Forward Biomedical Technology sector positions itself in a high value market place, but one where errors can be very expensive. Products are highly regulated and subjected to extensive quality controls. I find here a treasure of tips and techniques put together in a very simplified and user friendly manner. Whether one is a teacher or a student of Biomedical Engineering / Technology or a manufacturer / marketer of medical devices or a medical professional using the technology day in and day out, dipping into this collection will give one valuable insight.
Dr. R. A. Mashelkar Former Director General Council of Scientific & Industrial Research & Secretary, Government of India Department of Science and Technology, New Delhi
Soft Edition (.PDF Format)
Rs. 875/- (US$ 35) (Including Applicable GST Charges) For detail information and payment visit : http://www.medisourceasia.com/biomedical_technology/bt.htm
HIGHLIGHTS Chapters 1 : Introduction to Medical Device 2 : Materials : Medical Polymers, Biopolymers & OtherMaterials 3 : Applications 4 : Manufacturing : Technologies & Trends 5 : Packaging & Sterilization 6 : Markets & Emerging Trends
7 8 9 10 11 12
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Regulations & Quality Issues Innovation & Product Developments Adverse Events Healthcare Practices, Procedures & Techniques Environment, Waste Management & Safety Concerns Industry, Government, Research & Academic Institutions
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Pioneer & The Only Event For Medical Disposables & Implants Industry In India Webinar 01 02 03
Date Sept. 7, 2020 Sept. 8, 2020 Sept. 9, 2020
04 05
Dec. 14, 2020 Dec. 15, 2020
06 07 08
Dec. 16, 2020 Dec. 17, 2020 Dec. 18, 2020
Subject India : A Reliable Source of Medical Device Products and Technology For Africa Safety and Risk Management for Healthcare Professionals Technologies, Quality Requirements & Business Opportunities for Medical Textiles, PPEs / Face Masks Medical Device Industry : INDIA - A Potential Global Manufacturing Hub Medical Polymeric Materials, Components & Processing : Innovations Developments Indian MedTech Industry Ecosystem : Facilitating Growth Medical Device Industry Standards, Certifications & Regulations Making Innovation & Indigenization Stick : an IVD Industry Summit
YouTube Video Links https://www.youtube.com/watch?v=PgidSAF8CNk https://www.youtube.com/watch?v=p8pRMim2AM8 https://www.youtube.com/watch?v=lLbaXYNSOCA https://www.youtube.com/watch?v=9DO5OyTz2JY https://www.youtube.com/watch?v=Wkjit8ybsTk https://www.youtube.com/watch?v=QScII1fbivg https://www.youtube.com/watch?v=QiKB_BrkzT0 https://www.youtube.com/watch?v=UZl2UX5TB7A
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Bridging the Technological Valley of Death - “Chitra’s TechnoProve” Dr. G. S. Bhuvaneshwar - Former Head, Biomedical Technology Wing, SCTIMST Trivandrum Many potentially breakthrough ideas failed in the so-called “technological Valley of Death” due to a gap that exists between academic research and industrial commercialization. This is a great missed opportunity for economic and social progress. SCTIMST , Trianndrum is an exception as the Institute has created infrastructure called “Chitra’s Technoprove”…….
Polymer Ceramic Hybrid Acetabular Liner: Bench to Bedside Translation Dr. Bikramjit Basu - Professor at the Materials Research Center, IISc, Bangalore According to a published report of the World Health Organization (WHO), about 190 million adults suffer from osteoarthritis and related disabilities worldwide. A search for ideal prosthetic materials together with treatment methods, reconstructive solutions and surface designs is currently being pursued in the field of orthopaedic biomaterials.
MANUFACTURING E-beam Radiation Facility for Sterilization of Medical Devices V C Petwal - Radiation Processing In-charge, ARPF & Head, Radiation Processing Lab, Department of Atomic Energy, Govt. of India , Raja Ramanna Centre for Advanced Technology, Indore, M.P. Electron beam (E-beam) radiation processing is a modern sterilization technology which is both environmentally friendly and inherently secure. Due to the many advantages associated with it, the technology is rapidly growing across the globe.
MARKETS Go to Market Strategies for Medical Device Start-ups and Entrepreneurs in India Bhupesh Sood - CEO, SEC Global Consulting Tapan Kumar Patel - Principal Consultant, SEC Global Consulting While considering to venture into medical device manufacturing , Medical Device Start-Ups need to consider many factors including regulatory compliance . The article includes number of case studies.
MATERIALS PVC – A Persistent, Versatile Choice! Kamalnain Kurra - Director – Innovative Performance Plastics PVC has been the most widely used plastics in healthcare .This article highlights various aspects such as history, production, classification, developments , compounding , regulations, applications and …….
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GLOBAL TRENDS • Novel Plastic Film Capable Of Deactivating 99.99% Of New Coronavirus In 15 Minutes
AiMeD & REGULATORY UPDATES • DoP Notifies 19 Medical Devices To Boost Indigenous Manufacturing • There's Need To Integrate Various Regulatory Agencies With Single-window System: Pharma Secy • MvPI Evaluates 1,257 MDAE Reports Through Its Reporting Tools At IPC For Safe Medical Devices
INDUSTRY NEWS • Milacron Expands Line of Electric Injection Molding Machines • PLI Scheme Incentive Rate For Medical Sector Should Be Revised To 10%: Transasia • Hindustan Syringes And Medical Devices (HMD) To Invest Over Rs.100 Crore To Ramp Up Syringe Production • Medtronic Opens Engineering, Innovation Centre In Hyderabad • MTaI Seeks Relook At Revised Public Procurement Order On Medical Devices
PRODUCT GALLERY • Bioprocess Single-use Systems
DID YOU KNOW? • About Innovative Method for Recycling Disposable Plastic PPE Kits
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June 2016 to October 2016 • Did You Know : About Regulatory Science Priorities For Assuring Safety, Effectiveness, Performance and Quality of Medical Devices (September - October 2016) • Cover Story : Roadmap for Indian Medical Device Industry (January – February 2017) - Shri Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry ( A i M e D ) A n d J t . M a n a g i n g D i r e c t o r, Hindustan Syringes & Medical Devices Limited, Faridabad. • Cover Story : Indian Medical Device Industry to Develop Into A Global Manufacturing Hub (January – February 2017) - Shri Kishore Khanna, Managing Director, Romsons Group of Industries, Agra • Quality : Advanced Process Validation For Medical Device Manufacturers (January – February 2017) • Cover Story : ASEAN Medical Devices & Plastics Sectors : Immense Market Potential (March – April 2017) • Manufacturing : Developing Drug / Device Combination Products: Concept to Commissioning (March – April 2017) - Dr. Atul Sardana, Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi • Manufacturing : Packaging Testing for Medical Devices (March – April 2017) - Mr. Bunty Kundnani, Business Manager, Life And Health Science, UL India Pvt. Ltd., Mumbai • Global Trends : Global Medical Disposables Market to Reach US$193.9 Bn by 2018 (March – April 2017) • Global Trends : Medical Polymers Market to exceed $24bn by 2024 (March – April 2017) • Global Trends : Asia-Pacific Reprocessed Medical Devices Market Will Hit at a CAGR of 15.7% by 2017 to 2027 (March – April 2017) • Did You Know : About Drug / Device Combination Products & ASEAN Markets (March – April 2017) • Cover Story : Medical Polymers Processing – Selecting Right Materials & Manufacturing Systems (May – June 2017) • Materials : Compatibility of Thermoplastic Polyurethanes with Drugs for IV Sets (May – June 2017) - Ms. Elena Draganoiu, Global Technology Manager, Lubrizol LifeSciences, USA • Manufacturing : Designing and Manufacturing of Molds for Medical Components (May – June 2017) - Mr. Ketan Panchal, Production Manager, IndoGerman Tool Room, Ahmedabad
About Innovative Method for Recycling Disposable Plastic PPE Kits. It is estimated that during the Covid Pandemic, hospitals across the world use millions and millions of Personal Protective Equipment ( PPE ), the majority of which are single-use plastics. This results into challenges managing mountains of waste.. A South Wales ( UK ) company has developed an innovative method to recycle single-use personal protective equipment (PPE) in a bid to tackle this problem. Cardiff-based Thermal Compaction Group (TCG) has developed a device to recycle disposable plastic PPE at source, which re-engineers an average 24 tonnes of polypropylene waste each year per unit. The patented “Sterimelt” device thermally compacts polypropylene and re-engineers it so that it is suitable to make new products and help curb this global challenge. Initially developed to recycle polypropylene surgical tray wraps and drapes in hospitals, TCG has since adapted the machine to also recycle medical-grade surgical face masks and other types of PPE. The device works by heating polypropylene plastic up to 350 °C in 20-kg batches and then thermally compacting it into rectangular blocks that can be converted into pellets to make new plastic products. The blocks are then converted into a range of new items, including bins creating a sustainable circular recycling chain The innovative technology will significantly help to reduce carbon emissions by decreasing the volume of waste needing to be transported off-site. It is estimated that for every 10,000 kg of waste put through Sterimelt will result into saving 7,500 kg of carbon emissions, equating to a 75% saving on their current output. The Group currently has its Sterimelt devices in seven hospital trusts across the UK, including the Aneurin Bevan University Health Board in Newport, which was the first adopter of the technology in 2016. While the device works for most polypropylene-based products, there are certain elements to a medical-grade face mask that cannot be melted down such as the wired nose pieces. To help improve sustainability, it is advised that manufacturers across the globe make the PPE from a single polymer material to enable the entire mask to be melted down in one go. https://www.medicalplasticsnews.com/news/technology/solution-to-global-ppe-wasteproblem-unmasked/
“If you are working on something exciting that you really care about, you don’t have to be pushed, the vision pulls you”. -Steve Jobs
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D.L.PANDYA, B.E.(Chem), M.I.E.
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EDITORIAL ADVISORY BOARD Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. Vinny Sastri President, Winovia LLC, U.S.A. Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, HCG Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G. S. BHUVANESHWAR Consultant, Medical Devices – Design, development, testing and quality management. Adjunct Professor, Dept. of Engineering Design, Indian Institute of Technology, Madras. Dr. AJAY D. PADSALGIKAR, Ph.D. Senior Principal Scientist DSM Biomedical in Exton Pennsylvania, USA Dr. K.Sivakumar, M.Pharm, Ph.D Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon
PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. Jodhpur Char Rasta BRTS Bus Stop, Satellite Road, Ahmedabad-380 015, INDIA. Ph:+91 79-26740611 E-mail: info@medicalplasticsindia.con Website : www.medicalplasticsindia.com Reg. No. GUJ-ENG-00446/23/ALL/TC/94 dt. 3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-54 • Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content.
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Converting technologies developed by research and academic institutes into a marketed medical device is a complex process that requires more than simply building a working prototype and attempting to sell it. More so for the small and medium scale medical device manufacturers. Unfortunately, what the institutes as well as the small entrepreneurs do not realize that the path to up scaling and commercialization of the technology developed in the laboratory is many times long, arduous, expensive and requires understanding of business, law, engineering and regulatory principles. Investigating viability is also important along with ensuring the Intellectual Property Rights. The companies need to understand engineering challenges to set up a commercial scale unit. They need to confirm availability and feasibility of required raw materials and components. There is a need for a highly qualified team with experience in commercializing. Explaining about the gap that exists between academic research and Industrial Commercialization, Dr G S Bhuvaneshwar, former Head, Biomedical Technology Wing, Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST), Trivandrum has given a detailed account of how many potentially breakthough ideas have failed in his article on “Bridging the Technological Valley of Death – “Chitra’s TechnoProve”. As righly mentioned by Dr Bhuvaneshwar, SCTIMST, Trianndrum is an exception as the Institute has created infrastructure called “Chitra’s Technoprove” – which successfully converts high-risk medical devices developed in their laboratories into successfully commercialised technologies. In line with the above successful experiment, Dr Bhuvaneshwar has suggested a model called “Centres Of Technology Proving (CoTP) for building capacity for device development as a partnership between academia and industry. Another great contribution by an Institute is explained by Dr Bikramjit Basu, Professor at the Materials Research Centre, Indian Institute Of Science (IISc), Banglore in his article on, “Polymer Ceramic Hybrid Acetabular Liner : Bench to Bedside Translation”.After having developed a prototype, the Institute has collaborated with a Banglore based manufacturing partner for large volume manufacturing. Mr V C Petwal, Radiation Processing Incharge, Raja Ramanna Centre For Advanced Technology, Dept. Of Atomic Energy, Govt. Of India, Indore has introduced Electron Beam (E-beam) radiation processing as a modern sterilization technology for medical device which is both environmentally friendly and inherently secure. Mr Petwal has given detailed information about the “E-beam Radiation Facility” in his article. A methodological account of “Go to Market Strategies For Medical Device Start-Ups And Entrepreneurs in India’ is very elaborately given in the article jointly written by Mr Bhpesh Sood, CEO and Mr Tapan Kumar Patel, Principal Consultant of SEC Global Consulting, Ahmedabad. PVC remains one of the most used and investigated plastic materials for medical and pharmaceuticals application. The article on “PVC – A Persistent, Versatile Choice!” by Mr Kamalnain Kurra, Director, Innovative Performance Plastics gives an overview on an all major characteristics of the material. This issue of magazine also includes regular columns including Industry News, Product Gallery, Regulatory, Government and AiMed related news, Markets, Global Trends, “Did You Know” etc.
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Bridging the Technological Valley of Death – “Chitra’s TechnoProve” Dr. G. S. BHUVANESHWAR former Head, Biomedical Technology Wing, SCTIMST Trivandrum.
Technological Valley of Death Imagine how the world would look today, if the greatest technological inventions in history—such as the aeroplane, automobile, TV or the Internet—had been left sitting in research labs and not seeing the light of manufacturing? Many potentially breakthrough ideas failed in the so-called “Technological Valley of Death” due to a gap that exists between academic research and industrial commercialization. This is a great missed opportunity for economic and social progress; more so in India today as we struggle to translate laboratory research into societal value. The journey of new technology from research to commercialization goes through a number of stages (aka LEVELS) of design, development and scale-up. These TECHNOLOGY READINESS LEVELS (TRLs) were defined at NASA between the 1970s and the 1990s to assess the maturity of a technology or research to enable better and more objective management of projects. NASA’s TRLs :1. Basic principles observed 2. Technology concept formulated 3. Experimental proof of concept 4. Technology validated in a lab 5. Technology validated in a relevant environment 6. Technology demonstrated in a relevant environment 7. System prototype demonstrated in an operational environment 8. System complete and qualified 9. System deployed in an operational environment Large corporations are able to work at all levels of this scale; but small and medium sized companies cannot afford the high investments and different specialized competencies this approach requires. Hence, smaller companies have to rely on research conducted elsewhere; and the natural resources are Universities, Institutional Academia, public & private research laboratories (under CSIR and others).
“At what TRL does academia transfer technology to industry?” Academia tends to focus on TRLs 1–4, where new ideas are explored, research conducted and new solutions invented. Industry needs to generate income or profit from investments made and hence prefer to work in TRLs 7–9; where innovation gets commercialised into manufacturable / saleable products and services. Therefore, TRLs 4–7 represent a gap between academic research and industrial commercialization. This gap, generally referred to as the “Technological Valley of Death” emphasises the fact that many new novel research work reach TRLs 4–5 and die there. In India, Transfer of technology directly from the laboratory to a production plant results in numerous problems. One limiting factor is the low strength of R & D personnel in industry and their inexperience in scaling-up laboratory level knowledge and practice to a manufacturable know-how. Problems multiply in medical devices due to mandatory needs for implementing Good Manufacturing Practices (GMP). We are well aware of this gap and that few Academic R&D outputs have made it successfully into the market. For “Atmanirbhar Bharat” to succeed and make an impact on our economy, this “VALLEY OF DEATH must be successfully bridged” on a much larger scale across our vast country in the current high-tech scenario. Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum has been an exception. Between 1987 to 2000, the Institute successfully developed over 24 high-risk medical devices in their laboratories and 16 of them were successfully commercialised with transfer of know-how to industry. So what did Chitra do, that was different? How did it achieve this significant success in the very challenging area of Medical implants and high risk devices ?
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5. Complete QMS documentation & Training gets done at pilotscale. 6. Depending on feedback, further improvements could be carried out more easily due to the availability of the development team (who possess the basic know-why) 7. Full-set Technology Transfer documents detailing all the process flow and steps get generated : a) Testing and Validation Documents b) Process Control and Quality Assurance Documents c) Equipment specs, test set ups and basic set of Jigs and fixture specifically developed for the pilot production d) Complete packaging design details and labelling literature e) Technical support from the Institute during the manufacturing plant design, setting-up and first production batch validation.
Chitra’s TechnoProve
The PVC based BLOOD-BAG was the first know-how that was transferred starting in 1984. It was taken up by an young entrepreneur under the start-up company, Peninsula Polymers Pvt Ltd., Trivandrum. The product had been tested clinically at a laboratory batch-size of 75 - 100 bags. At this small scale, the process was repeatable and reproducible. The manufacturing plant capacity envisaged was 2 million bags / year. This huge level of scale-up without understanding the inherent challenges, created huge problems and set-backs in project implementation. This was solved only by a sustained commitment from both sides; but there were times when mutual confidence and trust levels were low and the outcome looked bleak !! But finally, the sustained efforts paid off and in 1987, commercial production Benefits to the Institute started. So, when the next set of 3 products – Bubble Oxygenator, 1. Support Clinical Trials with enough number of “Clinical quality” Artificial heart valve and Hydrocephalus shunt system were manufactured devices and demonstrate that Institute’s ready for scale-up and clinical trials, the Institute had to look at a investment in R&D was successful and justified different model of carrying out the technology scale-up and 2. Reduction in time from lab to market. transfer. The result of this effort was “TechnoProve”. 3. A CORE group of Institute faculty and staff got fully trained in “Quality” mindset for critical medical devices – “know-why” The primary problems or issues were :related to design & safety and understand the issues in scale 1. Lack of confidence in Industry, that the lab level know-how -up to manufacture. could be scaled-up for manufacture. 4. This learning enables the R&D group to foresee and plan for 2. Lack of understanding of the challenges in implementing at a scale-up issues during the R&D phase itself in future projects manufacturing scale, without developing the know-how at an “intermediate pilot scale”. Main Activities carried out 3. Lack of user data from Clinical trials to confirm that the product 1) Evaluation of alternate sources of raw materials. was acceptable in the market and hence saleable; resulting in 2) Development / identification of larger process equipment. low investor confidence and trust. 3) Vendor development of components. The primary base for TechnoProve exercise was set up on its 4) Manpower Training Biomedical technology Wing campus. This consisted of a 300 m2 5) Process standardization & QMS implementation Class 10,000 GMP facility with requisite utilities (distilled water, 6) Work and motion study and optimization of production line. ultrasonic cleaning, sterilisation, etc.,) required for manufacturing 7) Development of quality assurance procedures. implant grade Clinical quality devices at a pilot scale. Testing 8) Packaging and labelling design, development and validation. support for design verification and validation was provided by TechnoProve success stories: the test-labs of the Institute. PRODUCT INDUSTRY QUANTITY MADE The main principles of the TechnoProve were :♦ The R&D team of the Institute works with Industrial partner Bubble Oxygenator & SPIC, Madras 1250 units each in a project mode. The project was based on MOU between Cardiotomy Reservoir the Industry and the Institute, rather than a formal TTK Pharma, Madras 350 - 700 valves Technology Transfer agreement. This substantially reduced Heat Value Prosthesis Industry’s commitment and risk to start with.
Hydrocephalus Shunts
♦ The Project team work to scale-up from laboratory to pilot
Hindustan Latex, Trivandrum
2600 shunts
scale–learning and solving scale-up and manufacturing Concentric Needle Electrode SIDD, Chennai 1750 electrodes issues for both sides. SIDD, Chennai 300 units ♦ Implement QMS & document the know-how in detail (SOPs, Membrane Oxygenators Quality procedures, etc….) Wound dressings DTML, Aluva 7000 pieces ♦ Meet the device requirements for Clinical trials – in terms of Chest Drainage Systems Peninsula Polymers Ltd. 200 Systems quantity and clinical quality of devices needed. Trivendrum ♦ Industry could start market seeding and get market feedback after successful Clinical trials; while they get their PART-2 – Expanding the model : manufacturing plant ready. Government of India has identified the medical devices as a ♦ With the “TECHNOLOGY PROVED”, the Industry could priority sector for the flagship Make in India / Atmanirbhar Bharat confidently sign a Technology Transfer agreement and go on to program and is committed to strengthen the manufacturing set up their manufacturing plant at much lower investment risk. ecosystem. India is the fourth largest medical devices market in Asia. Estimates indicate that we import 70 to 75% of our medical Benefits to Industry – for a much smaller devices. The Production Linked Incentive Scheme (PLI) and investment .. Promotion of Medical Devices Parks Scheme, are two important 1. Observe the technology really works schemes recently announced. 2. Get proof about the Clinical Performance & Safety of the device Promotion of Medical Device Parks 3. Carry out market seeding, determine product acceptance and Promotion of Medical Device Parks aims to strengthen the evolve pricing strategy infrastructure base and develop a robust manufacturing 4. CORE group of industry personnel are fully trained, including ecosystem for medical devices in the domestic market. Financial the “know-why”
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assistance up to Rs. 100 crore each is proposed to be provided for the creation of common infrastructure facilities in 4 Medical Device Parks. Applications from many States and UTs are under scrutiny right now for these 4 slots. But medical devices is a hightech engineering technology driven segment and hence expanding indigenous manufacturing on a large scale will have to depend on indigenous technology and know-how. But where will these technologies be developed to support large scale manufacturing ? It is clear that for indigenous medical device manufacturing to grow and expand, we need indigenous know-how coming out as the fruits of our R&D investments. So, this requires substantial Capacity Building in the country on a longer term of 10 to 20 years together with targeted development of high priority medical devices and instrumentation. Centres of Technology Proving (CoTP) for building capacity for translational research and targeted device development as a partnership between Academia, industry and user needs to be created in these Medical device parks.
ORGANISATION & CONSTITUTION OF CoTP
IITs / R&D Labs Industry & Medical Centres
CoTP
Research Park / Incubator
Hospitals & Medical Centres
support the testing needs of the industry in general and other mission mode projects that are taken up. 7. Each CoTP will establish linkages with leading Engineering / Technology institutions in that region (IITs / NITs / etc) and Medical institutes and hospitals with the required clinical specialists. They will also have strong links to Medical device research parks and Incubators in that state / region.
Functions of each CoTP 1. Focus on Translation – take the working prototype from the laboratory level to pilot-scale level and clinical use quality, complete in all respects including packaging and sterilisation. 2. Organise a well-designed User trials / Clinical trial to validate the design, performance and safety; at the same time, this validate the technology and supports know-how creation. 3. Provide accredited testing and evaluation support for the products being developed there as well as to industry as a whole, so that regulatory requirements can be met internationally. 4. Maintain an information database to support the R&D activities; maintain a library of relevant international and national standards for understanding the international requirements for obtaining regulatory approvals. 5. Conduct workshops and training courses in areas like Design, design control, risk management, GMP, etc so that both researchers and industry personnel can be trained in this highly specialised area of medical devices development and manufacture. 6. Provide consultancy to Industry to solve their manufacturing and product performance problems; GMP requirements and quality system implementation. 7. Collaborate with industry for product improvement and technology validation; support them in documentation and regulatory applications.
Some Technology Focus areas :
Accredited Testing Lab
CoTPs can be modeled on the successful “TechnoProve Model ”: 1. Each CoTP will have a core area of Technical expertise / strength depending on its location and the current medical device industry strength in that state / region. 2. Core faculty of 20 to 30 engineers, scientists and technical staff. 3. Each CoTP will have a TECHNOLOGY PROVING FACILITY with suitable infrastructure, clean areas and facilities to manufacture the devices at a pilot scale required for Clincial trials and market seeding. 4. Each Technology Proving Project will be jointly carried out with an Industry partner and the originating R&D team. The sources of R&D could be from Academia or from Start-ups, who reached the stage of a good working Proof-of-concept. 5. The core team of the CoTP will provide the bridging links and support in cores areas like, vendor or supply management, cleaning & sterilisation, packaging, design verification and user validation (including designing clinical trials), etc. 6. Each CoTP will have an associated Accredited TESTING LABORATORY to meet the testing requirements for products and technologies in the area of that CoTP. This will also
a) Diagnostics (Point of Care /Home Care Diagnostics, early detection, screening of diseases) b) Minimally Invasive technologies (for diagnosis and therapy) and high precision surgical instruments; c) Imaging Technologies (invasive and non-invasive – laser and optical based system; ionizing and non-ionizing radiation systems; ultrasound) for diagnosis and therapy d) High quality Electronics instrumentation for diagnosis and therapy. e) Metallic & Rehabilitation devices –orthopedic implants;; orthotics and prosthetics; high-tech hospital furniture and mobility aids for the elderly and physically challenged. REFERENCES: 1. https://www.investindia.gov.in/schemes-for-medical-devicesmanufacturing 2. D.S.Nagesh and G.S.Bhuvaneshwar, “Technology Proving: Concept to Success”; chapter in the book “Silver Lines” published by SCTIMST, Trivandrum, 2007.
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Polymer Ceramic Hybrid Acetabular Liner: Bench to Bedside Translation Dr. Bikramjit Basu Professor at the Materials Research Center IISc, Bangalore.
According to a published report of the World Health Organization (WHO), about 190 million adults suffer from osteoarthritis and related disabilities worldwide. This is commensurate with the fact that the number of revision surgeries has increased at about the same rate as the number of primary surgeries of joint replacement due to prostheses failures. Currently, there are more than 100,000 cases every year of Total Hip Arthroplasty (THA) procedures in India. The available articulating joint-implants generally offer a trouble free life for about 10-15 years, which is inadequate, considering the increased lifespan for humans in many developing nations. Therefore, a search for ideal prosthetic materials together with treatment methods, reconstructive solutions and surface designs is currently being pursued in the field of orthopedic biomaterials. The global orthopedic market was approximately 30% of the total
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implants market and the market shares of segments in 2020. The growth rate of the need for orthopedic implants is estimated to be more than 25% per annum for the next five to six years. The global hip replacement implant market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.0% during the forecast period 2017–2023 to an aggregate of $7,150.0 million by 2023. The overall trend therefore shows a steady, yet slow expected market growth in the THR application domain. The THR market is further sub-divided into three sectors: total hip replacement, partial hip replacement and revision and hip resurfacing. Although several hip implant options are available commercially, these are currently imported and there are no affordable indigenous alternatives. In a decade-long research program, Prof. Bikramjit Basu’s research group at Indian Institute of Science, Bangalore, made
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important breakthroughs in developing three different generations of polymer-ceramic hybrid acetabular sockets, namely HDPE-HA-Al2O3 hybrid composites, polyethylene grafted graphene oxide (GO) reinforced high density polyethylene (HDPE) composites and lately, a UHMWPE-HDPE blend with surface modified GO reinforcement. For example, a new synthesis approach was developed to chemically couple GO in polymer blends, which resulted in high mechanical strength (~65 MPa) and wear resistance properties with acceptable biocompatibility. Research on this technology has also been conducted at IIT Kanpur. Gamma irradiation of the acetabular liner was shown to help in improving wear resistance, hardness and coefficient of friction, without compromising on biocompatibility. Improved wettability and surface polarity after gamma-ray sterilization further supported cell adhesion and stability of coefficient of friction. The resulting wear debris were found to be non-toxic. Optimum implant design was determined using Finite Element Analysis and theoretical wear analysis, and was customized according to the bone condition and body weight of the patient. It was shown that implant stiffness could be optimized to be close to the natural strain profile within bone. The scalability for manufacturing of acetabular liners (44, 46 or 48 mm outer diameter with 8 mm wall thickness) with acceptable surface finish has been established at the prototype level. The new implant design was accomplished by biomechanical analysis of principal stresses in periprosthetic bone around the acetabular joint, and current efforts are underway to adopt
machine learning algorithms to accelerate the implant design. The augmented bone tissue regeneration around the variants of hybrid composite were demonstrated in both cylindrical and segmental defect models in femurs of experimental rabbits for a period of up to 26 weeks. Indo-MIM, based in Bangalore, Karnataka, is the manufacturing partner for the fabrication of the designed hip implant prototypes. It is expected that this collaboration will lead to establishing the feasibility of large volume manufacturing of the implants, so that the translational impact to human healthcare would be realized. References 1. Vidushi Sharma, Suryasarathi Bose, Biswanath Kundu, Subhadip Bodhak, Mitun Das, Vamsi Balla, Bikramjit Basu; Probing influence of γ-sterilization on the oxidation, crystallization, sliding wear resistance and cytocompatibility of chemically modified graphene oxide reinforced HDPE/UHMWPE nanocomposites and wear debris; ACS Biomater. Sci. & Eng. 6 [3] (2020) 1462-1475. 2. S. Bodhak, S. Nath and B. Basu; Friction and wear properties of novel HDPE-HAp-Al2O3 biocomposites against alumina counterface; J. Biomaterials Applications 23 (2009) 407-433. 3. Subhomoy Chatterjee, Sabine Kobylinski and Bikramjit Basu; Finite element analysis to probe the influence of acetabular shell design, liner material and subject parameters on biomechanical response in periprosthetic bone, ASME Journal of Biomechanical Engineering 140 (2018) 101014.
About Dr. Bikramjit Basu Dr. Bikramjit Basu is currently a Professor at the Materials Research Center, with joint appointment at the Center for Biosystems Science and Engineering, IISc, Bangalore. He also serves as Visiting Professor at University of Manchester, UK and at the European Centre for Functional and Surface Functionalized Glass. After his undergraduate and postgraduate degree in Metallurgical Engineering from NIT Durgapur (1995) and IISc (1997) respectively, he earned in 2001 his PhD at Katholieke Universiteit Leuven, Belgium. He served as a faculty in Materials Science and Engineering at IIT Kanpur (2001-2011) and moved to IISc in May, 2011. Since 2015, he is leading India’s largest Translational Center of Excellence (CoE) on biomaterials, with 15 co-investigators. Prof. Basu’s untiring efforts have led to the creation of the national hub of activities on biomaterials and implants with involvement of several researchers.
He has published over 300 peer-reviewed research papers in leading journals and holds 7 Indian patents. He is the author of 7 textbooks, 2 edited books and one research monograph in the interdisciplinary areas of Biomaterials Science and Engineering Ceramics. He has taught undergraduate and graduate students in India, Belgium, Spain, UK, Slovenia and Nepal. Bikramjit received Government of India’s most coveted science and technology award, Shanti Swarup Bhatnagar Prize in 2013 for his significant contributions to the field of Biomaterials Science. He is the only Indian from India to receive the ‘Robert L. Coble Award for Young Scholars’, from the American Ceramic Society (2008) and the Richard Brook Award from the European Ceramic Society (2021).
Previous Issues Highlights
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Manufacturing
E-beam Radiation Facility for Sterilization of Medical Devices V C Petwal Radiation Processing In-charge, ARPF & Head, Radiation Processing Lab Department of Atomic Energy, Govt. of India Raja Ramanna Centre for Advanced Technology, Indore, Madhya Pradesh - 452 012 vikash@rrcat.gov.in Sterilization is a process of eliminating, killing or deactivating the facility for sterilization of medical devices at Indore (named microorganism like fungi, bacteria, viruses and bacterial spores. ARPF). The facility is based on two indigenously developed 10 Different methods such as heat, chemicals and ionizing radiation MeV, 6 kW electron linear accelerators (Linacs). are used for sterilization of medical devices. The sterilization • Biological shielding (to provide radiation protection to working method selected for a particular product depends on many personals and others) factors including availability. The medical device industry mostly • Electron linac (radiation source operating on electricity which uses Ethylene Oxide (EtO) gas and Gamma radiation to sterilize can be switched ON / OFF) large volumes of medical devices. ETO is facing significant • Conveyor system pressure from Environmental Protection Agencies. Gamma • Automated process control and safety system (to ensure sources have concerns of security, handling and safe storage process integrity) requirements lasting 100s years. Electron beam (E-beam) • Product storage areas for un-irradiated and irradiated products radiation processing is a modern sterilization technology which is • Dosimetry laboratory traceable to National Standardization both environmentally friendly Dosimetry Laboratory and inherently secure. Due to ( e q u i p p e d w i t h the many advantages radiochromic film and associated with it, the Alanine EPR dosimetry technology is rapidly growing system for process across the globe. d e v e l o p m e n t , validation and routine The electron beam radiation process quality processing for sterilization of monitoring) medical devices is now • Microbiology and QC available in India with FDA and laboratory (for microbial AERB licenses. Medical sterility test and device manufacturers QC measures for interested in availing the eincoming, outgoing and beam sterilization services or in process products) simply qualifying their products for e-beam Layout of the facility is shown processing to begin with are Figure-1 Layout of electron beam radiation processing facility in Figure-1 and the Linacs being welcomed by the facility. installed in the irradiation The indigenous technology vault are shown in Figure-2. offers tremendous scope in 2.0 Regulatory the country and supports AtmaNirbhar Bharat in high frame work for technology field.
r a d i a t i o n sterilization
1.0 Indigenous Ebeam facility development Raja Ramanna Centre for A d v a n c e d Te c h n o l o g y (RRCAT), a constituent unit of the Department of Atomic Energy, Government of India has set-up an electron beam
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Figure-2 Linac installed in the irradiation vault of the facility
Sterilization of medical devices by ionizing radiation is globally approved and widely used technology. Nearly 50% of the global sterilization requirement is met by ionizing radiation and it is considered the best technology for terminal March-April 2021
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Manufacturing The Indian pharmacopoeia, Volume-1, 2018 already includes electron beam from accelerator (machine source) as approved method for sterilization of medical devices. International standard ANSI/AAMI/ISO 11137:2006/(R) 2010 “Sterilization of health care products - Radiation” specifies the requirements for development, validation and routine control of a sterilization process for medical devices. The standard is widely applied worldwide for sterilization of medical devices using radiation. Therefore, from scientific, technological and regulatory purposes Gamma radiation from Cobalt-60, electron beams up to energy of 10 MeV and X-ray beam up to energy of 5 MeV are all equally permitted and are useful for sterilization applications. The regulatory limits on energy are such that “no radioactivity” is induced in the sterilized medical devices. This point is elaborated here to remove any misconceptions and to highlight that there is no chance of medical devices getting radioactive. ISO 13485 “Medical devices- Quality management systems- Requirements for Regulatory Purposes” specifies the requirements of quality management system to be implemented for sterilization of health care products. CDSCO and State FDA regulate the manufacturing and licensing of the medical devices in our country and have accorded approval for the e-beam facility at ARPF. ARPF has been designed, developed, licensed and is being operated in compliance to these regulatory requirements.
3.0 Regulatory Licenses for Sterilization of Medical Devices
harmful microorganism and sterilization is accomplished. Here, it is important to note that equal dose delivered by Gamma radiation or electron beam has equal ability to inactivate the microorganism and well evolved process standards exist to determine the dose. Hence, the sterilization dose used for Gamma radiation are safely transferred for electron beam irradiation.
5.2 Process details The typical schematic arrangement of electron beam radiation processing is shown in Figure-3. A high energy beam (diameter ~20 mm) of electrons is generated from the linear accelerator (Linac). The pencil beam is scanned in a vacuum chamber to form a 50 cm long curtain of electrons. These electrons are extracted from the chamber into the atmosphere through a thin titanium foil. The electrons impinge on the product which is moved in a controlled manner on a process conveyor system. The high energy electrons penetrate through the product box and deliver the required radiation dose. Depth to which electron beam radiation can reach in the product box depends on the density of the product. Hence, box sizes are to be determined based on product density in consultation with the e-beam facility. Two sided irradiation technique is generally employed to achieve uniform dose distribution within the product box and efficient energy utilization.
Plant IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification) tests and other safety related tests have been carried out. The quality management system complying the requirements of Medical Device Rules (MDR)-2017 has been implemented at the facility. The license for radiation processing of Risk Class-A medical devices has been obtained from Food and Drugs Administration (FDA, Madhya Pradesh). The process for obtaining license for medical devices of higher risk class is in process. The facility has been granted ISO 9001:2015 and ISO 13485:2016 certifications for providing electron beam processing services for sterilization of medical devices complying the requirements of ISO 11137.
4.0 Advantages of e-Beam Processing The e-beam process has the following advantages • Does not leave any residues in the processed products. • Does not use toxic and carcinogenic chemicals • Does not require device boxes to be opened, no chances of recontamination. • Can be switched ON or OFF as and when required, inherently secure. • Short exposure and processing time. The use of electron beam technology is rapidly increasing across the globe due to the many advantages associated to it.
5.0 How E-beam sterilization works 5.1 Scientific principle The e-beam is able to penetrate medical devices in their final shipping box. The e-beam deposits energy to the microorganism either directly or indirectly through interaction with other atoms or molecules in the surrounding. This process of energy deposition, generates a large number of free radicals. These free radicals are highly reactive species and cause chemical and biological changes in the system. Living microorganism essentially contain DNA molecules in the nucleus. The DNA suffers lethal damage by interacting with free radicals or through direct energy deposition process of the e-beam. As a consequence of the lethal damage to the DNA, the microorganism are not able to survive and this reduces the microorganism load in the device. At appropriate radiation dose, the process makes the products free of the
Figure-3 Typical scenario of radiation processing using electron beam
6.0 How to avail the sterilization services at ARPF The process to avail sterilization services at ARPF is simple, fast and responsive. Customer will obtain a “Loan License” from CDSCO (as per MDR-2017) for availing the irradiation services for sterilization of notified medical devices and provide the original copy of loan license to ARPF. In case irradiation service is required for nonnotified products, the customer may submit a self-certification that e-beam sterilization services are required and the product does not need loan license. The device manufacturer shall specify the minimum dose required to sterilize the device and the maximum dose that the device can withstand without compromising the functionality (the ISO 11137 recommends minimum sterilization dose of 25 kGy to achieve SAL value of 10 -6 for a product having initial bioburden less than 1000 cfu/gm). The manufacturer shall pack the product in suitable primary packing (PE film/ PET film etc) that provide sterility barrier to the product. Such packed devices shall be filled in a corrugated card board box having typical dimension 59 cm x 43 cm x 34 cm. This
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Manufacturing dimension of box is suitable for the products having packing density in the range of 0.12 to 0.15 g/cc. A different dimension of the box may be required, in case product packing density is different than mentioned above. Before commercial irradiation, the customer will send minimum 6 Nos of carton boxes to ARPF for process development and dose mapping study. ARPF is equipped with well calibrated dosimetry lab traceable to NSDL and Quality Control (QC) lab (Figure-4 a & b). Three dimensional volumetric dose mapping of theproduct shall be carried out to optimize the irradiation parameter for delivering the required dose within the specified limits. A feasibility confirmation, dose mapping number and product registration will be generated at ARPF and recommendation for further processing will be issued. Dose map exercise is required only one time before starting commercial irradiation.
first serve basis. In order to promote the use of e-beam technology and help medical device manufacturers to prepare their business model with e-beam sterilization, the irradiation service is being offered with nominal charges for one year. RRCAT will generate “zero” cost invoice mentioning the notional charges (not to be paid by customer) for the irradiation service in the remark column. The customer will have to pay only 18% GST on the notional charges through Reverse Charge Mechanism (RCM) basis and submit the challan to ARPF. The logistics charges will be born by the customer.
8.0 Conclusion An indigenous electron beam facility is operational with FDA license at Indore and is providing services for sterilization of medical devices. This is the first E-beam facility in the country licensed by AERB, FDA (MP State) and accorded with ISO 9001 and ISO 13485 certification for sterilization of medical devices as per the requirements of ISO 11137. It is a step in deploying DAE developed technology for medical application in making AtmaNirbhar Bharat an initiative of Government of India. Medical device manufacturers are welcome to use the facility.
Figure-4 (a) Dosimetry laboratory at ARPF
Figure-4 (b) QC and Microbiology laboratory at ARPF The customer shall send a request to jishnu@rrcat.gov.in or vikash@rrcat.gov.in in the order registration form to avail irradiation service. Once the order is accepted and material delivered to ARPF, it will be processed typically within 2-3 days (depending on the batch quantity). At present the plant has capacity to process every day nearly 100-125 boxes of above mentioned dimension (59 cm x 43 cm x 34 cm) for delivering 25 kGy. A “Certificate of Irradiation” specifying the date of irradiation and dose delivered will be issued for each batch irradiated at ARPF. Figure 5 shows the Petri dishes, self-standing VTM tubes (used for Covid-19 sample collection) and vacutainers (vacuum sealed blood collection tubes) standardised for E-beam sterilization. Figure 6 shows successfully irradiated batch of 125 boxes (100 boxes of petri dishes and 25 boxes of VTM tubes) by E-beam. Sterility test of the batch was verified by a NABL certified laboratory at Ahmadabad and passed successfully as no bacterial growth in the Thioglycollate medium and fungal growth in Soyabean casein digest broth was detected during the incubation period of 14 days. Apart from sterilization of medical devices the facility is being used for R&D work on sterilization of API (Active Pharmaceutical Ingredients) and new application development.
7.0 Service Charges The product irradiation services shall be provided on first come
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Figure- 5 Medical devices standardised for E-beam sterilization
Figure- 6 The first batch of 125 boxes of VTM tubes and Petri Dishes irradiated at ARPF
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Acknowledgement
The author deeply acknowledge the contribution and hard work of entire ARPF team of RRCAT for setting-up the first E-beam facility in the country for sterilisation of medical devices. March-April 2021
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Go to Market Strategies for Medical Device Start-ups and Entrepreneurs in India
Bhupesh Sood CEO, SEC Global Consulting
Tapan Kumar Patel Principal Consultant, SEC Global Consulting • Recognized Medical Devices as a sunrise sector under Make in India campaign, 2014 • The Medical Devices Rule of 2017 • Adopted risk-based classification based on GHT guidelines: Classes A, B, C, D • Perpetual licences for manufacturers • The Medical Devices Amendment Rules of 2020 bring all medical devices in India under regulation as drugs. The medical devices industry in India consists of large multinationals as well as small and medium enterprises (SMEs) growing at an unprecedented scale. • The current market size of the medical devices industry in India is estimated to be $11 bn. Around 65% of the manufacturers in India are mostly domestic players operating in the consumables segment and catering to local consumption with limited exports. Large Multinational Corporations lead the high technology end of the Medical Devices market with extensive service networks. There are 750–800 domestic Medical Devices manufacturers in India. The manufacturing is developing in its scale and geography: there are six Medical devices manufacturing “clusters” in the country. Clusters have “Medical Device Parks” developing around them: states have committed to set-up dedicated industrial parks where efficient domestic manufacturing at lower costs. In 2019, Andhra Pradesh, Telangana, Tamil Nadu, and Kerala have got inprincipal approval from Government of India for new medical devices parks.
Overview India is the 4th largest market for medical devices in Asia. Medical device sector is projected to register a CAGR of 14.8% and is expected to reach $11.86 bn in 2021-22 As stated by the new market research report on medical device outsourcing, the United States represents the largest market worldwide. Asia-Pacific is forecast to record the fastest CAGR of 14.9% over the analysis period- 2020. Less expensive production of devices coupled with adherence to stringent international quality standards marks the emergence of Asia as the most desirable production hub. Asian countries, specifically India and China, are emerging as attractive low-cost destinations for leading medical devices OEMs. India’s medical devices industry is poised for significant growth in the next five years: The market size is expected to reach $50 bn by 2025. 100% FDI is allowed under the automatic route for both brownfield and greenfield setups. Strong FDI inflows reflect the confidence of global players in the Indian market. Since April 2000, $2.1 bn in FDI. Of this, $600 mn was received in the last 5 years. Singapore, United States, Europe, and Japan are key investors Equipment & Instruments, Consumables and Implants have attracted most FDI . The Government of India has taken several steps to ensure the growth of a vibrant ecosystem of medical devices manufacturing in India over the past 5 years:
The Process from Ideation to Customer (i.e. Patient) Problem Statement
Literature Search
Market Study
Design a Prototype
Testing and Validation
Proof of Concept
Develop Design Protocol and Validation
Design a Business Strategy
Define Regulatory Pathway
Validate Regulatory Pathway
Make a Business Plan and get it vetted by CA/Professional
Create a Pitchdeck/Bank Documents
Pitch to Investors/Bank Approval
Create infrastructure as per product requirements
Hire minimum staff as per business plan
Get Test Licence from CDSCO
Trial Production
Get Audit done as per product category
Place the product in the domestic market
Comply international Country Specific requirements
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Exports
Product Testing as per standards
Figure 1 – Basic steps to be followed by Medical Device Start-ups / Entrepreneurs
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Markets Understanding the applicable standards
Choice of products
When any Medical Device Start-ups / Entrepreneurs is considering to venture into the medical device manufacturing he has to consider many factors before the product is placed in the market. He has to work a lot on the compliance requirements that are applicable to the product, that is proposed to be placed on the Indian market. Many such manufacturers will fail if they are not keeping an eye on the product related compliance requirements. Example 1 – Infusion Set – If you plan to make an infusion set , say Sterile Single Use Scalp Vein (Winged Needle) Infusion Set, then BIS requirements that need to be followed are IS 16097:2013. In addition to these, you also need to understand the sterilisation requirements along with testing and laboratory requirements. Example 2 – Blood Transfusion Set - Similarly, say Blood Transfusion Set (for Single Use Only), the requirements shall be ISO 8536-4 compliant spike, ISO 594/1 & ISO 594/2 compliant end connection. In addition to these, you also need to understand the sterilisation requirements. along with testing and laboratory requirements. Example 3 – Orthopaedic Implants – If you are planning to manufacture/develop high-end products, then you have to make sure that team has desired competence, a mix of biomedical and engineering staff; in addition to the technical staff. An understanding of raw materials, their source and applicable test standards like ISO 7206-10:2018 (Implants for surgery) is imperative because this will help you understand the design requirements at the very beginning of your product development stage.
You have a basket of over 3000+ products to choose from and manufacture in India. Minimum Licences Required: a) Company Registration (in case proprietorship you may skip this process) b) Manufacturing License c) Goods and Service Tax Number
Business Overview for a Medical Device Startups / Entrepreneurs “Turtle Diagram” is a great tool for visualizing process characteristics. Processes are made up of inputs, outputs, criteria, etc. Figure 2 allow you to look at the entire process, as well as the communication. Figure 2 can help you , better understand the process and what minimum requirements you must be considered by you, when you are planning to setup a manufacturing unit or want to act as a service provider for the medical device industry. Inputs
Processing
4Ms (Man, Material, Machine, Money) + Regulatory Requirements
Output The Product + Compliances + Waste Management
Figure 2 - Input - Output Overview
Competent Technical Staff: Medical Devices manufacturing shall be conducted under supervision of whole-time technical staff which is very important to ensure product quality.
Labelling of Medical Devices: Medical Devices should be labelled as per requirements prescribed in Drug and Cosmetic Act and Rules along with Indian Standards Specifications laid down from time to time by the Bureau of Indian Standards. For all international markets, there are country/region specific requirements which you need to understand before planning to approach customers. In international market, labels may also be required in different languages and disclosures.
Conclusion The Indian Government has identified the medical devices as a priority sector for the flagship 'Make in India' program and is committed to strengthen the manufacturing ecosystem. India is the fourth largest medical devices market in Asia. Currently, the Indian market has high reliance on imports but in recent times the exports have seen a surged. The Production Linked Incentive Scheme (PLI) and Promotion of Medical Devices Parks Scheme, are a testimony to this. These schemes have been cogently constructed to incentivize large-scale manufacturing and to build required infrastructure for developing manufacturing clusters within India. As a Start-ups / Entrepreneur, its very important to understand that Medical Devices is a highly regulated product and you have to plan very carefully when you are entering into this market. Though the investment may look small, as compared to returns; but it is also the fact that if you are ill- prepared or under-prepared, you will not be able to sustain. Also, as the world is talking about waste management and green energy, you must try to make Green Building at the start phase itself. This will make your product even more cost effective and greener for the supply chains. Lastly, an eagles’ eye on the compliance requirements is also beneficial as this will help you to stay focussed on the target that you set for yourself. Your project will not sway with the slight push of the compliance needs. Hence a proper plan will help you take benefit of one of the fastest growing market, with good growth potential and a wide customer base.
Case Study
Biblography
Scope – To setup a medical device manufacturing unit with about 35-50 people working in the premises. You have to consider these costs: a) Understanding the Land cost in the area where you want to setup the unit b) Building construction if you are setting up a Greenfield project c) Water Charges – Connection and ongoing d) Electricity Supply – Connection and ongoing e) Air Handling Unit for sterile products f) Factory Premises (As per WHO: GMP and/or Schedule M-III) g) Competent Technical Staff i.e., Manufacturing Chemist and Analytical Chemist h) Machinery and Lab Equipment
http://seip.urban-industrial.in http://healthworld.com https://pharmafranchisehelp.com (https://health.economictimes.indiatimes.com/healthfiles/future-growth-of-medical-device-market- in-india-ascompared-to-the-global-market/628 ) https://www.investindia.gov.in/sector/medical-devices https://www2.deloitte.com/content/dam/Deloitte/in/Documents/li fe-sciences-health-care/in-lshc- medical-devices-making-inindia-noexp.pdf https://16949store.com/articles/how-to-use-turtle-diagrams/
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Materials
PVC – A Persistent, Versatile Choice! Mr. Kamalnain Kurra Director – Innovative Performance Plastics
Polyvinyl Chloride also referred to as Vinyl is an extensively used thermoplastic in all aspects of our lives. “Our lifesaving medical industry being no exception is thriving on the benefits of PVC”. This is a much-known fact to all the stakeholders of the field. This article on PVC brings to highlight the various aspects s u c h a s h i s t o r y, p r o d u c t i o n , c l a s s i f i c a t i o n , developments, compounding, regulations, and its application in the healthcare industry. The objective of this article is to convey a basic understanding of the process of PVC compounding and its far-reaching pursuit in the medical industry. History – The evolution of PVC goes back to over a century when it was first polymerized during the period 1838-1872. The commercial production of PVC is estimated during the early 20th century. In 1913, German inventor Friedrich Klatte patented a polymerization process to manufacture PVC. In 1926, Waldo Semon invented plasticized PVC providing a synthetic replacement for increasingly costly natural rubber. Ever since then there has been no looking back for PVC with its endless list of usage – be it industrial, construction, household, packaging, and healthcare. PVC is widely used in pipes & fittings, films & sheets, wires & cables, flooring & profiles. Production – Most of the PVC in use today is manufactured by combining ethylene and chlorine. The electrolysis of saltwater produces chlorine, which is combined with ethylene (separated from oil feedstock during thermal cracking) to form vinyl chloride monomer (VCM). Molecules of VCM are polymerized to form PVC resin, to which appropriate additives are incorporated to make a customized PVC compound. Since ethylene is a product of the oil & gas industry, PVC is considered a petrochemical product. PVC can also be produced from hydrocarbons such as coal or plant derivatives such as sugar cane. Carbon and hydrogen are the main elements of most thermoplastic as they are entirely derived from oil. What makes PVC unique is the presence of Chlorine. PVC is made from 57% salt and 43% oil. The presence of chlorine with hydrocarbons provides several technical advantages to PVC and helps it to deliver unbeatable value. It makes PVC compatible with a wide range of materials, adds to its versatility, and makes it flame retardant. Chlorine plays a significant role during the recycling of
plastics as its presence helps as a marker to distinguish PVC from other materials. Classification – PVC being a thermoplastic offers exceptional clarity, is weldable, bondable (with adhesive or chemical), and can be extruded, molded, or calendared. Depending on the polymerization technique used for manufacturing PVC polymer, it can further be classified as mass or bulk polymerization grade, suspension grade, emulsion grade, or solution process grade. The suspension process accounts for over 80% of the global production. Developments – All along the previous year's PVC recipes have gone through a lot of changes to offer better performance and processibility, address environmental issues, and comply with legislation. Some developments include elimination, restricted use, or modification of heavy metal stabilizers (such as lead, tin, Zinc), non-use of specific plasticizers (for the medical industry), wider choice options for pigmentation, lubricants, and additives. Needless to mention the process improvements and choices at each step of compounding. The key steps during compound manufacturing are blending, compounding, and pelletizing. Various blending methods available are High-speed mixer, ribbon blending, paddle mixers and drum tumblers. Available methods for compounding include kneading, single or twin screw (with co-rotating or counter-rotating) extrusion, Farrel continuous Mixer and Banbury. Pelletization is the final step during compounding, it can be done using air (strand) or underwater (die face) pelletization. Compounders for the medical industry normally use a selection from High-Speed mixing, ribbon blending, kneading, screw extrusion, and die face pelletization. Compounding – PVC in its original form does not offer flexibility. The addition of plasticizer &/or other minor components to make the PVC amenable and suitable for flexible or rigid applications is known as compounding. These minor components are added to enhance the functionality of PVC and the quality of the end product. These salt and pepper ingredients are Stabilizers, Lubricants, Fillers, Processing aids, Pigments, Impact Modifies, and other additives. Depending on the end produce the formulation mixture can be dry blended or melt compounded. By and large the two major components for flexible PVC compound is the choice of PVC resin (identified by its K-
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Materials value) and Plasticizer. Resin & Plasticizer temperature, blending speed, time and temperature, sequence of addition of ingredients, screw design, L/D Ratio, the temperature at various zones in the barrel are the other key considerations during compounding. K-Value – An important parameter that influences the property of PVC compounds is the K-Value of PVC resin. K-Value represents a function of the average molecular weight, the degree of polymerization and the intrinsic viscosity of the resin. As a thumb rule, low K-value resins are used for rigid and higher for extrusion. For high-performance and specialty compounds (such as pump, kink-free and steam sterilizable compounds) further higher K-value resins are preferred. The increasing Kvalue offers higher plasticizer absorbance during compounding, better thermal stability and mechanical properties of the finished product, and a decrease in processability. Plasticizers – The flexibility and hardness of the PVC compound are adjusted by the amount of plasticizer. Traditionally phthalates have largely been used as a plasticizer since they offer flexibility, transparency, durability, and longevity in products. One of the most regular plasticizers, di(2ethylhexyl) phthalate (abbreviated as DEHP) is an organic chemical derived from fossil fuels. Use of DEHP for medical use has been prohibited (except for blood bags). This is due to the potential toxicity due to leaching out of DEHP. There are various chemistries commercially available for plasticizers. Some commonly used plasticizers for medical products are DEHT, DINCH, DOA, Citrates, TOTM. The main consideration for the selection of plasticizers in the medical application of PVC is migration, chemical, biological & toxicological properties, and its compliance with REACH, MDR, FDA directives. Sterilization of the end product also affects the selection of plasticizers. Regulations – There are several regulations worldwide which the PVC compound must comply with, based on its applications. Some of these are - REACH, US FDA, RoHS, MDR, VDI, NSF, California Proposition 65, ISO and Biocompatibility.
tubing. Since the last few years, PVC rigid has successfully replaced expensive engineered resins like Polycarbonate and has proven to offer equal strength, rigidity, and clarity. This has resulted in significant savings and helped to reduce device costs. Due to its low cost and versatility PVC remains a product of choice for single-use devices in dialysis, infusion, transfusion, drainage, respiratory and cardiology. PVC can be compounded with selected metals & polymers to meet antimicrobial requirements or with pigments and UV filters for light-sensitive drugs. PVC goes equally well with several radiopaque substances which augment its use in radiology. PVC in combination with other materials is used to create co-polymer tubing and molding parts to enhance its usefulness in the delivery of sensitive drugs. PVC is one of the most frequently used and investigated plastics for pharmaceutical packaging. Its benefits to price ratio remain unmatched and it is mainly used as a blister, container & delivery system. Very often PVC is coated or laminated with PVDC, COC or PCTFE to enhance the protective and barrier properties. PVC is also largely used in hospital interiors due to its d u r a b i l i t y, c h e m i c a l resistance, low maintenance costs, and affordability. Conclusion – The beginning of making any PVC compound is to identify its end application. PVC has been the most widely used plastics in healthcare and has consistently been in use for a long time. The options in the selection of ingredients & techniques, together with the right temperature, time, speed, and manufacturing conditions make the compound versatile. The when, how, and how much affect the reproducibility of the compound batch after batch. Undoubtedly, PVC compounding is often compared to cooking, only knowing the ingredients does not guarantee the same taste as prepared by a master chef! A Persistent, Versatile Choice, Indeed!!
Previous Issue Highlights
PVC in Medical – Medical device industry has been revolutionized ever since the use of single-use of medical devices. The use of PVC has improved medical safety drastically by reducing the risk of infections caused by multiple uses of traditional devices. One of the oldest and widest uses of PVC has been for blood bags (collection, processing & storage of blood & blood components). PVC has been proven to offer several advantages over other plastics and has replaced glass for blood bags since 1950. It offers safe transportation, better shelf life, permeability to preserve platelets, can be steam & gamma sterilized and stored at low temperatures, does not burst or tear during centrifuge, is translucent, relatively easy to manufacture, and is cost-effective. The non-kinking characteristic is one of the critical requirements during the usage of medical tubing since it may cause serious complications and life-threatening situations for the patient. The chemical structure of PVC ensures effective anti-kink qualities; hence it is vastly used in the manufacturing of kink-resistant
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Global Trends Novel Plastic Film Capable Of Deactivating 99.99% Of New Coronavirus In 15 Minutes A consortium comprised by companies Braskem, AplFilm and Nanox and the UFSCar (Brazil) and Jaume I of Castellón (Spain) universities have released a plastic film capable of deactivating 99.99% of the new coronavirus in 15 minutes. The scientific collaboration initiated 15 years ago between the UFSCar and UJI with company Nanox had already developed in 2014 a product with antifungal and bactericidal properties: a transparent PVC film with silver microparticles which has now given way to the technology patented by Nanox wih the support of the Vinyl Application Engineering team of Braskem and AlpFilm. Silica is a semiconductor that becomes active with metallic silver to generate highly oxidative molecules capable of deactivating 79.9% of the new coronavirus in three minutes and 99.99% in just 15 minutes. The product is already available on the market and is commonly used to pack food items such as meat, fruit, vegetables and cold meats, and could now also be used to protect surfaces. The tests to verify the power of the new plastic packages to suppress SARS-CoV-2, the virus that causes COVID-19, were conducted at the level 3 biosecurity laboratory of the Institute of Biomedical Sciences of the University of São Paulo (ICB-USP) in compliance with ISO 21702:2019, the technical standard to measure the antiviral activity in plastics and other non-porous surfaces. Companies Braskem and AlpFilm improved the film's formula, maximizing the protection potential against fungi and bacteria, achieving the virucidal effect. The technology developed by Nanox, managed by doctor Gustavo Simões, had the support of the Innovative Research
Programme for Small Companies (PIPE) of the FAPESP, and the scientific guidance of professor Elson Longo from the Centre for the Development of Functional Materials (CDMF), the Federal University of São Carlos and professor Juan Andrés Bort, head of the Laboratory of Theoretical and Computational Chemistry of the Jaume I University of Castellón. PVC solutions enable the production of a series of essential products ranging from medical and hospital products to packages, which ensure food safety, hygiene and cleanliness, among other factors, bolstering the fight against COVID-19," explains Almir Cotias, Vinyls director at Braskem Business, department responsible for the production of the raw material for PVC film AlpFilm Protecto. The product existed since 2014 with antifungal and bactericidal properties thanks to the presence of silver microparticles, but with the pandemic, we subjected it to a series of studies to adapt its composition in order to ensure its antiviral efficiency. Faced with the challenges imposed by COVID-19, we decided to focus our attention on researching and developing this product evolution to deactivate the new coronavirus by contact." Alessandra Zambaldi, Director of Foreign Trade and Marketing, AlpFilm https://www.news-medical.net/news/20210208/Novel-plasticfilm-can-deactivate-999925-of-the-new-coronavirus-in-15minutes.aspx
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DoP Notifies 19 Medical Devices To Boost Indigenous Manufacturing The Department of Pharmaceuticals (DoP) has notified 19 medical devices under para 3(a) of the Department for Promotion of Industry and Internal Trade (DPIIT) order for Class I local suppliers to boost indigenous manufacturing of medical devices. These include bandages without adhesive layer, electrocardiographs, suture needles catheters, cardiac catheters, endoscopes, hollow needles for injection, aspiration, biopsy and transfusion, syringes, W/N with needles, surgical knives, scissors and blade, blood transfusion apparatus, surgical gloves, artificial joints, orthopaedic or fracture appliances, other x-ray machines for medical use including EEG apparatus and ECG machine, among others. The DoP had earlier issued revised guidelines for implementing the provisions of public procurement (preference to Make in India) Order (PPO)-2017 DPIIT guidelines for procurement of Make in India medical devices. The DPIIT, pursuant to Rule 153 (iii) of the General Financial Rules 2017, had earlier issued PPO - 2017 dated June 15, 2017 which was partially modified on May 28, 2018, May 29, 2019 and September 16, 2020 respectively. “In view of DPIIT PPP-MII order notification dated September 16, 2020, the DoP has issued revised guidelines dated February 16, 2021 for implementation of the order for medical devices sector,” according to a DoP notice. “List of manufacturers have been issued which is indicative in nature. There may be other Class-I local suppliers also available in the market. Also suppliers indicated in the list may offer products which do not offer minimum local content requirement for Class-I local supplier. As such procuring entities may follow all prescribed procurement procedure without relying on the published list,” the DoP notice further stated. This is envisaged to promote manufacturing and production of medical devices in India with a view to enhancing income and
employment of local population. It is aimed to give maximum preference to local companies. The DoP move gives priority to bidders of government contracts that use more local content. The revised order has introduced a concept of Class-I, II and non-local suppliers, based on which they will get preference in government purchases of goods and services. Class-I local suppliers will get the most preference in all government purchases because their domestic value local content addition is 50 per cent or more. They will be followed by Class-II suppliers, whose local content value addition range is more than 20 per cent but less than 50 per cent. For verification of local content, the Class I and II suppliers shall be required to indicate percentage of local content and provide self-certification that the item offered meets the local content requirement norms. Concept of Class-I supplier has been introduced so that in cases where local suppliers are to be given the order, even within that group we should give first preference to the ones whose domestic value addition is significantly high. Under the revised guidelines, it is envisaged that all Central government departments, their attached or subordinate offices and autonomous bodies controlled by the Government of India should ensure that purchase preference will be given to domestic suppliers. DPIIT in order to facilitate the implementation of the PPO 2017 dated August 14, 2017 has also identified DoP as the nodal department for implementing the provisions of the PPO 2017 relating to goods and services related to pharmaceutical sector. DoP in supersession of the guidelines issued earlier dated October 16, 2018 and December 12, 2019 has issues the revised guidelines. http://pharmabiz.com/NewsDetails.aspx?aid=136402&sid=1
There's Need To Integrate Various Regulatory Agencies With Single-window System: Pharma Secy The medical devices industry, which is growing at a compound annual growth rate (CAGR) of about 15 per cent, holds the highest growth potential among all the constituents of the healthcare sector such as pharma and hospital services, an official statement said quoting S Aparna, secretary of Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilisers. New Delhi: There is a need for integration of various regulatory agencies with a single-window system for the medical devices industry, other than incentives for domestic production, a senior government official said on Thursday. The medical devices industry, which is growing at a compound annual growth rate (CAGR) of about 15 per cent, holds the highest growth potential among all the constituents of the healthcare sector such as pharma and hospital services, an official statement said quoting S Aparna, secretary of Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilisers. Speaking at the inaugural session of Medical Devices Expo 2021, she said, "It is important to remember that this is an inter-
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disciplinary sector with a huge range of products covering reagents, diagnostic kits, and high-end imaging equipment." She said that therefore, it is a sector that requires a nuanced approach. Beside incentives for domestic production of medical devices, she also highlighted the need for integration of various regulatory agencies with a single-window system. Aparna also said there is a need to put in place a transparent, stable, predictable and easy-to-navigate interface between investors, manufactures, exporters and the regulatory ecosystem. She also emphasised that innovation, adoption and adaptation of new technologies would be key to tap the huge opportunities in both domestic and export markets. The medical devices sector has been growing at an accelerated pace in pandemic times and is projected to become USD 65 billion industry by 2024, the statement said. It offers a big opportunity for domestic players, especially engineering MSMEs, to make deep inroads into global markets, March-April 2021
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the statement added. The Indian medical device market is the fourth largest in Asia after Japan, China and South Korea. It has, however, potential to overtake some of its peers in size and scale given the government support it has been receiving over the past few years. The government initiatives to boost the sector include 100 per cent FDI, setting up of medtech parks and the production-linked incentive (PLI) scheme. The recent Medical Devices Amendment
Rule 2020 is aimed at making the sector more regularised, the statement said. "The Covid-19 pandemic has pushed us further on the track of strengthening our medical devices industry and India has appropriately risen up to the cause," EEPC India Vice-Chairman, Arun Kumar Garodia said. https://medicaldialogues.in/news/industry/pharma/need-tointegrate-various-regulatory-agencies-with-single-windowsystem-for-medical-devices-dop-secy-s-aparna-75943
MvPI Evaluates 1,257 MDAE Reports Through Its Reporting Tools At IPC For Safe Medical Devices The Materiovigilance Programme of India (MvPI) has in total received and evaluated 1,257 Medical Devices Adverse Events (MDAE) reports till date through its reporting tools which were launched on February 8, 2019, at Indian Pharmacopoeia Commission (IPC), Ghaziabad. Out of the total 1,257 reports evaluated, 69% of reports were marked as serious and 31% reports were reported as nonserious as per the Medical Devices Rules (MDR) - 2017. All reporting tools and documents are available on the website of IPC-www.ipc.gov.in. IPC is currently working on the development of resource material and reporting tools as the National Coordination Centre (NCC) for MvPI which was launched in 2015. IPC functions as the NCC for MvPI and Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as its collaborating center. Technical support is being provided by the National Health System Resource Centre (NHSRC) in New Delhi. The Union health ministry had in 2019 also directed medical device manufacturers to register at the medical devices information sharing portal through hyperlink -www.mvpi.co.in. This portal serves as an India-specific tool to help IPC facilitate baseline study of products available with medical device companies in India and assure patient safety. IPC in consultation with Central Drugs Standard Control Organisation (CDSCO) has developed the portal to ensure that safe medical devices are available in the country. The MDAE reports are processed at IPC NCC- MvPI to get as much information and also determine reporters' authenticity. Thus, complete reports are carried forward to clinical assessment and root cause analysis expert committee. Based on the evaluation, it was found that around 76% of serious adverse events reports led to further medical intervention. These adverse events included mainly dissection, stent thrombosis, stenosis, migration of the implanted device, stent elongation among others. Around 7% of the serious adverse events led to the patient death and 10% of the serious adverse events led to the hospitalization of patients (prolongation of existing hospitalization or re-hospitalization). Around 7% of the serious adverse events were associated with other causes like the malfunctioning of the device, device break, device expulsion, pain, infection, manufacturing defects, quality issues, device explosion among others. Around 51% of total 1,257 reports were associated with cardiac stents including drug-eluting stents, covered stents etc, 5% of
reports were associated with catheter including, all peripheral stents, guide wires etc, 3% of cases were associated with heart valves, 11% reports were associated with intrauterine contraceptive devices, 4% reports were related to orthopedic implants and 2% reports were associated with IV cannula. All the other medical devices contributed to a total of 24% of adverse event reports. As the adverse events associated with devices are reported on a voluntary basis, most of the cases were reported for follow-up information. http://pharmabiz.com/NewsDetails.aspx?aid=137801&sid=1
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Industry News Milacron Expands Line of Electric Injection Molding Machines Milacron announced this week an addition to its line of electric Fanuc Roboshot injection molding machines in the Americas. The Alpha-SiB line, with 55-, 110-, 140-, 165- and 240-ton models, is based on the popular Fanuc Roboshot Alpha-SiA series. Various injection capacities are available for highprecision molding applications. Milacron said that it will deliver its first Alpha S140iB to a custom molder in the Midwest in the second quarter of 2021. Milacron and Fanuc adapted the Roboshot Alpha to meet the requirements of a variety of applications on both the clamping and injection unit, said the companies. Special features have been developed for applications involving medical products, liquid silicone rubber, optics, electrical connectors, and packaging. The Roboshot Alpha systems have proven especially popular in the medical and packaging spaces over the last two years,
according to Kent Royer, Technical Product Manager–Roboshot. “Since NPE 2018, we also have seen a high demand for the integration of Mold-Masters hot runner controllers,” he added in a prepared statement. “Using Modbus and SPI communications, we’ve developed capabilities that will reduce human error in operation and allow for the creation of custom shut-down sequences.” The Alpha-SiB series includes a high-resolution/performance Panel iH control and new electrical standards. Additionally, Milacron has announced that several previous options are now standard with the iB series, including increased mold stack height, three-stage air eject, expanded I/O for automation /sequencing, precision clamp-force control for consistent venting and reduced mold wear, and 200 Operator ID with custom lockout capability for security control and tracking. https://www.plasticstoday.com
PLI Scheme Incentive Rate For Medical Sector Should Be Revised To 10%: Transasia Synopsis "The PLI scheme is an excellent initiative to make India Atmanirbhar (self-reliant) in the sector. But the incentive rate is just five per cent for the medical technology companies, while the same for the automobile industry is 10 per cent. "We urge the government to raise it to 10 per cent," Transasia Bio-Medicals chairman and managing director Suresh Vazirani told. The Centre should increase the rate of incentive under the PLI scheme to 10 per cent from 5 per cent to reduce dependence on import of medical equipment and boost domestic manufacturing of such products, an official of a company involving in the sector said on Sunday. The government has introduced the production-linked incentive (PLI) scheme to enhance the country's manufacturing capabilities of medical equipment and encourage the development of technology. "The PLI scheme is an excellent initiative to make India Atmanirbhar (self-reliant) in the sector. But the incentive rate is just five per cent for the medical technology companies, while the same for the automobile industry is 10 per cent. "We urge the government to raise it to 10 per cent," Transasia
Bio-Medicals chairman and managing director Suresh Vazirani told PTI. The five per cent incentive rate is "inadequate" and should be increased to facilitate Indian companies to produce medical devices not only for the country but also for the overseas markets. According to an estimate, the import of medical equipment from China accounts for around 25 per cent of the USD 50 billion industry in India. Indian companies in the medical technology sector are not able to compete in the global market due to several infrastructural inefficiencies and high cost of funds, he said. The Rs 1,300 crore company is planning to set up its fourth manufacturing plant in the country. The medical-technology firm has three domestic units and two overseas facilities. "We are planning to build our fourth domestic plant. The company is in talks with Telangana and Andhra Pradesh for the project. It will involve a capital expenditure of Rs 100- 150 crore, and the facility will produce blood analysers," the official said. https://economictimes.indiatimes.com
Hindustan Syringes And Medical Devices (HMD) To Invest Over Rs.100 Crore To Ramp Up Syringe Production With the surge in Covid cases amid the rising demand for syringes during the ongoing vaccination drive in India, Hindustan Syringes and Medical Devices (HMD) on Sunday said that the company will invest over ₹100 crore to expand its production capacity from 2.5 billion syringes to over 3 billion. Rajiv Nath, Managing Director, HMD told that the company not only needs to invest in production lines of syringes-moulds, moulding machines, printing and assembly packaging, etc. but also in needle assembly, needles point grinding, recruiting workers and training them. "Our current production capacity is over 2.7 billion syringes per annum of disposable and auto-disable syringes are approximately 90 lakhs daily. And we are investing over ₹100 crore to ramp up capacity from 2.5 billion syringes to over 3 billion by next quarter," Nath informed. According to Nath, HMD has been practicing the government's 'Atmanirbhar Bharat' initiative for decades by making their components.
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"We do share the Prime Minister's vision and quest for an Atmanirbhar Bharat. It is in our DNA," Nath said. "It is another matter that government policies in the last 10 years favour imports of medical devices and components. So it's no more a competitive advantage to produce these components in India," he added. The company said that it is also facing few challenges in the process of production and supply due to the pandemic. The company has received orders for 240 million Kojak syringes for COVAX via UNICEF and 79 million for Brazil for Dispovan syringes via PAHO. "We had also shipped 140 million Kojak syringes to Covid-19 Vaccine Global Access (COVAX) last December. We have recently sold 15 million syringes to the Japanese government. In total, we serve over 120 countries worldwide," he said. https://www.businessinsider.in March-April 2021
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Industry News Medtronic Opens Engineering, Innovation Centre In Hyderabad Medtech player to strengthen its R&D facility. Medtronic pls, global player in medical technology, has set up its new Medtronic Engineering and Innovation Center (MEIC) here. The 150,000 sq ft centre employs engineers currently in the areas of software development and testing, test automation, mechanical design, analysis and hardware was formally inaugurated by KT Rama Rao, Minister for Municipal Administration & Urban Development, Industries & Commerce, and Information Technology, Government of Telangana here on Wednesday. “We see enormous potential in energising the medical devices innovation ecosystem in the country. The R&D team in India is a key contributor to Medtronic’s global product development,’’ Madan Krishnan, Vice-President and Managing Director, India Medtronic Pvt Ltd, said in the inaugural function. “The opening of the new site is an important milestone for us as it serves as a critical component in strengthening our global R&D organisation and will also drive innovation and growth,’’ he added. Globally, Medtronic has spent approximately $2.3 billion annually in R&D in recent years, and MEIC recently received an
investment of ₹1,200 crore for expansion in Hyderabad. This investment planned over five years aims to foster global innovation and create several job opportunities. With this expansion, MEIC aims to leverage the sizeable pool of diverse and skilled talent in India. Rama Rao said: “Hyderabad is already home to marquee technology and life sciences companies and now, we are extremely delighted to host the largest R&D facility for Medtronic outside the US.’’ Medical devices sector has been identified as one of the key focus sectors by the State, he added. MEIC serves as a global hub for development, testing and qualification for some of the most advanced and innovative technologies. The setting up of the new R&D facility is a step to create synergy by supporting Medtronic’s businesses globally, in various therapy areas including respiratory intervention, remote patient monitoring and digital health, surgical robotics, electrosurgical generators, cardiac rhythm and heart failure, and navigation, amongst others. https://www.thehindubusinessline.com
MTaI Seeks Relook At Revised Public Procurement Order On Medical Devices New Delhi, Mar 31 (PTI) The Medical Technology Association of India (MTaI) on Wednesday said the recent public procurement order on medical devices has come as a surprise to the industry and needs reconsideration. The order by the Department of Pharmaceuticals dated March 25, notifies 19 more items of medical devices for which only a class-I local supplier shall be eligible to bid irrespective of purchase value. MTaI claims that the revised Public Procurement Order (PPO) may deprive patients of their access to innovative and quality medical devices. The PPO has come as a big surprise to the industry in the absence of thorough stakeholder consultations and those consultations which may have been held were marked with tokenism, MTaI said in a statement. "There are just too many categories the PPO is attempting to facilitate, without even considering the technological complexity and the time which will be required to import substitute," MTaI Chairman & Director General Pavan Choudary said. Echoing similar views, MTaI Director Sanjay Bhutani said the revised PPO is a regressive step and may further impact the chances of India becoming an investment destination.
The industry seeks a reconsideration of the order and looks forward to a thorough consultation with the government to share its suggestions, it added. PTI AKT ANU ANU https://www.outlookindia.com
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Product Gallery Expanded Portfolio for Bioprocess Single-use Systems Ronkonkoma, NY, USA, April 13, 2021—Qosina, a global supplier of OEM single-use components to the medical and pharmaceutical industries, is pleased to announce a new extension to their product portfolio, developed specifically for the needs of the singleuse bioprocess industry. Qosina now offers a comprehensive selection of components for the design, development and manufacture of single-use systems (SUS). “Qosina has been a trusted supplier for over 40 years and has worked with some of the best-known brands,” explains Scott Herskovitz, Qosina President and CEO. “Our experience serving the needs of regulated customers positions us well to expand our products and services for the single-use bioprocess community. We have leveraged this experience and our extensive supply chain to provide a much-needed resource for bioprocess, vaccine production, and cell and gene therapy.” Qosina is a one-stop source for single-use bioprocess components, with low minimum order quantities, a liberal sampling policy and bill of material kitting, all supported by regulatory documentation and backed by Qosina’s assurance of supply. Explore Qosina’s single-use bioprocess component selection at qosina.com.
Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a one-centimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000. Visit Qosmedix, Qosina’s cosmetics division, at www.qosmedix.com. Qosmedix is a certified global supplier of beauty tools and accessories to the cosmetic, skincare, spa and salon industries. Debra Caporusso, Marketing Specialist, Qosina Corp., 2002-Q Orville Drive North, Ronkonkoma, NY 11779 USA T: +1 (631) 242-3000, ext. 295, Email: dcaporusso@qosina.com www.qosina.com
Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. • Exporting our products to almost more than 23 countries.
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I.V. Infusion Sets Blood Administration Sets Scalp Vein Set Urine Collection Bags Ryles / Feeding Tubes Catheters and Tubes Surgical Gloves.
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Soft Edition (.PDF Format) Chapters 1 : Introduction to Medical Devices 2 : Materials : Medical Polymers, Biopolymers & Other Materials 3 : Applications 4 : Manufacturing : Technology & Trends 5 : Packaging & Sterilization 6 : Markets & Emerging Trends 7 : Regulations & Quality Issues
8 : Innovation & Product Developments 9 : Adverse Events 10 : Healthcare Practices, Procedures & Techniques 11 : Environment, Waste management & Safety Concerns 12 : Industry, Government Research & Academic Institutions
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Biomedical Technology sector positions itself in a high value market place, but one where errors can be very expensive. Products are highly regulated and subjected to extensive quality controls. I find here a treasure of tips and techniques put together in a very simplified and user friendly manner. Whether one is a teacher or a student of Biomedical Engineering / Technology or a manufacturer / marketer of medical devices or a medical professional using the technology day in and day out, dipping into this collection will give one valuable insight.
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