely an identified best practice.

Another best practice that I?d cite, jumping over engagement planning for a second and moving to tracking, is the ability to be willing to break down kind of the functional walls in terms of sharing information.? So if you?ve got a medical function that?s engaging and a clinical function that?s engaging and a marketing and even a sales function that?s engaging with the same individual, maybe you can?t share all the information about the nature of engagement back and forth, but you certainly could use technology to selectively share that so that, again, there?s that common knowledge.

Scott Nelson:??? Uh-huh.

Jim Zuffoletti: That?s a big best practice that?s out there. ?Those are just a couple of things.

Scott Nelson:??? Real quick in relation to that point, what you?re saying is maybe not every single detail shared but for the most part everyone that needs to know is on the same page at the very least, being able to use that technology.

Jim Zuffoletti: Absolutely.

Scott Nelson:??? Yeah.? Right.? So, go ahead, sorry to interrupt.

Jim Zuffoletti: And sometimes it gets down to?oh no, and finally moving on to the sharing of content, Otavio has already referenced this, we?ve really seen a sea change in device over the last couple of years where they?re going in the direction that we?ve already seen take place in pharma, which is you?ve got to share content with KOLs for effective collaboration.? But as an organization, you have an incredible responsibility for that content, even when it leaves the building.? So what can you do to exert control over that content?? So that kind of savvy thinking about the content I?m sharing and how I can control it is another best practice that we?ve seen.

Scott Nelson:??? Very good.? And Otavio, if you want to just, even referencing some of these points and then adding in sort of your own two cents, because obviously OpenQ is a platform to help solve somebody?s issues, so I?d like to get a better feel, maybe prod a little bit more detail at, using OpenQ?s platform, how we can make sure that all the pertinent parties are at least on the same page.? Using that search and discover sort of the whole identification area, how can we get that objective list of surgeons and sort of cross-reference it with the tribal list as Jim pointed out?? Do you want to just kind of mentioned some of this stuff?? I?d like to get into some details about, I guess learn a little bit more about your platform from a details perspective.

Otavio Freire:? Sure, absolutely.? And thank you for the opportunity for doing that.

Scott Nelson:??? Yeah.

Otavio Freire:? So what we really realize is what the industry needed was?I don?t know how much of you are familiar with Salesforce?s technology, but Salesforce has this product called data.com.? And data.com is a means for you to go search and find context to add to your system.? We?ve recently signed a partnership agreement with Salesforce, so all our technologies now are on the Salesforce platform, and we did that because the industry has really massively adopted Salesforce.? Med tech has adopted Salesforce in a big way.

Scott Nelson:??? Right.

Otavio Freire:? And what we bring is effectively the data.com for life sciences, and it?s incredibly cool.? Think of it almost like the means by which you can find and rank and qualify the individuals that are most influential in the space.? You put in your search term, and we?ve built the ultimate database around everybody.? So we?ve got the master database in the space about the individuals and all their capabilities in over?now, we have half a billion records, so it?s incredibly rich.? And then the engine, you can play with the criteria, you can filter using the sliders around, you know, ?I want someone more trial-focused,? ?I want someone who?s a better speaker,? ?I want someone who?s really focused on advisory boards.?? So you play with your scales and sliders, and it comes back and says, ?This is the 100, this is the 99, this is 98,? all the way back to 1.

And you can then, from our technology, click checkboxes and add them to your CRM system, Salesforce or other systems, or Argo for example, and it?s very easily done.? So we?ve streamlined the process. We?ve cut down all the time it takes to finding individuals that used to be incredibly cumbersome before our solution came to market.? So that?s the first step.? This is a critical technology that enables that identification.

But also what we can do is we have experts, PhDs in several areas around that our customers are.? So if you say, ?No, I?m not a self-doer.? I want the expert to do this for me,? we can provide that, too.? So we have individuals that have built up that knowledge and they can go into our database and get you the correct list.

Scott Nelson:??? Okay.

Otavio Freire:? A few points to make is it?s seamless, it?s embedded into Salesforce and it?s really easy to move the data and then start taking action against it.? Does that kind of help how it works?

Scott Nelson:??? No, it does.? That?s great.? That?s a great example.? And just from an example standpoint, so if I want to identify certain KOLs or key opinion leaders, I?m getting ready for a product launch for, say, in my world, it would be maybe a new drug, Coda Balloon for example.? I want to identify all the interventional cardiologists that fit a specific criteria whether they?re more focused on the podium, the conference, kind of the podium talks, whether they?re more advisory kind of council-based, etc.? So I can identify certain criteria and just slide those criteria back and forth and come up with, you know, and fine-tune my list, all within this sort of identification system then.

Otavio Freire:? That?s correct, Scott.

Scott Nelson:??? Cool.

Otavio Freire:? Or you can have our people do that for you if you don?t have the time.

Scott Nelson:??? Gotcha.

Otavio Freire:? You play around with the data, so we offer kind of a high-tech service as well.

Scott Nelson:??? At the very least, I?m thinking, Jim, as you pointed, even if I?ve got my own tribal list, which if you?re a high-level physician [00:29:04] you?ve always got that tribal list, sort of that list in your pocket, so to speak, even if I just want to reference it, ?Hey, where is my list?? How does it compare to this sort of objective data??? I think that would be extremely cool.? That?s good stuff.? Was there something else, moving on kind of beyond the identification arena?? Was there another sort of a little bit more detailed tool in regards to?and maybe if you want to jump to sort of the control over the content, because you mentioned before the ability just to sort of have the document open up automatically from a remote location.? Maybe speak to that, because that?s kind of an interesting tool that I think the audience would find enjoyable to learn about.

Otavio Freire:? Yeah.? So, if you think about, you know, going back to the framework, you identified data.com for life sciences, you?ve added to OpenQ Salesforce, that sits on top of Salesforce, so now your medical team, your commercial team and a strategic management team, if there happens to be an internal name for the team we?ve [00:30:23] designed some variants there, are all on the same page on collaborating [00:30:28] to share the plan.? So now you?ve got the data, you?ve got the plan, and then you start mapping the content against it in light of specifically what you?re trying to accomplish with the key opinion leader over the course of the year.

So that content, it shows up on several places, but kind of jumping ahead, let?s say, now your interaction with that KOL is going to take in an institution and there is just no Internet access.? So we offer an iPad solution that syncs everything up so all the data, all the insight you need about your interaction and all the content is available on the iPad.? And a few things to point out there.? First of all, as you know, Scott, the industry?s gone massively mobile.? I would contend now that mobile is the platform for med tech.

Scott Nelson:??? Sure.

Otavio Freire:? And you need to start from it.? You need to think about it that way.? You can?t have a mobile solution with a little web interface.? That?s not real mobile, right?? You need to really build all of the tool set on the mobile.? And there?s a verification taking place there where the industry has really said, ?Mobile means iPad for us.? [Laughs]

Scott Nelson:??? Yeah.

Otavio Freire:? There is that dynamic where although, as you know, there are several mobile technologies, there are some public numbers out there.? As you know, [00:32:07] Global has just purchased 12,000 iPads.? Medtronic has an ad on the Apple?s site and they mention 5000 iPads that they?ve purchased.

Scott Nelson:??? Yup.

Otavio Freire:? So they?ve publicly disclosed the number of iPads that they?ve purchased, and they?re making use of it.? So we really felt like one of the critical technologies is to make sure that this framework to compliantly collaborate with these relationships [00:32:37] were done in a mobile setting.? So there you?ll find the content, you?ll find all the data, you?ll find the plan, and then you?ll find critical insights about individuals because we really felt like we couldn?t just provide data.? The industry has moved on from asking companies like OpenQ just for data, so with the onus of interpretation on them to providing the insight they need.? So they walk in and they understand critical [00:33:04] affiliations, they walk in and they understand the science preference of the individual, and then that interaction becomes a very effective one when you are exactly where the surgeon might be in terms of his desire for knowledge.

Scott Nelson:??? Gotcha.? Okay.? So I guess more kind of shifting to sort of the off-label issues, the unimproved kind of product issues and those sorts of statements, if I?m on the regulatory side and we?re working in conjunction with a certain KOL that?s going to do a talk at either some sort of dinner program or awareness event or some sort of conference, and we?ve got this pre-approved PowerPoint, I want to make sure that this is what?s approved from our regulatory people our legal team in-house, this is what is going to be presented.? And so just to get down into specifics, does that file that PowerPoint, for example?? Is that in the OpenQ system, and then that KOL then uses the OpenQ system to access that file to present on that content?

Jim Zuffoletti: So, Scott, that product that we have is called Empower.

Scott Nelson:??? Okay.

Jim Zuffoletti: And we?ve actually, referencing what Otavio is saying about mobile, we?re actually built around accommodating the needs of that surgeon who?s speaking promotionally on behalf of a device company in a couple of ways.? One scenario could be they bring their own laptop, but what you want to do is provide them with access to the content that they can present in an offline and a locked fashion and an expiring fashion.

Scott Nelson:??? Okay.

Jim Zuffoletti: And part of the power of Empower, our solution, is providing that ability so that the surgeon can go, can access that content online, can prepare their presentation, and then download that presentation into a locked file format that then they can go for and then present.? So they get access to the content, they get the ability to have some editorial control over it like ordering of slides and the like, but the medical device company gets the ability to ensure that certain slides are going to be covered, that content isn?t altered to introduce unapproved use and off-label claims.? So they can do it in a file format on their own computer or, as Otavio referenced, MobileQ, our mobility platform, is a platform that could be used by the surgeon themselves where they could actually go online, access the content that they?ve been approved to view, and then connect their iPad to a projector and make that presentation or a one-on-one presentation off their iPad directly with another individual.

Scott Nelson:??? Gotcha.

Jim Zuffoletti: So the content is available in multiple forms using Empower and MobileQ, but the guiding principle is, how can we make content easy for the KOL to access but protected and controlled to manage the interest and control the compliance for the medical device company.? Otavio, anything you want to add to that?

Otavio Freire:? One interesting thing about that, Scott, is, you know, you mentioned [00:36:31], it?s the phone-home capability, right?

Scott Nelson:??? Mm-hmm.

Otavio Freire:? So they?ve taken the file, they?re about to run, as you said [00:36:43] it might be mis-said and you want to avoid the embarrassment.? It won?t happen because the file?s going to call back the server and then basically say, ?Hey, am I good to go?? before it opens.

Scott Nelson:??? Yup.

Otavio Freire:? And it?ll say, ?Well, no.? So let?s update you.?? And then the surgeon gets presented to the popup that basically says, ?You know, we really have to update these slides here.? This is why.? This is the new version.?? So we ensure that that embarrassment that you [laughs] unfortunately had to go through is highly minimized.

Scott Nelson:??? Gotcha.? Okay.? And moving beyond sort of the controlling of the content, the sharing of the content, let?s go to that measure and monitor topic.? And I?d like to learn a little bit more about that because that?s always been somewhat of a fascinating issue to me, is you?ve engaged these KOLs to do whatever sort of [00:37:38] event, whether it?s a speaker program, grant funding for a study, a podium talk, etc.? How does a tool like OpenQ or how do you begin to measure sort of the ROI?? And is that really the aspect you were getting at, Jim, when you mentioned sort of the measure and monitor sort of tactic?

Jim Zuffoletti: Yeah, so a couple of quick thoughts on that, Scott.? One is, when the idea of ROI comes on, we really approach it from kind of two fronts.? One is that we say there?s no getting around that what we?re trying to do is help the performance of our customers.

Scott Nelson:??? Right.

Jim Zuffoletti: If they work with us, they?re going to get their products to market and adopted quicker because they?re going to be better collaborators.? But whenever we really talk about ROI, one of the things quite frankly we talk about is the ROI of compliance, which is we?ve seen in the device space our customers be subject to on-site reviews and audits by various federal agencies, and the power of adopting a technology like an Empower solution from OpenQ is that when the government shows up and conducts an investigation, you?re able to support your decisions that you?ve made and demonstrate the fact that you?ve been monitoring it.? So, set aside the fact that you can avoid the kind of multi-hundred-million-dollar fines that we?ve seen in this space, but you can also avoid those hundreds of thousands or millions of dollars that it takes from supporting the discovery aspect of an investigation.? So when we talk about ROI, we talk about it from that perspective, the kind of the ROI of compliance.

Broadly speaking with respect to monitoring and measuring, you can almost think about that as a look back on those different elements along the way, meaning, how do I monitor the identification process?? How do I monitor planning?? How do I monitor the tracking that?s taking place?? How do I monitor that content?

So, let me give you a couple of for instances.? A lot of device companies have explicit limits in terms of the amount of money that they want to pay an outside professional or the number of discrete engagements that they want to have with an outside professional.? It?s really, really difficult to manage those unless you have a central platform where you?re recording those engagements and the ability to monitor those engagements.? So the classic case will be, ?It?s the end of the year.? I?d really like to work with this person but this surgeon?s already at their [00:40:18] cap.?? And so that ability to monitor how somebody is doing, the tracking activity against the [00:40:25] cap is kind of a critical element.

Another area would be, in that identification world, there are no less than 27 different federal lists, and of course for every different state list where states regularly publish people who are subject to disciplinary actions, warnings, fines, and exclusions, and the process of monitoring your selection and identification process has to include that kind of continuous access to that stream of data, so that if somebody?s received a disciplinary action or an FDA letter, as a device company you?re able to act on that and say, ?Hey, I don?t want to work with that individual anymore,? or ?Maybe I should work with them less.?

So measuring and monitoring really, again, transcends that kind of whole engagement process.? In looking back, if you think about content, one of the things that we help companies measure is you like to know if the surgeon?s about to make a promotional speech on your behalf and hasn?t downloaded the content, so that you can have the rep or the physician relations person call that surgeon and say, ?We really need you to download that content before you make that presentation,? and that?s where the OpenQ technology can really step in.

Scott Nelson:??? Gotcha.? Very good.? No, that?s cool stuff.? I?m thinking of like, you referenced the API integration with Salesforce.com, and most people on this call or most people that are listening are somewhat familiar with Salesforce.com, that it?s a CRM, the whole CRM space, but is it safe to say that if I had to sum up OpenQ, it?s like a CRM for KOLs, right?? I mean, sort of on steroids, but a CRM on steroids for KOLs [laughs] and companies?? I mean, is that like a one-sentence summary of OpenQ?

Jim Zuffoletti: We like to think about what we do, because of the nature of kind of the changing relationship between the company and outside professionals, we often talk about collaboration, as the collaboration technology, because there is an aspect with CRM and there is this aspect of content control and enterprise content management.

Scott Nelson:??? Right.

Jim Zuffoletti: But often what we do is we think about it in terms of, how has the DNA of that relationship shifted?? That we refer to it as mobile social compliance.? Because at the end of the day, when our customers are looking for solutions, they?re not typically talking about just CRM or just content management.? They?re looking for the means that I can collaborate, and more and more when they?re saying they want to collaborate, they want to collaborate using a mobile platform and they want to collaborate more in terms of thinking about the social aspect of KOL engagement.? So that?s kind of how we think about ourselves.

Scott Nelson:??? Gotcha.? Okay.? Very good.? And I know we?re kind of reaching sort of the end of our time here, but I wanted to jump, you mentioned social and I wanted to cover that real quick because that?s obviously a huge issue, is in a world of social media, in a world of social is probably the better description, in the world of social today, how is that impacting the whole KOL arena?? And in fact , ironically enough, I read a blog post this morning by?he?s a big social physician.? I know his Twitter handle is like Doctor_V, I believe.? He?s a pediatric gastroenterologist, I think, out of Dallas.? He wrote a post about how does social impact KOLs, and he listed like four or five different sort of deals.? But can you guys speak to that?? If I had to summarize the question and kind of break it down into a really brief summary, is, how does social media impact that?? How does Twitter, Facebook, LinkedIn, etc., impact KOL engagement in this whole arena today?

Jim Zuffoletti: Well, first of all, Scott, let me say that we could do a whole podcast on that?

Scott Nelson:??? [Laughs] That?s right.

Otavio Freire:? [Laughs]

Jim Zuffoletti: ?and we?d like to talk to you at length at some point, but let me just give you a couple of quick thoughts, and then I?ll turn it over to Otavio as well.? So the social media impact is profound, and let me start by saying, we perceive that device really wants to become social.? At Salesforce they talk about the concept of the social enterprise, and a lot of what we talk about with companies is, how do you become the compliant social enterprise in terms of your collaborations and your kind of extended engagement with KOLs?? But thinking back to that whole engagement process, identify, plan, tracking, sharing of content, all of those can have social aspects to it.? You can gather data about KOLs that have to do with kind of their social behavior.? You could think about how you share content with a KOL in a social setting, like a social community.? You could think about the incredible [00:45:25] responsibilities that a company might be taking on because they want to understand kind of, again, everything that that KOL is doing, including perhaps what they?re saying in the social realm.? Otavio, anything else you want to add to that?

Otavio Freire:? Yeah, one thing that was asked to me, and I saw a customer stand up and make this mention, was social really is actually a measure to be more efficient and reduce costs, and it took a while to sink in, but then they started enumerating the things that they can social for that makes what they do and their budgets go farther, right?? And we certainly are at a time of the industry where that is an important focus of the industry, is to make sure that operationally they are doing more with less.? So if you think about the impact of market research where you can [00:46:21], if you think about how even in the KOL world, trying to bring in a whole set of individuals to a location and the travel costs and the honorarium costs where you can create a KOL community and use that [00:46:38] we exchange information with that KOL community and get the feedback that you need?the list goes on and on.? It?s really impactful.? It could be really impactful technology into several of the business [00:46:52] functions that a medical device company engages in, even the ability to have more insight and spend less to do it.

The analogy that one used was the Internet did that back in the mid-?90s, really allowed them to do more with less, and social represents another step change in that capability of using technology for better insights.? So it can be that impactful, but as Jim mentioned, to do it you?ve got to think about compliance and obligations.? So it?s a transformative technology.? I think it?s going to have a long-lasting impact on the med tech industry, but this is like we?re in the first inning.

Scott Nelson:??? Right.

Otavio Freire:? And there?s a long way to go, but it?s very exciting.

Scott Nelson:??? Right.? Yeah, and to your point, I mentioned that blog post that I read earlier this morning, is that one of the points that really stood out to me was the whole paradigm of you have the traditional KOLs that everyone knows.? They teach and every other surgeon, specialist, etc. listens.? So these select few teach, everyone else listens.? And with the advent of social, you have a lot more in that crowd, that listening crowd, standing up and saying, ?Well, wait a second.? I think this and I think that,? and through the power of social media their voices are now heard.? And so speaking to sort of that identification, that search and discover.? And I?m not sure if you guys are familiar with the Klout Score, which is kind of in the tech world a little bit?

Otavio Freire:? Yup.

Scott Nelson:??? ?but having a Klout Score for physicians could play maybe sort of a hidden benefit in sort of that search and discover process in trying to identify KOLs where if someone has a big social media presence, that may be a bigger deal than we think it is.

Otavio Freire:? And you renounce the royalties of that idea.

Scott Nelson:??? [Laughs] That?s right.

Otavio Freire:? [Laughs] It?s a great idea, Scott.

Scott Nelson:??? The Klout Score for physicians.

Otavio Freire:? The Klout Score, yeah, for KOLs.

Scott Nelson:??? That?s right.? That?s right.? I may have to look into that a little bit more.

Otavio Freire:? [Laughs]

Scott Nelson:??? Anyway, ideas are a dime a dollar, right?? It?s all about execution.? But anyway, the great stuff, guys, I know we?re running short on time here, so before we kind of conclude, for those listening that feel like, ?Well, I learned a ton.? This is a lot of information.? I like OpenQ,? I want you to give them an idea of where to go to get more information about your platform.? And also, if you had to leave the audience with just one thing, take one big thing away from this interview, what?s that one thing?

Jim Zuffoletti: Sure.? Let me handle the logistics, and then I?ll turn it over to Otavio for the big thing.

Scott Nelson:??? Sure.

Jim Zuffoletti: So, if folks want to hear more, we?d encourage you to come to our website www.openq.com.? We?re also on Twitter and on Facebook as well under OpenQ.? And the thing that I?ll pitch, frankly, Scott, is we do a series of educational webinars about different issues associated with engagement and mobility and social, and we encourage folks to come and join us on those webinars that we do, and then we make those available afterwards as well.? So come and listen and join the discussion, and we?re happy to engage in a dialogue.

Scott Nelson:??? Cool.

Otavio Freire:? And the one, I think if there?s one message to leave behind, is that there?s a framework out there for folks who are struggling with these issues that are the best practices in the industry, where you can put this in place and within a few weeks start reaping the benefit.? It is that powerful.? It?s a process and a technology framework, but once you?ve made the decision to adopt it it?s easy to get up and running, and it?s been [00:51:03] to several of our customers.? So if you are facing these challenges, please think about how you could use technology to address them because the solutions do exist.

Scott Nelson:??? Right.? Very good guys.? And there you have it folks.? I always encourage you at the end of these interviews, don?t just sit, don?t be that person that sits in the audience of life and just listens to these and doesn?t do anything.? And if you?re listening to this, you?re already probably a step ahead of most other people in your field, but do something.? I mean, go check out OpenQ.com.? Even if you don?t operate on a daily basis, like on that side of the fence, that KOL side of the fence, go check out one of the webinars just to get a better feel for like what goes on, just so you can expand your knowledge base and be able to have a higher level of conversations with your customers, with your counterparts, etc.? So go check it out, OpenQ, like the letter Q, OpenQ.com.

So we?re going to go ahead and end it here.? Guys, I?ll have you hold on the line, but thanks a ton for coming on and sharing your insights, your expertise.? There?s certainly a lot of information there, but there?s certainly some really cool stuff in regards to the whole topic of KOLs, grants and studies, all that stuff.? So thanks again for coming on.

Jim Zuffoletti: Thank you, Scott.

Otavio Freire:? Thank you, Scott.

Scott Nelson:??? Alright.? Until the next episode of Medsider, everyone. Take care.

[End of Recording]

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