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.
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