Medical Device

MiraCradle help reduce birth asphyxia deaths in India

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MiraCradle, an award winning medical innovation by Pluss Advanced Technologies Pvt Ltd, is now instrumental in reducing neo-natal mortality (death due to birth asphyxia) in over 100 hospitals in India and South Africa. MiraCradle has now been adopted by hospitals across 19 states and 2 Union territories across the country.

MiraCradle has recently received the prestigious CE Mark. With the help of this certification MiraCradle can now be exported to more than 50 countries without any further regulatory requirements. MiraCradle, designed, developed and manufactured in India is the perfect example of a “Make in India product” (in other words an Indian technology changing the global healthcare landscape). MiraCradle has also been adopted in South Africa with successful installations of 6 devices and 20 more installations expected in the next six months.

MiraCradle – Neonate Cooler is an affordable passive cooling device which uses the advanced savE phase change material (PCM) technology to induce therapeutic hypothermia among newborns suffering from birth asphyxia. According to a report by WHO, birth asphyxia, defined as the failure to establish breathing at birth, accounts for an estimated 650,000 deaths each year and is one of the primary causes of early neonatal mortality.

Samit Jain, managing director, Pluss Advanced Technologies Pvt Ltd says, “Birth asphyxia babies, who are unable to breathe properly, needs to be cooled to prevent brain damage because of low supply of oxygen to the brain. But, the only device available to cool the babies costs more than $25,000 and cannot be afforded by most hospitals in developing countries Pluss Advanced Technologies Pvt Ltd with its innovation MiraCradle has brought down the cost of a cooling device, by 80%.” Uninterrupted power needed to run a cooling device was an equally big challenge which has been done away with the usage of MiraCradle.

First device of this kind in the world MiraCradle is included in the WHO compendium of Innovative Health Technologies for Low resource setting.

Developed in collaboration with CMC Vellore in 2014, MiraCradle is the winner at the Innovators’ competition for DST-Lockheed Martin India innovation growth programme 2015, CII Industrial Innovation award 2014 and Kirloskar Technology award in 2015.

As stated above, MiraCradle- Neonate Cooler uses the advanced savE phase change material technology. Phase Change Materials (PCMs) are special thermal energy storage materials that store and release heat at a particular temperature. The thermal energy transfer occurs when the material changes phase from solid to liquid or liquid to solid. MiraCradle- Neonate Cooler uses the first of its kind – Form Stable PCMs. PCMs have been incorporated in a polymer matrix to ensure that when changing phase from solid to liquid PCMs retain its shape and form avoiding any risk of the PCM leaking from its encapsulation, thus making it completely safe for the user as well as the patient.

To ensure precise temperature control, MiraCradle- Neonate Cooler uses a cascaded system of PCMs. Cascaded system is a patented technology that employs use of two or more form stabilized PCM mattresses with melt/freeze at different temperatures. By engineering the melting points, thicknesses, conductivities and placement of the involved layers, a “quasi-automated” cooling system is created, which, while being completely passive, behaves like a servo-automated cooling device.

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USFDA just approved the world’s first ‘artificial pancreas’

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The FDA just approved a device that’s often referred to as an ‘artificial pancreas’. The device, made by Medtronic, is called the MiniMed 670G.

It’s been approved for people with type 1 diabetes over the age of 14. It works by automatically monitoring a person’s blood sugar levels and administering insulin as needed – no constant checking and injecting required.

Diabetes is a condition in which people have a hard time processing sugar. Type 1, in particular, is an autoimmune disease in which the body mistakenly kills cells that are supposed to make insulin, a hormone that helps people absorb and process the sugar in food.

Insulin is produced and released through the pancreas – that’s where the term ‘artificial pancreas’ comes in.

Roughly 1.25 million people in the US have type 1 diabetes. These patients often opt to have an insulin pump that can administer insulin as needed throughout the day.

Some also buy a glucose monitor, which is used to continuously monitor blood sugar levels; that way a diabetic can know if their levels are going too low or too high and find a way to correct it.

In contrast, the MiniMed 670G, referred to as a ‘hybrid closed loop’ system, is what Jeffrey Shoorin of the FDA said in a statement is a “first-of-its-kind technology”: the first approved system that combines both the glucose monitor and the insulin pump in one device.

According to the FDA, the device measures blood sugar every five minutes, then responds by sending insulin into the body, or holding steady. Diabetics can also manually request insulin around mealtimes.

A clinical trial of the MiniMed 670G involving 123 people with type 1 diabetes had no serious adverse events, though the FDA notes that “risks may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch.”

While the device is approved as of today, Medtronic will do additional testing to see how well it works in real-life situations. The company is also conducting additional trials to see if it can be used in children 7 to 14 years old.

“We are committed to preparing for commercial launch as quickly as possible,” Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic, said in a statement.

Here’s what the device looks like:

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HLL Lifecare gets Centre’s approval for 300 acres of MediPark in Chengalpettu

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The Union Cabinet chaired by Prime Minister Narendra Modi has given its approval to HLL Lifecare, a Mini Ratna PSU under Ministry of Health & Family Welfare, to sub-lease 330.10 acres of land at Chengalpattu, located in the outskirts of Chennai, to set up a medical devices manufacturing park (Medipark) through a special purpose vehicle. The shareholding of HLL in the project would be above 50 per cent.

The Medipark project will be the first manufacturing cluster in the medical technology sector in the country, envisaged to boost the local manufacturing of hi-end products at a significantly lower cost, resulting in affordable healthcare delivery, particular in diagnostic services to a large section of people. The proposed Medipark would contribute to the development of medical devices and technology sector and allied disciplines in the country, which is still at a nascent stage besides generating employment and give a boost to the government’s “Make in India” campaign.

Medipark will be developed in phases, spread over seven years for completion. In the first phase, physical infrastructure will be developed and plots will be leased from third year onwards. Knowledge management centre will be developed in the second phase, with grants and assistance from departments, which funds similar initiatives. HLL will sublease the land to investors, through a transparent bidding process to investors desirous to set up manufacturing units for medical equipment and devices. In the initial phase, the land cost to the qualifying entrepreneurs from medical device and equipment, manufacturing industry will be at a subsidized rate so as to attract others and the rate will go up gradually as the demand picks up. Thus the Medipark project will play an important role in enhancing quality healthcare delivery in India.

The project will reduce the dependence on imports and create a strong base for the growth of indigenous and domestic industry by providing access to state-of-the-art infrastructure and technology.  The domestic manufacturing of medical devices and equipment shall not only usher in a regime of assured and affordable healthcare delivery but also deepen and strengthen the penetration of quality healthcare services.

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Centre issues revised Sch M-III notification for medical devices

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The Centre has finally released the much anticipated revised Schedule M-III notification that is aligned with IS/ISO 13485. Experts see this as a first concrete step towards adopting a separate medical device regulation in the country, an urgent need of the hour to safeguard the interest of the industry. There has been no specific regulation for medical devices and has been irrationally linked with pharma sector through common statute.

Revised Schedule M-III contains its own set of requirements for quality management systems pertaining to all notified medical devices and IVDs, plus appendices covering device master files and site master files. With this notification of Schedule M-III, the sector will now be able to explore new business opportunities as it will now open up for investments into R&D that will enable India to emerge as a world class-manufacturing hub for medical devices.

Rajiv Nath, forum coordinator of AIMED pointed out that this comes as a huge victory to that sector that was long struggling to have a foothold in this country due to lack of any government support leading to unfavourable market condition for the domestic players. He said that such neglect towards the sector had a detrimental impact on medical device industry making India import dependent.

Until now, Drugs & Cosmetics Act, 1940, governed the medical device sector, which has very different R&D, technologies, production and taxation requirements from that of phrama sector. Industry had been pushing for changes in drug rules covering regulatory quality management framework and infrastructure requirements on the lines of the BIS and international ISO 13485 standard for regulatory purposes.

Nath who is also the joint coordinator of the Indian Medical Devices Regulatory Review Group (IMDRRG) added that overseas and Indian investors were always apprehensive to invest in medical device sector since it had pharmaceutical type GMP demands imposed by regulators in an arbitrary manner. Experts stressed that the sector was always incorrectly and incompletely regulated by unsure inspectors.

“We are glad that the government has started taking strategic measures to address the issues and challenges of the industry. With the active support of the Centre we will sure be able to develop India as a manufacturing hub for medical device sector,” he added.

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Health Ministry issues draft Medical Devices Rules, 2016

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The Union health ministry has issued the draft Medical Devices Rules which will be applicable in respect of substances covered under sub-clause (i) of clause (b) of section 3 used for in vitro diagnosis; substances that are in the nature of mechanical devices covered under sub-clause (ii) of clause (b) of section 3; and devices specified from time to time by the Central Government by notification in the Official Gazette under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

Medical device already marketed in India prior to the commencement of these rules shall continue to be marketed as hitherto before subject to the condition that the manufacturer shall provide evidence of previous sale in India and apply for license within a period of ninety days from the date the device is notified under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940). The Central Government shall, by notification, specify the date from which medical device referred in clause (2) shall be regulated in accordance with these rules.

Medical device already notified under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and marketed in India prior to the commencement of these rules shall continue to be marketed as hitherto before till the expiry of eighteen months from the commencement of these rules. For the purposes of these rules, the in vitro diagnostic medical devices which are already marketed in India and governed under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 shall be deemed to be medical devices and shall also continue to be marketed as hitherto before till the expiry of eighteen months from the commencement of these rules.

Under these draft rules, medical devices other than in vitro diagnostic devices shall be classified as low risk (Class A); low moderate risk (Class B); moderate high risk (Class C); and high risk (Class D).

The Drugs Controller General of India shall be the Central Licensing Authority and shall be the competent authority for enforcement of these rules in matters relating to import, manufacture of Class C and Class D medical devices, clinical investigation and clinical performance evaluation of medical devices and other related functions, provided that where any manufacturer intends to manufacture Class C or Class D medical device along with Class A or Class B medical device, the Central Licensing Authority shall be the competent for enforcement of these rules and no separate licence from the State Licensing Authorities shall be required in respect of devices of Class A or Class B.

The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement of these rules in matters relating to manufacture of Class A or Class B medical devices, sale, stock, exhibit or offer for sale of medical devices and other related functions: Provided that where any person intends to manufacture predicate medical device, prior approval from the Central Licensing Authority shall be necessary before applying to the State Licensing Authority.

The ministry has invited objections and suggestions from the stakeholders on the draft rules.

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