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How to Debunk the Most Common CAPA Myths

Posted by Jon Speer | greenlight.guru on September 21, 2017

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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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Contextual Intelligence: Getting to the “Issues Behind the Issues” on the Value of Medical Devices

Posted by Liz Scherer | 3D Communications on September 20, 2017

This post is brought to you by 3D Communications

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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How to Maximize Your Early Interactions with FDA: Perspectives from a Former CDRH Reviewer and Project Manager

Posted by Jamie Page | 3D Communications on September 14, 2017

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This post is brought to you by 3D Communications

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.

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The U.S. Medtech Industry's Irish Accent is Getting Stronger (part two)

Posted by Michael Lohan I IDA Ireland on August 29, 2017

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.

 

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The U.S. Medtech Industry's Irish Accent is Getting Stronger (part one)

Posted by Michael Lohan I IDA Ireland on August 22, 2017

 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.

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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.

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California: a community of medical technology innovation

Posted by Lauren Belisle on August 16, 2017

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. 

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Until We Update Archaic Health Laws, We're Only Scratching the Surface of What's Possible in Value-Based Medicine

Posted by Christopher L. White, Esq. on July 12, 2017

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. 

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Time to Change the Definition of Value in Medtech

Posted by Brian Chapman | ZS on June 15, 2017
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Ethical Codes Bolster an Industry’s Public Perception

Posted by Matt Wetzel on June 8, 2017

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.  

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Reflections On the U.S. Supreme Court’s Decision Limiting Use of the False Claims Act

Posted by Matt Wetzel on May 30, 2017

Note: this blog post was originally published on LinkedIn Pulse on January 11, 2017. 

In reflecting on 2016 legal developments, a key health law case that stands out is the Supreme Court’s decision endorsing the implied certification theory of the False Claims Act (Universal Health Services v. Escobar). Contrary to many press outlets, Universal Health Services will not serve – in 2017 and onward – to pave the way for more whistleblower suits. In fact, the Court’s decision raises the bar for whistleblowers, and its practical impact will be to restrict the use of the False Claims Act.

 

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