The absence of technical standards in the Medical Device Directive has forced medical imaging companies to conform to additional, country specific standards. The presence of multilayered and diffused national legislatives in a stringent regulatory environment has invariably complicated product and technology innovation.
Multiple national standards have made regulatory compliance a lengthy procedure. Constant alterations in specifications to meet the varying technical standards laid down by different countries have increased administrative workloads, time to market and product development costs.
"In a bid to save costs and time, most medical imaging companies end up retaining outdated technologies and focussing on countries with less regulatory hassles - which ultimately denies them access to more lucrative markets," explains Research Analyst Srividya Badrinarayanan from Frost & Sullivan.
The numerous national regulations have also created disparities in terms of technology and equipment features acceptable to the various countries - making it extremely difficult for companies to maintain multiple product lines. In order to extend their reach, medical imaging companies have been compelled to tailor marketing strategies around the individual national legislations.
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 healthcare suppliers in simultaneously launching a product in all European nations -in turn reducing time to market and increasing profit margins.
Developing single market regulations is likely to provide uniform standards - ensuring 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 for better protection of public health.
"Industry participants consider single market regulations beneficial for the entire medical imaging industry since these allow them to focus on research and development initiatives, instead of tedious regulatory compliance," notes Ms. Badrinarayanan.
On the other hand, since most of the variations in the standards are due to demographic determinants, purchasing power, budgets allocated in healthcare plans, economic conditions and political factors, multiple national regulations are a necessity for sustaining long-term growth.
Additionally, a greater number of regulations sideline the participants failing to comply with them, while increasing the intensity of competition among the existing companies. In order to garner the largest market share, companies are compelled to become price leaders - resulting in a significant fall in prices of medical imaging equipment.
Due to the strict regulatory mechanisms in place and the increasing competition, European medical imaging companies cannot afford to become complacent and must strive to enhance the safety and quality of their products. Most major companies are, accordingly, migrating towards advanced technology that offers better market value to the customers.
The mandatory Diagnostic Related Group (DRG) system was introduced in Germany in January 2004 as a tool to help clinicians and hospitals monitor quality of care and utilisation of services. The healthcare industry has welcomed the 'innovation clause' present in the DRG system that specifies reimbursement for innovative medical technologies.
The DRG system also categorises patients with similar medical diagnoses, treatment patterns and statistically comparable lengths of stay in a hospital, and attaches a reimbursement rate to each DRG. As rising healthcare costs combine with continuous demand for quality services and lower payments, comparative financial and clinical data on important DRGs has become vital.