PUBLICATIONS

       
WHITE PAPERS
 
   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series V:
September 2010

“Challenges in IDE Clinical Trials: Study Enrollment & Reimbursement”

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Series IV:
July 2008

“The Challenge of Orthobiologics Navigating the Coverage and Reimbursement Landscape in a Complex Marketplace”

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Series III:
February 2008

“Pre-Clinical Testing of Spinal Implants: Safety Versus Substantial Equivalence"

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Series II:
July 2007

“European Regulatory Overview”

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Series I:
October 2006

“Nucleus Arthroplasty™ From the U.S. Regulatory Viewpoint”

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FACT BOOK
 

The 2010 MCRA Fact Book
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FEATURED ARTICLES
 
 

January 2012 - Seminars in Spine Surgery
Regulatory Challenges in Getting Total Disc Replacements Onto the Market in an Era of Increased Food and Drug Administration Scrutiny

November 2011 - RAPS Regulatory Focus
Coverage of IDE Clinical Trial Costs: Navigating the Medicare Maze

June 2011 - ABA Health eSource
A Historical Framework for Accountable Care Organizations: Will CMS Meet Its Long-Term Goals with this Initiative?

July 2010 - Do Not Experiment with Clinical Trial Coding

May 2010 - Tracking Reimbursement and Payment Trends
Device firms with well-planned reimbursement strategies position themselves to secure market share and sales they might otherwise have lost.

May/June 2009 - Ortho Design & Tech
How Medicare Rule Would Impact Orthopedic Technology Firms

November 2008 - Ortho Design & Technology
Product Positioning and Reimbursement

September - October 2008 - Ortho Insights
CMS to Encourage Further Care Coordination and Quality Reporting

July 2008 - Gray Sheet
Expectations For Artificial Disc Trials Challenge Market Hopefuls

July 2008 - Gray Sheet
Artificial Disc Patent Case Could Define Shape of The Market

May 2008 - Orthopedic Design & Technology
Clinical Trial Reimbursement Integration and
Management

Spring 2008 - BONEZone
Executing Reimbursement Strategies for
Innovative Orthopaedic Technologies

March 2008 - Gray Sheet
Reimbursement is More Than Passing Thought For Spine Firm in FDA Trials

Volume 62, Number 3, 2007 - Food and Drug Law Journal
Medical Device Reporting: Issues with Class III Medical Devices

May 2007 - Orthopedics This Week
FDA Ortho Panel Recommends STAR Ankle PMA Approval –- With Elephant in the Room

November 2006 - New York Times
FDA Panel Supports Artificial Disks for Upper Spine

 
NEWSLETTERS
 
     


January 2012

Orthopedic
Intelligence
Newsletter

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August 2009

Overlooking the Hill

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June 2009
Overlooking the Hill

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  April 2009
Overlooking the Hill

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February 2009
Overlooking the Hill

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January 2009
Advancements in
Orthopedics

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December 2008
Overlooking the Hill

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Musculoskeletal Clinical Regulatory Advisers, LLC is the leading neuro-musculoskeletal / orthopaedic consulting firm assisting established and emerging companies in the development and commercialization of their technologies. MCRA’s consultants are industry leaders who support Clinical, Regulatory, Quality Assurance, Reimbursement, Intellectual Property, and Healthcare Compliance initiatives. MCRA’s integration of these key value creating initiatives, as well as its focused specialization, creates unparalleled expertise to its clientele.