The CMS/FDA Proposed Paralell Review Process: Download PDF (936 KB)
Can clinical trials, by design, realistically satisfy the needs of two Federal agencies with fundamentally different missions? By Kelli Hallas
Reimbursement Top Ten BONEZONE: Download PDF (979 KB)
Understanding how coverage, codes and payment impact the success of a new Medical Tecnology.
Reimbursement Top Ten Checklist 2011: Download PDF (260 KB)
A must have "to do" list for understanding the entire process of concept to commercialization.
Emerson Consultants Overview: Download PDF (120KB)
Snap shot view of Emerson Consultants and expertise in the areas of reimbursement, regulatory, clinical, and marketing.
Fundamentals of Reimbursement: Download PDF (170KB)
Overview of the reimbursement process with a specific look at the current reimbursement environment for nucleus arthroplasty technology and other new spinal devices.
Authors: Kelli Hallas and Barb Peterson
Explanation of differing data requirements for regulatory approval and reimbursement coverage. Also outlines the key drivers payers use to evaluate a new technology to determine coverage.
Author: Patty Curoe Telgener
Description of trends in the current reimbursement environment for continuous glucose monitoring and recommendations on coding and coverage.
Integrating Internal Strategies to Impact a Successful Product Launch: Download OrthoKnow article
Author Kelli Hallas unfolds the importance and dynamics of incorporating and unifying the four major phases of product development to guarantee market success in today's challenging medical device industry.
Integrating Internal Strategies to Impact a Successful Product Launch: Download August 2011 Bonezone Article PDF (4.1 MB)
Author Kelli Hallas outlines several key components necessary to build the foundation of a successful Strategy Integration Plan.