 Discounted Hotel Rate Ends Next Week!
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MDMA Member-Only Webinar
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Thursday, April 21 at 3pm ET
"Stress Testing Insurance Program Vulnerabilities: What Medical Device Executives Need to Know"
Hosted by
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Upcoming Scheduled Working Group Calls:
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FDA
Tues, 4/5/16 - 2pm ET
Tues, 4/12/16 - 1pm ET
Patent
Thurs, 4/14/16 - 2pm ET
International
Tues, 4/19/16 - 2pm ET
MDMA also has Communications
and Compliance working groups which hold monthly calls. MDMA's Device Tax working group will meet on an as-needed basis.
Participants of the above working groups will receive an email with call-in details prior to the call.
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Congress was on their Easter Recess last week, which continues through this week as well. The Senate will return to work on Monday, while the House is scheduled to return on Monday, April 11th.
Be on the look out next week for MDMA's "Device Tax Suspension Survey" which will be our first attempt to gauge what med tech innovators are doing with the additional resources. This is a critical part of our advocacy efforts to fully repeal this policy once and for all.
The MDMA Team
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Discounted Hotel Rates Ending Soon - Register Today for MDMA's Annual Meeting!
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MDMA's flagship Annual Meeting is quickly approaching in a matter of weeks, taking place in Washington, DC from May 4-6, 2016. Now is the time to lockdown your discounted hotel rate, as there is just one week left to do so. We have updated this year's agenda with several powerful speakers and discussion panels.
Each year, the MDMA Annual Meeting brings together more than 200 CEOs and senior executives and will cover key issues impacting the United States' leadership position in med tech innovation, and how we can all play a role in shaping the regulatory and legislative agendas.
Some of the confirmed expert speakers include:
- Robert M. Califf, MD, Commissioner, U.S. Food & Drug Administration
- Dean Kamen, Founder, DEKA Research and Development Corporation
- Jeffrey Shuren, MD, Director, CDRH
- Tamara Syrek Jensen, Acting Director, Coverage and Analysis Group, CMS
These experts and policy-makers will cover crucial topics on several discussion panels including:
- C-Suite Perspective - Adapting in Challenging Times: From Formation, Growth and Successful Exits
- Building the Right Culture & Team to Lead Your Organization
- How to Navigate Today's Reimbursement Challenges
- Payors and Providers in Today's Marketplace
The discounted room rates will end Wednesday, April 6th, so be sure to get yours soon! CLICK HERE for this year's agenda, and REGISTER TODAY!
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MDMA Announces New Vice President and General Counsel
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This week, Carolyn Bruguera joined MDMA as Vice President and General Counsel, building on our resources for the growing legal complexities facing medical technology innovators.
"Carolyn has an extensive background in dealing with the diverse legal challenges facing our industry, and she will be a tremendous asset to our members as they deal with compliance, post-market challenges, policy issues and more," said Mark Leahey, President and CEO of MDMA.
Carolyn M. Bruguera has extensive experience in the management of legal and compliance issues for medical device manufacturers. She previously served as General Counsel to Hansen Medical, Inc., a manufacturer of robots for intravascular procedures, and to Micrus Endovascular, a manufacturer of neurovascular devices which was acquired by Johnson & Johnson. She also has extensive experience in the design and implementation of compliance programs for medical device manufacturers, most recently as Vice President of Consulting Services for R-Squared Services and Solutions Inc., acquired by IMS Health. Carolyn received her undergraduate degree from Harvard University and her law degree from the University of California, Berkeley's Boalt Hall School of Law.
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MDMA Submits Comments to FDA on "Emerging Signals"
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MDMA submitted comments to the FDA this week on their draft guidance entitled "Emerging Postmarket Medical Device Signals ('Emerging Signals')." MDMA noted that while there are ways that FDA and industry can collaborate to enhance the current regulatory system to improve upon the agency's extraordinary safety record, we do however have significant concerns over the draft guidance.
Specifically, we noted that the draft guidance lacks clarity when it comes to the threshold of evidence that is required to trigger a particular action and public communications regarding a technology. In addition, if there is any difference of opinion between the perspective of FDA and the perspective of industry, there does not appear to be any mechanism by which those differences can be addressed and worked on prior to any public communications.
To read the comments that were submitted in their entirety, please click here.
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National Health Council Announces Patient-Centered Value Model
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Earlier this week, the National Health Council (NHC) released a framework meant to help patients, providers, payers figure out which value-based delivery models best serve patients' needs. Various value-based models and frameworks have emerged to replace fee-for-service payments over the last couple of years.
In order to include the patient community more, NHC created the Patient-Centered Value Model Rubric to provide a tool that patients, physicians, health systems, and payers can all use to assess the patient-centeredness of each of the different value-based models. NHC's Rubric was developed after a multi-stakeholder roundtable, at which participants identified six areas in which value models should consider when developing their frameworks to reflect patients' needs:
- Patient partnership in value model development
- Transparency to patients in the models assumptions and inputs
- Inclusiveness of patients perspective in the final model
- Diversity of patients/populations included in the model
- Outcomes patients consistently care about
- Patient-centered data sources
The rubric is meant to serve as a guide, as opposed to a final document with an exhaustive list of requirements. NHC's guidance serves as a roadmap, intended to advance patient priorities and perspectives into the emerging value-based healthcare delivery models. We will be covering the latest on this on our next Reimbursement Working Group call, taking place at a special time on Tuesday, April 12th at 1pm ET.
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