Medical Device Manufacturing : Critical Issues
Plastics In Healthcare - Expanding Horizons
 

By : Mr. Ravi Jalali, G.M. Business Development Reliance Industries Ltd.

Introduction to Plastics & Healthcare The plastics have changed the approach of healthcare scenario. In the year 1628, the blood circulation was discovered by William Harvey and then in 1901 blood group was discovered by Karl Landsteiner. Now it took plastics only to make use of these discoveries, because just by themselves it was just a piece of knowledge and was not useful for mankind. Finally it is plastics that made storage and transfusion of blood possible and like wise very well-known example in India is the invention of “ Jaipur Foot”. The short story behind the invention is that the person who invented it catch the idea from the workshop where the cycle was getting repaired.

Why Plastics for Healthcare ?
 

Plastics score more than any conventional material in terms of performance, economics and compatibility and hence these conventional materials have been replaced by plastics in gradual period of time. Some of the favourable characteristics of plastics in healthcare are as follows: Flexible, ductile, tough and light weight Low co-efficient of friction to facilitate flow Inert, Non-toxic & Bio-Compatible and hence can contact with blood, tissue, etc. Transparent - vital to monitor visually/ electronically flow through the tube Ease of sterilization Design, forming and jointing flexibility Low cost & hence disposable - making affordable healthcare possible Disposal of Bio-Waste / Recyclable

What Medical O.E.M. Look for plastics?

• Material should plastics that stand up in the consumer and less skilled user environment, where usage of difficult product should not be a problem.

• Materials selection on the basis of performance potential and ease of processing.

What is a Medical Device ?

Healthcare Product that does not achieve its intended purpose by chemical action or by being metabolised, eg. Electro-medical equipment and related software, Furniture supplies and consumables, Orthopedic appliances, Prosthesis and diagnostic kits, reagents and equipments.

Plastics in Medical Devices - Challenges

Property	Glass	Metal	Plastics
Flexibility	Poor	Poor	Excellent
Clarity	Excellent	Poor	Good
Design versatility	Poor	Poor	Excellent
Barrier properties	Excellent	Excellent	Good
Chemical resistance	Excellent	Poor	Good
Sealability	Poor	Good	Excellent
Performance Weight/Volume Ratio	Poor	Poor	Excellent

The base for manufacturing of medical devices is biocompatibility and there is lot of opportunity and hence one needs to see it and can get into some of this value added products. The challenges for use of plastic for medical devices and the challenges that Indian entrepreneurs faces are :

• Substantial investments

• Staying power for prolonged periods of market penetration because if you have to promote your product in market you will not be able to get revenue from the first day.

• Meticulous compliance with legal provisions, technical codes and practices.

• To process novel polymers and formulations for customised applications

• To manage intricate design complexity of components

• To identify process technologies for best production

Plastics in Healthcare

I. Broad Application of plastics in Healthcare is as follow :

a) Not in direct contact with human body and the products are :

Packaging of drugs and syringes, Disposables, Hearing/Low vision aids, Artificial limbs, Medical equipments

b) In direct contact with body tissues and fluids (Bio-Compatible) and the products are :

Body implants, Catheters, IV Cannulae, Blood & IV Fluid Bags

II. Few Specific Applications

• Plastics : PVC Blood bags, Blood tubing, Surgical gloves, Suction pipe, Infusion drip chamber, blister packaging

• HDPE : Blood filters, Catheter, Reconstruction of joints, Syringes, Splints, Bone fracture treatment, IV Fluid bottles, etc.

• LDPE : Packaging films, Wound covering films, Urine bags, Examination gloves, Catheter Tracheal Prostheses

• UHMWPE : Joint replacement prosthesis and Transplants

• PP : Membrane support suture, Packaging foils, Syringes, Non-wovens

• PTFE : Catheters & drainage tubes, Coating for suture membrane for artificial lungs, Cannulae, Artificial Bone/joints

• Polyamide : Surgical instruments, Suture material, Artificial skin

Global Market for Plastics- Proven Across the world.

The Global Market for Plastics is 175 MMTA in which share of Plastics in Healthcare Products is 1.8 MMTA(~1%). And in 1.8 MMTA there is, 80% share of PE, PVC, PP. Global Medical Device Market is $260 bill (2006)., There is growth of 7% though 2009 for Global Pharma Pkg. demand.

Global Trends

• Move from Glass to Plastics

• Shift of Healthcare away from Hospitals

• OEM’s/Manufacturers looking at Plastics to deliver in Consumer and less skilled environment

• Increase in demand for Clean room manufacture

• Nano/Smart materials

Indian Scenario

Current Spending on Health is 1% and is going to grow to 2-3% in next few years. The Per Capita Spending is $1. Hence healthcare is going to see highest growth among. all spending categories. The projections are that the growth estimated to be 12%. The healthcare sector is projected to grow to nearly US$ 40 billion by 2012. The healthcare spending could contribute to 8% of GDP and employ around 9 million people by 2012.

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