By Roz Sweeney, Ph.D. Nerac Analyst,
Uses of Clinical Literature Evaluations
Comprehensive evaluations of the clinical and technical literature serve a variety of purposes for medical device companies. Literature evaluations are frequently used in the following ways:
- To support design of clinical investigations (e.g. to understand expected outcomes and results for historical controls).
- To support regulatory approvals and ongoing regulatory requirements (e.g. literature route to CE mark).
- To develop a product’s value proposition. By better understanding the product’s economic and quality of life benefits, this work can be used for supporting pricing decisions.
- To provide support for reimbursement (e.g. supporting payment rates for procedures/ products). Typically, efficacy and cost-effectiveness of a product are the key parameters.
- To support product marketing claims or to refute competitor marketing claims (e.g. to support claims around safety and efficacy of the product).
Want to read the rest of the article? Fill out the form to download: Clinical Literature Evaluations to Support Medical Device Marketing
Related Posts
- 88By Ron Sills, Nerac Analyst, and Donna Mitchell-Magaldi, Nerac Analyst Originally Published: September 26th, 2014 In 2009, the European Commission released MedDev 2.7.1 Rev.3 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” as a supplement to the requirements of the EU Medical Device Directive 93/42/EEC. In order for medical devices to be marketed in…
- 76Issue: The client, a major cardiovascular stent company, wanted to ensure proactively that their intra-aortic balloon pump (IABP) catheters would comply with new EU regulations. Analyst Approach: The Nerac team reviewed over 1,000 publications to identify pertinent clinical research. A meta-analysis was performed on 260 applicable articles. Client Benefit: The analysis validated the efficacy of IABP catheters for certain…
- 74By Donna Mitchell-Magaldi, Nerac Analyst Originally Published: February 10, 2015 It is no surprise to anyone in the medical device industry that the European Commission is working on a new regulatory framework that will in essence take the three existing directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/42 regarding medical devices, and Directive…