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).
- Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond88By 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…