ABSTRACT OF THE

WORKSHOP ON

GOOD MANUFACTURING PRACTICES

&

INSPECTION OF MEDICAL DEVICES

 ORGANISED BY

 THE CENTRAL DRUGS STANDARD CONTROL ORGANISATION

 New Delhi * September 19, 2002

• Paradigm shift taking place on three fronts
• Technology & Tools
• Purchasing Methods
• Healthcare Delivery

Opportunities in Asian Medical Devices Industry

• Aging population is expected to change the dynamics of the healthcare market.

• Development of nursing home facilities, insurance for aged care, subsidies for medical personnel caring for the elderly resulting in growth of products relating to aged care, such as medial equipment, home devices, lifestyle drugs, etc.

• Market of used medical equipment emerging

Challenges Facing Asian Medical Devices Industry

• Government Regulations

• Economics

• Market Dynamics

• Distribution

The Indian Scenario

• Approximately 1.5 percent of the global medical devices industry

• The Indian market is in the infancy stage

• Major contributor to this market has been equipment and disposable used for general surgery.

• Opening-up of the insurance sector to private participants will dramatically affect the way industry has been operating.

• Demand for quality medical devices and decline in in-patient stays will create new opportunities in this industry.

• Immense opportunities: Current coverage extends to only 0.25 percent of the population.

Market Overview

Evaluation of the Indian Medical Devices Industry By Frost & Sullivan

Reasons For Success

• Diversity of the industry

• Emphasis on innovation

• Cost reduction

• Self-sustaining nature of healthcare products and services

The introduction of a few implantable devices fuels the need for complementary surgical instrument and operating room equipment. New imaging techniques are driving the need for sophisticated processing systems, display apparatus, and new diagnostic methods that boost sales of disposable items for blood and tissue sampling.

Market Overview

The medical devices industry is poised for an era of unprecedented growth. Aging population will keep traditional markets robust, while political initiatives and economics stabilization will open doors to currently undeveloped markets segments like self care and women’s health.

Small and medium-sized companies constitute the majority of the industry. Frost & Sullivan estimates:

• 65 percent manufacturers post annual sales of less than $1.0 million

• 51 percent have been involved in the industry for less than 10 years

• 77 percent have fewer than 200 employees

• 68 percent employ fewer than 50 people

The technology-driven channeled an abysmally low average of 1 percent of the total revenues in R&D. However, manufacturers are forecast to invest more in R&D in the near future, primarily because this industry rewards innovation. The merit of the product determines its market share and a small company with innovative ideas of useful inventions can also achieve success like any large manufacturer.

Smaller companies have been able to capitalize on market opportunities and were largely responsible for the success of the industry as a whole. Overall, rivalry is on the rise due to the influx of local manufacturers in the low-end segments and new foreign entrants in the high-end segments. [ Continue ]