MEDICAL DEVICES SCOPE AND DEVELOPMENT IN INDIA

MEDICAL DEVICES SCOPE AND DEVELOPMENT IN INDIA

by

Dr. Prasanth S BE BBA MBA PH.D.

ABSTRACT

Biomedical devices fall into three categories

depending on the end use. The need in India

at present is maximum for the disposable end of devices.

Some of the implantable like heart valve and orthopedic and dental implants can also be made in India with advantage.

There are many laboratories and organizations in India, which can take up the development work but few can take it up all the way to controlled clinical trials and finally the market place.

CHALLENGE AHEAD

—The basic problems are related to materials science in terms of compounding and fabrication.

—Since there are no vendors of certified biomaterials in India the device manufacturers have to establish biocompatibility.

—  This talk highlights

INTRODUCTION

—Design and development of biomedical devices cannot be an academic exercise. Ultimately these have to be used for minimizing human suffering.

—There are certain priorities in this area for India.

—There is a considerable interest shown by multi-national companies for sourcing from India because of the possibility of low cost production of adequate quality product in India.

—There is also huge local market for medical devices. Thus there is a major opportunity for Indian manufacturers.

DEMAND

As per the survey report

—World market of Biomedical device will reach 

$ 398bn in 2017 ( Wall street, 3rd November 2013).

—Indian market may increase to $ 5.8 Billion by 2014. 

( Bio spectrum, 3rd October 2013).

—There is a tremendous scope for Indian industry in biomedical devices, of the commonly used kind like catheters, bags, surgical disposables etc.

—Indian can be a global source for the lower end devices because it is possible to set up clean manufacturing facilities with internationally accepted certification to CE, USFDA or WHO specifications at one of the lowest delivered cost.

CATEGORIES OF DEVICES

Biomedical devices can be broadly classified under three categories:

—High tech, low volume products like artificial heart valves and heart assist devices.

—Medium tech, medium to large volume products like oxygenators, hydrocephalus shunts, blood bags, and angiography catheters.

—Low tech high volume products like urine bags, various tubing and catheters, giving sets, and fluids.

Note: More then 90% of the demand for biomedical devices in the country relate to the low tech and medium tech devices. These include dental and orthodontic devices, blood bags, disposables for extracorporeal circulation, and various forms of catheters giving sets and fluids.

MEDICAL APPLICATION OF BIOMATERIALS

—Implantable

—Disposables

—Hospital use articles

—Medical packaging

—Components of medical equipments

SHAPE OF BIOMATERIALS

—Fiber, Fabrics

—Films

—Membrances

—Tubes

—Powders

—Cements

—Coatings

—Moulded Shapes

—Machined Shapes

—Containers

BIO COMPATIBILITY

What distinguishes bio materials from others is the requirement of bio compatibility. Bio compatibility relates to two issues, materials – tissue interaction, and biodegrading. 

EVALUATION OF BIO COMPATIBILITY

In Vitro Procedures

—Tissue culture

—Inhibition of cell growth

—Haemolysis assay

In Vivo Procedures

—Intra-dermal irritation test

—Acute systemic toxicity test

—Intra muscular implantation test

—Histo-pathological tests of implantation site

MANUFACTURE

—The interesting point about the manufacture of most of these devices is that the technology is one of any precision light engineering production. The material used are drawn from virtually every source used by existing engineering manufacturing units.

—It is then a matter for enquiry why there is not local manufacture of biomedical devices in India with its strong infrastructure for precision light engineering. The reason lies in the need for a strictly administered Good Manufacturing Practice (GMP)

PROBLEMS FACE IN MANUFACTURING

—Most of the financing institutions are unaware of the social and commercial importance of indigenous manufacture of medical devices. They are reluctant to fund what are perceived as high-risk-low-return projects.

—Because of the high cost of imports the existing demand for biomedical devices is low, at least for the medium and high tech products.

—The Indian clinical community is averse to using devices of Indian manufacture.

—Lack of quality Manpower.

— Non-availability of quality testing facilities in India

R&D FACILITIES IN INDIA

—There are a vast number of R&D Institutions of higher education like Indian Institutes of Technologies, Indian Institute of Science, and some of the advanced universities, which are doing pioneering work in all aspects of material science.

—The council of scientific and Industrial Research, Government of India, has about 50 laboratories under its wing, many of which are engaged in various programmes in material research.

—Realizing the important of Biomedical Technology to healthcare delivery in India, the Government of India created a National Institute for medical Science and Technology at Trivandrum called Sree Chitra Tirunal Institute for Medical Science and Technology (SCTIMST).

CONCLUSION

—Extensive facilities exist in India for biomedical device development.

—The time span for development, Non-availability of good established testing labs, Lack of good talented manpower are challenging for manufacture. In spite of this the future looks rosy for India to be a global source for at least the huge demand for disposables.