Medical device industry : Origin, growth and challenges

Gujarat today has largest number of licensed medical device companies in the country with products ranging from common hospital  disposables to most critical cardio-vascular devices. Supported by a large network of supply chain , logistics and allied industries  medical device cluster is Gujarat is the largest in the country. The Gujarat Industrial Development Corporation has developed a special cluster zone devoted to medical device industry near Ahmedabad.

Origin of Gujarat medical devices and equipment industry
The medical devices and equipment industry in Gujarat originated with the I. V. Fluid manufacturing industry in the 1970s. The growth of this industry was supported by easy availability of plastic raw materials and also plastics processing capacities and skills available in Gujarat. The presence of a large number of pharmaceuticals & allied units has also helped a lot.

Industry size and major clusters
There are approx. 200 medical devices companies largely scattered around Ahmedabad, Vadodara and Surat. There are more than 100 raw materials, components and equipment suppliers supporting the medical device sector in Gujarat.

About 20 years back, Gujarat in general and Ahmedabad in particular contributed as much as 80 to 90 per cent of country’s production of medical disposables like I.V. Sets. The state still has a significant share in the production of I. V. Sets and other medical disposables.

The other sub-sectors with significant contribution include:  orthopaedic implants ,ophthalmic implants / products , diagnostic products , cardiology implants / products , surgical instruments / accessories , bandages and wound care products , non-woven and medical textiles , dental implants / products , electro-medical equipment , medical electronics equipment etc.

These units are supported and serviced by manufacturers / companies across the value chain in :

• Packaging materials for medical devices and pharmaceuticals
• Plastics raw materials / components ( injection moulded / extruded )
• Laboratory supplies
• Services including: testing / sterilisation / calibration / validation / quality certification / product developments / R&D / man power training etc.
• Engineering services including : surface treatments / coating / electrical – mechanical maintenance

Present institutional structure in Gujarat
Gujarat has several institutions that support the growth of medical device segment in the state. The following institutions directly facilitate the growth of the medical devices industry in Gujarat:

PERD Centre, Ahmedabad
The B. V. Patel Pharmaceutical Education and Research Development (PERD) Centre is India's first multidisciplinary, postgraduate research institute, dedicated to the pursuit of excellence in pharmaceutical sciences. Equipped with the latest and best R&D facilities, the Institute to-day run a dedicated course with focus on medical device industry.

CIPET, Ahmedabad
Central Institute of Plastics Engineering & Technology (CIPET)  renders technical and consultancy services to plastics and allied industries in different fields of plastics technology. It has facilities for designing, tooling, processing and testing of plastics. With well-equipped testing & R&D activities, CIPET has been involved in R&D of industrial relevance.

EQDC, Gandhinagar
Electronics and Quality Development Centre (EQDC), Gandhinagar is recognized by the Directorate of Standardization Testing and Quality Certification (STQC), Department of Information Technology, Ministry of Communication, Government of India.

Academic institutions
The following institutions offer graduate courses in biomedical engineering with a total intake of about 300 students per year:

• Government Engineering College, Gandhinagar
• Government Polytechnic , Gandhinagar
• L. D. College Of Engineering , Ahmedabad
• C. U. Shah College Of Engineering , Vadhavan
• Ganapat University, Mehsana

Cluster support programme By UNIDO : A Unique Success Story.
The SME Medical Device units of Ahmedabad/Vadodara faced a major challenge in achieving the stricter quality norms increasingly demanded by the Indian regulatory authority as well as by large-scale units, which can be their potential clients. This is because, in order to attain quality certifications the small firms often lack the required information, appropriate technical training, knowledge of desired plant layout/machinery requirements and were not able to locate affordable Business Development Service ( BDS )  providers to organize such activities.

The programme addressed these challenges in a step-by-step approach by building awareness among firms, sustaining a group approach to purchase of business development service (BDS), creating institutional linkages and finally building the capacity of existing and newly created associations to ensure the sustainability of the process.

The major problems faced by the cluster at the beginning of the intervention were:

• Need for quality upgradation
• Need of manpower training
• Business linkage through new channels
• Strengthening of institutional linkages

Implementation strategy
The above problems were addressed in a step-by-step approach by creating awareness among firms, building consensus on group approach, organizing institutional linkages and building capacity of the associations.

In these interventions , industry association , “Medical Disposables Manufacturers’ Association,” (MDMA) played a special role in disseminating a new vision for the cluster, which initially contributed significantly to ice-breaking and later triggered multiplication of initiatives; technical institutions provided training inputs; private BDS providers propped up confidence by securing business orders; and financial institutions provided financial support to the various activities. All these initiative where co-ordinated by the UNIDO methodology that triggered a proactive mentality and a growing dialogue among the various cluster actors.

As a result of these initiatives, a large number of units in Gujarat embarked on quality upgradation, many of them made an  investments varying from Rs 5 to 50 lakhs. New BDS providers were  introduced in the areas of quality, factory level training, contract business, export market and other support services. The programme created or strengthened linkages with technical/developmental institutions like PERD, CIPET , SIDBI, GITCO, SIDBI, SISI, etc. International networking has been undertaken with development agencies like CBI and NMCP.

Foundation for MSME Clusters ( FMC )
Subsequent to the successful completion of this and other similar programmes , a need  was felt to create an organization to contribute towards this process of cluster based development of MSMEs and thus enhance their competitiveness, generate sustainable employment and alleviate poverty.

At the suggestion of the Ministry of Small Scale Industries, Government of India, the United Nations Industrial Development Organisation (UNIDO) conceptualized and initiated the process of creating the Foundation for MSME Clusters.

Subsequently, the Foundation was legally constituted as a non-government, non-profit registered trust under the auspices of the Entrepreneurship Development Institute of India (EDI), Ahmedabad, in the year 2005.The Foundation Of MSME Clusters  today assists institutions undertake effective and inclusive cluster based local area development in developing and transition economies.

FMC  has focus on the following objectives:

• Cluster initiatives become inclusive.
• Cutting edge methodologies, tools, information and resources with respect to a cluster development program are accessible.
• Effective linkages emerge between clusters and important thematic institutions in the area of finance, infrastructure, environment, investment, RD, social responsibility and local governance.
• Trained and competent professionals and institutions are available to facilitate cluster-based development.
• Models of strong community based civil society organisations emerge to take up cluster based sustainable development initiatives.

The Indian medical device industry needs a number of such institutions which can lead  to  the development of a large number of clusters across the country.

SWOT Analysis
The medical devices industry in Gujarat is at a critical crossroad, where key decisions by entrepreneurs and the Government will set the direction and chart the course of growth for the sector. Hence it may be fruitful to have a look at the SWOT analysis carried out by one of the leading research organizations as follows :

Industry strengths

• Established base of support industry
• Huge latent domestic market
• Low-cost producer of quality medical devices
• Preferred destination for sourcing some major products
• Cheap and abundant low and medium skill manpower
• Major units with international quality certifications

Industry weaknesses

• Fragmented in nature and do not stand up for common needs
• Absence of linkages between industry and academia
• Need to transform from conventional methods to modern technologies
• Lack of accredited testing at intermediate stages
• Low investments in research and development
• Lack of regulations/standards
• Lack of highly skilled manpower
• Lack of shared infrastructure

Industry opportunities

• Increase in health care spending
• Internationally acceptance has commenced on benefits from the sector
• Immense potential to tap medical tourism of world demand
• Expertise to manage entire value chain activities within the country
• Increase in awareness towards high end R&D facility
• Opportunity for small players to grow, to fill the market gap
• Steady expansion towards the ambit of rural marketing

Industry threats

• Global competition from countries like China, Korea, Taiwan
• Competition from medical device clusters located at other locations like NCR in north and Chennai/Bangalore/Hyderabad  etc in South.
• Increasing dependency on imports
• Unorganized market for medical disposables
• Lack of regulatory framework