medical polymer based disposables new developments and

Seminar on Polymers As Biomaterials

Jointly Organised By

Medical Polymer Based Disposables New Developments And Future Scenario

D. L. Pandya

Indian Plastics Institute (Ahmedabad Chapter)And

National Biomedical Engineering Society

December 21, 2006L.D. College of Engineering, Ahmedabad

Medical Disposables

Disposables being one of the category of medical device, is

majorly used by hospitals & other related to medicinal branch.

Because of the recognition of Polymers/ Plastic properties

which is suitable or compatible to be used in Medical

Disposables, the Medical Disposable Market has developedDisposables, the Medical Disposable Market has developed

which has attained a remarkable position among the other

Medical Devices.

Growth Of Plastics

The use of plastics in medical applications is expected to

continue its steady growth as new polymers edge out metals,

ceramics, and other traditional materials. Innovative materialsceramics, and other traditional materials. Innovative materials

are replacing the conventional ones such as PVC.

Growth Of Plastics

Benefits Of Plastics As Medical And Health Care Products

Why Plastics ?

Sterilizability and resistance to disinfectants.

It has right combination of clarity, purity, toughness and

productivity.productivity.

Resistant to caustic solutions and chemicals and extremely

heat-resistant for the purposes of sterilisation.

Safe handling of plastic products due to their resistance to

breaking.

Benefits Of Plastics As Medical And Health Care Products

Why Plastics ?

Flexible, ductile, tough and light weight

Low co-efficient of friction

Inert in contact with blood, tissue and other body

fluids/matters

Transparent - vital to monitor visually/ electronically flow

through the tube

Less cost and recyclable.

Plastic Based Medical Disposables

Plastic Based Medical Disposables

Disposable Non-Woven Fabric Products

Major Components

Tubing (Extrusion)

Components (Injection Moulding)

Packaging

MEDICAL TUBING

Role of Plastics In Medical Tubing

The growth of minimally invasive surgery is a majordriving force for new applications of plastic tubing in thedriving force for new applications of plastic tubing in thehealthcare field. Market of plastic medical tubing hasbeen growing steadily right from its inception in forties.

Today, plastics are the dominant tubing materials fortransferring blood, oxygen and nutrients in hospitals and

clinics.

MEDICAL TUBING


Plays a pivotal role in many advanced medical procedures,

such as vascular catheters, conduits for acquiring biopsysuch as vascular catheters, conduits for acquiring biopsy

samples, and holders for stents being implanted into heart

arteries.

MEDICAL TUBING


Coextrusion can extend the performance properties of plasticCoextrusion can extend the performance properties of plastic

tubing by combining the best features of different polymers

Advances in co-extrusion technology are aiding the evolution

of plastic tubing with the latest developments that include

special formulations offering unique combinations of desired

properties such as strength, flexibility, a high gas-barrier

rating and lubricity.

MEDICAL TUBING

Material Suitability For Medical Tubing:

Inertness to body tissues and fluids

FlexibilityFlexibility

Resistance to sterilization conditions

Low extraction

Clarity

Low cost for high volume applications

MEDICAL COMPONENTS

MEDICAL COMPONENTS

Application of medical plastics is divided in two main product areas…..

Relatively “simple” components

Like Syringes, Pipettes, Petri-dishes etc. Like Syringes, Pipettes, Petri-dishes etc.

Specifications / production environment subject to very high demand

Syringes and pipettes calls for high quality as far as roundness & aperture cross sections are concerned

In case of Petri-dish the dimensional accuracy is in the focus

MEDICAL COMPONENTS

MEDICAL COMPONENTS

Medical products / systems

Like inhalers/ insulin pens etc.

Products are combination of complex individual componentsProducts are combination of complex individual components

Meant for specific function like storage and metering etc.

Mechanical plastic parts have decisive importance

From the production/molding point of view both the areas canbe treated in the same way

POLYMERS & MEDICAL DISPOSABLE INDUSTRY

Medical Disposables Manufacturers have successfully

established itself in last two decade. From an unorganized state,

the Industry has upgraded to almost the International Standard

with some of the firms now having the National and

International Quality Certifications like GMP, ISO, CE , WHO ,International Quality Certifications like GMP, ISO, CE , WHO ,

GMP etc.

The growth of the Plastics Industry has tremendously

supported the growth of the Medical Disposables

Manufacturing Industry.


Used in the form of tubes, components and packagingmaterials, plastics contribute more than 75 % of the cost ofproduction.

Different types of Plastics Raw Materials are the major inputs toDifferent types of Plastics Raw Materials are the major inputs tothis industry of course along with skilled labors force. Becauseof the cost and property advantages of the Plastic Materials, asignificant cost of production for the Medical DisposablesProducts is contributed by the cost of Plastic Materials.


Indian Medical Devices Industry

Promising market

With steady growth in GNP, population numbers and standardWith steady growth in GNP, population numbers and standard

of living, India represents one of the most promising markets.

The Indian market for medical equipment and supplies was

valued at USD 1260 million in 2004 and is expected to reach

USD 1.7 billion in 2010



Favourable factors For High Quality Medical Devices:

Free market environmentFree market environment

A developed industry

Investment in health infrastructure



Firstly, rising income and health consciousness amongst the

Indian population are driving people to seek specialised care.Indian population are driving people to seek specialised care.

The urban consuming class is expected to grow from 78 million

in 2001 to 250 million in 2010.



India’s increasingly affluent middle class is demanding access

to better healthcare; many Indians are now choosing to

purchase health insurance with either full or partial coverage, sopurchase health insurance with either full or partial coverage, so

a large percentage of the population can afford to receive high

technology treatment.

Several corporate houses have expanded into the hospital

business, while leading healthcare providers such as Harvard

Medical International and Cleveland Clinic have entered India

through joint ventures.



Revenues by Major Market Segments

Total Medical Devices Industry: Percent of Revenues by

Segment (India)Segment (India)

Segment Revenues (%)

Diagnostic Imaging 17

General Surgery 47

Clinical Instrumentation 09




Total Medical Devices Industry: Percent of Revenues by Total Medical Devices Industry: Percent of Revenues by

Segment (India)


Critical Care 05

Self-Care 05

Cardiac Surgery 04




Total Medical Devices Industry: Percent of Revenues by Total Medical Devices Industry: Percent of Revenues by

Segment (India)


Ophthalmology 04

Urology 02

Others 08



Medical Disposables Segment

Used by practically all hospitals and private nursing homes inUsed by practically all hospitals and private nursing homes in

the country, including diagnostic and pathological laboratories.

In hospitals disposables are used, both in the ward as well as

the OPD.

Still significant number of devices and disposables are being

imported at international prices.




Only few low end products are being manufacturedOnly few low end products are being manufactured

indigenously, such as fluid administration sets, blood bags, and

products such as condoms and copper – T . majority of the low

end devices and disposables are manufactured in the an

organized sectors.



FOUR LEVELS OF THE DISPOSABLE MARKET

Market

Share

Growth

Level 1 Syringes, Scalp Vein Sets, Needles, Urine 60% 15% Level 1 Syringes, Scalp Vein Sets, Needles, Urine

Bags

60% 15%

Level 2 Stopcocks, Nebulising Chambers, IV

Cannulas Extension tubes

15% 37%

Level 3 Blood bags, Endotracheal tubes, arterial

catheters

15% 35%

Level 4 Heart Valves, Dialysers 10% 20%



Medical disposables : The major products manufactured in India

I.V. Catheters or Cannulae

I.V.Sets and Tubes

Blood Bags

Disposable Hand Gloves I.V.Sets and Tubes

Disposable Catheters

Disposables Syringes and Needles

There are about 125 manufacturers of medical disposables

manufacturing units manufacturing the above products spread over

India starting from Calcutta to Trivandrum.

Disposable Hand Gloves

Disposable Non-Woven Fabric

Products



CATHETERS



CATHETERS

In medicine, a catheter is a tube that can be inserted into a bodyIn medicine, a catheter is a tube that can be inserted into a bodycavity duct or vessel. Catheters thereby allow drainage orinjection of fluids or access by surgical instruments.The processof inserting a catheter is called catheterization.

Catheters are among the more technology-based medicalinstruments available today and are becoming more so withevery new advancement in the industry.



CATHETERS: MAJOR MARKET SEGMENT

The major segments of the market are:The major segments of the market are:

1. Coronary catheters (including angiography & catheterization, electrophysiology, angioplasty, atherectomy and coronary ultrasound),

2. Renal catheters (including urology and dialysis catheters) and

3. IV / infusion catheters.




Together, they account for over 60% of total catheterTogether, they account for over 60% of total catheter

sales.

The coronary catheter segment of the market is undergoing

tremendous change and evolution at this time as new, more

effective, and less invasive products are introduced, each

building on the previous generation of products.

POLYMERS & MEDICAL DISPOSABLE INDUSTRYMedical Disposables Segment


The largest segment, however, is the renal market, which iscomprised primarily of urinary catheters and dialysis catheters.

The best-known urology catheters are Foley catheters, whichhave been commercially available since the 1930s. Thesecatheters and others, both internal and external condom-typecatheters, are used for incontinence, for dying patients, andoften for bladder drainage following surgery or anincapacitating injury or illness. These relatively easy-to-usecatheters are used throughout the world in hospitals, nursinghomes, and home-care settings.




Intravenous (IV) catheters are also widely used throughout the

world. These catheters are used on a short-term, long-term, orworld. These catheters are used on a short-term, long-term, or

an intermittent basis for infusion of blood, drugs, or other

fluids, and to obtain blood samples. Depending on the purpose

of the IV line, plus the length of indwelling time needed,

various catheter products are used. Types include standard IV,

peripherally inserted central catheter (PICC)/midline, central

venous catheters (CVC), and needles.



I. V. SETS

There are about 200 firms in India including organized sector as

well as small units manufacturing I.V. Sets, tubes etc.well as small units manufacturing I.V. Sets, tubes etc.

The small scale Medical Disposables Manufacturing Units in

Gujarat contribute approximately 60% of country’s production

and requirements Medical Disposable Products like

Intravenous Infusion (I.V.) Sets.



I. V. SETS

With the origin of this Industry in Gujarat about 25 years back,

this Industry has grown many folds mostly in small-scale sector.this Industry has grown many folds mostly in small-scale sector.

The total production of I.V. Sets in India is understood to be

around 300-350 million units per annum of which Gujarat

contributes about 60 %.



I. V. SETS

There are about 6 manufacturers of I.V. Cannulae in India

today. While the information about the total productiontoday. While the information about the total production

capacity is not available , a snap study carried out with the

existing units indicate that the units are operating at 100%

capacity and are in a position to export the products in a big

way. Some of the existing units are having quality certification

(CE Mark) required for the exports to Europe. Largely the

production is located in and around New Delhi.



Blood Bags

Disposable device used for collection, component separation,

cryostorage & transfusion of blood.cryostorage & transfusion of blood.

This is the first technology from the Biomedical Technology

Wing, The Sree Chitra Tirunal Institute for Medical Sciences &

Technology (SCTIMST), Thiruvananthapuram which was

commercialised in 1984.



Blood Bags

SCTIMST has licensed this technology to following Companies:

M/s. Peninsula Polymers Ltd., Trivandrum

M/s. Hindustan Latex Ltd, Trivandrum

M/s. J. Mitra & Bros, New Delhi

M/s. Electromedical Equip. & Allied Ind., Calcutta

There are about 7 Companies manufacturing Disposables

Blood Bags in India.



Dialysis Disposables

A person suffers from renal disease when, owing to an

impairment in their functioning, the kidneys, whose function isimpairment in their functioning, the kidneys, whose function is

to cleanse the blood of wastes such as uric acid & other toxic

substances, do not cleanse the blood efficiently.




Out of estimated 20 lakh suffer kidney afflictions every year,

10% are put on dialysis or need to have their kidney10% are put on dialysis or need to have their kidney

transplanted. And, the numbers, according to nephrologists, are

alarmingly doubling at the turn of each year. Forty percent of

birth defects in children are kidney related.




The various products required for the Dialysis Procedures as

mentioned above:mentioned above:

• Blood Lines

• Fistula Needles

• Adopters (Different Type)

• Extension Lines

• Introducer Needle

• Femoral Catheter

• Teflon Coated guide wire

• Vascular Access Catheters

[Hemodialysis / Aphaeresis]

• Dual Lumen Catheters with

curved extension

• Dual Lumen Catheters Jugular

Catheters




Non-woven fabrics are made from polymers such as PP, NylonNon-woven fabrics are made from polymers such as PP, Nylon

and PET.

While they are known as fabrics and look like textiles, they are

not woven fabrics like conventional textile fabrics.




Non-wovens offer excellent value-for-use in surgicalNon-wovens offer excellent value-for-use in surgical

applications, protecting, surgeons, doctors and their patient’s

from the spread of infectious diseases transmitted via blood and

other body fluids.




Disposable sterile non-woven surgical gowns and patient’sDisposable sterile non-woven surgical gowns and patient’s

protective sheet drapes are infectious liquid-borne pathogens

compared to the conventional muslin textile fabrics.




The improvement in asceptic technique made possible by non-

woven surgical packs and gowns & also other hospital

requirements such as hand-gloves , caps ,disposable face-

masks , sheets, shoe-covers, etc.




Non-woven fabrics have gained acceptance because of

performance advantages such as added convenience of

disposable diapers. Non- Woven Face Mask have high bacterial

filtration efficiency, comfort the wearer, convenience and

economical cost as compared to the benefits and the safety it

offers




The Indian non-woven medical disposables industry is growing

at a fast pace.

Tata Consultancy Services (TCS) has predicted a business of

140 crore for the non-woven disposables market in India by the

year 2008.




India is the preferred destination, foreign companies have set-

up 10 manufacturing units in the country in past 10 years.

Market Scenario

Contract Manufacturing and Outsourcing

Nypro Inc. (Clinton, MA)

Nypro Inc. (Clinton, MA) is a molder of plastic components forNypro Inc. (Clinton, MA) is a molder of plastic components forvarious industries, including fluid-management valves formedical devices.

The company has been doing business in China for more than30 years. It now has more than a dozen facilities in Chinaemploying around 7000 people, about half of the company’stotal staff.

Market Scenario

European Medical Device Industry

The Market Research Report

The Objective of the survey: Identifying trends in the medicalThe Objective of the survey: Identifying trends in the medicaldevice market to include manufacturers’ growth initiatives,supplier opportunities, innovation, ecommerce & the effect ofthe Euro on the medical device market & trading conditions.

150 interviews were conducted with Corporate ManagementRespondents including CEOs, Presidents, Managing Directorsand General Managers

Market Scenario


Important Findings Of the Market Research Report

The European Medical Device Industry market clearly

represents an important sector for many supply industries.

According to the report over half (55%) of the respondents are

interested in seeing new suppliers.

Market Scenario


Supplier Opportunities : Areas where they would be most

interested in seeing new suppliers.

Manufacturing 37% Calibration 26% Manufacturing 37% Calibration 26%

Injection Moulding

& Extrusion

36% Analytical

Services

26%

Testing 33% Packaging Of

Products

26%

Coating / Surface

Treatment

30% Clinical Trials 33%

Market Scenario


Design 33% New Material /

Equipments

29%

Supplier Opportunities:

Equipments

R& D 30% Components /

Production Of

Components

29%

Logistics/Distribution 30%

New Developments & Technological Innovations

Some dramatic developments in polymers for the medical

device industry have enabled device developers the means to

push the technological envelope. Polymers can be referred as

one of the important emerging material changing the scenarioone of the important emerging material changing the scenario

of health care delivery. Disposables used in hospitals have

become an integral part as it has been leading in combating

infection from diseases like: Hepatitis B, C & HIV.


Medical polymers based Disposables have given rise to manynew developments through different routes:

1) Substituting Existing conventional Materials/Product

Material

2) Substitution of Existing Products by new technology Products.

3) Indigenization

4) Attracting Multi National Companies by shifting production to India

5) Material Developments.


Substitution by Polymers

Polymers were definitely making their presence known as theobvious material of choice for the growing healthcare industry25 years ago.25 years ago.

The significant entry into the area of medical devices led tothe further shifting of polymers into the expanding area ofaccessories & all the various plumbing used in health caredelivery.



With the emerging use of plastics, its use started in the

products like:

Blood Bags / I.V. Pouches by substituting Glass Bottles.



Glass IV containers have largely been replaced with flexible PVC bags.



Blood & other fluids for intravenous use have been

administered from glass bottles, but they are difficult to store,

they crack & rubber bungs may act as a nidus for infection.they crack & rubber bungs may act as a nidus for infection.

When Bungs & bottles are reused particles of rubber may

become dislodged & form amboli. These difficulties & the

shortage of glass containers have led to the glass bottles to be

substituted by plastic.


Advantages Of PVC Bag

1) Fully Collapsible

2) High Transpartency

3) InfusionPressure

4) Closed System4) Closed System

5) Lower Risk Of Contamination

6) Non- Breakable

7) High Sterilization Temperature.



Thermoset rubbers are used in all medical applications of

rubber technology. Rubber expenditures often rank at or nearrubber technology. Rubber expenditures often rank at or near

the top of material costs in medical companies, because of the

need for elastomeric components in most medical products.


Factors driving move to replace thermoset rubbers

with TPEs :

1. Processibility and design flexibility of TPEs

2. Cleanliness of TPEs (Low extractable)2. Cleanliness of TPEs (Low extractable)

3. Material Cost

Any one or a combination of these three factors can lead to an

overall cost reduction for the product or to a marketplace

advantage over traditional thermoset products.


About Orthosis Callipers Developed By Dr APJ Abdul Kalam

Why did he develop ? … in his own words :

“One day an orthopaedic surgeon from the Nizam Institute of Medical Sciences (in Hyderabad) visited my laboratory. Medical Sciences (in Hyderabad) visited my laboratory.

He lifted the material and found it so light that he took me to his hospital and showed me his patients.

There were these little girls and boys with heavy metallic callipers weighing over 3 kg each, dragging their feet around.

He said to me: Please remove the pain of my patients.


About Orthosis Callipers Developed By Dr APJ Abdul Kalam

Why did he develop ? … in his own words

In three weeks, we made these Floor Reaction Orthosis 300 gram callipers and took them to the orthopaedic centre.

The children could not believe their eyes!

From dragging around a 3 kg load on their legs, they could now move around freely with these 300 gram callipers.

They began running around ! Their parents had tears in their eyes.


Develop low-cost Biomedical Devices: Kalam


Develop low-cost biomedical devices: Kalam

The President, A.P.J. Abdul Kalam, has called upon R&Dorganisations, academic institutions, non-governmentalorganisations, hospitals and industry to work together toprovide low-cost biomedical devices, using existing scientificprovide low-cost biomedical devices, using existing scientificand technological advancements and taking into account thelocal conditions and problems of patients in the country.

"This is one of the way of bringing down the cost ofbiomedical products supplied by multinationals,"


Technology/Product Development

New Technology to Deal with Swelling of Arteries

Completely new technology has come up to deal with

aneurysm (swelling) of the arteries. This relates to implanting

a PTFE (polytetra fluroethylene.) covered stent in the affected

artery to block off the flow of blood into the aneurysm.


Aortic aneurysm



New Technology to Deal with Swelling of Arteries

Mainly used to treat aneurysms where there is a dilatation ofMainly used to treat aneurysms where there is a dilatation of

the blood vessels or arteries. Such a procedure could be

carried out, for instance, when there is an aneurysm in a major

artery like the aorta. The aorta is the body’s prime hosepipe,"

Dr Ashok Bandyopadhyay told ET. Dr. Bandyopadhyay is

chief cardiac surgeon at Kolkata’s Peerless Hospital.



New Technology to Deal With Swelling of Arteries

The covered stenting technique is picking up in India, heThe covered stenting technique is picking up in India, he

said, primarily in metros like Mumbai, Delhi, Chennai,

Bangalore and Kolkata. Peerless Hospital, for example, has

recently pulled off a covered stent procedure.

The cost of the covered stenting tech is high:- because it’s a

comparatively recent development.



New Technology to Deal With Swelling of Arteries

The stent and equipment to carry out procedure have to beThe stent and equipment to carry out procedure have to be

imported from Singapore," Dr. Bandyopadhyay said.

Aneurysm cases which require covered stenting implantation

come up off and on and there is little reason why the

technique will not catch up fast in the coming days, Dr.

Bandyopadhyay summed up. (Ref : The Economic Times

dated May 30, 2006).



Anti-Infective Devices For Urinary Catheters

Use of urinary catheters has gained wide spread acceptanceUse of urinary catheters has gained wide spread acceptance

and is frequently used in hospitals. However, urinary catheters

are the major cause of nosocomial urinary tract infections

(UTI) and their prolonged use has lead to increased morbidity

in patients, in hospitals, nursing home and home care. In

addition they have an acute impact on duration and cost of

hospitalization.




Hence it is necessary to make indwelling devicesHence it is necessary to make indwelling devices

biocompatible and free of bacterial adherence.

It is essential that the surface of indwelling medical devices

should be smooth not only to allow healthy tissue cells to

grow easily and resist bacterial adhesion but also to destroy

bacterial cells that come into contact with them.




Surface modification of the existing device is relativelySurface modification of the existing device is relatively

straight forward strategy for creating indwelling medical

devices with desirable surfaces.




Poly vinyl pyrrolidone and polyethylene glycol are typicalPoly vinyl pyrrolidone and polyethylene glycol are typical

examples of hydrogel polymers used in indwelling medical

device surface modifications. Hydrophilic polymer film

formed by UV cross linking derivatives of Poly vinyl

pyrrolidone reduces bacterial adhesion Invitro on materials

used for Urinary Catheters.




There are alternate methods also to provide a surface free ofThere are alternate methods also to provide a surface free of

bacteria by incorporating non-toxic anti-infective agents such

as anti-microbials, anti-biotics and other pharmaceutical

agents that kills bacteria on the device surface.



Developing Medical Devices Using Lipid Resistant Polymers.

In the past few years, the use of lipid or fat emulsions for IV

therapy has grown in popularity.therapy has grown in popularity.

The reason is that lipid emulsions are better suited than are

aqueous solutions for administering certain drugs that may not

be water soluble. Since fatty solutions can attack the plastic

components while it is under stress load, causing anything from

minor crazing to cracks and leaks. Female luer fittings are

particularly susceptible to stress cracking.




As part of a drive to reduce costs, IV sets may be left in place

from 48 to 96 hours rather than changed out every 24 hours.from 48 to 96 hours rather than changed out every 24 hours.

The longer the exposure, the greater the chance for stress-

related attack of the component.




Recently, lipid-resistant polycarbonate grades have been

developed for the IV component market. These products havedeveloped for the IV component market. These products have

many of the attributes of standard polycarbonate grades but

with dramatically improved resistance to stress-related failure

when exposed to typical lipid emulsions.


Indigenization

Copper-T


Indigenization

A variety of Intrauterine Contraceptive Devices (IUDs)bearing Copper, used for spacing between two child, havebeen in use for about 30-35 years. The Population Council ofUSA developed Copper T 200B in early 1970’s.USA developed Copper T 200B in early 1970’s.

This device was most extensively used world over.

During 1975-1982, India also tried to manufacture IUDs atKanpur in a UP Govt. undertaking but could not succeed.


Indigenization

It is a flexible polyethylene T-shaped body with acopper collar on each of its transverse arms andcopper wire coiled around its vertical shaft.copper wire coiled around its vertical shaft.

A monofilament polyethylene thread is tied throughthe bulb at the tip of the T, resulting in two threadsto aid in detection and removal of the device.


Indigenization

The IIT , New Delhi took this as challenge and made allefforts. A device which was imported for almost 25 years wasnow made in India and the first supply of indigenous Coppernow made in India and the first supply of indigenous CopperT was available for use in 1992. This was possible becauseefforts were made on all necessary steps needed for a productto be manufactured in a GMP facility. Not only countrybecame self sufficient in this product but is exporting theproduct almost all over the world.


Indigenization

The Indian product is considered to be the best in

the world and almost 30-35 % of the requirement of the world and almost 30-35 % of the requirement of

the world is met by Indian manufacturers


Conclusion

With the convergence of many scientific and technologybreakthroughs, the pace of medical invention is accelerating,inspiring hope for better clinical outcomes with less invasiveinspiring hope for better clinical outcomes with less invasiveprocedures and shorter recovery times. Smaller parts alsorequired better materials & new techniques for processingthem to meet high tolerances.


Conclusion

The material developments would enable designers to push

the limits of materials & products to new heights.

Polymer technology will enable the wildest dreams to become

reality.

medical polymer based disposables new developments and

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