Medical Equipments and Devices

Introduction
The Healthcare Equipment and Services industry consists of companies engaged in the
manufacturing and distribution of basic medical equipment and supplies. The industry
includes forceps, surgical knives and gloves, bandages and dressings, syringes, stethoscopes,
medical laboratory equipment, x-ray films, dental drills, veterinarian instruments and other
related supplies. It excludes retail sales of drugs and medical supplies, and manufacturing and
distribution of high-tech medical equipment. The industry is extremely diversified and
supplies hundreds of thousands of products.

Medical products can be broadly classified into 2 categories: conventional products, which
have little or no technological variations and can be put to a lot of uses; and high-technology
products, which use cutting edge technology to address highly specific therapeutic and
diagnostic applications. In the former category, the margins are narrow and manufacturers
depend on high sales volumes to generate profits. Some examples of products in this category
include: surgical apparel, traditional wound dressings, kits, trays and a wide range of other
products.

The Medical Devices and Equipment industry, valued at US$ 2.5 billion contributes only 6%
of India’s US$ 40 billion healthcare sector. Moreover, it is growing at a faster annual rate of
15% than 10-12% growth seen in the Healthcare sector in its entirety. A rise in the number of
hospitals and the increased requirement for healthcare facilities creates a need for
sophisticated devices and equipment, which can provide accurate treatment to individuals.
The Medical Electronics segment of this industry incorporates control, conversion, sensing,
processing, storage, display, and transfer of information on anatomy and physiology by
making use of the Electronics and Communication Technologies. The Medical Equipment
industry is quite wide with > 14,000 different products types, as per the Global Medical
Device Nomenclature (GMDN). The products range from wound closure pads to stents and
IVD machines of medical devices. Further, it can be reasonably said that Medical Electronics
is an area, where Electronics and Information Communication Technology play a decisive
role.
Moreover, significant efforts have been made in the medical technology ecosystem to
stimulate innovation in this space so that the opportunities provided in the Indian market can
be capitalized by the companies working in this domain and the Indian consumer of
healthcare services stands to benefit.

In the past, the sector has significantly brought down the incidence of disease among
patients, families, society as well as improved the country’s health system, significantly.
However, in India the penetration of medical devices is low and inadequate due to the
barriers that prevent their usage.

Indian Medical Sector

Categorization of Medical Equipments and Device

(Segmentation)
Equipment and Instruments: USD 2.67 billion

 Diagnosing imaging and IV diagnostics forms major part of Equipment and

Instruments with market size in excess of USD 1bn and USD 0.4 bn
respectively. Approximately 51% of medical device imports are from the
Equipment and Instruments category.

 Key products: MRI machines, CT scanners, ultrasound machines, dental drills,

dental chairs, dental x-ray machines, etc.

 Key players: GE Healthcare, Philips Healthcare, Schiller Healthcare, Danaher

Corporation, Mectron India, Roche Diagnostics, Accurex Bio-medical, Narang
 Medical, etc.

 There is great potential in low-end and mid-range systems purchased by small

hospitals and facilities in rural areas.

Consumables and Disposables: USD 1.31 billion

 Syringes, Needles and Catheters form major part of Consumables and

Disposables with market size in excess of USD 1bn collectively.

 Consumables and Disposables is the only trade surplus segment of the medical
device sector with domestic players having a larger market share.

 Key products: syringes, needles, catheters, bandages and dressings

 Key players: Hindustan Syringes, Lotus Surgicals, Sutures India, B Braun,

Beckton Dickinson

 Most of the requirements are met through domestic manufacturing.

Implants: USD 0.35 billion

 Implants segment is highly import driven (dominated by USA) and expected

to grow faster than the other segments in the medical device sector.

 Few domestic companies in the Implants segment are offering customised

designs for the Indian population gaining competitive advantage.

 Key products: knee and hip implants, artificial joints, dental fixtures

 Key players: Smith & Nephew, Narang Medical, Zimmer Holdings, J&J

 Domestic players are experimenting with proprietary technologies and

technology tie-ups. Products customised for the Indian market may gain a
competitive advantage.

Patient Aids: USD 0.65 billion

 Hearing Aids and Pacemakers form major part of the Patient Aids segments
and constitute 70% of the market collectively.
  Import-driven segment: Most products are primarily sourced from Ireland,
USA, Australia, Singapore, China and South Korea

 Key products: hearing aids, pacemakers and artificial respiration apparatus

 Key players: St Jude Medical, Shree Pacetronics, Medisafe International,

Medtronics
 Significant potential for domestic manufacturing

Products in Medical Equipments and Devices

Syringe
A syringe is a simple reciprocating pump consisting of a plunger (though in modern syringes
it's actually a piston) that fits tightly within a cylindrical tube called a barrel. The plunger can
be linearly pulled and pushed along the inside of the tube, allowing the syringe to take in and
expel liquid or gas through a discharge orifice at the front (open) end of the tube. The open
end of the syringe may be fitted with a hypodermic needle, a nozzle or a tubing to help direct
the flow into and out of the barrel. Syringes are frequently used in clinical medicine to
administer injections, infuse intravenous therapy into the bloodstream, apply compounds such
as glue or lubricant, and draw/measure liquids.

Medical Gloves

Medical gloves are disposable gloves used during medical examinations and procedures to
help prevent cross-contamination between caregivers and patients.Medical gloves are made
of different polymers including latex, nitrile rubber, polyvinyl chloride and neoprene; they
come unpowdered, or powdered with cornstarch to lubricate the gloves, making them easier
to put on the hands. Cornstarch replaced tissue-irritating Lycopodium powder and talc, but
even cornstarch can impede healing if it gets into tissues (as during surgery). As such,
unpowdered gloves are used more often during surgery and other sensitive procedures.
Special manufacturing processes are used to compensate for the lack of powder. There are
two main types of medical gloves: examination and surgical. Surgical gloves have more
precise sizing with a better precision and sensitivity and are made to a higher standard.
Examination gloves are available as either sterile or non-sterile, while surgical gloves are
generally sterile.

Adhesive Bandage

An adhesive bandage, also called a sticking plaster (or simply plaster) in British English, is a
small medical dressing used for injuries not serious enough to require a full-size bandage.
They are also known by the genericized trademarks Band-Aid (as "band-aid" or "band aid" in
the US) or Elastoplast (in the UK).

Stethoscope

The stethoscope is an acoustic medical device for auscultation, or listening to the internal
sounds of an animal or human body. It typically has a small disc-shaped resonator that is
placed against the chest, and two tubes connected to earpieces. It is often used to listen to
lung and heart sounds. It is also used to listen to intestines and blood flow in arteries and
veins. In combination with a sphygmomanometer, it is commonly used for measurements of
blood pressure. Less commonly, "mechanic's stethoscopes", equipped with rod shaped
chestpieces, are used to listen to internal sounds made by machines (for example, sounds and
vibrations emitted by worn ball bearings), such as diagnosing a malfunctioning automobile
engine by listening to the sounds of its internal parts. Stethoscopes can also be used to check
scientific vacuum chambers for leaks, and for various other small-scale acoustic monitoring
tasks. A stethoscope that intensifies auscultatory sounds is called phonendoscope.

Stretcher

A stretcher, litter, or pram is an apparatus used for moving patients who require medical care.
A basic type (cot or litter) must be carried by two or more people. A wheeled stretcher
(known as a gurney, trolley, bed or cart) is often equipped with variable height frames,
wheels, tracks, or skids. In American English, a wheeled stretcher is referred to as a gurney.

Stretchers are primarily used in acute out-of-hospital care situations by emergency medical
services (EMS), military, and search and rescue personnel. In medical forensics the right arm
of a corpse is left hanging off the stretcher to let paramedics know it is not a wounded patient.
They are also used to hold prisoners during lethal injections in the United States.
Scalpel

A scalpel, or lancet, is a small and extremely sharp bladed instrument used for surgery,
anatomical dissection, and various arts and crafts (called a hobby knife). Scalpels may be
single-use disposable or re-usable. Re-usable scalpels can have permanently attached blades
that can be sharpened or, more commonly, removable single-use blades. Disposable scalpels
usually have a plastic handle with an extensible blade (like a utility knife) and are used once,
then the entire instrument is discarded. Scalpel blades are usually individually packed in
sterile pouches but are also offered non-sterile. Double-edged scalpels are referred to as
"lancets".

Scalpel blades are usually made of hardened and tempered steel, stainless steel, or high
carbon steel; in addition, titanium, ceramic, diamond and even obsidian knives are not
uncommon. For example, when performing surgery under MRI guidance, steel blades are
unusable (the blades would be drawn to the magnets, or may cause image artifacts).
Historically, the preferred material for surgical scalpels was silver, on account of its
antimicrobial properties (although the mechanics were not understood at the time). Scalpel
blades are also offered by select manufacturers with a zirconium nitride-coated edge to
improve sharpness and edge retention. Others manufacture blades that are polymer-coated to
enhance lubricity during a cut. Alternatives to scalpels in surgical applications include
electrocautery and lasers.

X-Ray Generator

An X-ray generator is a device that produces X-rays. Together with an X-ray detector, it is
commonly used in a variety of applications including medicine, fluorescence, electronic
assembly inspection, and measurement of material thickness in manufacturing operations. In
medical applications, X-ray generators are used by radiographers to acquire x-ray images of
the internal structures (e.g., bones) of living organisms, and also in sterilization.

CT Scan

A CT scan, also known as computed tomography scan, makes use of computer-processed

combinations of many X-ray measurements taken from different angles to produce cross-
sectional (tomographic) images (virtual "slices") of specific areas of a scanned object,
allowing the user to see inside the object without cutting. Other terms include computed axial
tomography (CAT scan) and computer aided tomography.

Medical Ventilator

A medical ventilator (or simply ventilator in context) is a mechanical ventilator, a machine

designed to move breathable air into and out of the lungs, to provide breathing for a patient
who is physically unable to breathe, or breathing insufficiently.

While modern ventilators are computerized machines, patients can be ventilated with a
simple, hand-operated bag valve mask.

Ventilators are chiefly used in intensive care medicine, home care, and emergency medicine
(as standalone units) and in anesthesia (as a component of an anesthesia machine).

Medical ventilators are sometimes colloquially called "respirators", a term stemming from
commonly used devices in the 1950s (particularly the "Bird Respirator"). However, in
modern hospital and medical terminology, these machines are never referred to as respirators,
and use of "respirator" in this context is now a deprecated anachronism signaling technical
unfamiliarity. In the present-day medical field, the word "respirator" refers to a protective
face mask.

Today, there are more than 10 000 types of medical devices available. The selection of
appropriate medical equipment always depends on local, regional or national requirements;
factors to consider include the type of health facility where the devices are to be used, the
health work force available and the burden of disease experienced in the specific catchment
area. It is therefore impossible to make a list of core medical equipment which would be
exhaustive and/or universally applicable.

Promotion of the Sector by the Government

The government is expected to develop a regulatory structure leading to quality products

being developed by manufacturers. However, the current regulatory structure lacks active
participation from the government but with the increase in competition in the sector, this is
just a matter of time. The last few years have seen an increase in domestic manufacturing of
medical equipment. With impetus from Government of India schemes, India is beginning to
look forward to being recognized as a manufacturing destination for sophisticated medical
technology.

The Private and Foreign Investments

International companies in this field are also using India as a manufacturing base by either
setting up facilities of their own or by acquiring domestic manufacturers. Some examples
include 3 M's manufacturing plant in Pune, Becton Dickinson's manufacturing facility in
Haryana, Hollister's setting up manufacturing facility in India and Philips Medical Systems'
acquisition of Medtronics and Alpha X-Ray Technologies. Medical Technology Parks have
been proposed by the Government of India in addition to the existing parks to encourage
domestic manufacturing of medical equipment.

FDI inflow will spur R&D and manufacturing innovations, in turn increasing the efficiency
and effectiveness of medical electronic products. Advancement of medical electronic product
quality and associated successful diagnostic rates are expected to create a spurt in adoption.

Role Played by Major Competitors in the Medical Technology Sector

Medical Technology companies are undertaking a lot of innovations out of India, both, for
the domestic as well as the overseas markets. Transasia Biomedicals has developed in-vitro
diagnostic equipment through its R&D base in Mumbai. The Sushrut Adler Group has
developed an external fixator for the Indian market. Johnson and Johnson has developed a
knee implant suitable for the Indian market as well as a reusable stapler for use in surgeries at
price points, which are amenable to the Indian market. Roche Diagnostics has developed a
screening device for cardio-vascular diseases, which is suitable for use in rural settings. GE
Healthcare has developed a low cost ECG machine and a low cost Ultrasound machine for
the Indian market. Philips Healthcare is using its recent acquisitions in India to develop and
launch a low cost Cath Lab for the Indian market.
Drivers for Growth of Medical Technology Sector in India

 Economic growth leading to higher disposable incomes

 Increased Public Spending in Healthcare
 Increased Private Investment in Healthcare
 Increased Penetration of Health Insurance
 Emergence of new models of healthcare delivery
 Public Private Partnership (PPP) route to Innovation

Key Challenges Faced by the Sector

 Low Penetration
 Accessibility
 Affordability
 Awareness
 Nascent Regulatory Environment
 Low Indigenous Manufacturing
 No Distinct Status of the Industry
 Need for Quality Benchmark at par with the Global Standards
 Complex Rules and Guidelines
 High Capital requirement

Recommendations for Government to Improve Sector

 Move toward adoption of the Global Harmonization Task Force’s (GHTF)

definition and rules-based classification of medical devices.
 Work towards making legislative amendments to enable comprehensive Medical
Device Regulations.
 Urgent Necessity for resource, funds allocation for training and skill up gradation.
 Evolve medical technology clusters with common facilities for development,
calibration, testing, quality control, waste management etc. hence, creating an
ecosystem for the benefit of SME’s focusing on medical technology.
  Increase public spending in healthcare from 1% of GDP to 3% of GDP to
radically alter the provision of healthcare services.
 Encourage greater collaboration between medical centers and technology universities.
 Increase the quality and enhance consistency of training received by medical and
paramedical staff thereby providing creative resources for leading medical innovation
efforts.
 Include medical technology education within the medical curriculum with
assistance from agencies like NIPER.
 Increase the training for regulatory staff especially at the State Level to ensure
consistent interpretation of regulatory approval processes for which partnership
with Industry associations maybe considered as a practice instead of sporadic
efforts.
 User further reform in the insurance sector to stimulate health insurance thereby
providing the financial incentives for medical technology innovation.
 Set up a venture investment fund to address the lack of early stage venture capital

3M

Company overview

3M Company (3M), incorporated on June 25, 1929, is a technology company. The Company
is a manufacturer and marketer of a range of products and services. The Company operates
through five segments: Industrial; Safety and Graphics; Health Care, and Consumer. 3M
products are sold through various distribution channels, including directly to users and
through a range of wholesalers, retailers, jobbers, distributors and dealers in a range of trades
in various countries around the world. As of December 31, 2016, the Company had operated
81 manufacturing facilities in 29 states. As of December 31, 2016, the Company had operated
122 manufacturing and converting facilities in 36 countries outside the United States.

Health Care Business

The Health Care segment serves markets that include medical clinics and hospitals,
pharmaceuticals, dental and orthodontic practitioners, health information systems, and food
manufacturing and testing. Products and services provided to these and other markets include
medical and surgical supplies, skin health and infection prevention products, inhalation and
transdermal drug delivery systems, oral care solutions (dental and orthodontic products),
health information systems and food safety products. The Company, through Treo Solutions
LLC, provides data analytics and business intelligence to healthcare payers and providers.
The Company, through Ivera Medical Corp., manufactures healthcare products that disinfect
and protect devices used for access into a patient's bloodstream.

In the medical and surgical areas, 3M is a supplier of medical tapes, dressings, wound closure
products, orthopedic casting materials, electrodes and stethoscopes. In infection prevention,
3M markets a range of surgical drapes, masks and preps, as well as sterilization assurance
equipment and patient warming solutions designed to prevent hypothermia in surgical
settings. Other products include drug delivery systems, such as metered-dose inhalers,
transdermal skin patches and related components. Oral care solutions include restoratives,
adhesives, finishing and polishing products, crowns, impression materials, preventive
sealants, professional tooth whiteners, prophylaxis and orthodontic appliances, as well as
digital workflow solutions to transform traditional impression and analog processes. In health
information systems, 3M develops and markets computer software for hospital coding and
data classification, and provides related consulting services. 3M provides food safety
products for food processors to test the microbiological quality of food.

Stryker

Stryker Corporation is a Fortune 500 medical technologies firm based in Kalamazoo,

Michigan. Stryker's products include implants used in joint replacement and trauma
surgeries; surgical equipment and surgical navigation systems; endoscopic and
communications systems; patient handling and emergency medical equipment; neurosurgical,
neurovascular and spinal devices; as well as other medical device products used in a variety
of medical specialties.

In the United States, most of Stryker's products are marketed directly to doctors, hospitals
and other healthcare facilities. Internationally, Stryker products are sold in over 100 countries
through company-owned sales subsidiaries and branches as well as third-party dealers and
distributors.
Johnson & Johnsons
Johnson & Johnson is an American multinational medical devices, pharmaceutical and
consumer packaged goods manufacturing company founded in 1886. Its common stock is a
component of the Dow Jones Industrial Average and the company is listed among the Fortune
500.

Johnson & Johnson is headquartered in New Brunswick, New Jersey, the consumer division
being located in Skillman, New Jersey. The corporation includes some 250 subsidiary
companies with operations in 60 countries and products sold in over 175 countries. Johnson
& Johnson had worldwide sales of $70.1 billion during calendar year 2015. The company has
made the 3rd largest pharmaceutical settlement with the U.S. Department of Justice.

Johnson & Johnson's brands include numerous household names of medications and first aid
supplies. Among its well-known consumer products are the Band-Aid Brand line of
bandages, Tylenol medications, Johnson's baby products, Neutrogena skin and beauty
products, Clean & Clear facial wash and Acuvue contact lenses.

Market share of medical devices

While the Medical Equipment and Supplies industry has a number of large operators, small
and medium businesses (SMBs) have historically dominated the market. Smaller businesses
usually have quick adaptability, ability to identify unmet market needs and substantial
innovative potential, and thus form an important component of the healthcare industry
globally. According to Net Resources International, 56.0% of new industry products are
developed by small businesses. Small companies however, join larger companies in order to
gain access to global distribution networks, substantial research and development budgets as
well as the knowledge of working with the FDA to successfully bring the product into the
market. Shown below is a graphic of the market share in the industry:
Sales

Others
Johnson& Johnsons
Strykr
BD
Baxter