KTR unveils ‘Made in Telangana’ medical devices

Hyderabad: Telangana Minister of Industries and Commerce KT Rama Rao on Tuesday unveiled India’s first world-class and path-breaking devices developed by Huwel Lifesciences,EMPE Diagnostics and Blue Semi at Medical Devices Park, Hyderabad. Industries & Commerce Department Principal Secretary Jayesh Ranjan, Telangana Life Sciences CEO Shakthi M Nagappan, and Medical Devices Park Vice President Paridhi Gupta were also present.

On the occasion, KTR said: "I’m delighted to witness yet another milestone in the medtech sector in Telangana with the signing of the MoUs for product testing and the launch of world class ‘Made in Telangana’ devices by our homegrown companies - Huwel Lifesciences, EMPE Diagnostics and Blue Semi.”

He further said, “It gives me immense pride in stating that many of these products are first in the world while the rest are first in the country. While the collaboration for testing will further enhance scale-up and growth, the launch of these innovative products is a testament to the vibrant medtech ecosystem in the State.”

Telangana has been the front-runner in the field of lifesciences, and is also one of the first States in India to recognise medical devices as a high-potential and high growth sector. Medical Devices Park setup by the Government of Telangana has been producing world class medical products from the State for the country and all over the world.

Launched in 2017, Medical Devices Park today is India’s biggest functional medical devices cluster with firms committed to invest Rs 1,500 crore and generating employment of 7,000 direct jobs. The State government has now taken a leap forward to extend the ‘Make in India’ to ‘Innovate in India’ by creating an end-to-end support ecosystem and market for innovative product development, including product testing for medtech companies and entrepreneurs.

Huwel Lifesciences, a leader in invitro diagnostics and reagents, having a state-of-the-art facility in the Medical Devices Park has developed two Point of Care Testing (POCT) devices - first-of-its kind, palm-top molecular device, Huwel UniAmp, for nucleic acid testing of various infections; Hemomeasure and FerriQuant, Haemoglobin testing device and Semiquantitative LFA based assay ferritin test. Huwel has about 20 manufacturing licenses for various diagnostic kits and devices and is the largest supplier (5.4 crore tests in 25 States) of indigenously manufactured Covid RTPCR kits in India.

Dr Shesheer Kumar, Managing Director & Founder, Huwel Lifesciences said: “Huwel’s capabilities of indigenisation and scale up has been demonstrated by being largest supplier of RTPCR kits in country with all components made in house in Hyderabad, Telangana. Currently manufacturing POCT devices which are path breaking for confirmatory testing of infections at field and haemoglobin testing device for mass implementation, we are making products for the world from Telangana. We are confident that in the near future Hyderabad can be medical devices hub too, like vaccines for the world.”

EMPE Diagnostics has established global production and R&D facility in Genome Valley, Telangana with an investment of Rs 25 crore, with an aim to produce 2 million tuberculosis diagnostic kits per month and has further expansion plans in Hyderabad. The company has now developed an accurate, simple, rapid, and inexpensive diagnostic test kit to detect TB and its antibiotic resistance. Their mfloDx technology is awarded with patents in 19 countries and today they launched their first of its kind in the word test kit for MDR-TB Rifampicin and Isoniazid along with controls, that has received license from CDSCO, and is ready to be supplied to TB clinics. EMPE Diagnostics is the first ever company to receive grants from European Innovation Council and Bill & Melinda Gates Foundation.

Raghavendra Goud, CEO of EMPE Diagnostics said, “We are very happy and proud to be having our global manufacturing unit which is an ISO certified plant in Genome valley- a vibrant ecosystem. Our special thanks to the State Government for constant encouragement and support extended to us. We have current capacity is 25 million kits and will be expanding to 100 million kits soon. Our mission is to produce the kits in Telangana and supply them to the world.”

Blue Semi, a T-Hub headquartered company, launched EYVA, world's first gadget that can measure 6 key vitals in just 60 seconds including non-invasive blood glucose (no prick/ no pain) with just a touch. With over 660,000+ scans completed and customers in 26 out of 28 states in India, EYVA has proven its effectiveness.

Sunil Maddikatla, CEO and Founder, Blue Semi said "The nurturing atmosphere in Telangana has been pivotal in the advancement and triumph of ground breaking health tech innovations like our EYVA gadget. Empowered with the necessary resources, startups can fearlessly forge ahead, revolutionizing healthcare and technology for a better future."

Besides these, several companies and startups based in Hyderabad are focused on building next-generation medical device products like 3D-printed bionic arms, imaging systems, digital health solutions, mobile dialysis units and implants. Medical Devices Park offers facilities to support innovation, research & development, manufacturing as well as product testing, warehousing and logistics, and is now catching the attention of global investors also, with many lining up to establish their units in this facility. Marquee companies such as Medtronic and B Braun have already made Hyderabad their growth centre and just last month, Medtronic had announced an investment of approximately Rs 3,000 crore (more than $ 350 million) to expand the Medtronic Engineering & Innovation Center (MEIC) in Hyderabad.

Further, with the focus on promoting the sector and consolidating the leadership position of Telangana, Government through Telangana Life Sciences Foundation (TLSF) signed MoU with six distinguished organisations with ISO certified facilities, in presence of the minister, to facilitate medical device testing and prototyping services to tenant companies in the Medical Devices Park. This is consequent to the Medtech CEO Roundtable chaired by KTR during the 20th edition of State’s flagship BioAsia convention held earlier this year in Hyderabad, wherein the CEOs had highlighted the need for immediate ramping up for testing facilities as the industry is coming under mandatory regulatory controls.

From syringe to implants to MRI scanners, medical devices encompass a very broad and complex variety of technologies and apart from performance the crucial aspect of devices is safety. In order to comply with all safety requirements, sets of universal standards and norms have been prescribed, making product testing extremely crucial.

Companies such as RCC Laboratories, T-Works, Palamur Biosciences, Vimta Labs, Electronics Corporation of India Ltd. (ECIL) and Vivo Bio Tech Ltd, have collaborated with TLSF to extend their services, including biocompatibility testing, safety evaluation, pre-clinical services, EMI/EMC testing, animal testing, chemical testing, toxicology/risk assessment, environment testing, and nuclear testing, and prototyping at subsidized prices exclusively for companies operating within the Medical Device Park. The State government would continue to facilitate more collaborations to add to the basket of these testing services including gamma irradiation, rapid prototyping, etc.

This collaboration represents a holistic approach by the State Government and a significant step towards fostering growth, scale-up, innovation, and excellence within the state's medical device ecosystem. By leveraging the combined expertise and resources of these six organizations, along with an enabling policy environment, Government of Telangana is helping companies move up the value chain and build products of relevance not just for India but for the world.

Suchitra Ella, Director, RCC Laboratories said “As a leading global pre-clinical contract research organization, we sincerely appreciate this initiative by TLSF as it will benefit both R&D and manufacturing sectors in life sciences based in Telangana State”

Sujai Karampuri, CEO, T-Works said that, “T-Works, country’s largest prototyping center is delighted to collaborate with TLSF by offering state-of-the-art prototyping services with preferential access to support product design and development for medical devices companies based in Hyderabad”

Dr. S. Ramamoorthy, CEO, Palamur Biosciences stated that “As one of its kind preclinical large animal facilities in the medical device industry, Palamur Bio recognizes the immense potential of the medical device park in driving innovation and collaboration. Through our partnership with the TLSF, we aim to contribute our expertise, resources, and technologies to create a vibrant ecosystem that fosters breakthrough discoveries and advancements in healthcare. Together, we are committed to revolutionizing patient care and shaping the future of medical technology."

Satya Sreenivas Neerukonda, Executive Director, Vimta Labs said that, “Vimta is delighted to collaborate with TLSF in its endeavor to transform Telangana as a preferred global destination for excellence in manufacturing, research & development of Medical Devices by offering state-of-the-art EMI/EMC, Chemical Characterization, and biocompatibility services to support product development and international regulatory compliances for quality and safety of medical equipment.”

V Chandrasekhar Patnaik, Chief Business Officer, Vivo Biotech has said “We are extremely happy to sign an MoU with Telangana Life Sciences division, we have offered special discounted prices to the partners of TLS. Both parties will get benefitted out of this great initiative taken by Hon’ble Minister Shri KTR sir. We are keen and excited to work as TLS business collaborators”.

Anurag Kumar, Chairman and Managing Director, ECIL said “ECIL has set up a state of the art NABL Accredited EMI/EMC and Environmental test facilities and is happy to enter into a MoU with TLSF to support medical devices manufacturing companies in Telangana”

Huwel Lifesciences - Palm top molecular device Huwel UniAmp nucleic acid testing device for various infections

A unique amplification process with sensitivity and specificity of the test at par with RTPCR. Results are obtained in 7-30 mins based on the infection load and single cartridge can be used for multiple diseases.. Test process eliminates the requirement of extraction of nucleic acid. Being very easy to handle, the machine can be operated by anyone with minimal training. It can be used at any place, on physician desk, gynecologists, corporates, railway stations and even in door-to-door screening of infections like TB. The device is validated for HPV, sexually transmitted diseases, influenza A/B, and COVID and the TB assay validation is in progress.

Huwel Lifesciences - Point of care Hemoglobin testing device and Semiquantitative LFA ferritin test

The device uses 4 µL of finger prick blood and uses proprietary chemistry formulation for accurate measurement of hemoglobin in blood in just 2 minutes. Huwel Lifesciences has developed this device with AI based algorithm developed by Prof. Suman Chakraborty of IIT Kharagpur

EMPE Diagnostics’ mfloDxTM technology is a combination of molecular (padlock probe-rolling circle amplification) and sensitive lateral flow biosensors, which can detect the presence of TB bacteria and to identify antibiotic resistance accurately, in less than 3 hours even at resource limited clinics. This test does not require expensive infrastructure, skilled manpower or tedious procedure, rather it is rapid, user-friendly,

easy to read, and can be performed using regular laboratory equipment.

EYVA, developed by BlueSemi, is the World's 1st gadget that can measure 6 key vitals in just 60 seconds including non-invasive blood glucose (no prick/ no pain) with just a touch. With over 660,000+ scans completed and customers in 26 out of 28 states in India, EYVA has proven its effectiveness. Designed to measure blood glucose, blood pressure, heart rate, ECG, oxygen levels, and even HBA1C not just for a single person but for up to 4 people it has become a need-of-the-hour family gadget that allows users to instantly access, and analyse health data and provide quick actionable insights, along with enabling them to monitor daily, weekly & monthly trends to accordingly personalise their holistic health regimen using their EYVA App.

For more information on Medical Device Park- visit

https://lifesciences.telangana.gov.in/life-sciences-grid/clusters/medical-device-park/

For more information on Huwel Lifesciences Pvt Ltd.-visit

https://www.huwellifesciences.in/

For more information on EMPE Diagnostics-visit https://www.empediagnostics.com/

For more information on BlueSemi-visit https://bluesemi.io/

For more information on Palamur Biosciences-visit https://www.palamurbio.com

For more information on Vimta Labs-visit https://www.vimta.com/

For more information on Electronics Corporation of India (ECIL)-visit https://www.ecil.co.in/

For more information on Vivo Bio Tech Ltd.-visit http://www.vivobio.com/

For more information on RCC Laboratories-visit https://rcclabs.com/

For more information on T-Works-visit https://tworks.telangana.gov.in/