Preferred Circulation

The cows are coming around again.

After years of radio silence, bovines on the Tate family farm in south central Alabama are responding anew to the sound of their owner’s voice. “All he has to do is call the cows and they come running,” Norma Jean Tate says, smiling slightly at the thought.

That simple, ordinary (and moderately boring) farm chore has become a celebratory milestone of sorts for Tate and her 80-year-old husband Earnest, the first African-American police chief of Selma, birthplace of the modern civil rights movement. For several years, the retired lawman had been too sick to call his beloved cattle due to a narrowing aortic valve that robbed him of his energy, appetite, and vigor. Last spring (2015), outflow from that diseased valve had become so constricted that Earnest could hardly walk without becoming winded. His heart had begun to fail him. 

“I remember I was so sick. I would walk a piece and then have to take a break to catch my breath,” Earnest Tate recalled. “It seemed like I wasn’t going to catch [my breath]. I told my wife, ‘I can’t live like I’m doing.’ ”

Earnest’s body couldn’t go on in such a poor state, either. Too frail to support a major invasive procedure like open-heart surgery, its only option for survival was a transcatheter aortic valve replacement (TAVR), a less invasive treatment in which a replacement heart valve is threaded through the thigh and wedged into place over the damaged vascular pipe.

Cardiologists at UAB (University of Alabama) Medicine replaced Earnest’s natural aortic valve with a man-made one from Edwards Lifesciences Corporation. Comprised of bovine pericardial tissue, the SAPIEN XT Transcatheter heart valve is delivered through a 16-French expandable sheath and ranges in size from 20 millimeters to 29 millimeters (the latter size is reserved for patients with particularly large annuli). The SAPIEN XT valve is approved in the United States and Europe for pulmonic valve replacements as well as aortic and mitral applications, including valve-in-valve procedures in both adults and children. Edwards boasts its SAPIEN product platform has replaced more than 100,000 faulty valves worldwide.

Within hours of joining the SAPIEN statistical microcosm in July 2015, Earnest’s health had improved dramatically. “He just looked 100 percent better,” Norma Jean recounted in a short video on Edwards’ website. “I’m very grateful that he had the procedure done because he’s like his old self again.”

A healthier version of his former self, of course.

“When I woke up, I said, ‘Whatever they did, it worked. I can breathe.’ I was in the ICU the night after the procedure, and in the morning, the doctor came in to check on me. He said, ‘I can’t believe you’re sitting up and smiling at me, as sick as you were yesterday.’ I told him, ‘I don’t know what y’all did, but whatever it is, it’s working.’ I feel like I can do anything I want.”

And more than a year after his procedure, Earnest is back to doing anything he wants: tending to his cows, riding his tractor, and baling hay on the farm—all testaments, really, to a medical technology that was unheard of just two decades ago, but could truly revolutionize the treatment of cardiac conditions in the decades ahead. TAVR is one of the fastest-growing interventional cardiology sectors, with annual gains averaging 16 percent over the next four years, according to market research firm Technavio. Moreover, the global market for the technology could top $2 billion over the next 10 years as the number of TAVR procedures quadruples—going from 71,000 in 2015 to 289,000 in 2025—and companies like Boston Scientific Corp., Direct Flow Medical, and St. Jude Medical Inc. attempt to siphon sales from the two market leaders, Edwards Lifesciences and Medtronic plc.

Total market value also could be impacted by clinical data comparing TAVR outcomes with open-heart surgical aortic valve replacement (SAVR) results. Since debuting five years ago, TAVR products—namely, Edwards’ SAPIEN platform and Medtronic’s CoreValve—have shown marked improvements in survival for seriously ill, formerly inoperable patients. Results have also been exemplary for extreme-risk and high-risk surgical patients.

Both the CoreValve and SAPIEN heart valves are undergoing investigational device exemption studies this year to measure outcomes in low-risk surgical patients. Some industry pundits believe the results could determine the future of aortic stenosis treatment, particularly if the data shows TAVR outcomes similar or equal to SAVR. Others, however, contend the technology is still too expensive and unproven (over the long-term) to supplant open-heart surgery.

Regardless of its impact on SAVR, transcatheter aortic valve replacement technology will almost certainly transform the interventional cardiology market in the coming decades. “I believe TAVR is a breakthrough technology,” opined Martin B. Leon, M.D., of New York-Presbyterian Hospital/Columbia University Medical Center in New York, N.Y. “It’s astounding how quickly this technology has grown. It’s equally astounding to see how some of the disturbing complications we confronted in the early days have been reduced over time. I think no one would argue that there has been dramatic global growth and universal acceptance with seemingly unlimited potential.”

To further explore TAVR’s future potential, as well as the possibilities on tap in the interventional cardiology market, Medical Product Outsourcing spoke to a half-dozen device manufacturing professionals and consultants over the last few weeks. Participants included:

Ben Harren, vice president of global sales and marketing for Donatelle, a New Brighton, Minn.-based contract manufacturer serving the cardiac, diagnostics, neuromodulation, orthopedic, and vascular sectors, among others. The company is an experienced designer, developer, and manufacturer of cardiac leads, ventricular assist devices, balloon catheters, coronary stent delivery systems, and guide catheters.

Robert LaDuca, CEO of Duke Empirical Inc., a Santa Cruz, Calif.-headquartered provider of medical device tubing and catheter components. Its products serve various markets, including interventional cardiology, neurology, vascular therapy, stent/implant delivery, structural heart therapy, vascular access, transcatheter heart valves, and ablation.

Maura Leahy, marketing manager for Creganna Medical, a designer and manufacturer of minimally invasive delivery and access devices. The Galway, Ireland-based company’s products range from standard angioplasty balloons and catheters to complex cardiac balloons for advanced clinical applications.

Jessica Lenhardt, senior director of marketing; Jim McCormack, manager of global marketing communications; and Joseph Penn, portfolio development manager for Teleflex Medical OEM, a provider of custom-engineered medical components based in Gurnee, Ill. Its services and technologies have been used in the creation of diagnostic and interventional catheters, cardiac balloons, balloon catheters, and sheath/dilator sets (introducers). The firm recently opened a Customer Solution Centre in Limerick, Ireland, for the development of catheters.

Dave Liebl, executive vice president, interventional products, for Heraeus Medical Components, a St. Paul, Minn.-based provider of comprehensive medical component manufacturing services. The company’s interventional product portfolio includes coils, guidewires, micro components, torque coils, core wires, ground wires, and hypo tubes.

Steve Twork, global market manager, medical devices, for Bal-Seal Engineering Inc., a provider of custom-engineered sealing, connecting, conducting, and EMI shielding and grounding solutions. The company’s Bal Spring canted coil springs are used for holding, latching, and electrical contact in various medical applications.

Michael Barbella: Please define the interventional medtech market.
Ben Harren: Interventional medtech is the segment of medtech that enables the prevention or treatment [of disease or conditions] utilizing some form of therapeutic device. Using cardiology as an example, a subset of cardiologists specialize in diagnostics, and another subset specialize in interventional procedures. Though the products used by these different groups are similar, there are significant differences between devices that are used for intervention to deliver therapy versus those that are diagnostic in nature. As we think about the interventional market, it boils down to the type of products our customers are purchasing, building and selling that deliver some sort of therapeutic benefit.

Robert LaDuca: In my experience, interventional markets are markets where the devices that are being used to treat the patient are going to be invasive in some manner. It’s not non-invasive like taking your temperature or taking your pulse; the act of a needle entering your arteries or veins is an interventional procedure. It is a broad term that is used for diagnosing and treating a patient that involves entrance into the body with some level of risk associated with the intervention. Typically, fields that have not been considered interventional or part of the interventional market may be surgical fields such as cardiac surgery. Now, for example, cardiologists perform interventional cardiology procedures which use catheters to deliver stents to coronary arteries and open up blockages to restore blood flow without surgery. So, that market—interventional cardiology—developed from cardiac surgery. The entry point for the catheter is now routinely performed without a surgical incision, but rather an arterial puncture is made with a hollow needle. This shift to percutaneous access transforms a cardiac repair procedure with surgical access performed by vascular surgeons to an interventional procedure performed by interventional radiologists or interventional cardiologists. Similarly, there are markets that are developing currently due to advancements in device technology that allows for treatment of diseases which previously did not have interventional products available. It is the market availability of new products which enables the development of interventional markets. For example, interventional pulmonology—we now have devices that access the bronchial tree to take biopsies and deliver implants to improve breathing. Previously, lung resection was the only available way to treat diseases like emphysema, to reduce lung volume which eases breathing. Now, interventional pulmonologists navigate catheters into the bronchial tree to exclude parts of the lung, providing similar benefits to the patient, but with significantly less trauma and recovery time. We’re seeing the rapid expansion of interventional markets due to the market’s demand for innovations which lower cost, improve patient benefit, and lessen the morbidity and mortality of procedures.

Maura Leahy: At Creganna Medical, we define the interventional medical technology market as constituting medical therapies that are delivered using a minimally invasive approach. Minimally invasive therapies leverage the natural pathways and vasculature of the body using image guidance to reach diseased organs, diagnose disease prevalence, deliver a therapeutic medical device, or other treatment. Access and delivery devices such as sheaths, catheters, and guidewires are synonymous with interventional medicine. Catheters are a fundamental tool for any minimally invasive surgery—they establish access and enable the surgery.

Dave Liebl: The interventional medtech market in our view is the field of products and technologies that support a percutaneous approach (versus surgical) toward medical procedures spanning nearly all disciplines of the medical market. Our contributions to the interventional medtech market include specialty/procedural components, assemblies, and delivery systems, catheters and guidewires for vascular access and PICC procedures, structural heart applications, peripheral vascular, interventional cardiology, neurovascular, gastrointestinal, endoscopy, and electrophysiology.

Steve Twork: The interventional medtech market encompasses both tools and techniques. It combines the use of radiology and medical devices to offer patients non-invasive alternatives for treatments that traditionally required invasive surgical procedures and hospitalization. Interventional procedures use high-resolution imaging devices such as gamma cameras, X-ray computed tomography (CT), positron emission tomography (PET), and ultrasound devices for implanting devices, or for guiding a needle alongside nerves to treat conditions such as disc herniation with radiofrequency ablation. High-resolution imaging equipment enables physicians to target difficult areas of the body using endoscopic, laparoscopic, and arthroscopic methods. Use of this imaging-driven method is becoming common in orthopedic spine and vascular surgeries for treating peripheral arterial disease (PAD), and for delivering stents to the heart.

Barbella: What trends are you seeing in the interventional medical device market? What factor(s) are driving these trends?
LaDuca: A trend that we see continuing is funding for devices that show promise to improve patient outcomes by either modifying the treatment procedure or providing additional benefit to stakeholders by solving a known limitation of existing technology. Since the economic crises in 2008, we saw more gradual improvements in device technologies, as investors adopted a more cautious approach to developing products that have a known pathway towards commercialization, that meet the additional criteria of reduced procedural cost and improved clinical outcomes. I would hold that there are incremental improvements relating to function, as opposed to the broader innovation that has been the case in prior years, where there was less emphasis on cost reduction and efficient outcomes for patients and hospitals as well as payers.
People are looking to find ways to improve existing procedures while lowering costs­—specifically, that might be a better way to take a biopsy with a device that provides a greater likelihood of successful sample collection. Sometimes diagnostic tests are performed, but do not achieve the objective as there can be limitations to obtaining the sample at the target location. This can be due to challenges in anatomy and device limitations. Thus, incremental diagnostic device improvements may allow for more patients to be treated with existing therapies upon definitive diagnosis. Another trend is for device manufacturers with existing products to expand the markets for their products by expanding the indications for use. This is being done through the design of clinical trials that can provide evidence for increasing the patient population. Expanding established markets is a trend that will continue because of the cost pressures that are on the industry. An attempt to expand the indications for use of a patent foramen ovale closure device to treat migranes is an example of a clinical device trial intended to demonstrate evidence for the expanded indication to reach new patient populations.

Leahy: Over the last number of years, the general healthcare sector has become increasingly demanding. Budget pressures for healthcare providers in developed economies are well documented, while demand continues to grow for their services as populations age and new therapies emerge. The response of providers has been to focus on delivering improved medical outcomes while managing resources effectively. Hospitals are seeking integrated solutions and complete product offerings covering the entire healthcare workflow. In response, we are witnessing a rapid consolidation in medtech as companies strategize to serve the evolving demands of the healthcare sector. Many of these consolidating acquisition strategies are focused on filling gaps in existing product portfolios across the full interventional device horizon in an effort to respond to these new buying patterns.

New interventional treatments are also part of the response to the cost pressures in healthcare budgets, so innovation is also a critical solution. Acquisition strategies of large companies also focus on acquiring growth assets that augment differentiation in attractive markets.

The investment model for early stage companies is also transforming; large consolidated medtech players are increasingly investing in innovative start-up organizations to boost their internal R&D capacity and gain a stake in next-generation devices, as traditional VC [venture capital] models decline. At a recent medical device conference, analysts identified that between 2012 and 2015 corporate investments by large medtech companies in start-ups more than tripled, while traditional series A funding halved.

Consolidating trends are also mirrored in the value chain for the outsourcing sector. Medtech customers are increasingly looking for partners who can provide broader “one-stop shop” solutions across multiple capabilities, lead innovation for their products, and deliver efficiency gains. In response, the outsourcing sector is also consolidating to deliver on these requirements.

Barbella: What factors are driving growth in the interventional medtech market? How have these growth factors evolved?
Harren: Growth continues to be fueled by evidence, clinical relevance, and adoption of therapeutic intervention. An example would be balloon dilatation catheters and stenting. The data developed through clinical studies continues to support intervention via medical devices. There’s incredible momentum for medical devices in the interventional market and it will continue because the clinical data supports this form of therapy.  

LaDuca: I think there is growth. Being on the front edge of the development of devices as a contract manufacturer, we see the industry is active and still growing. Why do I think it’s growing? There are new markets that are opening up where there’s a need for technological improvements and also markets where existing technologies can be applied to expand the patient populations that are candidates for treatment. Developing new applications for existing technologies such as steerable catheters, allow therapies to be delivered to more distant locations in the body such as neurovascular arteries and peripheral vasculature. Taking advantage of existing technologies to gain more targets within the body is a trend that is continuing even if we don’t see new billion-dollar markets opening up like we did with stent grafting.
The hunt for large markets that have unmet clinical needs and a technological solution that can be developed in five years—that pool of opportunities is shrinking because the ubiquity of device technologies is quickly expanding. You see things like cancer being one of the “big frontiers” left to be tackled. Paraplegia and spinal cord injuries are another area that presents challenges for solutions but also represent huge opportunities. It’s hard to predict a market that’s going to produce growth but I think we can see the genetics and personalized medicine markets as huge areas for growth. We also see a a current growth trend in the area of stimulation. Chronic pain, neurostimulation, stem cells, and biologics—those are examples of current and future high-growth market areas.

Leahy: Since the first coronary angioplasty was performed in a human in 1977, interventional medical devices have become a founding pillar for what we now consider modern medicine. The reasons for growth are many, yet all are primarily rooted in the combined benefits to physicians, patients, and payors when a minimally invasive approach is utilized. Consider the patient presenting with coronary artery disease. Before the advent of interventional approaches, the physician’s primary surgical option was a four to six-hour bypass surgery. Today, a stent can be placed in a catheter lab in about one hour. From the perspective of the payor, a coronary surgical bypass will cost over $150,000. Stenting is more cost efficient by a typical factor of four. Many patients can have a successful non-complex stent placement as a same day procedure, in contrast with a typical five to seven–day hospital stay associated with coronary surgical procedures. In summary, a higher number of patients can be treated more cost effectively with shorter hospital stays and less trauma to the body. Minimally invasive techniques can also create new markets, for example, within new subsets of patients or for new treatment protocols. Take, for example, the treatment of diseased aortic valves—high risk patients who would not be candidates for surgery now have a minimally invasive option in the form of TAVR (transcatheter aortic valve replacement.) Many fields of medicine are now permeated by minimally invasive modalities; this evolution will continue as new devices are developed and brought to market by the industry.

Jessica Lenhardt, Jim McCormack, Joseph Penn: At Teleflex Medical OEM, our research indicates the major factors driving the growth of the interventional device market include a rising aging population, a dramatic increase in number of people challenged by cardiovascular diseases, and substantial demand for devices used during minimally invasive procedures.

• More patients are seeking minimally-invasive surgeries (MIS) because these procedures translate to shorter hospital stays, lower rates of infection, and smaller incisions. In some procedures, MIS is the only option for patients unable to undergo open/invasive procedures. Surgeons, medical device companies, and outsourcing partners are challenged to come up with new procedures, devices, and delivery systems to replace traditional, open procedures with less or minimally invasive procedures.
• As MIS has gained in popularity, there are more requests for smaller devices and delivery systems that are equal, if not better performing, than their replacements. These new devices need to demonstrate improved steerability/navigation and articulation, visualization, and accuracy of delivery.
• The revolution toward transcatheter procedures leads to tighter specifications and tolerances, enabling therapeutic drugs to be delivered to the exact location. Market growth will be influenced by the call for microcatheters, low-profile large-bore catheters, nitinol devices, and balloon delivery.
• An influx of newer therapies that will require even more custom-configured delivery devices. For example, the high performance catheter used for ablation of cryogenics versus radiofrequency will have different performance and temperature characteristics. 

Liebl: During the past two decades, interventional procedures have made gains year after year as a proven, reliable, and cost-efficient treatment option. As the global market has expanded, this growth has become a catalyst for medical component and device companies to deliver greater innovation, performance, and efficiency; in turn, this enables medical professionals to deliver better outcomes, faster recovery times, and higher quality care. And as we see longer life expectancies, everyone from patients to payers to providers is dealing with healthcare cost pressures; interventional procedures are proving to be a popular treatment choice. As interventional therapy surgical procedures become less invasive and smaller in scope, medical professionals require greater control, precision, and performance in the devices and delivery systems. To do that, our strategy and mission are simple: be relentless in our continuing technology innovation and expand our portfolio of products and services so our customers can bring their products to market faster and at lower costs.

Twork: Advances in high-resolution imaging are a key driver. These advancements have enabled surgeons to more effectively perform procedures that were difficult or invasive in the past. Interventional radiology has provided real-time feedback so that the physician can make more-informed decisions on the spot. Advanced imaging techniques have led to treatments that typically are more cost-effective and less traumatic to patients than open surgical methods. Another key driver is the positive patient outcomes from these procedures that support the advent of evidence-based medicine.

The technologies behind these drivers are equally important. When it comes to meeting performance and safety requirements in this market space, many interventional device designs must rely on custom electrical conducting and fluid sealing components. For example, electrical contacts, such as those offered by Bal Seal Engineering, are frequently used to help minimize noise and deliver optimal signal strength and resolution in ultrasound imaging equipment. The Bal Spring element inside these contacts offers extremely low electrical resistance and ensures consistent conductivity. Its individual canted coils compensate for misalignment and surface irregularities that could otherwise compromise device performance.

Similarly, biocompatible sealing solutions play an important role in the interventional medtech toolkit. Bal Seal spring-energized seals made from FDA-approved and bio-compatible polymer formulations such as PTFE and UHMWPE, help protect sensitive electronics in MRI and CT scanners from potential damage caused by the ingress of fluids, dust, and other contaminants.

Innovations in imaging technology have now made ultra-high definition 4K resolution a reality. Because these interventional diagnostic and surgical procedures are guided via imaging, it has had a great impact on the advances in these techniques. Radiofrequency ablation, for example, is best performed under fluoroscopy for guidance to target and place the needle. The advancements in imaging resolution have made these procedures more viable and thus preferred to more invasive surgical options.

Barbella: Please discuss some of the challenges involved in developing interventional devices. How has your company overcome (or helped customers overcome) these challenges?
Harren: Speed to market for our interventional device customers is absolutely critical as the market continues to advance at break-neck speeds. A significant number of capable OEMs compete in the marketplace, all attempting to bring the next therapeutic advance to their customers in a condensed timeline, even when compared with other medical device segments.

At Donatelle, we have the benefit of being vertically integrated in one location and providing solutions in design and development all the way through market-release production. The knowledge transfer throughout development and into production is important in shortening timelines. Our longstanding, in-house toolmaking expertise provides us with an advantage in eliminating delays throughout development and in production.

Even with the pressure to be first-to-market, there exists absolutely zero room to cut corners. Quality will always be the top priority and the capability to achieve the highest level of quality is very important. At Donatelle, we benefit from the fact that we are 100 percent focused on medical devices. For nearly 50 years, this focus has allowed us to create a culture of quality. Because we are not distracted by other industries and regulations that may not apply to the medical world, we are able to devote all our resources and efforts to the medical markets. Quality is ingrained in who we are, so as we’re managing projects and working with customers, we’re very much speaking the same language and we’re very much motivated by the fact that we know our products will get used for very critical procedures.

We’ve been significantly involved in the evolution and design of therapeutic catheters for atrial fibrillation ablation. One of our customers partnered with us by incorporating our engineers into their development team to take advantage of our expertise in prototyping, precision machining, and molding. They brought us into the development very early, allowing our engineers to work very closely with theirs. The early collaboration has provided many benefits including advances in functionality and cost efficiencies due to early assessment for manufacturability. 

LaDuca: There’s a need to evaluate different designs efficiently from a time and cost standpoint. The ability to design experiments and parallel paths for design iterations is a critical factor in designing an optimized product within the lowest cost possible. I think the biggest challenge we see is getting knowledge out to the device developers such that they know what is available from a materials standpoint, processing standpoint, and design standpoint so whether they are choosing a development partner or developing internally developers need find the best combination for advancing their particular technology. There are often competing factors associated with the product’s requirements.  To reach an optimal design, these factors need to be understood within a totality of options available to optimize multiple variables. We see that engineers really benefit from the expertise of processors who work with a wide variety of materials and processes. Oftentimes designers are not aware of what is available.There’s a need to have more knowledge sharing and accessibility to more comparative information for device developers.

We aim to inform our customers as to the options that are available from a processing standpoint. We share our experience designing for manufacturability and engage in active listening to determine the best ways to meet the performance requirements for the device. Explaining to customers what tolerances can be held and what processes will be used as it relates to both development timelines and also long-term cost is also helpful towards making informed decisions. I think it’s important for device developers to utilize the most appropriate technology for their product, but they also benefit by a broader understanding of the alternatives that are available. That can be harder to obtain when you’re getting your information from sources that have an interest in their particular field of knowledge. For example, if you’re looking for a novel type of balloon catheter, you might go to a silicone manufacturer that manufactures silicone balloons and they steer you towards a silicone balloon option. They may not produce thermoplastics and had they had a broader capability set of experiences in materials, they may have been able to recommend a silicone alternative that performs better in some critical areas like permeability.

Leahy: As experts in access and delivery of medical devices, our primary technical challenge can be simplified as seeking to keep the dimension, or profile, of the access device or delivery catheter as small as possible, yet big enough to accommodate and deploy the medical therapy while maintaining overall system deliverability to navigate through the vasculature. This is a very fine balancing act that requires ongoing innovation in design, materials, and process techniques. We have developed Centers of Excellence across our global network, each Center focused on particular therapy or technical capability areas. Staffed with expert engineers and equipped with all of the tools and resources required to drive innovation for particular categories of interventional devices, we have had significant success partnering with customers to design and manufacture delivery systems for their next generation devices.

Lenhardt, McCormack, Penn: If Teleflex Medical OEM could make a catheter that has a smaller OD (outer dimension) than ID (inner dimension), it would be golden. The reality is that the market is being pushed to come up with ways to make the delivery device as small as possible while being extremely flexible for device deployment. In addition, the market demands devices with precise and accurate delivery of therapeutic drugs, implantable pacemakers, vascular grafts, valves, and energy ablation (radiofrequency, ultrasound, and cryotherapy).

Teleflex Medical OEM overcomes device development challenges by:

• Developing a proprietary technology for creating large-bore, thin-walled, concentric, tight-tolerance catheters.
• Combining our material science knowledge with technical expertise to meet device performance requirements.
• Focusing on design for manufacturability for more efficient and cost-effective manufacturing.
• Developing vertical integration of our in-house capabilities that allow us to provide development and manufacturing solutions for achieving desired flexibility, steerability, visibility, wall thinness, and deployment capabilities.

Innovation is the cornerstone to expansion of the device market. Unfortunately, many of our customers don’t have the resources or staff to undertake R&D projects. Plus there is a real need to get device characteristics right since a majority of a product’s lifetime cost is committed by the concept phase. Teleflex Medical OEM has a viable solution with our global hub for device development we refer to as the “Customer Solution Centre” (CSC).

The CSC’s goal is to reduce technical risk, develop a device that is more market-ready, contain costs, and accelerate speed to market. We can take a project from concept to demonstrative prototypes in a relatively short time span. Unique to the CSC is data-driven decision making based on our proprietary database that allows quick analysis of various design elements and materials that influence device manufacturability and performance.

Barbella: What specific areas (balloons, catheters, guidewires, etc.) are companies investing their research dollars in? Why are these areas attracting funding?
LaDuca: I would say that it’s more directed towards the unmet clinical need. Rather than seeing dollars head towards a particular technology or modality of treatment like stents, funding is going towards technologies that promise to address the multiple criteria that are needed now. One of these [criteria] involves addressing an appropriate sized market with technology that has a lower execution risk because it’s an incremental technology—one that has a proven theme behind it with a track record for accomplishing similar types of endeavors. That’s an important checkbox. We see continued importance of IP and protection against competition. There’s a tendency towards using funds for the product development and less for infrastructure development, using more distributed network of resources rather than in-house resources, or brick-and-mortar building up of infrastructure. For example, a company that is developing a new product might not have a go-to-market strategy which includes salespeople; it may rely instead on distributor networks, or entering foreign markets where there are different channels of distribution than in the U.S. Checking off the box of market opportunity would be strategies that lessen the cost of commercialization by having a staged approach to enter markets with lower cost of entry first, like Europe. We have seen that trend, and it’s continuing because of our regulatory environment being slower, less predictive, and more expensive. The money flows towards research and development of projects that have an established path to reimbursement, where either codes are existing or there is a well-developed strategy for introducing new codes.

In general, the clinical markets in which we’re seeing continued activities are valve repair and replacement technologies—structural heart and peripheral vasculature, mostly because there’s a large patient population that hasn’t been fully treated yet. For example, transcatheter delivery of heart valves, or TAVR, has been approved here in the U.S. for patients that are high risk for surgical intervention. The expansion of the indication to treat all patients—not just high-risk patients—represents a market growth opportunity for the device manufacturers that rely on data from clinical studies to expand the indication. I think we see the expansion of existing markets to meet the needs of higher numbers of patients—that is a continuing trend and an indication as to where the markets are hot. Those markets exist but they’re more mature as opposed to brand-new markets that take longer to develop and don’t have as clear a path for approval, such as gene editing or the development and use of embryonic stem cells. The treatment of diabetes with interventional devices is a very new field that has yet to mature but still shows promise for potentially new approaches to a huge problem. There aren’t very many [approaches] now—there are a few attempts at [interventional] approaches [for diabetes] but that might be an area where we see more activity. I think we’ll continue to see further applications of the stimulation technology for treating specific types of pain and possibly other conditions like inflammatory conditions. I think we also have seen trends toward higher rates of diseases that we’re not sure what the causes are—higher rates of autism, auto-immune disease, allergies—these are things that may have complex causation mechanisms that may involve hereditary aspects and environmental as well as immunological aspects. Further work and understanding those types of changes are going to be future areas of importance. Other areas of focus include the development of new drugs that treat rapidly evolving diseases like the Zika virus and other pandemics, and the growing resistance to known antibiotics and vaccines.
We have the easiest way to transport ourselves all over the globe now, and with the migrations that are happening there will be more awareness in the future to treat the diseases closer to where it’s most cost effective. We will need to come up with distribution models that take medicine out to remote regions. We will see those trends become more important as companies look at traditionally third-world markets in a different light, whether it be for developing drugs and technologies specific to those markets at a low cost, or reflecting the changing demographics in future treatments. We see that here in the U.S. with emergency care and attempts to make the emergency room not the first point of entry for healthcare for the part of the population that is poor.    

Liebl: Reimbursement is now tied to therapy performance including reduction in infections all of which drive the need for smarter medical devices. As a processing innovation example, Heraeus has the Heraeus BiFlex and TriFlex torque coils which bring greater flexibility and higher torque ratios vital for facilitating delicate and demanding procedures.

Barbella: Please discuss the future growth prospects of the interventional device market. What factors might affect future gains?
Harren: The growth in interventional markets will continue, and at a very strong rate. This growth and the needs of the market—quality and time-to-market, for
example—make this an important focus as it aligns with Donatelle’s capabilities and mindset.

Miniaturization will continue to be a priority as well—as interventional products strive to be even less invasive. There are a number of OEMs and a significant number of new technologies being developed that are deployed through the vasculature or through a minimally invasive approach versus historically lengthy and invasive surgical approaches. Therefore, having the capabilities to meet these needs will be meaningful. The benefit for Donatelle is that we are well-positioned to respond due to how we have built our organization and the capabilities we have in place.

LaDuca: The political environment can have an impact on the growth of these medical markets because as we’ve seen with devices that require a longer regulatory path, the investment criteria is a longer play with more risk. We see a shift towards lower-risk projects that can be completed in a shorter period of time, for example, with 510(k) approvals rather than PMAs. One example of changes in regulatory policy that is related to political policy—in any election year you have candidates speaking about healthcare policies but through a change in leadership they could affect departments like the FDA as well as the NIH. We will see investors react to changes in regulatory and political leadership. We see the negative attention that Congress has paid to drug manufacturers who purchase generic drugs and then raise the prices on those generics—we’ve seen backlash against that such as the recent 500 percent increase in the cost of the EpiPen.  

Leahy: Growth will continue driven by a number of factors. Firstly, new minimally invasive techniques continue to emerge that are extremely relevant to millions of patients. For example, over 26 million people in the world live with heart failure today. It is only in the last five years that we have witnessed approval of the first minimally invasive therapies to treat structural heart diseases. This field represents one of the most innovative fields of minimally invasive medicine today. Secondly, the vast majority of our medical devices today are mechanical in nature. Our industry has yet to begin, in earnest, the journey to integrate multiple technologies into every single device and to make our devices smarter. This will call for expertise not alone in traditional medical device design but also electromechanical and software design coupled with capability in technologies such as sensors and smart technologies. Now that Creganna Medical is part of TE Connectivity, we are incredibly excited about the future in this area. Finally, growth will continue from emerging markets. Many emerging markets are still in relatively early stages of development and as clinically capacity grows there is rapid adoption of minimally invasive techniques due to the multiple benefits associated with the therapeutic approach.

Lenhardt, McCormack, Penn: Exciting technologies have evolved in the combination devices space, as seen with the launches of absorbable stent and drug-eluting balloon technologies. At Teleflex Medical OEM, we think there will be continued growth as the indications for use expand to treat larger populations through minimally invasive approaches such as transcatheter valve delivery.

The interventional device market will continue to grow for several reasons:

• Customized interventional medical, such as cardiovascular and endovascular therapies, will continue moving toward the integration of 3D printing, which today is largely utilized in orthopedics.
• The adoption of integrated sensing technology into implantable medical devices as a means to provide patient’s biometric data to the physician.
• Alternative delivery approaches for valves and stents have increased the need for precision tolerancing in the manufacturing capabilities of catheters, with radial access becoming a popular access route.

Expanded indications to treat high-risk patient populations, such as TAVR/mitral valve, that previously have been inoperable.

The efficacy of MIS is continually improving, in many instances demonstrating equivalency or superiority over open approaches.

Advancements in minimally-invasive interventional approaches (drug-loading stents, drug-eluting balloon, and renal denervation) will act as an alternative to, or be combined with, pharma-based therapies.

Liebl: The drivers of growth in the interventional device market are strong. As the patient population increases and life spans continue to extend the need for medical procedures will increase in the next decade and beyond as well. The key factors influencing its growth will be the ability to delivery therapies at a cost that is sustainable for healthcare systems worldwide. We are uniquely positioned to address the overall cost of care through technology innovations, clinical and procedural knowledge, and strong relationships in the industry to assure we’re positioned to meet the market trends where they are going.

Twork: There has been an explosive growth of many interventional methods designed to manage chronic spinal pain. According to a recent study by Manchikanti et al., from 2000 through 2013, in fee-for-service Medicare beneficiaries, the overall utilization of interventional techniques services increased 236 percent at an annual average growth of 9.8 percent, whereas the per 100,000 Medicare population utilization increased 156 percent with an annual average growth of 7.5 percent. According to the study, “The specialty has a specific responsibility to provide medically necessary services while at the same time improving quality and curbing costs.” The interventional device market should continue to grow as long as it can show positive patient outcomes to support its value in terms of evidence-based medicine requirements.