Medical Plastics Data Service Magazine January - February 2021 by Medical Plastics Data Service

D A T A

S E R V I C E

Vol. 29

38 18 39

No. 1

Jan.-Feb. 2021

Medical Device & In Vitro Diagnostic Devices: MDR 2017 and Industry Preparedness Dr. Sanjeev Kumar Gupta, Managing Consultant, Intrust-Consulting LLP Working towards preparedness for compliance can be intimidating in terms of time, money and efforts. However, it can be very rewarding and may enable industry to think for global markets since most markets have overlapping regulation. Demystify Series : Getting CE Mark for Medical Devices from India Leo Mavely, Founder & CEO, Axio Biosolutions An Entrepreneur’s perspective of how not only MDR 2017 but going beyond it , in case if one is looking at global markets , getting CE Mark helps implement a proper Quality Management System and helps in market growth as well as builds credibility.

HEALTHCARE Lifesaving Lessons Learned at Kauvery Hospitals through a year that went "viral!” Dr Manivannan Selvaraj, MD, DnB Founder & Managing Director, Kauvery Hospitals Covid – 19, as a new disease to which there was no immunity and no bank of knowledge to draw capital and confidence from has taught many lessons to last a lifetime to Doctors and Hospitals .

MATERIALS Calcium And Zinc Based Heat Stabilizers For Medical Applications Chinmay Kulkarni, Executive - Business Development & Technical Services, Goldstab Organics Pvt. Ltd. Since, PVC is not stable when it is exposed to heat, the performance of PVC is largely dependent on the additives especially heat stabilizers.

GLOBAL TRENDS • UK, A Global MedTech Hub Offers Prime Investment Opportunities for MedTech Companies • Bio-Process Systems Alliance ( BOSA ) Elects Mr Scott Herskovitz, President and CEO, Qosina Corp., USA to Board of Directors.

AiMeD & REGULATORY UPDATES • High Costs Of 24 Medical Devices Trigger Suspicion; Govt Seeks Price Details • Siemens, Wipro GE, Sahajanand, Nipro Among Firms Selected Under Rs. 3420 cr PLI Scheme For Domestic Manufacturing Of Medical Devices

INDUSTRY NEWS • Goldstab Organics Expands Capacity with new state-of-the- art Calcium/Zinc Based PVC Stabilizer Plant • Messe Frankfurt India and Andhra Pradesh MedTech Zone (AMTZ) join hands to launch MedTech Innovation Forum in India • Intake Of Students In Medical Devices Courses At NIPERs Increased To Strengthen Manpower Resources

PRODUCT GALLERY • Vast Selection of Critical Care Components for Respiratory Medical Device Design

DID YOU KNOW? • About Health Technology Assessment & Management

ARTICLE INDEX • Medical Plastic Data Service - 2020 Article Index

January-February 2021 D A T A

S E R V I C E

D A T A

S E R V I C E

June 2016 to October 2016 • Cover Story : Supplier Quality Management For Medical Device Manufacturers: A Critical Step Towards Global Regulatory Compliance (May – June 2016) • Cover Story : Medtech Companies Need Collaboration With External Partners For Innovation And Growth (May – June 2016) • Technology : Innovative Computer-Aided Catheter Reprocessing System (CRS) for Cleaning Catheters Developed By Chandigarh Biomedical Engineer (May – June 2016) • Technology : India’s New IPR Policy Looking To Spur Innovation In Med-Tech Sector (May – June 2016) • Global Trends : Medical Adhesives : Fastest growing Segment (May – June 2016) • Did You Know : About Best Practices to Ensure Good Supplier Management (May – June 2016) • Cover Story : Medical Plastics – New Materials & Technologies Help Medical Device Industry (July – August 2016) • Manufacturing : Supply Chain Management–Boon Or Bane For The Medical Device Industry (July – August 2016) • Global Trends : Medical Device Companies Fear Parallel Regulation After Brexit Vote (July – August 2016) • Global Trends : Plastics Remain Material Of Choice In Parenteral Packaging Market (July – August 2016) • Did You Know : About Implants As The Fastest Growing Application For Medical Plastics (July – August 2016) • Technology : INDIA ’S First Medical Technology Zone – AMTZ (September - October 2016) • M a n u f a c t u r i n g : H o w To M e e t Biocompatibility Needs Of Polymeric Medical Components (September - October 2016) • Quality : Quality Management System: Changing Scenario & Challenges In Medical Device Regulations (September - October 2016) • Global Trends : How Plasma Can Aid Catheter Manufacturing (September - October 2016)

About Health Technology Assessment & Management Health technology assessment Health technology assessment (HTA) refers to the systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform a policy decision making. Considering the definition of health technology, as the application of organized knowledge and skills in the form of medicines, medical devices, vaccines, procedures and systems developed to solve a health problem and improve quality of life. The HTA approach is used to inform policy and decision-making in health care, especially on how best to allocate limited funds to health interventions and technologies. The assessment is conducted by interdisciplinary groups using explicit analytical frameworks, drawing on clinical, epidemiological, health economic and other information and methodologies.

Management and use To ensure access to appropriate medical devices, proper management and use of medical equipment must be considered. This area is often referred to as clinical engineering or health-care technology management. The management process begins with understanding the needs of the country, region, community, or facility and ends with decommissioning. In between, the process consists of good procurement practices, appropriate donation solicitation and provision, logistics of delivery and installation, inventory management, maintenance, safe use and training, and measurement of clinical effectiveness. WHO recognizes the importance of medical device management in contributing to the provision of quality health care and thus, under the Global Initiative on Health Technologies began developing tools and resources for Member States in this critical area. ( Ref : WHO | WHO Technical Specification for Medical Devices )

"Learning is the only thing the mind never exhausts, never fears and never regrets” -Leonardo da Vinci

January-February 2021 D A T A

S E R V I C E

D A T A

S E R V I C E EDITOR

D A T A

D.L.PANDYA, B.E.(Chem), M.I.E.

S E R V I C E

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. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com 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.

However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

Medical Device Industry Regulations In India The regulatory process started in 1989. By February 2020, the scope for medical device industry in India under any kind of regulatory control increased from some less than 100 companies to now thousands of companies. The increase post February 2020 will be very steep in number since now it includes anything and everything under the category of “Medical Devices”. This sudden and steep rise is a great challenge not only for the regulatory authorities but for the Industry as well as other stakeholders like Industry Associations, notified bodies, consultancies and other service organisations as well as professionals directly / indirectly associated with Indian Medical Device Industry. The magnitude and challenges in terms of time, money and efforts is very aptly described by Dr Sanjeev Kumar Gupta, Managing Director, Managing Director, Intrust-Consulting LLP in his article, “Medical Device & In Vitro Diagnostic Devices (IVD) : MDR 2017 and Industry Preparedness”. CE Marking : An Entrepreneur’s Perspective On the other side, going much beyond MDR 2017, in the article titled, “Getting CE Mark For Medical Devices From India”, Mr Leo Mavely, Founder & CEO, Axio Biosolutions has given an Entrepreneur’s perspective of how not only MDR 2017 but going beyond it, in case if one is looking at global markets, getting CE Mark helps implement a proper Quality Management System and helps in market growth as well as builds credibility . While elaborating on the cost – benefit analysis for a start-up company to undergo process of getting CE mark, he has given a detailed account of the process starting from the need for an external professional agency for help, selecting notified bodies to how with the help of a passionate team, getting CE mark helps the company to be successful in global markets. Opportunities In UK for Indian MedTech Industry Interested To Expand Globally. An abstract from the report by UK Department for International Trade highlights how UK offers prime investment opportunities for MedTech Companies to expand globally. It focuses on the opportunities in life sciences to attract investors interested in Medical Devices, software related medical devices, diagnostics and genomics innovations. A detailed account of how the UK is a global MedTech hub providing companies with opportunities to grow internationally through its well-established global connections and strong record of FDI and MedTech exports. It includes details about how the Department of International Trade ( DIT ) provides end-to-end support for inward investors in UK including accessing market opportunities, access and introductions to the right people, setting up in UK, bespoke market research, on-going government support as well as entrepreneurial assistance. COVID – 19 : Lessons Learned at Kauvery Hospitals Covid–19, as a new disease to which there was no immunity and no bank of knowledge to draw capital and confidence from for Doctors. It has taught many lessons to last a lifetime to Doctors and Hospitals. Dr Manivannan Selvaraj, MD, DnB, Founder & Managing Director, Kauvery Hospitals in his article on, “Lifesaving Lessons Learned at Kauvery Hospitals through a year that went Viral !”, has shared their invaluable experience for the benefit of all. As always, this issue also includes regular columns like Industry News, Global Trends, Product Gallery and also an Article Index highlighting all major contents of all the issues of our magazine for the year 2020.

January-February 2021 D A T A

S E R V I C E

January-February 2021 D A T A

S E R V I C E

Medical Device & In Vitro Diagnostic Devices: MDR 2017 and Industry Preparedness Dr. Sanjeev Kumar Gupta Managing Consultant, Intrust-Consulting LLP

Since 1989 the regulation of Medical Device (MD) and IVD Industry in India has been growing consistently under Drugs & Cosmetics Act 1940. Several notifications were issued in 1989, 2002 and 2005 covering 16 categories of MD-IVD with in the purview of this Act. Several awareness programs were organized by The All-India Drugs Control Officers Confederation (AIDCOC) and Indian Pharmaceutical Graduate Association (IPGA) for different stake holders. India’s regulatory body CDSCO consisting of Central Licensing and State Licensing Authorities further built its capacity in regulatory matters of MD-IVD under a WHO Capacity Building Program at NIPER, Mohali. Subsequently, close interactions between regulatory body and industry associations (AiMED, ADMI) lead to development & notification of Medical Device Rules 2017 paving way for structured regulation of MD-IVD in country. From 1st January, 2018 these Rules brought a paradigm shift in regulatory procedure for MD-IVD in country along with clarity on classification of devices, requirement of technical documentation, customization of application forms, fee structure, timelines. This helped several manufacturers to prepare themselves and submit applications on easy-to-use MD-Online Portal of CDSCO. More so a manufacturer specific dedicated dash board added value for each user. Large number of manufacturer’s completed their transition of licenses from D&CAct to MDR2017 by end of 2019 with many more in progress. Simultaneously regulation was preparing to bring more MDIVD under the ambit of MDR Rules 2017. Two gazette notifications which were published in February 2020 were significant. One expanded the definition of medical devices (Refer Box 1) and another advised the actions to be taken by industry (Figure 1). Before it could get into industry awareness sessions the country was hit by pandemic. As a blessing in disguise entire country learnt about Ventilators, PPEs, VTM, RNA- Extraction Kits, RTPCR, Antibody Tests and Antigen Tests were all over NEWS papers and TV. Many also learnt about ICMR and CDSCO for the first time as Import Permissions were given and Emergency Manufacturing Licences were given. MD-IVD-Regulation all were at forefront.

Box-1 Definition of Medical Devices under Medical Device Rules 2017 and Amendment 2020 Before 11th February 2020 “medical device” means,(A) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (I), (B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii), (C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act; Explanation: For the purpose of these rules, substances used for in vitro diagnosis shall be referred as in vitro diagnostic medical device.

From 11th February 2020 All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (I) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iii) (iv) supporting or sustaining life; (iv) (v) disinfection of medical devices; and (v) (vi) control of conception.

January-February 2021 D A T A

S E R V I C E

A large number of manufacturers and importers of newly notified medical devices have not seen and experienced the requirements given in MDR 2017 owing to the fact that these were not regulated until February 2020. The Figure 2 shall help them know that compliance to these Rules needs several levels of preparedness such as a) clear understanding of Rules, b) requirements of infrastructure, c) QMS & Quality and d) requirements of personnel. It is easy for some and nightmare for many. The different chapters, schedules and appendix of MDR 2017 and Amendment 2020 offer excellent guidance to prepare for all these segments. Industry can also take services from Consultants who have medical device domain knowledge and experience. It would be pertinent and effective to undergo a comprehensive training for clear understanding. All kinds of conflict of interests shall be addressed while hiring a consultant and all consultancy shall be availed against a signed quality agreement as per firm’s outsourcing SOP.

The Good Manufacturing Practices (GMP) for MD-IVD have been covered under Quality Management System (QMS) explained under Fifth Schedule of MDR2017. While licensing process application does not require ISO13485 certificate, the registration process requires ISO 13485 certificate to be uploaded on portal. This is significant as this requirement necessitates implementation of ISO13485 and a certification. All manufacturers and importers shall make all efforts to understand ISO13485 and integrate their existing processes with processes required by standard. In addition to above applicants would require several levels of technical documents to support their applications for licensing. The technical documents submitted on portal help regulatory officers to gain knowledge about company (administrative documents and Site Master File), its product development activities (Design & Development), product characteristics (Device Master File, Appendix II for MD and Appendix III for IVD), safety through Risk Management Report & Essential Principles Checklist and effectiveness through Clinical Investigation (Medical Devices), Performance Evaluation and Clinical Performance Evaluation Reports for IVD. As these come under Rules many products may now need to be subjected to structured clinical studies to generate authentic technical documentation. Such evaluation may be time and money intensive. A number of manufacturers may find it difficult and may again need services of Experts & Consultants who have domain knowledge and experience in clinical studies. The preparedness requires contacts and working contracts with CMTDL, MDTL and NABL laboratories (Box 2). Among various preparedness manufacturers would also need to identify applicable technical standards to ensure safety and effectiveness of products. The MDR 2017 explicitly emphasize that manufacturer must demonstrate compliance to a) CDSCO standards, b) BIS standards, c) ISO & other international standards and d) Manufacturer’s in-house standards in order of availability. The working towards so much of preparedness for compliance can be intimidating in terms of time, money and efforts. However, it can be very rewarding and may enable industry to think for global markets since most markets have overlapping regulation.

Box-2 Industry need to select CMDTL, MDTL and NABL in sequence of availability for Performance Evaluations. CMDTL: Central Medical Device Testing Laboratory such as Sri Chitra Institute of Medical Sciences for MD and NIB for IVDs MDTL: Medical Device Testing Laboratory such as NIV, Pune NABL Accredited Labs: > 2500 labs across country

Clinical Investigations and Clinical Performance Evaluations can be conducted at NABH accredited hospitals in accordance with Rules.

Dr. Sanjeev Kumar Gupta Managing Consultant, Intrust-Consulting LLP A-301/A Green Heritage, Sector 20, Kharghar 410210, Navi Mumbai (Maharahstra), India +919879617573 Info@intrust-consulting.com, www.intrust-consulting.com intrust.info@gmail.com

January-February 2021 D A T A

S E R V I C E

Demystify Series : Getting CE Mark for Medical Devices from India Leo Mavely Founder & CEO, Axio Biosolutions

Today we announced CE approval for our second range of medical device dressings- MaxioCel. This announcement was particularly gratifying as i) Approval was in Class III- High Risk category, and ii) Entire process was completed during COVID-19 pandemic. This is the second CE approval for the range of medical devices we have developed. First range was Axiostat- stop bleeding patches which also went on to get USFDA approval. As a founder, it was quite an intimidating experience to take the device through this process for the first time. Second time, not so much. Thanks to our rockstar team. Thought of sharing our experience so that it could help more fellow founders or at the very least become a placeholder for few. I will try to make this as short as possible and will break it into a few sections for quick and easy reference.

1. Why do you need CE Marking?

1. Why do you need CE Marking ? 2. How expensive it is to get CE Markin ? 3. Whats the process of getting CE Marking for a medical device ? 4. Do we need an external agency or a consultant to get CE marking ? 5. How to select the right Notifying Body (NB) ? 6. How did Axio go about the process of getting CE approval for MaxioCel ? 7. Is CE approval really worth it ? 8. As a Founder should I prioritise CE Mark over Fund raising ?

Short answer is, you get to sell in more countries globally, thereby increasing your footprint exponentially and also it helps in building credibility within the doctor's community in India. Every country follows their own regulatory system, for eg: USFDA is for selling in the US. CE Mark is mandatory to sell medical devices within any of the 32 European Union countries. It also validates that your device complies with all regulations put forward by European Union, which is accepted by many other countries too.However CE mark is accepted by many countries and hence investment can be justified easily.

2. How expensive is it to get CE Marking? This could very well vary depending on the type and risk classification of your medical device. However a fair estimation could be anywhere from 10lacs to 30lacs for Class I, Class II devices and 30lacs-1crore+ for Class III devices. Based on development costs, pre-clinical studies and clinical studies (with new MDR regulations this could be mandatory), cost can even go into few crores, especially if it is an implantable device.

3. What's the process of getting CE Marking for a medical device? Emergo has laid out an easy to understand stepwise process: • Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC), or Active Implantable Medical Devices Directive (90/385/EEC). • Determine the classification of your device. • Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.

January-February 2021 D A T A

S E R V I C E

• Prepare a CE Marking Technical File or a Design Dossier. • Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev4 and MDD (or MDR). • Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe. • Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless your device is Class I, is not sterile, and has no measuring function. • Obtain CE Marking and ISO 13485 certificates from your Notified Body. • Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.

4. Do we need an external agency or a consultant to get CE marking? In my experience, a lot of pitfalls in documentation can be avoided early on if you have someone experienced to guide you. As the CE marking process is largely audited by reviewing documentation, every mistake can prolong the audit review and thereby adding $$$ to your bills. I have seen minor mistakes in the “Declaration of Conformity” being granted a Major Observation “Non Conformity” during audits. Hence, while it is not a mandatory requirement, I recommend to start the process of your first medical device with either having someone experienced in your team and/or an external consultant who could guide you.

5. How to select the right Notifying Body (NB)? Unlike USFDA, CE Marking is not a single organisation procedure. Third parties or notifying bodies such as TUV, DNV, BSI and many more are authorised to conduct audits and determine the preparedness to grant the CE mark. You can find a list of approved notifying bodies here. However selection of the right NB is easier said than done. • Firstly, you need to make a list of Notified Bodies based on the product codes they are authorised to conduct audits on.

Then, see how many of them are qualified to conduct an audit on your medical device. • Secondly, request for a meeting/call to discuss the device with each one of them. • Thirdly, get a quote and compare from each Notified Bodies qualified for your type of medical device. • Then, select the notified body based on their: ■ Past experience in auditing and approving similar devices ■ Their location- Ask if they have auditors based out of India to conduct an audit. If auditors need to come from Europe, cost can significantly rise. ■ Check their reputation in the market- Easiest way is to ask your Distributors/Customers. ■ Budget- This can also be negotiated based on how many man days they need to allocate for the audit. I have seen companies getting expensive Tier 1 Notified Body for a Class I- low risk device. While it may be a safe bet, do ensure it does not end up emptying your bank accounts. At the end of the day all CE Mark approvals give the same access to the market. While there used to be notified bodies with bad reputation, that is no more the case in Europe especially with MDR (Medical Device Regulations) coming in force by April 2021.

6. How did Axio go about the process of getting CE approval for MaxioCel? The whole process started around 8 months back when COVID19 pandemic was in rage. As we already had approval in India for MaxioCel, many of the documentation such as Design files (DHF etc), Tech files were already in place. We also had real time stability data, PMS (Post marketing surveillance) data, Preclinical animal study data, and Human studies data collection was ongoing. Our manufacturing facility already has Quality Management System (QMS) compliance with ISO 13485:2016 and is being audited regularly by our notified body. These helped us in getting the submission process in order soon.

Axio Biosolutions Pvt Ltd Axio is a deep-science medical technology company with extensive expertise in biomaterials based medical devices for pre-hospital, intra-operative and post-operative clinical needs. Our focus is on devices for management of trauma, surgical and chronic wounds. We bring together our biomaterials expertise with the contemporary knowledge of medicine and engineering to design novel solutions for management of trauma, surgical and chronic-infectious wounds. Our flagship product, Axiostat, is a patented, clinically validated haemostat that stops moderate to severe bleeding instantly in surgeries and in pre-hospital trauma. Axiostat is USFDA 510(k) cleared and is also European CE approved. In Advanced Wound Care range, Axio has launched the nextgeneration MaxioCel wound dressing. MaxioCel is designed to heal patients suffering from acute and chronic wounds (diabetic foot ulcers, pressure ulcers, burns, bed sores, cavity wounds and surgical site infections) by effectively managing exudates, pain reduction and scar less healing.

Axio has recently expanded its portfolio to include RESIST+ range of high-quality hygiene and protection solutions. RESIST+ range includes alcohol-based sanitizers, surface disinfectants, disinfecting wipes, and antimicrobial hand wash, manufactured under without any toxic chemicals. All Axio products are manufactured in state-of-the-art ISO 13485 and GMP certified facility. Axio intends to be the first choice for any customer looking for advanced wound care, hemostatic, and hygiene solutions worldwide and the company is positioned to upgrade wound care and hygiene care in both the institutional and consumer segments.

January-February 2021 D A T A

S E R V I C E

As we do for any such approval process, we soon created a core interdisciplinary group with our in-house Regulatory team headed by Ramya, Quality team by Saurabh and R&D team by Dr Kiran. They along with other team members actively started daily scrum meetings and collaborated on Google Docs in real-time. We had to build a complete CER (Clinical Evaluation Report) document which needed help from our in-house clinical research team. Also the most important document which is Risk Management had to be made. Each of these ran into 600+ pages and went through multiple iterations by our team. Remaining Biocompatibility and Animal studies were also completed during this period. We also occasionally checked-in with our external consultant team and also with the notified body team to ensure we are all on the same page with respect to timeline and document preparedness. After few months we got the audit dates from Notified Body. They did many man-day audits with 4 of their auditors. Thanks to a thorough preparation, our audits went without any Non Conformity. This was a pleasant surprise as we usually do not see an audit without any NC. Final review was conducted at European office of the notified body and we got the clearance last week.

7. Is the CE approval really worth it? This answer could vary based on your specific go-to-market strategies. If you are a 100% India market focused company, then

CE mark may be unnecessary. However going through the CE Marking process is a great way to bring discipline and to implement a proper Quality Management System in your organisation. It also guides the entire team to the goal of developing and shipping products that comply to global standards. If you are looking at expanding into global markets, I strongly recommend you to consider getting a CE mark for your medical device. It brings a lot of credibility in the global market and also gives you a single window access to one of the largest lucrative medical device markets in the world.

8. As a founder should I prioritise CE Mark over fundraising? This is a common question I get from many medtech founders. While there is no right or wrong answer for this, my recommendation is to not invest in getting CE Mark atleast until you have raised a seed round of a crore or above. Be prepared for it and get your design files in place, ensure you have a roadmap towards the submission process. Walk the potential investors through the process and ensure they understand the timelines for your global GTM clearly. Finally this wouldn't have been possible without a team who is passionate about building quality global products. A big shoutout to all Axions who helped us attain this. Hope this article is helpful. Feel free to reach out to us for any clarifications and our team will be happy to share our learnings.

January-February 2021 D A T A

S E R V I C E

Healthcare

Lifesaving Lessons Learned at Kauvery Hospitals through a year that went "viral!” Dr Manivannan Selvaraj, MD, DnB Founder & Managing Director, Kauvery Hospitals

In 2020, five COVID- designated Kauvery Hospitals admitted over 7000 patients with moderate/ severe/critical COVID and sent more than 95 % of them safely home. That included 108 doctors in the community 98 % of who went home safely. Several times that number were treated at Kauvery Fever Clinics and Emergency Centres, 24 hours a day, at all five Kauvery Hospitals, and followed up carefully in home-isolation. Meanwhile we kept every one of our five thousand health workers safe. Looking back, we wondered how did we manage that?! Our hearts and minds told us how. This was a new disease to which we had no immunity, and no bank of knowledge to draw capital and confidence from. We were extremely vulnerable. So, we opted to hit the ground running; think, and act fast, on our feet. What we learned, we pass on now, for every one’s benefit. You are welcome to drink at our fountain; here is the magic potion we distilled from the simmering cauldron of COVID! • Keep your health workers safe- at hospital, in the community and at home. All other resources can be replenished swiftly, but not the health worker. • Give a mask to everyone who enters the hospital; facilitate frequent hand sanitation and socially distance every one by 2 feet/6 meters. • Teach patients and families how to use the mask, how to sanitize hands and why we should socially distance oneself. Tell them- “Prevention is smart, it works!” • Teach and train health workers - “Protection is smart, it works!”. • Be frank and tell both that we do not know whether treatment works; it is a new disease and we are all learning together. But we know for sure that both prevention and protection work; they keep you safe from COVID. • Elicit travel and contact history, and TEST, TEST and TEST (to quote Dr. Tedros, Director General of WHO), but practising due protection. • Advice Quarantine to contacts, and Isolation to infected people. • Determine levels of protection and provide Personal Protective Equipment (PPE) to every health worker, at every level. Supervise practice of ‘Donning and Doffing” through “Buddies”.

• Used PPE are very hazardous material, to be disposed strictly as per prescribed policy. • Documentation and communication are the two key factors in the isolation wards. Avoid paper, use Electronic Medical Records (EMR). Use collar mikes for communication. Staff to wear large name tags. • Ensure communication with family and referral doctor, for each patient. That is the life- line, never to be taken for granted. • The most effective treatment for COVID is “careful, appropriate, efficient and closely monitored SUPPORTIVE care. That keeps patients safe, and saves patients. • Hypoxia is treated with delivery of Oxygen through the most appropriate route, delaying intubation and ventilator till it is absolutely necessary. • “Proning” helps. • Next comes careful fluid management and prevention/ treatment of clotting and bleeding issues. • In the intensive care unit, LESS is MORE. • Choice of a drug to be given in COVID is to be based on internationally proven evidence of benefit. • Throughout the year experience and evidence continued to emerge from all over the world. • Evaluating both, national and international guidelines also continued to evolve. • Kauvery put into place what the BMJ and WHO later called “Living Protocols”; they were online and live, 24/7, incorporating immediately, emerging, sound and well – tested evidence into them. • All Kauvery COVID management teams remained “in sync” across five designated COVID hospitals. • Besides Oxygen and anticoagulation, the only drug for which there was evidence of benefit to the patient with hypoxia was Dexamethasone. • WHO’s Solidarity trial, the largest multi-country trial in COVID, eventually showed only weak evidence in favour of Remdesivir. • Solidarity trial also reported no evidence in favour of HCQ and Lopinavir-Ritonavir in COVID. • ICMR’s PLACID multi-centre trial of Convalescent Plasma showed no benefit. • No trial has showed evidence in favour of empirical exhibition of Oseltamivir. January-February 2021

D A T A

S E R V I C E

Healthcare • No trial has concluded its inquiry into benefits from Ivermectin in COVID. • Monoclonal antibodies, single or as cocktails, are not yet in use in India for out-patient treatment of early COVID. • There is no evidence of benefit from empirical exhibition of Azithromycin or Doxycycline as antivirals. • Secondary infection or Sepsis in COVID is to be treated in COVID only as per hospital’s antibiotic stewardship policy on diagnosis and treatment. Procalcitonin is a useful marker of bacterial infection. • Evidence on Cytokines in COVID has continued to evolve. Specific cytokine levels and related inflammatory markers have been consistently higher in bacterial sepsis than in “Viral sepsis”. • The jury is still out whether in COVID we are seeing a “Cytokine storm” or a “Cytokine breeze!” • Roche’s own research led to withdrawal of indication of Tocilizumab as anti- inflammatory agent in COVID in view of related immunosuppression and secondary infections. • The most important lesson learned from COVID was that risk of severe and critical disease was more in the presence of uncontrolled “Non-Communicable Diseases” (NCDs) – Diabetes Mellitus, Hypertension, Coronary Artery Disease, Heart Failure, Chronic Lung, Liver and Kidney diseases, significant physical and intellectual disability, Hypothyroidism and obesity. • The starkly evident corollary to be learned from this is that a “Healthy way of life” is our greatest protection against developing severe or critical COVID or any other pandemic in the future. • There are some possibly related puzzles in COVID as stated below which we need to study and unravel. • Many patients have presented “de novo” with major organ complications, without a clear history of typical COVID like fever, sore throat, cough, body ache, loss of smell or taste and fatigue. • These presentations involved all major organ systems- cardiac arrest, arrhythmias, heart failure, stroke, acute kidney injury in the back ground of chronic kidney disease, Diabetic Ketoacidosis, thrombotic occlusions in circulation acutely threatening organs and limbs etc. • Another related phenomenon is a set of major organ complications that occur either during hospitalization for COVID or in the post-COVID period. Any pre-existing chronic NCDs can decompensate during or after COVID. Restabilization of them is an integral part of responsible and successful COVID management. • The baffling phenomena of “Long COVID” may overshadow the life of any one who was infected, whether it led to an asymptomatic state, or mild/moderate/ severe/ critical COVID. The responsible COVID physician offers continuity of care till the quality of life is restored to the patient. • Pregnancy was a risk factor for developing severe COVID. Paediatric COVID could threaten a child’s life with Multisystem Inflammatory Syndrome or vascular thrombotic emergencies. At Kauvery hospitals the mother and child were kept safe from the ravages of COVID. • Patients with cancer were doubly at threat from COVID; cancer or its treatment could leave patients immunocompromised and cancer care often got disrupted during COVID. At Kauvery the clock did not stop for cancer, the care continued. • World over, non –Covid care suffered during COVID; but not at

Kauvery. For example, we did not hesitate when COVID patients required surgery. We did not deny patients who needed surgery during COVID times. Life should not wait for disease and death to capture it. Even renal transplantations were successfully offered at Kauvery Hospitals. COVID taught us some unforgettable “collateral” lessons without which our “education” would not have been complete. We at Kauvery Hospitals learned during COVID: 1. How to mix ethics, humaneness (the quality of compassion or consideration for others, people or animals), technology and planning for a creating a successful anti- viral formula. 2. How planning becomes the best vaccine to prevent pandemics. 3. About fostering the organisation - that people are the key and that collaboration, enabling and empowering each other, and intelligent adaptation of technology simplify both problems and solutions. 4. About personal life- that everyone is equally vulnerable, that health is wealth and that the family is the best investment in life. The world also learned - how and why women leaders excelled in COVID times, and how we failed to recognize the unique perspective, insight, instinct and intelligence they can bring to hospital and health care management. Just as an example we quote: In developing countries, the best maternal and child welfare programs are to be found in those countries- yes, you guessed it- that have women health ministers!

January-February 2021 D A T A

S E R V I C E

Materials

Calcium And Zinc Based Heat Stabilizers For Medical Applications Chinmay Kulkarni Executive - Business Development & Technical Services Goldstab Organics Pvt. Ltd.

The pandemic of 2020 has changed the world in many ways like never before. But there is a silver lining. Plastics have gained great respect in society in general thanks to the contribution of PPE kits and medical devices in the fight against Covid-19. Plastic has been the undoubted hero in this battle that protected frontline workers as a shield and helped to cure patients in the form of medical devices. Among all the plastics, Polyvinyl Chloride (PVC) is used in medical applications widely due to the unique combination of properties. PVC is ‘additive friendly’ polymer, and with the help of various additives it can be made either flexible or rigid, transparent, opaque or translucent. Other than these physical properties PVC is durable, biocompatible and resistant to harsh chemicals. These properties may seem obvious at first glance but if we look at it closely, it sets PVC apart from other materials. For example, glass is very good for chemical resistivity and biocompatibility but there’s limitation due to rigid and brittle nature of glass. It can’t be used for all applications and careful handling is required. Whereas, PVC can replace glass in many applications as it not only provides required biocompatibility and chemical resistance but also the toughness of material in terms of mechanical properties allows it to be used with little care. Similarly, PVC also gives advantage over metal as it doesn’t corrode and has great chemical resistance. Hence lipids, alcohol, acids and bases can be stored safely in PVC container. Single use medical applications of PVC like gloves, masks, sterile syringes, blood bags, IV bags, tablet packaging, is a game changer. Sanitization is a constant challenge in front of medical workers and historically multi-use medical devices were the main reason behind infections due to cross contaminations. Moreover, traditional sterilization facilities such as use of ethylene dioxide, steam and autoclave were time consuming. Whereas, new age sterilization techniques like use of gamma rays is very well suited for polymer based medical equipment and these devices can be sealed or made ‘ready for use’ in very short time. PVC and its additives that are used in the medical applications fulfill all the requirements of safety during working period and also retain the properties of the compound even after modern sterilization techniques. Since, PVC is not stable when it is exposed to heat, the performance of PVC is largely dependent on the additives

especially heat stabilizers. In the case of manufacturing medical devices, non-toxic and eco-friendly heat stabilizers are the natural choice of processors. These stabilizers are also expected to provide final products high degree of clarity, good mechanical properties and excellent chemical resistance. Generally, for transparent applications Calcium and Zinc based stabilizers are recommended to use. Calcium Stearate and Zinc Stearate are the core stabilizing agents which are manufactured using plant based stearic acid, calcium hydroxide and zinc oxide. Both of these ingredients can be used for food contact applications safely. But since these grades are to be used for medical applications, all raw materials used to manufacture stabilizers must be USP compliant. Apart from metallic stearates other organic and inorganic co-stabilizers are also used in the formulations. The inorganic stabilizers are mainly acid scavengers that restrict the release of toxic gases such as hydrochloric acid and organic co-stabilizers are used to improve color hold and UV stability of the final product. Along with these stabilizers many processors also use Epoxidized Soya-Bean Oil (ESBO) in flexible compound to improve heat stability and UV resistance of the final article. ESBO is also bio based product and can be used safely in all food contact or insertable parts of devices such as tubes. Moreover, PVC is being used in hospitals in the form of floorings and wall claddings in hygienic rooms. Hygienic surfaces need to be cleaned with various cleaning agents and due to chemical resistance PVC claddings are preferred. The added advantages such as durability, low maintenance cost and acoustic properties in the material, PVC is preferred by modern health care architects for interior design of the hospitals. For such rigid applications internal and external lubricants are also used in combination with the stabilizers to make processing easy. Use of PVC and Ca-Zn based stabilizers is a sustainable solution. All single use and multi-use articles can be recycled. Mostly material is transparent and made with premium grades of additives. Hence, once sterilized it can be sold at a very good price to the recyclers. Secondly, in many other transparent applications, methyl tin stabilizers are used which are not compatible with Lead based stabilizers. But since, Ca/Zn stabilizers are primarily used in medical applications the material to be recycled can be used in any system as Ca/Zn based stabilizers are compatible with all ingredients. January-February 2021

D A T A

S E R V I C E

Global Trends UK, a Global MedTech Hub Offers Prime Investment Opportunities For MedTech Companies

January-February 2021 D A T A

S E R V I C E

Global Trends

January-February 2021 D A T A

S E R V I C E

Global Trends

January-February 2021 D A T A

S E R V I C E

Global Trends Bio-Process Systems Alliance (BOSA) Elects Mr Scott Herskovitz Mr Scott Herskovitz President and CEO, Qosina Corp., USA

Qosina President and CEO Scott Herskovitz Elected to Board of Directors of the Bio-Process Systems Alliance (BPSA) Ronkonkoma, NY, USA, February 3, 2021-Qosina, a global supplier of OEM single-use components to the medical and pharmaceutical industries, is proud to announce that President and CEO Scott Herskovitz has been elected as an at-large board director of the Bio-Process Systems Alliance (BPSA). The BPSA, an affiliated organization of the Society of Chemical Manufacturers & Affiliates (SOCMA), is an international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA board members serve staggered two-year terms. "I am honored to be elected as a BPSA board member and work alongside this highly respected group of industry leaders," explains Herskovitz. "As a global supplier of single-use medical components, Qosina is committed to supporting the BPSA and their focus on the essential and safe utilization of single-use bioprocessing systems for the production of biopharmaceuticals and critical vaccines." 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 <http://www.qosina.com/newproducts>, visit www.qosina.com<http://www.qosina.com> <http://www.qosina.com> or call +1 (631) 242-3000. Visit Qosmedix, Qosina's cosmetics division, at www.qosmedix.com<http://www.qosmedix.com> <http://www.qosmedix.com/>. Qosmedix is a certified global supplier of beauty tools and accessories to the cosmetic, skincare, spa and salon industries. Contact : Qosina Corp., Rachelle Morrow, +1 (631) 242-3000 rmorrow@qosina.com<mailto:rmorrow@qosina.com><mailto:rmorrow@qosi na.com<mailto:rmorrow@qosina.com>>

January-February 2021 D A T A

S E R V I C E

High Costs Of 24 Medical Devices Trigger Suspicion; Govt Seeks Price Details While the prices of four categories of medical devices - coronary stents, drug-eluting stents, condoms, and intrauterine devices are already fixed by NPPA, the prices of the rest are fixed by the manufacturers themselves India's medicine price regulator National Pharmaceutical Pricing Authority (NPPA) has given three weeks' time to manufacturers and importers of 24 categories of medical devices to furnish pricing details of all such products. In a directive on February 16, NPPA said it has the mandate to monitor, and if needed in public interest, regulate maximum retail prices (MRP) of medical devices that are notified by the government as drugs. Currently, 28 categories of medical devices are under the purview of mandatory regulation by the authority. While the prices of four categories of medical devices - coronary stents, drug-eluting stents, condoms, and intrauterine devices are already fixed by NPPA, the prices of the rest are fixed by the manufacturers themselves. The authority now seeks to monitor the price movement of all 24 categories of medical devices. The product categories for which NPPA has sought information include nebulizer, blood pressure monitoring machine, digital thermometer, glucometer, surgical dressings, blood bags, in vitro diagnostic devices of HIV, HbsAg and HCV, disposable hypodermic syringes etc. Commenting on the directive, Rajiv Nath, coordinator,

Association of Indian Medical Device Industry (AiMeD) said that while the NPPA is seeking to monitor the maximum retail price (MRP) of the products covered under its jurisdiction, it may be more prudent to capture the import landed price on which GST is first paid (first point of sale) with the MRP to monitor possibly irrationally high trade margins. He also wanted NPPA to seek ex-factory price (post discount) on which GST is charged first time (first point of sale) and the MRP to also monitor possibly irrationally high trade margins. According to Nath, it is common practice to "artificially inflate MRP to satisfy excessive margin needs of the healthcare provider or retailer which is not only harmful to consumers but also ethical manufacturers who lose out on competitiveness if they are unable to satisfy needs of their buyers." "It's a strange marketplace since last one decade where hospital buyers are not negotiating on lower buying price but for higher labelled MRP and higher trade margins. This unethical practice needs to be regulated. Price monitoring is a start but it should not be from price to stockist by an importer, but from first point of sale when goods enter the country," he adds. Incidentally, all medical devices are now regulated under Drugs Act though only 37 have so far been notified for compliance. https://m.businesstoday.in/story/high-costs-of-24-medicaldevices-trigger-suspicion-govt-seeks-pricedetails/1/431935.html ,

Siemens, Wipro GE, Sahajanand, Nipro Among Firms Selected Under Rs. 3420 cr PLI Scheme For Domestic Manufacturing Of Medical Devices Siemens Healthcare, Sahajanand Medical Technologies, Nipro India Corporation and Wipro GE Healthcare are among the companies selected under the Production Linked Incentive (PLI) scheme for the promotion of domestic manufacturing of medical devices. In a bid to boost domestic manufacturing and attract large investment in domestic manufacturing of medical Device Sector, the Department of Pharmaceuticals had launched a Production Linked Incentive (PLI) Scheme with a total financial outlay of Rs.3,420 cr. for the period 2020-21 to 2027-28. Domestic medical devices market in India is heavily dependent on imports which contribute to more than 85% of the market. India’s domestic medical devices market in 2019-20 was estimated to be ₹75,611 crore of which imports were worth ₹41,412 crore. While electronics and equipment accounted for 56 per cent of imports, followed by consumables and disposables which accounted for 18 per cent and surgical equipment which constituted 10 per cent of total medical devices import. The manufacturers of following medical devices were eligible under the PLI Scheme that was unveiled by the government last year 1. Cancer care/Radiotherapy medical devices 2. Radiology & Imaging medical devices (both ionizing & nonionizing radiation products) and Nuclear Imaging Devices 3. Anaesthetics & Cardio-Respiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care Medical Devices

4. All Implants including implantable electronic devices like Cochlear Implants and Pacemakers. The Government has approved applications of Siemens Healthcare, Allengers Medical Systems, Allengers OEM, Wipro GE Healthcare, Nipro India Corporation, Sahajanand Medical Technologies, Innvolution Healthcare and Integris Health. Sr. Name of Approved Applicant and Eligible No. product

Commited Investment (in Rs. crores)

M/s Siemens Healthcare Pvt. Ltd. CT Scan and MRI

91.91

M/s Allengers Medical Systems Ltd. (AMSL) CT Scan, MRI, Ultrasonography, X-Ray, Cath Lab. Positron Emmission Tomography (PET) Systems Single Photon Emmission Tomography (SPECT) Mammography and C arm

50.00

M/s Allengers OEM PVT. Ltd. (AOPL) X-Ray Tubes, Collimators, Flat Panel Detector and Monitors

40.00

M/s Wipro GE Health care PVT. Ltd. (WGHPL) ‘CT Scan’, ‘Cath Lab’ and ‘Ultrasonography’

50.22

M/s Nipro India Corporation Pvt. Ltd. (NICPL) ‘Dialyzer’

180.00

M/s Wipro GE Healthcare Pvt. Ltd. (WGPHL) ‘Anaesthesia Unit Ventilator’ and ‘Patient Monitor’

53.86

January-February 2021 D A T A

S E R V I C E

Sr. Name of Approved No. Applicant

Name of Eligible Product

Commited Investment (in Rs. crores)

M/s Sahajanand Medical Technologies Pvt. Ltd. (SMTPL) - ‘Heart Valves’, ‘Stents’, ‘PTCA Balloon Dilatation atheter’ and ‘Heart Occluders’

166.89

M/s Innovolution Healthcare Pvt. Ltd. (IHPL) ‘Stents’ and ‘PTCA Balloon Dilation Catheter’

21.75

M/s Integris Health Pvt.- Ltd. (IHPL) for Eligible Products 75.00 Transcatheter Aortic Heart Valve

The Department of Pharmaceuticals said that the setting up of these plants will lead to a total committed investment of Rs. 729.63 crore by the companies and commercial production is projected to commence from 1st April, 2022 .

• Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp

The disbursal of production linked incentive by the Government over the five years period would be up to a maximum of Rs.121.00 crore per applicant per target segment. The setting of these plants will make the country self-reliant to a large extent in the specified target segments in the Medical Devices Sector, the department said. The remaining pending applications are proposed to be taken up for approval by end of February, 2021. https://swarajyamag.com/insta/siemenswiprogesahajanandnipro-among-firms-selected-under-rs-3420-cr-plischeme-for-domestic-manufacturing-of-medical-devices

January-February 2021 D A T A

S E R V I C E

Industry News Goldstab Organics Expands Capacity with new state-ofthe-art Calcium/Zinc Based PVC Stabilizer Plant

Goldstab Organics Pvt. Ltd. has a stated commitment to the sustainable development of PVC industry. Demonstrating this commitment, Goldstab has made significant investments in a worldclass manufacturing plant for the non-toxic Calcium based Stabilizers. The new plant, having name-plate capacity of 20,000 TPA, was inaugurated on 24th October, 2020. Goldstab Organics Pvt. Ltd., which is the largest producer of Stabilizers in India, offers all types of PVC Stabilizers, which include Lead based, Calcium and Ca/Zn based, Mix Metal Liquids and Tin Stabilizers. With the new expansion going on stream, the total capacity stands at 60,000 TPA. The plant employs state-of-the-art technology, where manufacturing processes are controlled and monitored by advanced PLC and SCADA systems. The material handling is completely mechanized with zero-human-touch. This guarantees extremely high level of consistency, which is very critical for Calcium/Zinc based Stabilizers. The complete vertical back integration allows excellent control on input quality as well as renders cost effectiveness. The opening ceremony was attended by the luminaries from various PVC processing industries like Prince Pipes and Fittings, KLJ Polymers & Chemicals, Apar Industries, LAPP India, Polysil Pipes, Polycab, Great White Electricals and Ravasco. The plant opening was done with ceremonial cutting of the ribbon by the doyen of the PVC field, Shri R.C. Gupta. the Technical Director of KLJ group.

The future trends in PVC Stabilization The imminent regulation for ban on Lead Stabilizers in PVC Pipes is expected to have a huge impact on the PVC Stabilzers market. Although, as per the regulation, Lead Stabilizers have to be phased out over 4 years, it is expected that the change over will gain momentum as soon as the draft regulation is notified by the government and majority of the users will shift in coming 1 – 2 years. The new facility of Goldstab will enable the processors to source high quality Calcium based Stabilizers locally and eliminate import dependency. The plant produces products which are REACH and RoHS compliant and also has FSSAI certification for food contact applications. Thanks to the intense R&D efforts at Goldstab Research Centre, the new generation technology is developed which reduces the

net cost differential between the Lead Stabilized PVC compound and Calcium/Zinc Stabilized compound to a very reasonable levels. Goldstab has now a specialized technical services team who can render technical support to customers who wish to change from Lead Stabilized systems to Calcium/Zinc based systems.

January-February 2021 D A T A

S E R V I C E

Industry News Messe Frankfurt India and Andhra Pradesh MedTech Zone (AMTZ) join hands to launch MedTech Innovation Forum in India With an objective to draw attention to the growth opportunities and latest developments in the Indian Medical device industry, Messe Frankfurt Trade Fairs India has joined hands with India’s first integrated medical devices manufacturing ecosystem – AMTZ. The joint cooperation aims to provide further impetus to indigenous manufacturing of medical devices and bring forward innovations and specialised medical tools and technologies that can attract domestic and global investors. As the nation takes steps to develop its healthcare infrastructure including an ecosystem for its medical device industry, the launch of MedTech Innovation Forum aims to create a collaborative platform for medical device manufacturers, innovators and technology experts to exchange advancements and innovations for the development of the Indian medical devices industry. Slated from 7 – 8 October 2021 in Visakhapatnam, the first edition of this key business event is expected to bring industry leadership together with government and medical consultants to address integral challenges of import dependency, need for technology collaborations as well as medical technology advancements that can be introduced in the industry. The forum has received strong support from apex industry bodies – AIMED (Association of Indian Medical Device Industry) and ADMI (Association of Diagnostics Manufacturers of India) ADMI. Commenting on the development, Mr Raj Manek, Managing Director, Messe Frankfurt Trade Fairs India Pvt Ltd said: “India’s response and agility in scaling up manufacturing of medical devices together with strong initiatives by the government on making the sector ‘Atmanirbhar’ makes it opportune time to introduce a forum that focuses on bringing medical technology innovations to the forefront. We are proud to combine strengths with AMTZ in this goal and are confident that the critical insights on MedTech advancements and challenges will enable the sector to create an environment for improved trade and investment opportunities.”

The Indian medical devices market, which accounts for more than 13% of the Asia-Pacific (APAC) medical devices market, is expected to grow at a compound annual growth rate of 7.5% through 2025. Dr Jitendra Sharma, MD & CEO, Andhra Pradesh MedTech Zone elaborated: “The industry is poised for significant growth in the next five years, however, it is still largely importdriven with 90% of sophisticated devices being imported from around the world. The dialogue with medical device manufacturers and innovators will open up opportunities to empower the country’s strong healthcare and medical devices industry in the post COVID-19 era. Dr Sharma further added that AMTZ aims to put the Indian medical device industry on the global map by encouraging sector innovations and we are happy to join hands with Messe Frankfurt in this endeavour as their expertise and reach across sectors in India will help bring in key stakeholders together.” Messe Frankfurt India has been actively involved in tracking industry growth and addressing rising concerns on counterfeit products in the pharmaceutical industry through its Pharmasafe India conference and webinar series. In August 2020, the Indian subsidiary held the first virtual edition of the Medical Device Innovation Summit to address growing demand for specialised medical equipment and is now closely working with industry leaders in the sector to launch Medtech Innovation Forum as a large-format Confex in October 2021. Touted as India’s largest medical devices manufacturing park, the Andhra Pradesh Medtech Zone (AMTZ) has dynamically contributed to the fight against COVID-19 pandemic through large-scale manufacturing of domestic rapid testing kits, PPE and ventilators. As a scientific infrastructure supported by the government, the zone intends to reduce import dependence and lower cost of healthcare by an estimated 40 to 50 per cent and is taking active steps to develop R&D, testing labs and provision for acceleration for start-ups. https://www.eventindustrynews.com

Intake Of Students In Medical Devices Courses At NIPERs Increased To Strengthen Manpower Resources Intake of students in medical devices courses at National Institute of Pharmaceutical Education and Research (NIPER) Mohali, Guwahati and Hyderabad has been increased to strengthen manpower resources for medical devices sector in the country. Admission of 34 students has been made for the new course of M Tech (Medical Devices) with 11 seats in NIPER Mohali, nine in NIPER Guwahati and twelve in NIPER Hyderabad. The government is also planning to explore every prospect of revenue generation in the existing seven NIPERs in the country to help them evolve into self-sustaining premier institutions. At present, there are seven NIPERs across the country at Mohali, Ahmedabad, Hyderabad, Rae Bareli, Guwahati, Hajipur and Kolkata. The Government of India has termed NIPERs as Institutes of National Importance. The Centre also has plans to strengthen industry-academia linkages which can also be leveraged to commercialize patents which are held by NIPERs. The Union minister for chemicals and fertilizers D V Sadananda Gowda and Minister of State (MoS) for chemicals and fertilizers

Mansukh Mandaviya had held a review meeting last year in the month of September to monitor functioning of NIPER Mohali and Rae Bareli through video conferencing. The meeting was also attended by Department of Pharmaceuticals (DoP) secretary Dr P D Vaghela and other senior officers. NIPERs across the country play an important role in the development of upcoming bulk drug and medical device parks and the Centre has renewed its focus on drug discovery for diseases like TB, malaria, kala azar, cancer, diabetes, obesity, drug repurposing and drug development. NIPERs across the country are today being developed as centers of excellence as R&D is the thrust of the present government with priority to support the MSME sector through extension of services like testing, consultancy and incubation centers. NIPER Mohali has been ranked 3rd and NIPER Raebareli at 18th by NIRF in the pharmacy sector. NIPERs are national level institutes in pharmaceutical sciences with the objective of becoming centres of excellence for advanced studies and research in pharmaceutical sciences. http://www.pharmabiz.com/NewsDetails.aspx?aid=135041&sid=1

January-February 2021 D A T A

S E R V I C E

Product Gallery Vast Selection of Critical Care Components for Respiratory Medical Device Design

Ronkonkoma, NY, USA, February 4, 2021Qosina offers countless off-the-shelf solutions for oxygen and respiratory medical device projects, stocking a range of non-sterile respiratory care components in a variety of materials, sizes, colors and configurations. This includes pediatric and adult sizes, as well as many BPA- and latex-free, PVC, and DEHP-free PVC options. Qosina also stocks an assortment of respiratory accessories, such as hose clips, in-line flow indicators and more. To learn more, please browse Qosina's full line of respiratory c o m p o n e n t s < h t t p s : / / w w w. q o s i n a . c o m / r e s p i r a t o r y 2?utm_source=news&utm_medium=pressrelease&utm_campa ign=respiratory_feb>. Qosina adheres to the strictest of quality standards and is committed to providing high quality products. 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 <http://www.qosina.com/newproducts>, visit www.qosina.com <http://www.qosina.com> or call +1 (631) 2423000. Visit Qosmedix, Qosina's cosmetics division, at www.qosmedix.com<http://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.

January-February 2021 D A T A

S E R V I C E

January 2020 to December 2020 Column

Content

Column

November-December 2020 Cover Story Cover Story Cover Story Select Presentations Select Presentations Select Presentations Select Presentations AiMeD & Regu latory Updates

Industry News

Did You Know?

• • • •

Webinar Themes and Abstracts of Presentations IMDI 2020 WEBINAR 07, Dec 17, 2020 : Highlights IMDI 2020 WEBINAR 08, Dec 18, 2020 : Highlights India : Top 5 Global Manufacturing Hub : Challenges To Overcome • Medical Polymeric Materials and Components : Innovations & Developments • Medical Device Industry India : A Potential Global Manufacturing Hub • Indian MedTech Industry Ecosystem : Facilitating Growth • DoP Issues Revised Guidelines For Procurement Of Make In India Medical Devices • Medical Devices Industry Seeks Clarity On PLI Scheme • Centre To Amend MDR-2017 To Include Provision To Allow Import Of Medical Devices Having Lesser Shelf-life • Health Ministry To Remove Requirement Of Audit For Class-A Medical Devices Manufacturing Site By Notified Bodies • Centre To Amend MDR 2017 to Include ASTM In Product Standards To Enhance Competitiveness Of Indigenous Medical Devices • Narayana Health And MSMF Team Up With BIRAC To Set Up Advanced Med Tech Innovation Centre • Poly Medicure to Enhance R&D Capabilities To Deliver High Quality Medical Devices • Haryana Set To Become Hub Of Medical Devices As Around 100 Industrial Units Set Up Plants In The State • About Impact Of COVID-19 on “Medical Swabs” : Applications and Markets

September-October 2020 Cover Story

Quality Materials

Waste Management Global Trends

AiMeD & Regu latory Updates

• How Can India Become A Global Medical Device Manufacturing Hub? • Role Of Industrial Parks For The Growth Of Indian Medical Device Industry • Bio 360°Life Sciences Park (LSP) and MedSpark In Thiruvananthapuram, Kerala • Quality Certifications In Medical Device Sector • Quality Requirements For Medical Textiles, PPES / Face Masks • Understanding The Complexities Of Medical Grade Polymers • Polymers for Prevention and Cure : The role plastics play in improving health and safety • Rational Use of Personal Protective Equipment: An Environmental Perspective • Placing A Medical Device On The Great Britain, Northern Ireland And European Union (EU) Markets From 1 January 2021 • Qosina Partners with Resolution Medical to Offer a 3DPrinted Sterile Nasal Swab for COVID-19 Testing • AiMeD Applauds Dr. P. D. Vaghela For His Contribution To Indian Medical Device Industry At His Farewell • AiMeD Unveils Figure Of The Growth Rate Of Indian

Industry News

Did You Know?

Medical Device Industry During Covid-19 Pandemic • Health Ministry Issues Draft National List Of Essential Assistive Products • Hindustan Syringes Sends Over 56 Million Pieces to Covax Facility • Japan Commits Rs 3500Cr To Strengthen Indian Health Sector • Medical Device Industry Demands Separate Marketing Practices Code Different From Pharma Industry • COVID-19 Treatment: CDSCO Shows Green Flag To Baxter India Oxiris Filter • SCTIMST inks MoU with Tynor Orthotic to boost orthotic devices • IPC Rolls Out PPE Adverse Event Reporting Form As Part Of MvPI For Patient And Health Worker Safety • NATHEALTH and APACMED join hands to advance medical technology for UHC in India • Kraton’s BIAXAM kills up to 99.99% of microbes including SARS-CoV-2 • About Complying With Global Medical Device Packaging Requirements

July-August 2020 Cover Story

• The Impact of COVID-19 on The Medical Device Industry • The Importance Of R&D And Innovation In The Post COVID19 World • Combating COVID-19 With Effective Change Management • US Medtech Industry’s Response to COVID-19 and Opportunities for future Case Study • Case Study On Solution To Protect Healthcare Professionals By Tekni-Plex Future Trends & • Atma Nirbhar India in Medical Devices Sector Development Innovation & • Devices For Safe Transfer Of Corona Infected Patients Technology And Protection Of Healthcare Workers Materials • Polycarbonate Is The Material Of Choice For Medical Face Shields AiMeD & Regu • Industry Hails CDSCO’s Sugam Portal In Expediting latory Updates Licensing Process For Ease Of Doing Business • DoP Appoints IFCI As PMA To Implement PLI Scheme To Promote Domestic Manufacturing Of Key APIs & Medical Devices • Medical device industry demands separate marketing practices code different from pharma industry Industry News • Atal Innovation Mission To Support Startups With COVID19 Solutions • Medical Device Industry Suffers Up To 85% Drop In Revenues During Apr-June: MTaI • Indian Company Manufactures N-100 Mask Which Filters 99.97% Air • COVID-19 Treatment: CDSCO Shows Green Flag To Baxter India Oxiris Filter Product Gallery • Qosina’s Swab Inventory Ranges in Application from COVID-19 Testing to Cleaning and Polishing Did You Know? • About Use Of Biopolymer Materials For Medical Devices?

January-February 2021 D A T A

Content

S E R V I C E

January 2020 to December 2020 Column

Content

Column

May-June 2020 Cover Story

• Gujarat – A Pioneer & No 1 Manufacturing Hub For Life Science Industry In India • Healthcare Sector, Navigating the COVID Storm • Indian Diagnostics Industry – Challenges & Opportunities Post Corona Pandemic Materials • The Contribution of Plastics In the Treatment of COVID 19 Patients Quality • Essentials of PPEs Against COVID 19 Innovation & • J Mitra Launches Covid-19 Total Antibody Detection Elisa Technology Test Kits • DBT – AMTZ COVID Medtech Manufacturing Development • An Indigenous High-End ICU Ventilator To Combat Covid-19 by Sahajanand Laser Technology Ltd. • Technologies From IIT Guwahati For COVID 19 Management • SCTIMST Launches Agappe Chitra Magna For Detection Of COVID-19 • IIT Kanpur & SGPGIMS Develop Safer Alternative To N-95 Mask Global Trends • Braun Expands Global Test Centre For Medical Devices In Penang AiMeD & Regu • Industry Asks PPE Manufacturers To Comply With ISO latory Updates 13485 Certification Before Registering On CDSCO’s Medical Device Portal • AiMeD Urges Govt To Make India Second Manufacturing Hub For Medical Devices In The World Industry News • HMD launches India’s First Dispovan Insulin Pen Needle • MTaI Asks Govt To Commit Definitive Package On Developing Healthcare Infrastructure • NCL, BEL To Produce Medical Devices For Tackling Pandemic • Gujarat FDA Issues Licenses To 12 More Oxygen Manufacturers To Produce Medical Oxygen To Cater To COVID-19 Patients Product Gallery • Cost-Effective Off-the-Shelf and Custom Tubing Did You Know? • About Why Single-Use Medical Plastics Have Become Heroes of the Fight Against COVID-19?

March-April 2020 Cover Story

Global Trends

• The Importance Of Medical Device Packaging • Salient Aspects Of Medical Device Packaging • Quality Management Of Packaging Materials For Medicines and Medical Devices • Looking For Contract Ethylene Oxide Sterilisation Facility? • Why Anticounterfeit Packing for Medical Devices ? • COVID-19 and The Critical Role Of MedTech

Content

AiMeD & Regu latory Updates

• Labeling Requirements – Compliance to Law • ANNEXURE – II CHAPTER VI (MDR 2017) LABELLING OF MEDICAL DEVICES • AiMeD Welcomes Govt’s Schemes For Promotion Of The Domestic Manufacturing Of Medical Devices Industry News • NPPA Notifies All Medical Devices As Drugs Under DPCO-2013 For Quality Control & Price Monitoring • Govt Announces Rs. 13,760-cr Package To Boost API & Medical Device Production In India, Industry Cheers Up • Cabinet Approves Promoting Domestic Manufacturing Of Medical Devices Product Gallery • Single-Use Bioprocessing Components • Components To Reduce Critical Enteral Misconnections Did You Know? • About Anti-Counterfeiting Packaging Technology for Medical Devices

January-February 2020 Cover Story

• Medical Device Industry Supplier Quality Management & Regulatory Expectations • Importance Of Implementing ISO 13485 – Suppliers’ Perspective • Indian Medical Disposables Industry & Contribution Of Plastics Event Report • Event Report on “Medical & Healthcare Plastics Pavilion” @ PLASTIVISION INDIA 2020 • Abstracts Of Presentations By Expert Speakers Markets • Trends In Medical Device Distribution In India AiMeD & Regu • Govt. Issues Notification To Regulate All Medical Devices latory Updates From April 1., Industry Concerned Over Compliance Costs • Medical Device Industry Seeks Predictable WTO Permissible Tariff Structure To Boost Domestic Market • Health Ministry Seeks Stakeholders Suggestions On Framing Recruitment Rules For Medical Device Regulators Industry News • Trivitron Healthcare Eyes Over Rs 1,000-Crore Revenue In FY'22 • Nagpur: Research Will Make Cochlear I50% Cheaper Says Nitin Gadkari • Medtech Firm Axio Biosolutions Lands $5.2M Funding Led By Omidyar • Medical Devices Trade Margins Likely To Be Capped At 30% • NGOs Ask Govt To Reject US’ Demand To Adopt “TRIPSPlus” IP Provisions And To Do Away With Price Caps On Medical Devices Product Gallery • Adhesives for Bonding Components Did You Know? • About Cardiac stents account for 47.95% of Serious Adverse Events

January-February 2021 D A T A

S E R V I C E

JIMIT MEDICO SURGICALS PVT. LTD.

January-February 2021 D A T A

S E R V I C E

January-February 2021 D A T A

S E R V I C E

• • • • • • •

January-February 2021 D A T A

S E R V I C E

I.V. Infusion Sets Blood Administration Sets Scalp Vein Set Urine Collection Bags Ryles / Feeding Tubes Catheters and Tubes Surgical Gloves.

ISO 9001 – 2015 ISO 13485 – 2012, CE, WHO GMP., MD – 5, MD - 9

• ECG PAPER & ECG ACCESSORIES • ECG PAPER ROLL & Z FOLDING • NASAL CANULA • OXYGEN MASK • NEBULIZER MASK • NEBULIZER COMPRESSOR • MULTI FLOW MASK • VENTURY MASK • HIGH CONCENTRATION MASK • BREATHING FILTER

• • • • • • • • • • • • •

B/PAP & C/PAP MASK COUTRY PENCIL MOUNT CATHETER "T" RECOVERY KIT BREATHING CIRCUIT AMBU BAG BAIN CIRCUIT 3 BALL SPIROMETER PATIENT ID BELT YANKAUR SUCTION SET NEBULIZER CHAMBER GUIDAL AIRWAYS B.P.METER

864/1, Nr. Indian Petrol Pump, Hirapur Char Rasta, Mehemdavad Road, Ahmedabad - 382 435.

January-February 2021 D A T A

S E R V I C E