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THE CHALLENGES OF DEVICES AND DIAGNOSTICS

ROUNDTABLE

With moderator NEIL GREENBERG, Editor, Healthcare Sales & Marketing

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Our panel of experts:

CHRISTIE BLAKELY

Vice President of Marketing, Sports Medicine and Surgical Specialties RTI Surgical

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ERIC HALVORSON

President of the Americas Comeg Medical Technologies

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WALLY HADDICK

V.P. of Sales, Canada and Latin America DeVilbiss Healthcare LLC

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DAVE SAUNDERS

Senior VP, Product Development Galen Robotics

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ERIC SHAPIRO

Vice President, Global Marketing Luminex Corporation

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We see a lot of coverage in the press about the “pharma” industry and its challenges and image. What this typically means is pharmaceutical and biopharm companies. But the hurdles faced by both the devices and diagnostics sectors are equally daunting. In our very first issue, we convened a panel on devices. Here we invite back a few of the participants in that roundtable—Messrs. Shapiro and Halvorson—and a few others to discuss what’s happening in both devices and diagnostics. What we find is that there are issues similar to what the rest of the industry faces (regulation, new marketing channels) and others unique to these sectors. Our gratitude to all our experts for their detailed and enlightening contributions. Read on!

Where are you now, and why did you make a move from your previous position?

Eric Shapiro: When Given Imaging was bought by Covidien and Covidien was bought by Medtronic, I had an opportunity to look for something else. I was supportive of medical devices, but biotech fascinated me as the next frontier of medicine.

Luminex helps decode data at the cellular level, and we partner with other companies in the industry to make a difference in healthcare. The transition was not easy. Biotech is a fairly exclusive club that wants to attract people who can hit the ground running.

Wally Haddick: After spending almost 14 years at Covidien in various sales and marketing leadership roles, I completed my MBA at the Columbia Business School executive program. That milestone sparked me to follow a dream to work for a private equity (PE) portfolio, medical device company. High risk; high reward. After joining the DeVilbiss Healthcare leadership team in May 2010, Drive Medical acquired the company in July 2015 from Vestar Capital Partners. The acquisition completed a PE portfolio exit and created an opportunity to lead the Latin American Division for one of the fastest growing durable medical equipment businesses that markets and distributes its products globally.

Eric Halvorson: Comeg is a leading endoscopy company in Europe, and we are expanding into the US. The endoscopy market is a growth area in healthcare. Procedures are transitioning from hospitals to ASCs to offices due to technology improvements and reimbursement challenges for the patients.

How does what you are doing now compare to what you were doing then?

Wally Haddick: Previously, I have been operating in more mature or developed markets. In Latin America, covering two continents and more than thirty countries, you have numerous unique emerging markets with varying currencies, economic and political environments, and various states of payer influence. What is the same is the expectation of the end customers seeking maximum value from their partners.

Eric Halvorson: As President of the Americas, I am building a quality brand and first class team. We are establishing our base of KOLs, and offering the customer a unique value proposition which takes into account the ever expanding financial challenges of our healthcare system.

Eric Shapiro: I was leading regional marketing at Given Imaging. Now at Luminex I’m leading global marketing. In some ways they are very similar. I began my career carrying a bag in pharmaceutical sales, and I’m still focused on keeping the customer first and foremost in my mind. The customers have changed a bit. As a regional marketing leader I had two groups of customers, the sales force, and healthcare practitioners and their patients. As a global leader I still have all of these, but I also work further upstream, in strategy, from product ideation through commercialization, and have to make sure that my regional marketing teams are well prepared to help their customers.

What challenges is your company facing at the moment?

Christie Blakely: Currently my company is facing challenges similar to most companies in the medical device space. These include navigating the ever changing product reimbursement landscape, understanding changes in how procedures are being paid, and expanding our messaging to include a highly varied external stakeholder group that extends beyond the surgeon as the traditional sole decision maker.

Eric Halvorson: As a newer company in a competitive space, we are building a base of COE and KOLS. Our technology is developed in Germany and France, and building our brand is the first goal. We’re up against a few very large companies who have much more visibility. Our technology has been well-proven over time but not used in the U.S. So we have to work hard and fast to build a brand name, get our products in front of surgeons, and highlight our advantages.

Dave Saunders: A sizable challenge is continually advancing our core technology as a surgical robotics platform while keeping pace with increasing demands for supporting features. A few examples of such capabilities: integration with the hospital’s electronic health record system, remote monitoring and service, the ability to review surgical plans on a computer or tablet prior to the procedure and even interoperability with other medical devices. These capabilities affect how our core technology functions (although not directly), how our customers can interact with our core technology, and the ease of integration into hospitals expanding their own use of information technology to provide better patient care.

Eric Shapiro: One of our challenges is that the space is evolving so rapidly. Information emerges every day that highlights something new, including major breakthroughs that are happening at the cellular level. Consolidation is occurring because the cost of development is so high. It’s impossible to develop tests internally for every target that is identified, so we have to maintain an understanding of priorities in the marketplace, and how to execute and commercialize products. To be competitive you need to have multiple assays, yet it’s prohibitively expensive for small companies to develop and bring more than one assay to the market at a time. Smaller companies that are doing innovative work in focused areas are being acquired by larger companies that are looking to grow in these targeted areas.

Wally Haddick: The biggest challenge for us is the same since the beginning of time for any sales or marketing executive, “How do you add value beyond price?” Value is the quotient of “perceived benefits received” in the numerator and “price paid” in the denominator. It is always easier to “see” the price paid and thus making it smaller is always the focus in most markets. Our role is to make sure that the benefits received are as clear and impactful as possible. I’ve seen that done well and poorly in operating room surgical markets and I see it the same way in emerging markets seeking respiratory and durable medical equipment.

How are you applying what you have learned from the device world to these challenges?

Wally Haddick: Insights still rule the day. Do you know what your key product and customer insights are? And how effectively do we communicate about both daily? Matthew Dixon and Brent Adamson call it “commercial teaching” in their book The Challenger Sale. They define it as “reframing the way the customer assigns value to the areas where you outperform your competitors.” Again, the easiest conversation you can have with any partner is on price. It is easy to measure.

Dixon and Adamson note four important things that your (sales) teaching must do: 1) Lead to Your Unique Strengths; 2) Challenge Customers’ Assumptions; 3) Catalyze Action; and 4) Scale Across Customers. Most organizations have infrastructure and awareness in place to do most of the four. In my experience, “challenging the customers’ assumptions” takes the most preparation with great insights from across the organization and it takes the most skill to move away from price and engage the customer in a meaningful dialogue.

Eric Halvorson: I have had the opportunity to build medical device businesses in the past. Establishing a great team and aligning with KOLs is the foundation that is most often needed. This is what we are doing. We have brought on great people, experienced, with the same values and a successful track record. We also have KOLs from multiple specialties. Surgeons rely on colleagues.

How will the challenges affect your mission?

Eric Shapiro: Our job is to empower the healthcare practitioners who are treating, managing and/ or curing patients. This is what marketing is concerned with—helping the physician, lab tech, or lab director solve problems in a cost-effective manner.

Eric Halvorson: As a smaller company, we are fast, nimble and flexible. We are able to service our customers with little red tape, and adapt to the changing market demands very quickly. Speed, from product development to marketplace: speed in responding to customers’ needs, speed in decision making. Speed is our weapon.

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Dave Saunders: Keeping abreast of these changes requires dedicated monitoring of the ever-changing ecosystem of modern hospital IT infrastructure. Generally speaking, these include hospital security for the patient; analytics to measure doctor performance, training, and simulation; claims analysis; and development of best practices.

Christie Blakely: I don’t think these challenges affect our mission: RTI Surgical promotes a higher standard of patient care and creates value by leveraging employee talents to develop the highest quality surgical solutions. No matter what environment we operate within, our company will stand true to this mission as we all firmly believe in the value of excellent patient care and encouraging employees to understand and utilize their talents for growth.

What new strategies have you needed to employ to move forward?

Eric Halvorson: Focusing the team and then being prepared to pivot when new opportunities present themselves. We’re able to adapt to customer needs quickly. Having a flatter organization allows us to make decisions quickly. This requires hiring experienced people and giving them a lot of flexibility. We also have unique features that were developed to make it easier for surgeons, nurses and technicians. This is perfectly suited to the needs of the customers, in terms of usability and affordability. We’ve very deliberately not over-engineered it with lots of capabilities that will rarely if ever be used. The software is intuitive: each surgeon can swipe a card before the operation and the equipment automatically re-sets to that physician’s needs and the operation being performed. It’s a breakthrough. So the strategy is basically getting it in front of right people.

Eric Shapiro: We highly leverage a stage gate process as we take our products from ideation through evaluation to feasibility, and development. Getting the information needed to make the best-informed decisions at each gate is critical. Every gate increases the cost by factors. We delve into the questions. Is there really an unmet need? How big is it? If we came up with a solution could we make a difference in a customer’s life? By the time we launch it 2-3 years later, will it still be relevant? The stage gate process applies to both devices and diagnostics. Diagnostics, however, requires expertise about a wider swath of diseases, so our team has to have a wider breadth and greater depth.

Christie Blakely: Going forward I think companies really need to figure out a way to be heard given all the “noise” of social media and the internet. Technology is such that companies know every item we’ve browsed on Amazon yet the personal connection, human to human, is lost. Medical device is moving toward a more non-personal connection but I truly believe the company that maintains solid personal relationships with our customers (while leveraging the benefits of technology) will realize sustainable growth in their space. So while we’re all more connected than we’ve ever been, we also are losing one of the most important connections of all, and that is the human relationship.

Wally Haddick: The strategies are not new as much as process refinement. Drive DeVilbiss is one of the fastest growing durable medical equipment businesses that markets and distributes its products globally. We have been busy with organic growth, acquisitions and integration. To move forward, we have needed to understand the unique benefits on our broad portfolio where we “win” versus the competition. Further, it takes a lot of work and focus to enrich the story when “challenging the customers” assumptions during prospecting and negotiations.

Dave Saunders: In a heavily regulated industry, technology often moves faster than the code of federal regulations it adheres to. This affects IT integration, cybersecurity issues, and the application of new artificial intelligence and neural net technologies. Collectively, these may greatly impact medical device usage and application as well as research on new medical treatments and disease causes. We will continue to seek innovative ways of applying new technologies to our platform while at the same time managing the risk of having to push too hard for regulatory approval.

What does your company have to do to address these in terms of adjusting sales techniques?

Christie Blakely: Our company is constantly adjusting sales techniques to best fit the need of the individual customer. For some customers, that means a highly individualized relationship and approach. For others, that means participating in a purchasing agreement as part of a national GPO. What we do know for sure is that techniques are not a one size fits all. Understanding customer needs and priorities and then delivering a product or service in a highly engaging way that builds trust and connection will ensure loyalty.

Eric Shapiro: We train the sales force on some very specific scientific information, which is very challenging. A diagnostic rep may have a biology undergraduate or graduate background yet still have to present in a way that resonates with the customer, while telling a compelling story. One other thing that remains critical is understanding what makes our offering unique from the customer’s perspective. How do we communicate why the customer should want to work with us and our technology?

Eric Halvorson: Creativity is very important to our organization. We will not follow the same path as the other players, we are looking for differentiated people, products, Services, and process to better serve our customers.

Dave Saunders: Our company is still in the preclearance stage for our surgical robotics platform, which gives us the advantage of not needing to make changes to our existing sales force when we are ready to go to market. When we are ready to go to market, we will equip our sales team with an updated playbook.

Wally Haddick: When we did our work years ago improving our product launch process at a prior company, we saw one of the biggest issues was a linear process from customer requirements to the eventual commercial launch. There were hand-offs from one stage to the next and one department to the next. The institutional learning about the customer experience was lost in these transitions. The most important organizational need is to ensure “swim lanes” vs. “silos” within key departments during product and market reviews. Insights are not exclusive to marketing. When researching, developing, and putting the message into practice, all shareholders need to talk and at all stages of the product lifecycle.

What do you have to do to address the challenges in terms of marketing?

Christie Blakely: From a marketing perspective it is becoming more and more about delivering value and enhanced patient outcomes than anything else. Surgeons and facilities are being assessed more critically than ever, and if a company cannot provide savings AND a product that performs consistently, then they will not be successful. So for marketing, we have to define and articulate a solid value proposition backed with clinical data. Period.

Eric Halvorson: Guerilla marketing. You will not see us advertising in the major journals. You will see and hear about us through social media, KOLs, and MD to MD.

Eric Shapiro: I went to a course a few weeks ago on biotech for managers, and the things that are being learned at the cellular level can give you incredible information that was unimaginable just a few years ago. In the past the industry was much more focused on addressing a specific targeted disease. Now we have multiple tests that span a wide variety of syndromes. The pace of innovation we have to work with in the diagnostic space feels much more rapid than when I was in devices.

But marketing is still marketing. It’s about identifying the unmet need, and prioritizing that versus other unmet needs, then building a compelling business case with an understanding of the opportunity relative to the total available market.

Wally Haddick: Dixon and Adamson note that 80% of marketing collateral winds up in the trash and 30% of sales time is spent reproducing the collateral! I remember one call to a doctor as an inexperienced pharmaceutical sales person. I was giving my pitch and handing the collateral over for each product I was detailing. As I was doing this, the physician was multi-tasking. As I handed him the sales brochures, he would grab them without looking and without missing a beat put them right behind him into the garbage can. Now, that’s not a marketing problem, but it does underscore how important it is to “grab mind share” and “catalyze action.”

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Listening and collaboration are important. One former president I worked under would say that interdepartmental meetings are like a sideline offensive meeting in football on third and long. The Head Coach, QB, Offensive Coordinator and others will provide their insights, input, and recommendations, but when the timeout is over, the QB runs to the huddle, calls the play, and everyone is on board supporting getting the first down. No dissension. Great teams debate vigorously then unite indefatigably.

What are the impediments to growth?

Eric Halvorson: How fast can we run? The market is looking for our solution.

Dave Saunders: When developing software capabilities for a medical device, acquiring regulatory clearance sometime comes one piece at a time, slowing our ability to bring cutting-edge capabilities to market. With good project management, accounting for those individual steps in advance, the regulatory impact on time-to-market should be manageable.

Eric Shapiro: The R&D costs are significant. Our clinical studies are extremely robust and very expensive, because you may have to run a panel of twenty targets, and for every target you have to validate that your test is detecting what it’s supposed to detect.

Luminex is well respected and has been an innovator for a long time, but with technology evolving, we will need to continue to invest to stay on the cutting edge in our industry.

Christie Blakely: I would summarize impediments to growth in five key areas: 1) regulatory requirements globally; 2) decreasing pricing due to new bundled payment models enacted by CMS and private payers; 3) timely execution of and financial funding for clinical studies; 4) navigating MACRA and adjusting strategies to truly meet the needs of the customer; and 5) the extensive timeline for value analysis committee review for new products/technologies to be approved within a certain facility or health system.

Wally Haddick: With more than thirty countries in emerging markets, the biggest impediment is regulatory and compliance planning. Drive DeVilbiss has been busy with acquisitions and integration recently and operates in more than 80 countries globally. It is important to have the discipline and focus to sit without partners and plan strategically beyond the current fiscal year.

What is your competitive situation?

Eric Halvorson: We are in a very competitive space with large multinational companies. Without risking telling them what we are doing, I will say we offer the customer what they need, when they need it.

Christie Blakely: Many of the large orthopedic companies are developing entirely new business units to address the CCJR bundled payments initiative. Other companies are expanding their education footprint in order to continue to deliver more personal customer/ company interactions. All companies are funneling more and more dollars into supporting clinical studies, as this is a requirement of value analysis committees as they determine whether or not to allow a new product or technology to come into their facility. Lastly, companies are investing more time and energy on GPO and IDN agreements as participation in these define a company’s ability to access surgeon customers within a single facility.

Dave Saunders: Now, with a general acceptance and customer demand for surgical robots, the industry is moving towards adapting more capabilities of the computer systems to do things a surgeon on their own cannot do, or that only the very top practitioners are capable of. We see a lot of interest in greater simulation and training, augmented reality, and even the incorporation of neural net technologies into our own surgical robotic platform. Merging a surgical robotics platform with a simulation and training platform improves education capabilities, extends the physical capabilities of some surgeons in the field, and has the potential to greatly advance the level of patient care possible throughout the entire hospital system. These technologies could also improve patient care in developing countries and battlefield situations.

Where do you see the industry a year from now? Five years?

Wally Haddick: In the next four years, the World Bank expects the population of people over 65 years of age in Latin America and the Caribbean to grow by 18% (more than double the European Union at 7%). By 2024, the total number of people over 65 years old in Latin America (68.4MM) will surpass the total in the United States! We see partners in emerging markets winning because they are disrupting the payer side focusing on outcomes rather than resources and processes of old fee for service patient care as Clayton M. Christen detailed in The Innovator’s Prescription. The medical device market is deep into connectivity, patient data transparency, and providing value to decision makers as a unique benefit. Those healthcare companies who can continue to leverage their scale, broad product offerings, and innovative thinking will outpace market growth in the next five years.

Eric Shapiro: Molecular diagnostics are growing rapidly. The overall market is expanding significantly. As our knowledge continues to grow, companies are continually figuring out how to detect more diseases. At the same time, we still don’t have accurate tests for many diseases, nor do we have the tools to knock them out. These have to be evolved. But we are doing more and more research to better identify at the molecular level what may be the source of many diseases. For example, look at Zika. The African strain was around for many years, but the South American strain evolved differently, and had consequences not commonly seen with the African version, like microcephaly.

Eric Halvorson: The surgeons are very interested in both the traditional outcomes of surgery and the patients’ satisfaction of their services. Cost to the patient is part of the changing dynamics, as the patient is being asked to pay higher deductibles. This drives new behaviors from the patients, who are now the consumers. I see this trend continuing, and the consumer becoming more savvy and educated in their choice of care.

Dave Saunders: As a heavily regulated industry, technological availability will lag until someone has an incentive to push that technology into a device. The most promising of those technologies are providing AI assistance to the surgeon through 1) more autonomous movement of the robot (e.g. a recent animal study where a robot autonomously sutured two ends of a colon) or 2) by providing greater imaging capabilities and augmented reality. I see the potential for incorporating augmented reality and integrated heads-up displays into medical imaging systems (e.g., endoscope displays and microscopes) to improve the speed and efficacy of patient care. Neural net and artificial intelligence-based image recognition technologies enable medical professionals to identify relevant displayed information faster than on their own, allowing them to focus on delivering a high level of patient care.

Right now hospital networks are busy coming to terms with advances in the IT infrastructure required to handle large patient loads, reduce readmissions and errors, and still make a profit. The more ubiquitous these highly integrated hospital networks become, the more we should also see a demand for the Internet of Medical Things (comprising medical devices that can be monitored, data collected from, and automatically acted upon). No hospital will tolerate, in the long term, every medical device having its own app and obscure set-up overhead. Consequently, the Internet of Medical Things needs to be well-designed by every medical device company participating in it. Functionality must be more or less seamless and security, while no one should ever claim to be hacker-proof, should be top-of-mind for all companies and vulnerabilities should be constantly sought out, identified and mitigated as quickly as possible.

Christie Blakely: I have been in medical device for 29 years and I have seen tremendous change throughout this period. Having said that, I do think we will see change within the next five years unlike anything we’ve seen in the last 20. Rapidly changing technology will lead this change. Patients will be connected to their providers, physicians will receive real time data on their patients through wearable or implantable technology, companies will continue to acquire and merge in order to deliver broader portfolios and savings to health systems, and patient outcomes will continue to be at the center of all we do. Having said that, and going back to a point I made earlier, it will be more important than ever to maintain personal relationships with our customers. There is nothing that will ever replace the importance of buying from someone you know and trust.

MEET OUR PANEL OF EXPERTS

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CHRISTIE BLAKELY

Vice President of Marketing, Sports Medicine and Surgical Specialties RTI Surgical

Christie oversees all aspects of RTI’s marketing for the orthopedic, sports medicine, plastic and general surgery areas of the business. This includes developing strategic plans for the franchise and directing the priorities of product development. Prior to joining RTI, she spent more than five years at Zimmer Inc., including serving as director of relationship management and surgeon communications, director of U.S. regional marketing for hips, and director of global marketing for hips. Her experience also includes overseeing the hip portfolio at Exactech Inc., and sales and product management at Smith & Nephew. Christie received her BBA and MBA from the University of Memphis.

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cblakely@rtix.com  

RTI Surgical® is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed.

WALLY HADDICK

V.P. of Sales, Canada and Latin America DeVilbiss Healthcare LLC

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Wally is responsible for commercial operations and P&L for Canada and Latin America. Previously, he spent more than fourteen years at Covidien where served as product manager, sales vice president, and marketing vice president. He began his career in 1992 as a sales representative for Pfizer, Inc.

Wally.haddick@gmail.com  

DeVilbiss Healthcare is a leader in the design, manufacture and marketing of respiratory medical products which are distributed in more than 100 countries around the world. DeVilbiss Healthcare is a privately held Limited Liability Company owned by Vestar Capital Partners. Vestar is a leading private equity firm specializing in middle-market growth capital investments.

ERIC HALVORSON

President of the Americas Comeg Medical Technologies,

Eric leads Comeg’s novel visualization and surgical technologies expansion in the Americas. He has also served as VP and General Manager for Coloplast, as well as VP Interventional Respiratory and VP Chief Marketing Officer at Olympus. Eric held previous executive positions at Smith & Nephew and Boston Scientific. He is an experienced medical device leader with private and publicly traded companies, leading cross-functional teams with P&L responsibilities, and a proven turnaround and growth expert, improving EBIT through reorganization, leadership, and developing a focused strategy. Eric has delivered strategically important acquisitions and managed integration of newly acquired companies. He is a past Board Member of Spiration and ASGE.

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Eric.W.Halvorson@gmail.com  

Comeg of the Americas is part of Sopro-Comeg, which was formed from the merger of Sopro, a well-known company specializing in medical imaging, and Comeg, which since 1977 has been innovating in the world of endoscopy. The company has commercial offices on five continents. Its technologies are focused on improving procedural efficiency and patient outcomes in ENT, GYN, URO, and laparoscopic surgery.

DAVE SAUNDERS

Senior VP of Product Development Galen Robotics

With nearly 30 years of professional experience with Internet technology and medical devices, Dave has brought over 40 innovative products from early development to market. He’s the professional nerd on the executive team for Galen Robotics, which focuses on bringing new innovations to market from the top research groups and hospitals in the US. Dave assesses company assets, resources and intellectual property, and strategizes on the best approach in taking to market products that are meaningful to practitioners and patients. This includes rapid learning and assimilation of new technologies and techniques, development of business plans, system design and continued management of the IP portfolio. Prior to his position at Galen Robotics, Dave was VP of Product Development for Trak Surgical, VP Engineering, and was part of the R&D management team at Lucent Bell Labs.

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dave.saunders@galenrobotics.com  

Galen Robotics identifies optimal convergences of advanced technology and medical device concepts by bringing software-based navigation, imaging and data collection to existing, dumb medical devices. The company brings a fresh, Silicon Valley-based, entrepreneurial approach to creating medical device market opportunities, and applies its software expertise to making medical devices intelligent and more effective.

ERIC SHAPIRO

Vice President, Global Marketing Luminex Corporation

Eric provides leadership, best practices and execution guidance to the Global Marketing team responsible for the company’s longterm strategy and all upstream marketing, along with support of regional downstream marketing efforts. He’s also responsible for guiding and focusing efforts of Scientific Affairs, Creative Services, Digital User Experience, Trade Shows and Events, and Corporate Branding teams for this ~$250M biotech company. Previously, he was principal of ESS Strategic Consulting, VP Marketing for Given Imaging and held several positions at KCI Medical, including VP Marketing, VP Field Patient Coordination and Director, Corporate Development.

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eshapiro@luminexcorp.com  

Luminex is committed to creating innovative, breakthrough solutions to help its customers improve health and advance science worldwide. It serves the needs of customers in diverse markets, including clinical diagnostics, pharmaceutical drug discovery, biomedical research, including genomic and proteomic research, personalized medicine, biodefense research, and food safety. Its goal is to transform global healthcare and life science research through the development, manufacturing, and marketing of proprietary instruments and assays that deliver cost-effective, rapid results to clinicians and researchers.

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