For the past several years, policymakers and industry have been exploring ways to improve the quality of health care furnished to individuals while promoting efficiency and value. As I have discussed in the past, I believe that medical technology companies can be a key player in these coordinated care efforts in light of their specialized clinical knowledge, economic expertise, data analytics proficiency, and supply chain management capability. Unfortunately, various regulatory roadblocks stand in the way of the medtech industry’s full participation in the shift to more coordinated care.

Having spent the better part of my professional career nurturing relationships between big pharma and academia, it’s interesting to observe that there are still areas which are underserved. Case in point, the medical device industry is increasingly finding value in the halls of academia, especially those with powerhouse engineering departments. But who has time to walk the halls looking for PIs who may or may not be open to industry collaboration?

This week marks the one-year anniversary of a rarity in Washington, DC: enactment of a health care bill with bipartisan majorities in both the House and Senate; support of the Administration; as well as the backing of patients, physicians, hospitals, and the pharmaceutical and medical technology industries.

The 21st Century Cures Act, signed into law Dec. 13, 2016, is one of the most significant pieces of health care legislation in recent years. Designed to accelerate the discovery, development and delivery of life-saving and life-improving therapies for patients, the law includes a number of process reforms at FDA to improve the efficiency and predictability of the drug and medical device review processes as well as significant funding for new health care research at NIH.

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.