medical polymer based disposables new developments and
TRANSCRIPT
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.
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.
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
Role of Plastics In 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
Role of Plastics In 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
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 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.
POLYMERS & MEDICAL DISPOSABLE 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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
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
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Indian Medical Devices Industry
Favourable factors For High Quality Medical Devices:
Free market environmentFree market environment
A developed industry
Investment in health infrastructure
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Indian Medical Devices Industry
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Indian Medical Devices Industry
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Indian Medical Devices Industry
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
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Indian Medical Devices Industry
Revenues by Major Market Segments
Total Medical Devices Industry: Percent of Revenues by Total Medical Devices Industry: Percent of Revenues by
Segment (India)
Segment Revenues (%)
Critical Care 05
Self-Care 05
Cardiac Surgery 04
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Indian Medical Devices Industry
Revenues by Major Market Segments
Total Medical Devices Industry: Percent of Revenues by Total Medical Devices Industry: Percent of Revenues by
Segment (India)
Segment Revenues (%)
Ophthalmology 04
Urology 02
Others 08
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Indian Medical Devices Industry
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Indian Medical Devices Industry
Medical Disposables Segment
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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%
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
CATHETERS: MAJOR MARKET SEGMENT
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
CATHETERS: MAJOR MARKET 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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
CATHETERS: MAJOR MARKET SEGMENT
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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 %.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
Dialysis Disposables
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
Dialysis Disposables
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
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
Disposable Non-Woven Fabric Products
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
Disposable Non-Woven Fabric Products
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
Disposable Non-Woven Fabric Products
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
Disposable Non-Woven Fabric Products
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
Disposable Non-Woven Fabric Products
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
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
Disposable Non-Woven Fabric Products
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.
POLYMERS & MEDICAL DISPOSABLE INDUSTRY
Medical Disposables Segment
Disposable Non-Woven Fabric Products
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
European Medical Device Industry
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
European Medical Device Industry
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
European Medical Device Industry
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.
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
Substitution by Polymers
With the emerging use of plastics, its use started in the
products like:
Blood Bags / I.V. Pouches by substituting Glass Bottles.
New Developments & Technological Innovations
Substitution by Polymers
Glass IV containers have largely been replaced with flexible PVC bags.
New Developments & Technological Innovations
Substitution by Polymers
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.
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
Substitution by Polymers
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.
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
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,"
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
Technology/Product Development
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 Developments & Technological Innovations
Technology/Product Development
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 Developments & Technological Innovations
Technology/Product 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).
New Developments & Technological Innovations
Technology/Product Development
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.
New Developments & Technological Innovations
Technology/Product Development
Anti-Infective Devices For Urinary Catheters
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.
New Developments & Technological Innovations
Technology/Product Development
Anti-Infective Devices For Urinary Catheters
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.
New Developments & Technological Innovations
Technology/Product Development
Anti-Infective Devices For Urinary Catheters
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.
New Developments & Technological Innovations
Technology/Product Development
Anti-Infective Devices 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.
New Developments & Technological Innovations
Technology/Product Development
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.
New Developments & Technological Innovations
Technology/Product Development
Developing Medical Devices Using Lipid Resistant Polymers.
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.
New Developments & Technological Innovations
Technology/Product Development
Developing Medical Devices Using Lipid Resistant Polymers.
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.
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
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
New Developments & Technological Innovations
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.
New Developments & Technological Innovations
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.