Medical Devices Making in India

The Indian healthcare system continues to be impacted by aspects of availability, affordability and quality of health services. Given these, India lags behind averages of BRIC Countries. A key area of concern for India is the proportion of non-communicable diseases which is expected to rise in the next decade. The total healthcare expenditure in India was only 3.9% of GDP, compared to 8.9% for Brazil, 6.2% for Russia and 5.2% for China. Out-of-pocket expenditure is as high as 61%, with only 25% of the population being covered by health insurance.

While the government and value chain participants have undertaken several steps to address the issues of healthcare access, quality and affordability, these have been executed in silos. Specifically, while medical device companies have focused largely on extending life expectancy and improving quality of care, there is a need to increase affordability for a widespread impact. The challenge therefore for companies in India is to produce medical devices that are both cost competitive and effective to increase penetration and use. It is in this context that the Make in India initiative becomes significant for the medical devices industry.

Medical devices play a role not only in screening, diagnosing and treating patients but also in restoring patients to normal lives and in regularly monitoring health indicators to prevent diseases. With technological advancements, the role of medical devices is now expanding to improve quality of care across each stage of the healthcare continuum:

Screening and diagnosis:

Both accuracy and complexity of screening and diagnosis are increasing. Point-of-care / portable diagnostic devices provide care at home resulting in improved outcomes, patient satisfaction and, increased access to care in under-penetrated and remote regions, while facilitating treatment outside health facilities.

Treatment/Care:

Advanced surgical equipment is not only enabling doctors treat highly critical and complex cases but also reducing length of hospital stays. It is increasingly allowing elective but complex surgeries like knee replacement, bariatric, pain management, etc. to be shifted to outpatient / short stay surgery centre.

Restoration:

Hospitals and physiotherapy-rehabilitative centres are now enabling patients to restore their health faster and return to normal productive lives through the use of advanced assistive and rehabilitative device.

Monitoring:

Health screening devices are enabling patients to take charge of their health at home and regularly monitor health indicators. Further, devices are being used to monitor patients remotely for early diagnosis thus minimizing hospital visits and reducing pressure on the country’s over-burdened medical resources.

Overall growth in healthcare infrastructure

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There is a significant increase in the number of hospitals and hospital beds in India. Bed strength had increased from 0.8 million in 2002 to 1.6 million in 2012, and is further expected to increase to around 2.9 million by 202513. This increase has been driven primarily by growing presence of corporate hospital chains, international companies and service providers entering tier 2 and tier 3 cities.

• There is an increasing presence of diagnostics laboratory chains focusing on imaging and pathology. It is estimated that there are more than 100,000 diagnostic laboratories across the country, with the number expected to grow at a rate of 15% – 20%.
• The healthcare industry is also witnessing the emergence of new formats like chains of multispecialty outpatient clinics, mother-and-child hospitals, short stay surgery centres, IVF centres, etc; which are driving demand for medical devices.

Increasing focus of healthcare providers on quality and accreditation

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There has been a strong focus on upgrading medical technology by hospitals and laboratories to comply with accreditation requirements. Around 285 hospitals in India are NABH accredited with 472 additional proposals submitted for accreditation. Similarly, 347 laboratories in India are NABL accredited with 150 additional proposals submitted.

While the potential of the medical devices sector is acknowledged with its inclusion in the ‘Make in India’ initiative, it is essential to leverage the initiative to kickstart indigenous manufacturing and realize the twin objectives of accessibility and affordability.

Advin Health care is aimed at understanding the context, Constraints and opportunities for medical device Players, healthcare provides and key policy makers; Exploring the significance of India and other global manufacturing destinations; and aligning ‘Make in India’ fo medical devices with other key government supports.

Current landscape and key considerations for growth

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The medical devices market grew at a 10% CAGR in the past five years, reaching a value of USD 3.7 billion16 in 2014. From 2014 levels, if the industry continues on its organic growth trajectory, it is expected to reach USD 8.6 billion in size by 2020, growing at a CAGR of around 15% against the expected global industry growth of 4-6%.

In this scenario, the focus on augmenting healthcare infrastructure due to increased demand and improved access is expected to provide the requisite industry growth. Currently, the Indian medical devices industry represents just over 1.3% of the global medical devices market of USD 335 billion, which is dominated by USA (USD 134 billion in 2014). With an enabling policy framework and ecosystem support, industry estimates indicate a potential to grow at ~28% to USD 50 billion by 202519. This growth is expected to be driven by indigenous manufacturing and exports and, sales from local innovation.

Export Scenario

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India has a 75-80% import dependency on medical devices. Export of medical devices from India stood at US$ 2.53 billion in FY21, and are expected to rise to US$ 10 billion by 2025.

To increase export of medical devices in the country, the Ministry of Health and Family Welfare (MOHFW) and Central Drugs Standard Control Organisation (CDSCO) implemented the following initiatives:

Re-examination and implementation of Schedule MIII (a draft guidance on good manufacturing practices and facility requirements) System for export labelling Clinical evaluation and adverse reporting clarification State licencing authority to extend free sales certificate validity from 2 years to 5 years to allow exports Create a list of manufacturers with export licencing for easy access to regulatory authorities worldwide.

The Medical Devices Virtual Expo 2021 showcased Indian products and enabled direct interaction between Indian suppliers and buyers/importers from participating countries; 300 foreign buyers from the healthcare sector participated in this event.

Overview

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Dilation and curettage (D&C) is a procedure to remove tissue from inside uterus. Health care providers perform dilation and curettage to diagnose and treat certain uterine conditions — such as heavy bleeding — or to clear the uterine lining after a miscarriage or abortion.

In a dilation and curettage, your provider uses small instruments or a medication to open (dilate) the lower, narrow part of uterus (cervix). Your provider then uses a surgical instrument called a curette, which can be a sharp instrument or suction device, to remove uterine tissue.

Who needs a dilation and curettage (D&C?)

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You may need a D&C if you have or had:

• A miscarriage.
• Leftover tissue in your uterus after an abortion.
• Unexplained bleeding between menstrual periods.

Sometimes, you have a D&C and hysteroscopy. During this procedure, your provider inserts a device into your cervix to see the inside of your uterus. You may have a hysteroscopy with a D&C if your provider is trying to diagnose a problem.

To diagnose a condition

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Before doing a D&C, your provider might recommend a procedure called endometrial biopsy or endometrial sampling to diagnose a condition. Endometrial sampling might be done if:

• You have unusual uterine bleeding
• You have bleeding after menopause
• You have unusual endometrial cells, which are discovered during a routine test for cervical cancer

To perform the test, your provider collects a tissue sample from the lining of your uterus (endometrium) and sends the sample to a lab for testing. The test can check for:

• Endometrial intraepithelial hyperplasia — a precancerous condition in which the uterine lining becomes too thick
• Uterine polyps
• Uterine cancer

If more information is needed, your provider then might recommend a D&C, which is usually done in an operating room.

To treat a condition

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When performing a D&C to treat a condition, your provider removes the contents from inside your uterus, not just a small tissue sample. This might be done to:

• Prevent infection or heavy bleeding by clearing tissues that remain in the uterus after a miscarriage or abortion
• Remove a tumor that forms instead of a typical pregnancy (molar pregnancy)
• Treat excessive bleeding after delivery by clearing out any placenta that remains in the uterus
• Remove cervical or uterine polyps, which are usually noncancerous (benign)

A D&C might be combined with another procedure called hysteroscopy. During hysteroscopy, your provider inserts a slim instrument with a light and camera on the end into your vagina, through your cervix and into your uterus.

Your provider then views the lining of your uterus on a screen, checking for areas that look unusual. Your provider also checks for polyps and takes tissue samples as needed. During a hysteroscopy, uterine polyps and fibroid tumors can be removed.

At times, a hysteroscopy might be done combined with an endometrial biopsy before a full D&C procedure.

What are the advantages of a dilation and curettage (D&C)?

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A D&C can help your provider figure out why you have abnormal bleeding. It can also help detect abnormal endometrial cells, which may be a sign of uterine cancer. After a D&C, your provider sends the sample of cells to a laboratory where pathologists can identify if you have normal or abnormal tissue, polyps or cancer.

A D&C may also be important for your health after a miscarriage or abortion. It removes any leftover tissue to prevent heavy bleeding and infection.

ADVIN D & C Instrument SET

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• Sponge Holding Forceps
• Vulsellum Forceps
• Ovum Forceps
• Uterine Sound
• Curette
• Sims Speculum Med
• Dilator Set 8

Chronic Kidney Disease

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Chronic kidney disease (CKD) means your kidneys are damaged and can’t filter blood the way they should. The disease is called “chronic” because the damage to your kidneys happens slowly over a long period of time. This damage can cause wastes to build up in your body. CKD can also cause other health problems.

The kidneys’ main job is to filter extra water and wastes out of your blood to make urine. To keep your body working properly, the kidneys balance the salts and minerals—such as calcium, phosphorus, sodium, and potassium—that circulate in the blood. Your kidneys also make hormones that help control blood pressure, make red blood cells, and keep your bones strong.

Kidney disease often can get worse over time and may lead to kidney failure. If your kidneys fail, you will need dialysis or a kidney transplant to maintain your health.

The sooner you know you have kidney disease, the sooner you can make changes to protect your kidneys.

What are the symptoms of CKD?

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Early CKD may not have any symptoms

You may wonder how you can have CKD and feel fine. Our kidneys have a greater capacity to do their job than is needed to keep us healthy. For example, you can donate one kidney and remain healthy. You can also have kidney damage without any symptoms because, despite the damage, your kidneys are still doing enough work to keep you feeling well. For many people, the only way to know if you have kidney disease is to get your kidneys checked with blood and urine tests.

As kidney disease gets worse, a person may have swelling, called edema. Edema happens when the kidneys can’t get rid of extra fluid and salt. Edema can occur in the legs, feet, or ankles, and less often in the hands or face.

Symptoms of advanced CKD

• chest pain
• dry skin
• itching or numbness
• feeling tired
• headaches
• increased or decreased urination
• loss of appetite
• muscle cramps
• nausea
• shortness of breath
• sleep problems
• trouble concentrating
• vomiting
• weight loss

What is Haemodialysis?

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With haemodialysis, a machine removes blood from your body, filters it through a dialyzer (artificial kidney) and returns the cleaned blood to your body. This 3- to 5-hour process may take place in a hospital or a dialysis centre three times a week.

You can also do haemodialysis at home. You may need at-home treatments four to seven times per week for fewer hours each session. You may choose to do home haemodialysis at night while you sleep.

What happens before hemodialysis?

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Before you start haemodialysis, you’ll undergo a minor surgical procedure to make it easier to access the bloodstream. You may have:

• Arteriovenous fistula (AV fistula): A surgeon connects an artery and vein in your arm.
• Arteriovenous graft (AV graft): If the artery and vein are too short to connect, your surgeon will use a graft (soft, hollow tube) to connect the artery and vein.

AV fistulas and grafts enlarge the connected artery and vein, which makes dialysis access easier. They also help blood flow in and out of your body faster.

If dialysis needs to happen quickly, your provider may place a catheter (thin tube) into a vein in your neck, chest or leg for temporary access.

Your provider will teach you how to prevent infections in your fistula or graft. This provider will also show you how to do haemodialysis at home if you choose to do so.

What happens during haemodialysis?

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During haemodialysis, the dialysis machine:

• Removes blood from a needle in your arm.
• Circulates the blood through the dialyzer filter, which moves waste into a dialysis solution. This cleansing liquid contains water, salt and other additives.
• Returns filtered blood to your body through a different needle in your arm.
• Monitors your blood pressure to adjust how fast blood flows in and out of your body.

What is peritoneal dialysis?

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With peritoneal dialysis, tiny blood vessels inside the abdominal lining (peritoneum) filter blood through the aid of a dialysis solution. This solution is a type of cleansing liquid that contains water, salt and other additives.

Peritoneal dialysis takes place at home. There are two ways to do this treatment:

• Automated peritoneal dialysis uses a machine called a cycler.
• Continuous ambulatory peritoneal dialysis (CAPD) takes place manually.

What happens before peritoneal dialysis?

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About three weeks before you start peritoneal dialysis, you’ll have a minor surgical procedure. A surgeon inserts a soft, thin tube (catheter) through your belly and into the peritoneum. This catheter stays in place permanently.

A healthcare provider will teach you how to perform peritoneal dialysis at home and prevent infections at the catheter site.

What happens during peritoneal dialysis?

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During peritoneal dialysis, you:

• Connect the catheter to one branch of a Y-shaped tube. This tube connects to a bag that has dialysis solution. The solution flows through the tube and catheter into the peritoneal cavity.
• Disconnect the tube and catheter after about 10 minutes, when the bag is empty.
• Cap off the catheter.
• Go about your usual activities while the dialysis solution inside the peritoneal cavity absorbs waste and extra fluids from the body. This process can take 60 to 90 minutes.
• Remove the cap from the catheter and use the other branch of the Y-shaped tube to drain the fluid into a clean, empty bag.
• Repeat these steps up to four times a day. You sleep with the solution in your stomach all night.
• Some people prefer to do peritoneal dialysis at night. With automated peritoneal dialysis, a machine called a cycler pumps the fluid in and out of the body while you sleep.

ADVIN NEPHROLOGY / Haemodialysis SETUP

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We, Advin Provides international Quality Standards Products for Haemodialysis Product

• Haemodialysis Machine
• Dialysis Chair
• RO Plant
• Bicarbonate Mixture
• Dialyzer
• Blood Line set
• AVF Needle
• Haemodialysis Double / Triple lumen Catheter Kit
• Acid Concentrate Part A Liquid / Solid
• Bicarbonate Part B Liquid / solid
• Bicarbonate Bi-Bag
• Bicarbonate Bi-Cart
• Hot Disaffection
• Cold Sterilant
• Peritoneal Dialysis Kit
• Heparin
• EPO Injection

Kidney Transplant – a successful answer for patients experiencing end stage renal sickness. The rates of Kidney failure are expanding alarmingly with factors like hypertension and diabetes adding to it. When the kidney begins disintegrating, it becomes Chronic Kidney Disease.

With time, working of kidney progressively deteriorates till it can’t support body works; this is End Stage Renal Disease. At this stage, dialysis becomes compulsory for proper working of the body. What are the choices accessible for a patient with End Stage Renal Disease? Haemodialysis: As a part of Haemodialysis, a patient goes through least of 2-3 dialysis each week in the medical clinic.

To keep up with such a patient on dialysis, a vascular access is expected through which arterial blood is pumped into the dialysis machine. After the cleaning procedure, blood is returned back into the body.

Continuous Ambulatory Peritoneal Dialysis: This is a type of peritoneal dialysis which can be done by the patient himself at home. A tube is inserted into the abdomen precisely, through which dialysing liquid is filled. The patient needs to make 2-3 such exchanges day to day for typical working of the body. This is relatively expensive and may introduce infection if not done carefully.

Kidney Transplantation: This is the best technique that is also cost effective, where the patient can return to an ordinary life. A healthy kidney from donor is transplanted into patient to support ordinary renal function. Patient is kept up on dialysis till Kidney transplantation is finished. Legally, family members who can give the kidney are the patient’s father, mother, brother, sister, grandparents and spouse. Unrelated transplantation is possible only in some cases where there is no suitable family donor.

What are the base necessities for a Kidney Donor? Donor should be from matching blood group or O+ve (universal donor) as in blood transfusion. Such transplantation is called ABO compatible transplantation. Presently ABO inconsistent renal transfer is likewise conceivable with good results. Donor’s kidneys should be working well so his/her renal function can be supported regularly with a single kidney after donation. Donor likewise goes through HLA typing which decides the number of antigens that are matching. Minimum mismatch means good and long-term implant survival. What is the interaction for Kidney Transplant? After all conventions are finished, the donor and patient are presented to an independent authorisation committee that has been approved by the govt. for an approval.

The donor kidney is first recovered through an open a medical procedure or laparoscopic medical procedure. In the recipient his/her native kidneys are left accordingly and the new kidney is transplanted in the lower abdomen. During the surgery, the artery and vein of the giver kidney (renal corridor) are joined to the artery and vein of the patient, respectively. This re-establishes blood circulation in the transplanted kidney, thus restoring functioning of the kidney. The Ureter of the donor kidney is joined to the urinary bladder, thus finishing a medical procedure.

Post- surgery, what should the patient watch out for? In spite of being a relative’s kidney, the body’s immune system doesn’t accept any foreign organ and tries to reject it, making the kidney non- functional. To keep away from this, the immune system is suppressed by immuno-suppressive drugs, which should be taken forever. Post-surgery, patients can continue ordinary life after kidney transplantation. Assuming antigen match is good, the kidney can work for over 30 years.

Nephrology Products

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We, Advin Health Care, provide international quality standard products for Nephrology Products.

• Dialysis Machine
• Dialysis Patient Chair
• Dialyser Reprocessing Machine
• Nephrology Products

advin is a leading supplier to Australasian healthcare facilities for all their hospital furniture needs. Our extensive sourcing capability provides our clients with a broad choice of options to meet their budget, clinical performance, safety and patient comfort needs.

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