This week, several of my colleagues and I are at AdvaMed’s annual MedTech Conference where we are discussing a wide range of topics, including value-based contracting, cybersecurity, and digital health. Earlier today, I led a panel focused on the decline of early-stage investment in medtech, and its impact on startup activity. During the session, we dove into how dwindling investments in those early phases could put future innovation at risk. We also discussed potential strategies for attracting new medtech investors.
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Many organizations misinterpret CAPA's role, often placing too much emphasis on tracking and managing the reaction to a non-conformance (corrective action) and not placing an equal, if not greater, amount of weight toward risk mitigation and assessment (preventive action).
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For those who work in the medical device arena, talk of “being customer-centric” is all the rage – especially when it comes to placing a value on your product. But, in the medtech and pharmaceutical industries, the term “customer” refers to more than just the patient. It refers to all stakeholders – the diverse set of individuals, organizations, regulators, and policymakers who influence the perception of value, and eventually, the market access of your product. So, when we think about “customer-centrizing” efforts around value communications, we need to consider every stakeholder who defines value. A powerful process to achieve this is Contextual Intelligence or CI.
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As someone who spent the last seven years working at the Center for Devices and Radiological Health (CDRH), I can tell you that the underlying relationship between a company and its review division really matters – from submission, through a potential Advisory Committee meeting, and beyond. Taking the time to develop a good relationship with FDA, and doing it in a strategic way, can make the difference between a relatively smooth path to approval or a long, frustrating road ahead.
Michael Lohan is Head of Medical Technology & Healthcare Services at IDA Ireland. In this role, he is an ambassador spreading the word about Ireland's opportunities to medtech and biotech companies around the world. IDA Ireland is proud to be a platinum sponsor of The Med Tech Conference since 2007. Come visit IDA Ireland at booth #323. In the second part of this two-part blog, Lohan concludes his discussion about why American medtech companies have been choosing Ireland as their European base of operations. View part one of this blog here.
An industry with inexhaustible demand like medtech, where people always need innovative healthcare solutions, must also focus on business issues to maximize success. In the US, companies weigh the challenges of improving their R&D, yet expanding production efficiently, find qualified staff, navigate regulations and better reach key markets? Many US medtech companies are looking to Ireland to solve these challenges. Addressing these concerns is why 13 of the top 15 U.S. medtech companies have chosen facilities in Ireland, with more than 300 medtech companies currently doing business in the country, up from 50 in 1993.
While the medtech industry is thriving, with sales increases of 10% or more in 2016 over the previous year, this bullish market outlook is tempered with the usual bearish concerns over competition, funding, effective R&D and other business issues. With Europe and the United States being the key markets that medtech firms focus on, many US firms are finding that having an Irish operation not only delivers many advantages but gives their products access to a lucrative market and plentiful opportunities to drive value.
Companies such as Boston Scientific, Abbott, Vistakon, Medtronic, Teleflex, Stryker, Cook Medical, Zimmer Biomet, DePuy Synthes, Hollister and BD are just some of the existing medtech firms with expanding Irish operations. Ireland now employs more than 32,000 people in medtech, which is the highest number in Europe as a percentage of a population. One quarter of the world's diabetics -- 30 million people -- rely on an injectable device manufactured in Ireland, while half of all ventilators used by acute hospitals worldwide are also made there. Meanwhile, three quarters of global orthopedic knee products were produced in Ireland.
There are several important reasons why American medtech companies have been choosing Ireland as their European base of operations.
As of today, we have just 40 days until The MedTech Conference powered by AdvaMed kicks off in San Jose! There is so much to look forward to during our time in Silicon Valley...one of which is that we will be in a region world-renowned for its entreprenuerial spirit, tech start ups, investor community and more.
Note: this blog post was originally published on LinkedIn Pulse on February 28, 2017.
Medical technology companies have long been recognized for their life-saving contributions to diagnosing and treating patients – from medical imaging to genetic testing to implantable devices. In fact, medical technology advances are credited with helping to add five years to the average U.S. life expectancy since 1980 and slashing the number of days spent in hospitals by 59 percent between 1980 and 2010. The newest medtech innovations are truly astounding, from the use of 3D printing of tissue to diagnostics linked to smartphones, to innovations in medical robotics and nanotechnology.
Note: this blog post was originally published on LinkedIn Pulse on February 14, 2017.
A commitment to the core values of patient care and innovation serves as medtech’s heartbeat. The people who work in the medtech industry are committed to delivering high-quality care and good patient outcomes every day. They understand that what they do has a direct and positive impact on patients’ lives. They understand that their work contributes to the development of breakthrough technology. And they understand that the products they make could one day be used to save or improve the life of a loved one.