Strategic Analysis of the Impact of Regulations on the Radiology Practice in Europe

This publication has been discontinued on July 19, 2011.

Introduction

Abstract

Complicated Regulatory Procedures Challenge Medical Imaging Companies

European medical imaging companies are finding it increasingly difficult to develop technologically advanced products and expand their reach in a stringent regulatory environment. In addition to the Medical Device Directive, numerous multi-layered and diffused local legislatives complicate regulatory compliance thereby, increasing the time to market. Companies also face rising costs due to constant alterations required in product specifications to meet the varying technical standards in different locations.

This Frost & Sullivan research analyses the impact of regulations on the European radiology market. It provides an overview of the advantages and disadvantages of the regulations on the medical imaging industry. This analysis also emphasises the need for a single market regulation and discusses the effect of Diagnostic Related Groups (DRG) on the European medical imaging industry.

Single Market Regulation to Stimulate Growth in the Medical Imaging Market

Medical imaging companies in Europe are lobbying for the implementation of a common set of regulations as opposed to multiple national standards to govern their radiology practice. "Single market regulations would help the healthcare suppliers to market the same product all over Europe, which in turn reduces production cost and increases profit margins," explains the analyst.

The major variations in regulations are in terms of the acceptable radiation limits, form of data storage and type of technology. Developing single market regulations provides uniform standards that ensure consistency in the safety and quality of products. Such regulations are also expected to remove barriers to trade thereby, bringing in state-of-the-art medical technology that translates into better protection of public health.

Stringent Regulations Ensure High-Value Products

"With a strict regulatory mechanism firmly in place and increasing competition, European medical imaging companies cannot afford to become complacent and must strive to enhance their value proposition to customers," says the analyst. Most major companies are migrating towards advanced technology and competitively priced products that offer better market value to the customers.

The Diagnostic Related Groups (DRG) system encourages technological advancements by reimbursing expenses related to innovative medical imaging technologies. The DRG also reimburses costs related to patient examinations based on the type of test and the group to which the patient belongs. Although DRG generates mixed reactions from the medical imaging industry, as rising healthcare costs combine with constant demand for quality services, comparative financial and clinical data from important DRGs become critical.

Table of Contents

• STRATEGIC ANALYSIS OF THE IMPACT OF REGULATIONS ON THE RADIOLOGY PRACTICE IN EUROPE
  • Introduction
    • Overview
  • Research Scope and Methodology
    • Research Scope & Methodology
  • Introduction and Background
    • Introduction and Background
  • The Key Regulatory Environment in Europe
    • The Regulatory Environment in Europe
    • Key Safety Regulations
    • Key Patient Data Security Regulations
    • The Workflow Regulations
  • The Healthcare Plans
    • Diagnostic Related Groups - The German Way
    • Impact of the Diagnostic Related Groups on the European Medical Imaging Industry
    • Impact of Diagnostic Related Groups on Rest of Europe
  • Disparity in Regulations in Europe
    • Key Differences in Regulations among European Nations
    • The Reasons for the Disparity in Regulations in Europe
  • The Impact on the Medical Imaging Industry
    • The Impact of Regulation on Technology
    • Impact of Regulations on Medical Imaging Market
    • Impact of Regulations on the Customer
    • Impact of Regulations on Pricing of the Equipment
    • Impact of Regulations on Competition
    • Impact of Regulations on the Time to Market
    • What the Industry Says
  • Towards the Future
    • Advantages and Disadvantages of Regulations
    • Towards the Bright Future
    • Need for Harmonisation
    • Towards a Single Market Regulation
    • The Impact of Single Market Regulation
    • What Companies Should Do
  • Key Regulatory Organisations and Industry Participants
    • Key Regulatory Organisations and Industry Participants
  • About Our Company
    • The Healthcare Team
    • Consulting Capabilities

Related Reports