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Europe and Asia are on the front lines of the global battle for medtech supremacy as the BRICs falter.
May 6, 2016
By: Michael Barbella
Managing Editor
Some life stories defy explanation. Such is the tale of Bob Callaway and Doug Jennings. Bob and Doug are college roommates, best friends, and lifelong business partners who co-found and operate a multi-million-dollar energy company in the 2006 Seth Horne novel, “Friendship – Fate – Fortune.” They grow up on opposite sides of the United States—Bob in the bustling urban center of Shrevesport, La., and Doug amid the rural tranquility of Three Forks, Mont., near the geographical origin of the Missouri River. Raised with similar values—hard work, loyalty, respect for others—the pair’s lives are oddly connected well before they meet. The coincidences linking the two, in fact, assume a fairy tale-like quality in the book—both men, for example, receive football scholarships to Louisiana State University, though Doug’s offer arrives rather serendipitously with the help of Bob’s uncle, a Colorado rancher (with prime hunting property frequented by LSU coaches) who has conducted business with Doug’s father for years. Even more incredulously, Doug realizes he’s been to the Callaway family ranch and knows Bob’s aunt and uncle fairly well (“Those are some of the nicest people I know,” he tells Bob within hours of their initial meeting). Naturally, the two athletes are assigned to the same LSU dorm room (thanks to Divine will), and together make a series of fateful decisions that ultimately spawns their wildly successful business partnership. “Some people believe that what happens or has happened is simply a coincidence, while others would say those same circumstances are due to fate,” author S. Jackson Horne concludes in the novel’s first chapter. Indeed, Horne makes a strong case for fate in his story, skillfully connecting the dots between apparently unrelated incidents and choices to reveal a sublime pre-ordained plan. Bob’s first job, for instance, is with the fictional Shrevesport-based Jackson Drilling Company, whose owner supports LSU athletic programs and offers work to local high school students attending the college on athletic scholarship. “This job would prove to be a defining moment in Bob’s life, owing to many seemingly unrelated occurrences,” Horne writes. Moments like that exist in the non-fiction world as well. Consider the real-life tale of Wayne Allen, Colin Forde, and Liam Mullins, Ph.D.—three strangers with diversified backgrounds and professional experience united by a mutual interest in healthcare and a desire to run their own business. Allen, an experienced senior manager in the medtech industry, worked for Synthes Spine for seven years, leading the research, development, and commercialization of spinal implants and instruments. He is a former general manager of Vysera Biomedical Ltd., a Galway, Ireland-based firm that develops and patents a biomaterial for gastroenterology and urology applications. Forde is an experienced medical device developer who successfully led a number of large projects from concept through CE mark to commercialization. He worked with both startups and multinationals, including Medtronic plc, Clearstream Technologies Ltd., and Creganna Medical, where he worked as senior R&D engineer. Mullins also has a medical device background, working in design, animal trials, finite element analysis, fatigue, clinical trial design and biostatistics, manufacturing, patenting, and market analysis. He is listed as an inventor on four filed patents, and has helped startup firms through various stages of product development. After completing his Ph.D., Mullins joined Veryan Medical (Galway), where he spearheaded the design of the BioMimics 3D peripheral stent—a nitinol product with unique three-dimensional helical geometry. In 2011, all three men quit their jobs (unbeknownst to each other) to participate in an inaugural medical device innovation program created by Enterprise Ireland, a government organization tasked with developing and growing Emerald Isle businesses. Modeled after a similar project at Stanford University (California), Enterprise Ireland’s BioInnovate Program is a 10-month “specialist innovation” venture designed to foster medical device creation and development. The program pairs biomedical engineers and medics with marketing, legal, public relations, and/or IT experts to form small teams that immerse themselves in Irish hospitals for eight weeks to identify unmet medical needs in a particular specialty (cardiology, urology, orthopedic, etc). Once a need/issue is identified, BioInnovate participants work to transform their ideas into market-ready products. “It’s really a way to help generate next-generation medtech companies and products. The key part of the program is identifying areas in need of better solutions,” explained Tom Kelly, Manager of the Industrial, Lifesciences and Consumer Division at Enterprise Ireland. “Typically what you might expect is two or three ideas coming together, after the team filters through many other ones. Then, one particular need is chosen for further development, and that need can be supported through our commercialization fund. The BioInnovate program is founded on a very strongly researched and identified [unmet] need within the hospital system. For those with an entrepreneurial flair, it’s an effective way to identify and develop ideas from which a business can be built.” And funded. Over the last five years, BioInnovate has built quite an impressive resume of successes, fostering the development and private investment of 10 or so medical technology ideas, including a perianal fistula-healing implant, a wearable urinary reflux monitor, and a one-shot vascular embolization device. The latter product was developed by Allen, Forde, and Mullins during their BioInnovate residency in 2011. Dubbed the Caterpillar, the device is designed to improve the safety and efficiency of embolizations—a surgical procedure that permanently stops blood flow to damaged or diseased blood vessels. The device replaces the coils (small metallic springs) currently used to create a “nest” and subsequent blood clot that eventually shuts down the blood vessel. The trio is hoping the Caterpillar will help their startup company, Galway-based Embo Medical (founded in 2012), gain valuable market share in the $500 million global peripheral vascular embolization sector. “Initiatives like [BioInnovate] help to encourage the establishment of companies that are developing their own products and have the potential to either grow in time to significant size, or those that eventually will get acquired,” Kelly said. “We are well aware of the importance of attracting entrepreneurs into Ireland in addition to having a home-grown base of entrepreneurs. That kind of thinking really works its way through our system. We also like to support people who may be looking to set up a new business in Ireland as well as those with good ideas. We’re keen to recognize the good ideas. Once they are found, they have to be nurtured and supported. We have a very well-developed system of support, which makes Ireland a particularly attractive center for medical technology businesses.” And a dominant one as well. Ireland is one of Europe’s largest medical products exporters, sending 12.6 billion euros worth of merchandise to more than 100 countries annually. The Republic’s medtech sector employs 29,000 people and produces 80 percent of the world’s cardiovascular stents. In addition, one-third of all contact lenses sold in global markets are exported from Ireland, and roughly one-fourth of the planet’s diabetics rely on Irish-made treatment products, according to Enterprise Ireland statistics. Most of the country’s 400 medtech companies are engaged in research and development, often plugged into the tertiary education sector. But an ecosystem of sub-suppliers has evolved in recent years, enabling local companies to work side-by-side with OEMs on breakthrough medical innovations, government officials note. “We continue to move up the value chain,” Irish Medical Devices Association (IMDA) Director Dr. Sinead Keogh told the Irish Independent medtech magazine in December 2015. To ensure its continued ascent, the Irish government is taking a number of steps to boost the country’s role in the global medtech market. In January, lawmakers announced a 5 million-euro investment in Health Innovation Hub Ireland at University College Cork. The initiative is designed to deepen links between the Irish health service and vital new technologies. Then in February, the IMDA published a new 2020 Strategy that is designed to make Ireland a “global medtech hub.” The plan recommends the government adopt various measures that will nurture a stronger entrepreneurial culture. “…[T]o unleash our true potential and seize emerging opportunities, recognizing and rewarding a culture of innovation will play a vital role in stimulating the sector to develop new capabilities and meet the challenge of achieving cost-effective, sustainable healthcare systems,” Keogh wrote in the 2020 strategic plan. “Home-Grown” Medtech in Switzerland That “culture of innovation” is far more widespread than Keogh realizes (or perhaps dares to admit). It has existed for centuries in Switzerland, beginning with the 1541 jewelry ban tendered by French theologian/pastor Jean Calvin. The order sired a new industry, as Geneva goldsmiths applied their jewelry-making skills to pocket watches (Calvin deemed the watch to be a practical instrument, and thus allowed its production and sale). Such creative thinking (and versatility) has helped foster the growth of Switzerland’s medical technology sector, estimated to be worth about 14 billion francs, or 2.3 percent of GDP, according to government data. Representing 1.1 percent of all gainfully employed workers and 5.2 percent of total exports, the Swiss medtech industry outperforms its counterparts in Germany, the United Kingdom, and United States. The industry also leads Europe in the number of full-time positions (52,000) and the world in companies per capita (roughly 1,450 manufacturers, suppliers, dealers, and service providers at last count). Moreover, the sector’s proportion of medical technology-related patents is nearly three times as high as the global average, Switzerland Global Enterprise statistics show. The agency reports that Swiss companies register patents both domestically and abroad for more than 1,200 medtech inventions each year. “The medtech industry in Switzerland has a long, rich history and deep roots in the manufacturing sector. It started by itself…it wasn’t the result of an initiative by authorities, but rather a bottom-up kind of evolution,” said Peter Biedermann, managing director of the Medical Cluster, a network of 400 companies representing the country’s healthcare value chain. “If you look at some other countries—like Ireland, for example—the industry has grown from a top-down approach. There were policies put in place to attract companies, and make it easy for international firms to go to Ireland. But in Switzerland, the medtech industry is home-grown. It has matured on its own, shaped by history and the innovative companies that have started in our country and expanded.” Nurturing that natural growth, of course, are government-sponsored funding and initiatives to support medical innovation. The Commission for Technology & Innovation, for instance, supports the transfer of knowledge and technology between higher education institutions and industry in a targeted and result-oriented manner. In addition, Swiss businesses and researchers are linked with development opportunities through access to international programs and networks such as EUREKA, ERANet and EU FP7/Horizon 2020, or European Technology Platforms. The government’s most recent initiative is intended to ensure the country’s future as a medtech innovation hub. Earlier this year, bureaucrats unveiled a network of five “innovation parks” intended to boost Swiss industry, science, and technology. Organized by Switzerland Innovation, a privately funded foundation, with support from the federal and cantonal governments as well as several universities and research institutes, the parks are designed to serve as business incubators for the development of novel products and technologies. They also are meant to attract international R&D teams. The Swiss government has backed 350 million francs ($348 million U.S.) in loans to fund R&D at the parks through 2024. “We want to position Switzerland among the best of the best in terms of research and innovation,” Swiss President Johann Schneider-Ammann told dignitaries and guests at the parks’ January launch. “That’s how we will maintain our global competitiveness, our economic prosperity, and our strong jobs market. The Innovation Park shows that our country is capable of actually putting a great idea into action.” Singapore: Gateway to Asia Innovation parks also show the kind of commitment governments are willing to make to medical technology. Singapore expressed its devotion to the industry in a similar manner to Switzerland, spending roughly S$700 million (Singapore) dollars ($518 million U.S.) over the last dozen or so years to create a 340,000-square-foot campus for biomedical research. The 13-building campus, called Biopolis, is designed to promote research collaboration between private companies and public/scientific educational bodies. More than 2,500 public and private sector researchers from 70 countries conduct fact-finding missions on Biopolis’ grounds, according to Singapore President Tony Tan Keng Yam. Any commercially promising technologies developed at Biopolis can potentially be manufactured locally, at Tuas Biomedical Park. Located on the western tip of Singapore, the 280-hectare (692-acre) campus provides companies with access to skilled talent, research expertise, manufacturing capabilities, and transportation logistics. “[Medtech] companies see great value in Singapore because there is a solid base of research, product development, and manufacturing here,” Weng Si, director of biomedical sciences for the Singapore Economic Development Board, told Medical Product Outsourcing. “We are seeing more medical technology innovation resulting in the commercialization of products, and that is resulting from the partnerships being formed here. The centralized location of research, product development, and manufacturing is something we strongly encourage because it can help companies take a more holistic approach to medical innovation. We want to help companies with that, so we are very committed to working with them to establish and grow strategic operations in Singapore.” Extremely committed, actually; in January, Prime Minister Lee Hsien Loong unveiled a S$19 billion dollar ($14 billion U.S.) plan to support the country’s R&D efforts over the next five years. The money is up 18 percent from the 2010-2015 plan, which allocated S16 billion dollars to support research. Healthcare and biomedical sciences will receive the largest allocation of S4 billion dollars, or 21 percent of the total budget, as part of a government push to further develop an integrated biomedical sector and healthcare ecosystem. “Medical technology is not something new for Singapore. What we see driving its growth are trends like an aging population and rising middle class as well as a keen interest in Asia as a growth market,” Weng Si noted. “Singapore therefore provides value to companies looking to grow their business in Asia, and as a result has been the beneficiary of a lot of companies planting the flag in Asia.” More than 30 have staked their claim in the nation, including Baxter International; Becton, Dickinson and Company; Biotronik; Medtronic plc; and Siemens Medical Instruments. In recent years, Singapore’s medtech sector has experienced a shift from high volume devices such as medical disposables and consumables (e.g., syringes, catheters) to high-value devices like electromedical equipment and instrumentation (e.g., research instruments, analyzers, hearing aids). A variety of medical products are manufactured in the country, including 10 percent of the world’s contact lenses, more than 70 percent of the world’s microarrays, and about half the planet’s thermal cyclers and mass spectrometers. Though it is part of Singapore’s burgeoning biomedical sciences sector, the medical technology industry wields considerable economic power on its own. The industry increased its manufacturing output exponentially so far this millennium, going from S$1.5 billion in 2000 to nearly S$10 billion based on preliminary figures last year. Over the same period, its workforce almost tripled and now approaches 12,000, according to Weng Si. “Once a company establishes itself in Singapore, we help them access what they need in terms of talent, funding, research, and regulatory assistance,” she said. “We also have a strong support system for clinician innovators, giving them the resources they need to explore their interest in medical technology. It’s really about building upon the fundamentals to ensure that medical innovation continues. Medtech is a critical part of the future for the Biomedical Sciences industry in Singapore.”
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