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Table of
Contents Vol. 23
No. 4
July.-Aug. 2015
20 Cover Story
• Indian Medical Device Industry : Government Initiatives For Regulations, Safety & Competitiveness - The decision of the Department of Pharmaceuticals to come out with a draft National Medical Device Policy, 2015 is the first government initiative to give a proper direction to the growth of this sector in the country. Various other Government initiatives include…….
24 Technology • Cold Plasma Treatment For Biomedical Applications - Mrs. Purvi Dave, Scientist SC, Facilitation Center for Industrial Plasma Technologies Institute for Plasma Research, Gandhinagar, Gujarat - Cold Plasma (a kind of glow discharge) Treatment is very much useful for surface modification of bio-polymers / medical plastics. Bio-polymers / medical plastics are widely used for biomedical applications such as artificial organs (Prosthetic Materials) and cell scaffolds. • Plasma Treatment Improve Adhesion To Polymers
31 Global Trends • Impact Of New European Regulations On Outsourcing Of Medical Devices - Medical Device Companies will operate under a stricker regulatory environment in Europe following the approval of new regulations governing Medical Devices and In Vitro Diagnostics by the Council of the European Union.
32 Industry News • Provisions Of DPCO, 2013 Applicable To Notified Medical Devices: NPPA • Gujarat FDCA To Meet Commerce Ministry To Seek Release Of Funds For Biocompatibility & Medical Device Testing Lab • U.S.-India Business Council Concludes Successful Medical Device Trade Mission To India
18 Did You Know? • Balancing Product Development Effectiveness with Regulatory Compliance
36 Events • • • •
Medicall 2015 : October 9 - 11, 2015, Bombay Convention and Exhibition Center, India. Compamed 2015 : November 16 - 19, 2015, Dusseldorf, Germany. Plastivision Arabia 2016 : January 10-13, 2016, Expo Center, Sharjah. 13th National Conference And Technology Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016. 12-13 February, 2016, Ahmedabad. • Medical Fair India 2015 : March 11-13, 2016, Bombay Convention & Exhibition Center, Mumbai.
July. - Aug. 2015
17
Flashback March 2003 From Editor’s Desk Dear Readers, Thailand and the neighbouring Indochina markets for Vietnam, Laos and Cambodia have opened vast opportunities for the Indian medical technology Industry to take latest medical and healthcare products and services to their doorsteps. Thailand is working towards achieving the goals outlined in the UN’s Millennium Development Goals established at the United Nations Millennium Summit in September 2000. Three of these goals call for specific improvements in health such as reduction in child mortality, maternal deaths and combating the spread of HIV/AIDS, malaria and TB. The healthcare industry in Thailand has seen major transformations taking place. The health status of the Thai people have improved considerably and rapidly over the past 3 decades. Indian visitors to HOSPIMedica THAILAND will also benefit tremendously from the participation several groups from China, India, USA and the Indochina region in addition to the national pavilions like State of Bavaria / State of North-Rhine Westphalia (Germany), Austrian Chamber of Commerce, Taiwan Medical Industry Association and Thai Medical Device Suppliers’ Association. This issue contains very informative articles covering various important subjects like Evaluation of Medical Devices, Regulatory Affairs, Medical Plastics Materials and the latest developments taking place in the field of medical materials globally. Dr. Norman Estrin has very elaborately discussed the basics of US FDA : 510 (k) and the various requirements for its submission. Dr. Norman Estrin is a recognized authority in the medical device and cosmetic industries. He has had over 30 years of experience in directing scientific and technical and regulatory programs in these industries. He is Regulatory Affairs Certified (“RAC”) by the Regulatory Affairs Professional Society. The use of plastics in medical applications is expected to continue its steady growth as new polymers edge out metals, ceramics, and other traditional materials. Innovative materials are replacing the conventional ones such as PVC. Medical devices are becoming smaller and lighter but have performance advantages over much larger and more expensive equipment. “Global Trends” highlights the recent trends in the field of Plastics used for medical applications. “Product Gallery”, a new feature in this issue, introduces products of interest to both the manufacturers as well as users and marketing companies. We are happy to mention once again that the internet has strengthened us by allowing us to provide much more information to our readers than we could before. We invite our readers to benefit from our web sites, www.medicalplasticsindia.com and www.medisourceasia.com .
18
Did You Know ?
?
Balancing Product Development Effectiveness with Regulatory Compliance Medical device companies are experiencing growing pains as they navigate the challenging waters of regulatory compliance while simultaneously keeping up with the pace of innovation. When it comes to implementing product development processes that comply with regulations, many have overcompensated, resulting in overly-bureaucratic systems that are impacting delivery performance and causing them to come up short on time to market, R&D ROI, new product revenue, and schedule predictability goals. Though a single process design has the advantage of one system for both business and quality system needs, this approach increases opportunities for non-compliance and hinders project teams that need flexibility to adapt business processes to specific project needs. Implementing a program that couples product development effectiveness with compliance is no easy task, but deploying a methodology that includes improvements in process definition and work flow structure, innovation governance and decision making, project teams and team structure, and software systems and tools can help companies realize benefits including: Meeting and exceeding development effectiveness goals, Achieving time to market goals ,Hitting planned product launch dates , Eliminating unnecessary process bureaucracy as well as Accelerating product development process maturity. A mature, high performing product development process with low compliance burden is the goal. Top performing medical device companies demonstrate how to achieve this goal and deliver safe, effective, and commercially successful medical devices. (Ref:http://ww2.frost.com/files/3914/2200/7195/Beyond_Compliance.pdf)
In a Nutshell.... “Genius is the ability to hold one’s vision steady until it becomes reality” - Benjamin Franklin
July. - Aug. 2015
EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.
ASSOCIATE EDITOR Mr. Rahil Engineer, B.E. (Biomedical Eng.)
EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon 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 ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, 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 Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India. Dr. J. V. Tyagi Consultant, Medical Device Certification 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-58 •Ph:098795 55948
Editor’s Desk
From the
Regulations, Safety And Competitiveness Every medical device is designed for a purpose. A device is clinically effective when it produces the effect intended by the manufacturer relative to the medical condition. The performance of a medical device is closely linked to safety. For example, a blood collection syringe with a blunt needle would perform badly for collecting blood and could also inflict injury and hence the safety and performance of medical devices are normally considered together. The regulatory process ensures that the manufacturer has effectively implemented the risk management process and fulfilled other regulatory requirements. It is obvious therefore that establishing an appropriate regulatory framework for medical devices will enable industry to better address the needs of the patients. However, it is also important for the government to understand that issues related to the pharmaceutical sector are different from that of medical devices. Competitiveness Of Indian Medical Devices In Domestic Market The Indian Medical Device Manufacturers are not able to tap the domestic market due to inherent challenges. The Department Of Pharmaceuticals is planning to initiate a nationwide study to scrutinize why the domestic manufacturers are not able to benefit from the local market opportunities in spite of having substantial export market. This issue highlights the recent initiatives by government through various departments is to facilitate the growth of the medical device industry in India. Beyond the need for proactiveness from the government, a recent study by “Infosys Management Consulting Services” has identified the various challenges and suggested following strategies for the Industry to implement : - “Understand dynamics of the market, local sentiments, challenges and opportunities better. - Partner with domestic technology companies for an efficient market entry and market growth strategy. - Revolutionize domestic sales force. - Add more value to healthcare providers and patients alike, not just through products, but also services wrapped around the product” The study further discusses success stories of indigenous companies having managed to navigate the hurdles and emerged successful despite the challenges associated with Indian Medical Device Industry. One of the domestic technology company, Institute Of Plasma Research, Gandhinager (Gujarat) and the technology being offered by them regarding cold plasma treatment for Biomedical Applications is introduced in this issue. It is an eco- friendly process and can induce hydrophilicity / hydrophobicity to the polymer surfaces resulting in better cell adhesion, anti-bacterial properties, biocompatibility as well as bio-functionality compared to virgin ones. The Institute offers the technology through their Facilitation Centre for Industrial Plasma Technologies (FCIPT). This issue also covers the regular features including Global Trends, “Did You Know”, Industry News, Events / Event Calendar etc.
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.
July. - Aug. 2015
19
Cover Story Indian Medical Device Industry : Government Initiatives For Regulations, Safety & Competitiveness The recent initiatives by government through various departments is expected to make the Indian Medical Device Manufacturing Sector grow faster in the next five years. The initiatives include the Bill to delineate Medical Devices from Drugs, removing Duty Anomalies, Materiovigilance Programme to monitor Safety of Medical Devices and many more. Major challenges faced by Indian Medical Device Industry are lack of regulatory structure, harmonized standards, accreditation and adverse custom duties. Absence of any regulations for curbing imports of poor quality or substandard quality medical devices, lack of R&D capabilities with high reliance on outsourcing technology, are some of the leading factors affecting the competitiveness of Indian medical consumables.
being monitored in the country. The basic objective of MvPI is to collect safety data in a systematic manner so that regulatory decisions and actions on the use of medical devices could be taken on time by the health authorities. These government initiatives should play a key role in developing this industry and ensure availability of quality medical devices at reasonable prices to the patient community in the country.
The decision of the Department of Pharmaceuticals to come out with a draft National Medical Device Policy, 2015 is the first government initiative to give a proper direction to the growth of this sector in the country. The main objective of the policy is to set up National Medical Device Authority, an autonomous body for regulating the manufacture and sales. Such a national body should be able to strengthen the domestic base of this sector, reduce dependence on import and bring affordability and availability of these critical products.
One more development is regarding inverted duty structure. It is expected that the Department of Pharmaceuticals will shortly recommend to rectify the inverted duty structure for the growing medical devices sector. An inverted duty structure impacts domestic industry adversely as manufacturers have to pay a higher price for raw materials in terms of duty, while imported finished products land at lower duty and cost lesser. The duty structure will have to be modified. For this, the Department of Industrial Policy and Promotion( DIPP) and Department of Pharmaceuticals will jointly finalise the recommen-
Preference to local manufacturers in government purchases, institution of a regulatory framework around self-certification, and creation of a separate department for medical devices are some of the other suggestions put forth by AIMED. Another move initiated by the health ministry is to come out with a Materio-Vigilance Programme of India (MvPI) intended to ensure safety of medical devices used in the country. There has been several complaints of malfunctioning of medical devices supplied by both Indian companies and MNCs from various parts of the country. Adverse events of even critical medical devices are not 20
dations. Establishing an appropriate regulatory framework for medical devices will enable industry to better address the needs of Indian patients. The industry is encouraged that the government has taken cognizance of the fact that issues related to the pharmaceuticals sector are different from that of medical devices. The proposals for medical device parks, autonomous regulatory authority, 100 percent FDI, incentives for R&D, etc., will all foster the development of the industry. More details on each of the initiative is explained at length in the following press releases. July. - Aug. 2015
Cover Story Department Of Pharmaceutical To Study Factors Affecting Competitiveness Of Indian Medical Devices In Domestic Market Keen on pushing the interest of the medical device sector, the department of pharmaceutical (DoP) is soon planning to initiate a nationwide study to scrutinise why the domestic manufacturers are not able to get proper market opportunities in spite of having substantial export market. To gauge the factors affecting competitiveness of Indian medical consumables, DoP called a high level meeting with key stakeholders from the industry. The focus of the meeting was to explore the reasons for losing out to competing imports and identify the roadblocks that hamper the growth of domestic sector from within. Experts state that unfair market conditions, lack of proper regulatory guidelines coupled with partial attitude that is duly focused on imports are key reasons for lack of dominance of domestic manufacturers in the country albeit having huge potential and required expertise to export to other countries. It is understood that through this initiative the government intends to aid the industry by providing infrastructural support to the deserving companies, while tweak preferential market access and public procurement policy as per the needs of the sector to benefit the industry. Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry (AIMED) informed that the industry is looking forward to be part of this initiative as it comes as a welcome move finally taken to address the concerns of the industry. “It is high time to finally confront the reality on why Indian manufacturers are not able to get the opportunity to expand their business within the country, even when we have the expertise for the same. The government must take cognisance of the fact that unfair market practices is rampant in the country due to competition from lower cost imports of China and other countries, contributed due to low duties and 17 percent subsidy by China on Chinese exports; competition from MNCs which are either not putting any MRP or putting very high MRP as desired by corporate hospitals are some of the major factors affecting us,” stressed Nath. He further added that proactiveness from the government to tackle these issues is the need of the hour to protect the interest of the stakeholders, who are currently suffering silently due to Centre’s indifference. (Ref: http://www.pharmabiz.com/ArticleDetails.aspx?aid=89723&sid=1)
www. medicalplasticsindia.com
THE ONLY INDIAN PORTAL SITE ON MEDICAL PLASTIC / DEVICES TECHNOLOGY AND TRADE July. - Aug. 2015
Government to Soon Remove Duty Anomalies in Medical Devices Sector
New Delhi: The government is working on several steps, including removing duty anomalies, to boost medical devices manufacturing sector and make it a $50-billion industry in the next five years, as per a top official. Secretary in the Department of Pharmaceuticals V K Subburaj said that soon recommendations will be made to rectify the inverted duty structure for the growing medical devices sector. He said the departments of health and pharmaceuticals along with the Department of Industrial Policy and Promotion (DIPP) are working on the matter and soon they will make recommendations to the Revenue Department on the issue. An inverted duty structure impacts domestic industry adversely as manufacturers have to pay a higher price for raw material in terms of duty, while imported finished products land at lower duty and cost lesser. “The important hurdle (which the sector is facing) is the regulatory mechanism The duty structure has to be modified. Health, DIPP and Pharma are jointly discussing the issue to finalise the recommendations as per the opinion of Mr Subburaj at a CII function. Domestic medical devices makers have been asking the government to address this issue. “We will ensure that this deficiency gets corrected very shortly. That will set the tone for medical devices industry in the country,” he added. Commenting on the potential of the sector, he said: “Now we have to scale it to $50 billion and to enable that, we have to take policy decisions.” Currently, the medical devices industry in India is estimated to be $5 billion annually. The secretary also said the department is working to create a separate vertical for medical devices in the Drugs and Cosmetics Act. “Once it becomes a $50-billion industry, I do not think we can afford to combine it with the Drugs and Cosmetics Act. There should be a separate Act for the sector. We have combined it with drugs for long and that mistake is likely to be sorted out shortly. I think very shortly we will have a separate vertical within this Act exclusively for medical devices,” Mr Subburaj said. To give an identity to the subject, he said, the government has empowered the Pharmaceuticals Department to take the medical devices sector. Earlier, different departments were handling different issues related with the sector, such as quality control was looked after by the Health ministry, FDI by the DIPP and export was taken care by the Commerce Ministry. The department, he said, is also working on the issue of the preference purchase procedures. “We are discussing with the electronics and MSME departments to see that products manufactured in India, especially made by medium and small scale sector, get preference for purchase,” he said. (Ref: http://profit.ndtv.com/news/pharma/article-government-to-soonremove-duty-anomalies-in-medical-devices-sector-1211936)
21
Cover Story Ministry Of Health Launches Materiovigilance Programme To Monitor Safety Of Medical Devices
AdvaMed Demands Passage Of D&C Amendment Bill To Delineate Medical Devices From Drugs
In a strategic move to protect the health of the patients, the ministry of health & family welfare approved the commencement of the ambitious Materiovigilance Programme of India (MvPI) to monitor the safety of medical devices in the country. The MvPI was formally launched on July 6 at Indian Pharmacopoeia Commission (IPC), Ghaziabad by Dr G N Singh, Drug Controller General of India (DCGI).
The Advanced Medical Technology Association (AdvaMed), an association of medical device manufacturers in India, has demanded the passage of Drugs and Cosmetics Amendment Bill, delineating medical devices from drugs, in the upcoming session of parliament.
It is understood that while IPC will function as the national coordination centre for MvPI, Sree Chitra Tirunal Institute of Medical Sciences & Technology (SCTIMST) will be functioning as National Collaborating Centre for the same. At the same time, the National Health Systems Resource Centre (NHSRC) under the ministry of health will collaborate and work as technical support and resource centre. While stressing on the importance of this initiative, Dr Singh said this is an important step towards ensuring patient safety measures in the country as medical devices are as crucial and important aspect of healthcare as drugs. “Considering the current healthcare needs of the country, MvPI is a necessity essential to safeguard the interest of the patients. Thus we would ask all the stakeholders to come forward and support us in this national cause.” He further stressed that this will go a long way in generating India’s safety data collection on the medical devices running in the market in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated here. Dr V Kalaiselvan, principal scientific officer, IPC informed that following the launch, the technical committee had a high level meeting in which the members of the steering committee and working group took important decisions on identifying the 10 adverse effect monitoring centres and data management system, along with finalising the other aspects relating to the modalities for the same. Interestingly, this programme is meant to monitor medical device associated adverse events (MDAE), create awareness among health care professionals about the importance of MDAE reporting in India and to monitor the risk-benefit profile of medical devices. It will also play key role in generating independent, evidence-based recommendations on the safety of medical devices so as to communicate its results to the stakeholders. At present, there is no mechanism to monitor or regulate the use of medical devices in the country against any possible adverse events. Thus experts from the industry strongly feel that this move will finally help in bringing some regulatory semblance to the sector. Especially since monitoring for possible adverse events pro-actively will not only help in ensuring better patient safety but also improve the standard of the industry as well.
Though the government had cleared the amendment to the Drugs and Cosmetics Act bill delineating the medical devices from the pharmaceutical and drug products in the year 2013, the bill has not got complete formal nod of the parliament, due to which there are so many legal hurdles that are becoming stumbling blocks for the growth of medical devices sector in the country. “The Bill is historic because it creates a distinction between drugs and medical devices for the first time in India’s legislative history. We believe that by establishing an appropriate regulatory framework for medical devices, it will enable industry to better address the needs of Indian patients,” says Sanjay Banerjee, chair of AdvaMed India. First introduced in the Rajya Sabha in 2013, the Bill has since gone through several revisions. The health ministry has organised a series of consultations with other departments, industry and civil society to ensure that the amendments address all concerns adequately. In fact, the nascent medical devices sector entered the limelight last year with Prime Minister Narendra Modi calling out to medical device manufacturers to ‘Make in India’, and the department of industrial policy and promotion (DIPP) opening up the sector to 100 percent automatic foreign direct investment. Once the final bill is passed, then, it is regarded as benchmark legislation because it outlines a regulatory system that is appropriate for medical devices, and is broadly harmonised with international regulations. It will ensure quality of medical devices, and therefore patient safety, and remove bottlenecks to easy availability. It will grow domestic manufacturing capacity, allow domestic industry to compete globally, and incentivise international industry to invest in ‘Make in India’. “Without the legal backing, the medical devices are still considered as drugs. Because of this, medical devices manufacturers are facing hurdles in product registration and approval for manufacture of new devices,” says Banerjee. For decades, the medical device industry has gone unrecognised in India. Currently, of the 14000 types of medical devices that exist, only 22 are on the government’s list and even these are treated as drugs. The obfuscation of the two categories in India has created ambiguity about safety standards and quality control, and limited the ability of the medical device industry to address issues of access, availability, affordability and safety. (Ref: http://www.pharmabiz.com/NewsDetails.aspx?aid=89447&sid=1)
(Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=89344&sid=1)
22
July. - Aug. 2015
Technology Cold Plasma Treatment For Biomedical Applications Mrs. Purvi Dave, Scientist SC Facilitation Center for Industrial Plasma Technologies Institute for Plasma Research, Gandhinagar, Gujarat. fcipt@ipr.res.in, www.plasmaindia.com We all have been taught that there are three states of matter: solid, liquid and gas. The plasma is the fourth state of matter. In a more simple way, we can say plasma is an ionized gas. Scientists say that 99% of universe is in plasma state. If we supply sufficient energy to gas either in the form of heat or electricity, electron comes out from the atom or molecule and thus electrons, ions and reactive gaseous chemical species are generated. In plasma stateions, electrons, neutrals, activated gaseous species coexist. We see natural plasmas around us in the form of lightening and aurora. Sun and stars are live example of natural plasma. Examples of common man made plasmas are fluorescent lights, neon bulbs and plasma arc, plasma TV etc.. Plasma arc is used for cutting and welding of thick steel sheets. Scientists and researchers around the world are working to develop different plasma technologies for variety of applications to serve mankind. Plasma state can be generated in the laboratory. Plasma can be generally classified broadly as: (i) non-thermal or cold plasma and (ii) thermal or hot plasma. Cold Plasma (a kind of glow discharge) Treatment is very much useful for surface modification of bio-polymers / medical plastics. Bio-polymers / medical plastics are widely used for biomedical applications such as artificial organs (Prosthetic Materials) and cell scaffolds. Surface properties of the material play an important role in determining overall biocompatibility of the materials because the surface of the materials will first come into contact with biological environment. The initial response of the biological environment to such materials, therefore strongly depend on the surface properties of the materials. Thus the modification of the surface of the materials is the convenient and effective way to create and develop biomaterials for clinical applications. Although many synthetic biomaterials have physical properties that meet and even exceed those of natural body tissue, they can often cause adverse physiological reactions such as infection, inflammation and thrombosis formation. Through surface modification, bio-compatibility as well as bio-functionality can be achieved without changing bulk properties of the material. In order to obtain optimal biological performance, it is usually necessary to apply surface treatments or coatings to biomaterials. Plasma treatments are used to incorporate chemically reactive functional groups on to the polymer surface and thus make them hydrophilic. Hydrophilicity plays an important role in cell and bacteria behaviour.It is reported that enhancing the surface hydrophilicity by introducing oxygen containing functional groups such as hydroxyl (-OH), carbonyl (-COOH), ketone (-C=O) leads to an July. - Aug. 2015
increase in cell attachment. It is also reported that Hydroxyl groups contributes to cell colonization. It is well known that cell walls of most bacterial strains are negatively charged. Therefore more negative surfaces construct an initial defence line against microbial adhesion by an electrostatic repulsion. Air plasma treatment can introduce negatively charged functional groups on the surface. With increasing concentration of these groups, the surface becomes more hydrophilic and more negatively charged. Thereupon due to the strong repulsive forces, the antibacterial effect increases [Fatemeh et al. Applied Surface, Science 2015]. Similar type of research work in the field of surface modification of polymer surfaces by eco-friendly plasma process is being done at Facilitation Centre for Industrial Plasma Technologies (FCIPT), Institute for Plasma Research (IPR). IPR, Gandhinagar is an Autonomous R & D Institute under the Department of Atomic Energy (DAE), Government of India situated near Gandhinagar, Gujarat, India. FCIPT is a division under IPR, which mainly focuses on technology development for social benefits and industries. FCIPT develops plasma based technologies and commercializes through Technology Transfer to Industrial Partners. In our study, plasma is capable of reducing Water Contact Angle (WCA) from 100 ° (WCA of untreated PE) to as low as 15 ° in the case of low pressure plasma treatment and 43 ° in the case of atmospheric pressure plasma treatment. WCA is the measure of wettability of the material. Polyethylene is one of the promising medical plastic which is widely used in various prosthetics in biomedical industries. At FCIPT, IPR we have developed plasma surface modification process for polymers which uses ambient air to produce plasma at atmospheric pressure. After plasma treatment polymer surface (Polyethylene, PET, PP) have become hydrophilic in nature, which is of relevance to biocompatibility. This treatment can also be done by low pressure air / oxygen plasma. Below figure shows oxygen plasma generated in our laboratory. In our study, plasma is capable of reducing Water Contact Angle (WCA) from 100°(WCA of untreated PE) to as low as 15° in the case of low pressure plasma treatment and 43 ° in the case of atmospheric pressure plasma treatment. WCA is the measure of wettability of the material. Polyethylene is one of the promising medical plastic which is widely used in various prosthetics in biomedical industries. Results of water contact angle and surface energy after atmospheric pressure air plasma is shown in figure-2.
24
Technology Plasma Treatment Improve Adhesion To Polymers Polymeric materials are of great interest in various biomedical fields. For instance, acrylic polymers are applied as prosthetic materials in ears, dentures, face prosthesis, breath tubes and joints. Engineering polymers, such as PEEK, POM, polyamides and PTFE are used widely in medical product manufacturing, such as catheters, micro-catheters, nasogastric feeding tubes and endotracheal tubes.
Incorporation of oxygen containing functional groups after plasma treatment is shown in below figure-3. This results are FTIR spectrographs. Another device capable to form plasma plume is Non Thermal Plasma Torch (NTP). Recently FCIPT, IPR has developed a compact device NTP. A plume of plasma comes out of this device. This type of plasmas is useful for healing skin wounds, blood clotting in few seconds. The plasma torch is like a small pen which provides very narrow cold plasma plume which interacts with skin or blood. Figure below shows view of a finger exposed to this plasma. Dentists can use this torch for cleaning cavity in effective manner or for root canal treatment. The NTP has a potential to use in cancer therapies as well. Conceptually this device can be inserted in to lungs with a probe and lung nodules / metastasis can be exposed for effective treatment. However this application is yet under evaluation. FCIPT, IPR welcomes interested organizations / industries to contact us at below contact details. Dr. Nirav Jamnapara Technology Commercialization Cell FCIPT, IPR fcipt@ipr.res.in, ww.plasmaindia.com P:07923269017. FCIPT, IPR has organized one day workshop on “Applications of Cold Plasma in Surface Engineering” on September 11, 2015. Registration is Free. Interested candidates can email us at fcipt@ipr.res.in to register. Pre-registration is compulsory. For more details of this workshop please visit www.plasmaindia.com.
25
One important property which create technical challenges in a production environment is the characteristic low surface energy of polymers and the resulting intrinsically poor adhesion characteristics. Various methods of improving adhesion are available but often don’t lend themselves to production settings and frequently involve the use of harsh and environmentally unfriendly chemicals to physically attack and etch the surface of the material. Plasma surface modification offers a reliable and environmentally friendly alternative surface preparation for most engineering polymers. Plasma treatment techniques have advantages over other approaches because it has the ability to uniformly modify the surface and a few top monolayers of the material surface without any change in the bulk properties. Plasmas can be a vacuum types (batch) or atmospheric types (in-line) and contain reactive gas species which, by careful choice of gas type and process parameters, can be used to increase the surface energy of a wide range of engineering polymers, and in doing so significantly improve wetting characteristics and therefore adhesion characteristics. In-line atmospheric plasma surface treatment has been successfully demonstrated to increase the surface energy of PEEK from 35mN/m to >72mN/m, ensuring permanent PAD print adhesion. The treatment is active on PEEK for several weeks and so parts can be stored until needed. For PTFE catheters, air is ineffective due to the strength of the C-F bond. Batch processes are preferred which allow different plasma gases to be used and which are more effective in fluorine extraction from the surface. The surface energy of PTFE is raised from 18mN/m to >72mN/m in this case also. Both batch and in-line plasma treatments offer a reliable and repeatable surface preparation method for improving adhesion to a wide range of engineering polymers used in medical device manufacture. (Ref: http://www.medicalplasticsnews.com/technology/plasmatreatments-improve-adhesion-to-polymers/)
July. - Aug. 2015
Biomedical Technology Tips & Techniques By : D. L. PANDYA A Valuable Insight For Medical Device Industry, Biomedical Engineers & Doctors
! NErW ged &
Available Now in Soft Copy CD ROM : Rs. 500/- (Including Packing & Forwarding,Charges in India) Pdf File : Rs. 350/-
Enla ated Upd ition d 2nd E
Quite often, medical product manufacturers receive complaints of device malfunctions,serious injuries or deaths associated with medical devices. Manufacturers are also required to have additional postmarketing activities, postmarket surveillance for the monitoring of products after their clearance to market and device tracking for maintaining traceability of certain devices to the user level. Considering the current healthcare needs of the country , the Government of India has recently launched Materiovigilance Program to monitor Medical Device Associated adverse evnts ( MDAE ) , create awareness among healthcare professionals about reporting and monitoring risk – based profile of Medical Devices. The program will not only help in ensuring better patient safety but also improve the standard of Industry as well.
The genesis of this book lies in a series of columns covered in our Medical Device technology magazine and internet portals over a period of more than 23 years. The book covers a wide range of Devices from simplest Infusion Devices, Endotracheal / Tracheostomy Tubes,Catheters ,Leukocyte reduction filters, Guide wires, Dialysis Filters, Vascular Haemostasis Devices, Blood Coating devices to artificial heart . It also highlights important issues like safety of healthcare professionals, reuse of single-use devices, cross-contamination, allergies to use of latex, sterilization methods, dialysis procedure etc. Readers would also enjoy and get enlightened by the quotes given on all the pages which speak volumes “In A Nutshell”.
Foreword (First Edition) 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. This book is written by a technocrat – an engineer with an academic inclination and compiled by him for an industry that he has been a part of for more than 25 years. This should be in every library and also in the personal possession of those who should know about handling of Biomedical Technology Products.
Dr. R. A. Mashelkar
Director General Council of Scientific & Industrial Research & Secretary, Government of India Department of Science and Technology
Biomedical Technology
!& NnlEarW d ge
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ted Upda tion di 2nd E
Tips & Techniques
Product and Subject Index • • • • • • • • • • • • • • • • • • • • • • • • • • • •
Adverse Events Ageing Population Artificial Heart Bacteria Clog Biopolymers Blood Bags Blood Contacting Devices Bone Cement Cardiac Guide Wires Catheter Introducers Catheter Related Infections Catheters Centre For Devices And Radiological Health (CDRH) Combination Product Conductive Plastic Cornea Coronary Drug-Eluting Stents Dialysis Filters Dialysis Procedure Distribution Channel Endotracheal Tubes Engineered Medical Coatings FDA Regulations Frugal Innovations Global Medtech Manufacturers Haemodialysis Treatment Health Related Technologies Health Technology
• • • • • • • • • • • • • • • • • • • • • • • • • • •
Healthcare Plastics Recycling Healthcare Professionals Healthcare Supply Chain Hemodialysis Catheter Heparin In Medical Devices Hospital Waste Humanitarian Use Devices I.V. Administration Sets I.V. Bags Intelligent Materials / Surgical Implants Intravenous Filter Sets Intravenous Infusion Sets IV Catheter Knowledge Management Leukocyte Reduction Filters Luer Taper Fitting As Connectors Medical Components Medical Device Medical Device Adverse Events Medical Device Coatings Medical Device Innovation Medical Device Safety And Performance Medical Devices Medical Devices : Remote Monitors Medical Devices Containing Latex NeedlesOrthosis Callipers Outsourcing
• • • • • • • • • • • • • • • • • • • • • • • • • • •
Packaging Failures Pediatric Medical Device Phakic Intraocular Lenses Plastic Stents / Treatment Of Benign Esophageal Polymers Prefilled Syringes PU Dressings PVC : Environmental Perspective PVC Tubing Reuse Of Single-Use Devices Risk Management Safe Injection And Safety Practices Safer Healthcare Sillicon Sensors For Catheters Steam For Sterilization Sterilisation Methods Sterilisation Package Sterilization Sterilization Packaging Tracheostomy Tube Transvaginal Surgical Mesh Uhmwpe Fibers Urological Devices US Healthcare Industry Vascular Hemostasis Devices Vinyl And The Environment Welding Of Thin Polymeric Films WHO Report Medical Devices
ORDER FORM Payment : Enclosed by cheque in favour of “Classic Computer Services” Payable at Ahmedabad.
CD ROM : Rs. 500/PDF Format : Rs. 350/Name :
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Mail to Business Development Executive, “ Classic Computer Services”, B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta, Ahmedabad-15, India. Phone : +91 79-26740611 • Fax : +91 79-26754867 • E-mail : mpds00@vsnl.com, dlpandya@gmail.com Website : www.medicalplasticsindia.com, medisourceasia.com
®
Alpha Medicare and Devices Ltd.
(taking care…Since1984)
Manufacturers & Exporters of Disposable Medical Devices
GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY 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 NEW PRODUCTS • 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. ISO 13485 : 2003 • Exporting our products to almost more than 23 countries. Contact : Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com
July. - Aug. 2015
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Shree Dye Stuff Manufacturer of PVC Compound, (Surgical Grade, Molding & Tubing)
According to the customer requirment • Flexible PVC tubing grade compound • Flexible PVC moulding grade compound • Flexible PVC tube for I.V. Set, S.V. Set, X-ray opeque tube and Oxygen tube. • Flexible PVC compound for Urine bag roll Contact Pragnesh Shah C-3 TPS 88, bharat Small Scale Industrial Area, B/h Gujarat Offset, Narol - Vatva Road, Ahmedabad - 382 445 Mobile : +91 98246 49740, +91 93761 82700, +91 90168 13881 E-mail : shreedyestuff@gmail.com, Pritishah777@gmail.com
Our First Priourity is Customer Satisfaction
AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp
Contact Yogesh Patel M. : +91 98241 21383 MEDIC ARE DEVICES
8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026. Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com
SHAILESH SURGICAL Leading Manufacturers and Exporters of Surgical Disposable Products PRODUCTS MANUFACTURED ISO 9001
REGISTERED
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• • • • • • • • • • • •
I.V. INFUSION SETS SCALP VEIN SETS BLOOD ADMINISTRATION SETS BLOOD DONER SET URINE COLLECTION BAG RYLES/FEEDING TUBES DISPOS ABLE SYRINGES & NEEDLES DISPOSABLE GLOVES SURGICAL DRESSINGS ADHESIVE TAPES PLASTER OF PARIS FORMULATIONS Office: L-8, “Manhattan”
Near Lion’s Hall, Mithakhali, Ellisbridge, Ahmedabad-380 006, India Phone: (91-079) 26420281, 26440236
July. - Aug. 2015
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VIRTUE CERTIFICATION SYSTEMS PVT. LTD We are entrusted with the responsibility to manage in India on behalf of the world renowned accredited certification Body G2S Italy, ASCE (E) from IASPL & ACS Registrars – UKAS Accredited. We are involved on the certification activities in the following areas : • ISO 9001:2008 - QMS • ISO 14001:2004 – EMS • OHSAS 18001:2007 – OHSAS • ISO 22000:2005 – FSMS • ISO/IEC 27001:2005 – ISMS • ISO 13485 : 2003 – QMS for Medical Devices • ISO 30000 – Ship Building & Repairing • CE Marking • GMP We have collaboration with European Notified Body for CE Marking & SA 8000 certifications. We have assisted over 6500 clients all over the country, as an expansion plan we also require well qualified personnel’s in various districts to conduct the audits and provide after sale services, for Business Associates kindly apply for your location with complete details. Business Plan preferred.
We are a leading Consulting organization providing an integrated services with focus on project technology :
Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training and c-GMP. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850
Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe.
For further details OR clarification pleases contact :
Virtue Certification Systems Pvt. Ltd. “Virtue House” 28, Defence Co-Op Society, Nr. Navrachana School, Sama Road, Vadodara – 390008. Gujarat. Ph. : 91-265 – 2794158 / 98250 43523 Email: shankarbkm@gmail.com OR virtueinternationals@gmail.com
F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com Website : www.unikalindia.com
GMP. & ISO 9001 – 2000 Certified Company
AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products:
Products • Flexible Packaging Material • Paper Pouch • Aluminium Foil • Foil Seal • Ribbon Pack Pouch
Contact : Jignesh Patel : +91 94265 25388 +91 90163 36699
Kavya Packaging Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : kavyapack@yahoo.com
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I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / URINE BAGS / MEASURE VOLUME SETS ETC.
Manufacturers / Exporters / Hospital Suppliers Dealer are requested to Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • cannulaexpert2001@yahoo.co.in • amigo.surgicare@gmail.com Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India July. - Aug. 2015
Global Trends Impact Of New European Regulations On Outsourcing Of Medical Devices During the last two decades, there has been a steady increase in the outsourcing of medical device manufacturing to contract manufacturers, service providers, and component suppliers in European Countries.The medical device approval process in European Countries has generally been guided by national law where a conformity assessment is performed by a notified body and the device obtains a CE marking meaning it can be sold in the European Economic Area. However, over the past few years there has also been an increase in the frequency of recalls and increased scrutiny of the supply chain by regulators.The new European Medical Device Regulation (EMDR) places additional burden on manufacturers and their suppliers. Medical device companies will operate under a stricter regulatory environment in Europe following the approval of new regulations governing medical devices and in vitro diagnostics by the Council of the European Union. The Council proposes stricter requirements on medical device manufacturers, who would be required to: • Create a post-market surveillance system appropriate to a device’s type and risk class • Submit periodic safety update reports (PSURs) akin to pharmaceutical requirements • Appoint a person with “requisite expertise” in the field of medical devices to be responsible for regulatory compliance • Respond more quickly to public health threats or deaths linked to medical devices • Conduct clinical investigations demonstrating the safety and performance of highest-risk (Class III) devices • Consult with an expert panel to review the manufacturer’s clinical development strategy • Submit post-market clinical follow-up plans and post-market studies of an equivalent device, provided the device is designated as equivalent by the notified body, or designated as a modification of a device already marketed by the same manufacturer • Notified bodies will undergo a stricter designation process and increased monitoring by competent authorities, but they also will be given authority to carry out unannounced factory inspections
Labeling and Packaging If packaging and labeling is outsourced, then suppliers must invest in new equipment and software to implement on demand printing. Implementation of Revised ISO Standards In parallel with changes to the medical device regulations for Europe, the quality system standards (i.e., ISO 9001 and ISO 13485) will also be changing. ISO 9001:2015 is expected to be released in October 2015, and the DIS2 for ISO 13485:201x was just released for comment. If these revised standards are harmonized, then contract manufacturers will be forced to implement these changes in order to meet the CE Marking requirements. If contract manufacturers want to survive during this period of tougher European regulation, contract manufacturers and component suppliers need to be proactive and get additional training. Training needs to include general quality system requirements, EMDR. Suppliers should also consider developing new quality agreements to address the new regulations. (Ref: http://www.meddeviceonline.com https://www.linkedin.com/pulse http://www.mddionline.com
This means trial costs are going to increase as there would be a need to collect additional clinical data to demonstrate efficacy and safety of a medical device. The EMDR is also pushing for greater data transparency meaning companies will need to prepare data in a traceable and readily available way to respond to any liability issues. Increased Frequency of Audits Manufacturers are required to demonstrate control of suppliers and records of evaluating suppliers. The most common practice is to categorize suppliers as having either “critical” or “non-critical” status. Increased frequency of audits and audits of more suppliers will stretch the human resources of suppliers and manufacturers alike. Ultimately, manufacturers will need to consider alternative solutions to on-site audits, such as remote auditing and sharing audit reports with other manufacturers.
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July. - Aug. 2015
Industry News Provisions Of DPCO, 2013 Applicable To Notified Medical Devices: NPPA The National Pharmaceutical Pricing Authority (NPPA) has clarified that orthopaedic implants along with other medical devices will be treated as drugs, hence provisions of DPCO, 2013 are applicable to notified medical devices. Refuting the contention of the medical devices manufacturers, especially the manufacturers of orthopaedic implants, that the provisions of DPCO 2013 are not applicable to medical devices, the NPPA said, “Para 20 of DPCO, 2013 provides for monitoring of non-scheduled formulations. Orthopaedic implants along with other medical devices are notified as ‘drug’ under Drugs & Cosmetics Act & Rules thereunder. Therefore your contention that the provisions of DPCO, 2013 are not applicable to medical devices is totally incorrect.” It may also be noted that Para 25 of DPCO, 2013 requires every manufacturer/importer to issue a price list in Form V. Further Para 29 empowers the government to call for any record and to inspect such report at the premise of the manufacturers relating to
sales of the formulations, which include 14 notified medical devices. Accordingly, it has been decided to seek the following information/documents in order to examine price violation, if any, in respect of notified medical device, manufactured/imported/ marketed by the company, the NPPA further mentioned in its clarification. Earlier in May this year, the NPPA had sought detailed information about the prices of notified orthopaedic implants from the manufacturers to initiate stringent action if they are found to be charging exorbitant prices from the consumers in violation of Drugs & Cosmetics Act. The NPPA’s action was in the wake of reports in the media that the prices of orthopaedic implants regulated as ‘drugs’ under Drugs & Cosmetics Act & Rules thereunder, are sold at exorbitant price with high profit/trade margin. The NPPA had then asked the manufacturers of notified orthopaedic implants to provide details like product specification with brief description/literature for different types of notified medical devices manufactured/imported by the company
and other details like ex-factory price/ landed cost (including applicable duties); distributor cost; maximum retail price (MRP); and percentage of increase in MRP (year to year) in the last three years. The NPPA said that Para 20 of the DPCO, 2013 provides for monitoring the prices of non-scheduled formulations and to ensure that no manufacturer/importer/distributor is allowed to increase the MRP of a nonscheduled drug more than ten per cent of MRP during preceding twelve months and where the increase is beyond ten per cent, it shall reduce the same to the level of ten percent of maximum retail price for next twelve months. The manufacturers/ importer/distributor shall be liable to deposit the overcharged amount along with interest thereon, from the date of increase in price in addition to the penalty. (Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=89286&sid=1)
Gujarat FDCA To Meet Commerce Ministry To Seek Release Of Funds For Biocompatibility & Medical Device Testing Lab Gujarat Food & Drugs Control Administration (FDCA) is expected to meet commerce ministry to speed up the release of funds for setting up of the country’s first biocompatibility and medical device testing lab. The state drug regulator had earlier this year drafted a proposal to the Centre to sanction a budgetary allocation of Rs.15 crore for the same. The Engineering Export Promotion Council (EEPC) under the commerce ministry constituted to support the growth of engineering sector including medical devices has given positive response towards setting up of this lab. It is understood that the status of this ambitious proposal is in the final stages of approval. Dr. H G Koshia, commissioner of Gujarat FDCA informed that once the funds are released, the work on the project will be immediately commenced within the food and drug testing facility in Baroda. He said that getting funds from the Centre is the tough task as once that is cleared, they will be able to make progress quickly especially
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since they have already identified a suitable location within the building, which is located in the middle of the thriving industrial belt.
manufacturers, a process which is not only time consuming but also very costly for domestic manufacturers.
“The funds that we have sought is for infrastructural development, acquiring high tech equipments for testing and getting trained manpower. It is an ambitious project and will certainly help to support the industry in the long run, especially since, in spite of it being one of the growing sector, India does not have a biocompatibility and medical device testing lab in the country. If things go as planned, we hope to operationalise this lab as early as end of this year.”
Expressing strong support to this move, experts pointed out that this will not only offer an affordable option for the manufactures but will also instill confidence among the stakeholders. (Ref: http://pharmabiz.com/ ArticleDetails.aspx?aid=89485&sid=1)
It is understood that medical device manufacturers who wish to do business today are forced to pay huge price for their products to be tested by international testing agencies. At present, domestic manufacturers are forced to send their devices to other countries like Singapore to get their products tested before marketing it. International testing agencies do the biocompatibility study for them, generating the data and filing the reports for the July. - Aug. 2015
Industry News U.S.-India Business Council Concludes Successful Medical Device Trade Mission To India
The U.S.-India Business Council (USIBC) concluded its Medical Device Trade Mission to New Delhi and Gandhinagar. The delegation expressed its commitment to addressing India’s most pressing public health challenges, and called for further dialogue with the government on issues related to ease of doing business, disease management, and the implementation of training programs for medical device regulators.
The delegation was chaired by Maulik Nanavaty, Senior Vice President and President for Neuromodulation at Boston Scientific, and included participation from Abbott, Medtronic, Zimmer, Johnson & Johnson, Quintiles, General Electric, Varian Medical, and AZB & Partners.
Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking
“Through this series of fruitful discussions, we have identified opportunities to continue collaborating with the Government of India in support of its priorities to attract investment and talent to the medical device sector. India has made considerable strides in developing innovative industries across
a number of sectors and maintains strong potential to do the same in medical devices. With India’s first-rate engineering talent, experience in IT innovation, and the Modi government’s Make in India focus, it is even more important for the government and industry to work toward creating the proper ecosystem for medical device innovation. This will expedite the ongoing creation of research and development and product innovation that medical device companies offer India, leading to faster growth of medical device manufacturing in the country. The time is opportune to fulfill the government’s mandate of Make in India and Innovate in India,” said Maulik Nanavaty of Boston Scientific. Meetings with the Government of India included the Ministry of Health, Department of Industrial Policy and Promotion, Drugs Controller General of India, Ministry of Commerce, Ministry of Finance, Department of Pharmaceuticals, and the Ministry of Chemicals and Fertilizers. “USIBC
member
companies
encouraged by the openness of the Government of India to engage with industry on best practices and areas of potential collaboration. Discussions included the importance of developing a critical mass of patients with access to healthcare and improving patient awareness of healthcare costs. USIBC members noted in their meetings that they publish Maximum Retail Prices (MRP) on all medical devices sold in India. The Indian medical device industry is going through rapid transformation and is projected to grow at a higher rate as health insurance becomes more widely available and the country’s consumers continue to demand better healthcare services. USIBC’s medical device members are excited about the opportunities in India,” said Amy Hariani, Director and Legal Policy Council at the U.S.-India Business Council. (Ref: http://firstreport.in/news-release-u-s-indiabusiness-council-concludes-successfulmedical-device-trade-mission-to-indiafirstreportindiagmail-com-gmail/)
were
Manufacturer And Exporter Of a wide range Of Medical Devices
Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc... The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing. – Supply of Components for Medical Devices.
ANGIPLAST Private Limited
ISO 9001-2000
REGISTERED FIRM Wide Range Of Products :
The company manufactures a wide range of Medical devices, which fall under the main domains of : Infusion Therapy, Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery.
Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com
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July. - Aug. 2015
Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE
Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : HINDUSTAN SURGICAL Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, Village - Pithai - 387630. Ta.: Kathlal, Dist. Kheda, Gujarat. Email : hindustansurgical@yahoo.com Website : www.hindustansurgical.com Tele/Fax : (O) ++91-25440223 Cell :9824060964
Corresponding Address: HINDUSTAN SURGICAL Hasmukhbhai B. Patel 23, Manav Mandir Bungalows, Taxshilla Colony, Old Aradhana School Circle, B/h Ramannagar, Sukhipura, Maninagar, Ahmedabad - 380008 Email : info@hindustansurgical.com
SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • • • • • •
Urine Container Adaptors (PP) Regulators / Cord Clamp All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures PP Mucas Container And many other Surgical Medical Components
Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 28/29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (F) 22731656 (M) 9825474789 E-mail : sanidhya.ent@gmail.com 34
July. - Aug. 2015
National Healthcare An ISO 9001 : 2008 Company
Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.
Injection Moulded Medical Components and Extended Tubes :
PACK-EQUIP (Mfg. Packaging Machinery) 91, Avnish Society, Opp. Pavitrakunj Society CTM Cross Road, Amraiwadi Ahmedabad-380 026 Phone : 25855027 (M) 9825380739
I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.
Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in
ISO : 13485 : 2012
JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 &
CERTIFIED COMPANY
Manufacturers & Exporters of Disposable Medical Devices Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, Dressings etc.
Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850
E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com July. - Aug. 2015
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Events
Since its première in 1992, every year, COMPAMED has taken place in Düsseldorf during the middle of November in parallel to the world’s largest medical trade fair, MEDICA, and since its start, it has been writing its story of success. Always scoring top results in reference to the number of exhibitors and visitors on a yearly basis, COMPAMED has long since developed into the leading international marketing communication platform for suppliers of the medical technology industry. It’s not just the numbers that are right with, for the first time, more than 700 exhibitors from 37 nations during last year’s trade fair. Also the quality of the range of offers has changed through the years and has continuously improved at the same tempo the changes in the medical technology market have. Where, at one time, simple parts, components and equipment for technical devices and medical products had primarily been presented, today, COMPAMED is a hotspot for complex high-tech solutions.
and valves, among other things), materials/ substances, microand nanotechnology, made-to-order manufacturing, electronic manufacturing services (EMS), complex manufacturing and equipment partnerships (e.g. OEM – Original Equipment Manufacturers) as well as packaging and services.
This is because, nowadays, suppliers and medical technology providers are cooperatively driving the development of new systems and processes in close coordination. In the process, the development competence of the suppliers, in part, is often the point of origin for groundbreaking innovations with regard to efficient and effective medical care.
All information can be accessed online at http://www.compamed.de and http://www.medica.de.
The success of COMPAMED can also be explained by this close integration of development processes on behalf of the suppliers as well as their customers. Holding MEDICA in parallel creates the ideal conditions for exhibitors. Thereby, COMPAMED is the ideal place for suppliers to exchange information with medical technology providers and system partners. Alone the approximately 4800 exhibitors of MEDICA are also potential visitors of COMPAMED. A significant change concerning the running time of COMPAMED and MEDICA will open up more opportunities to establish an intensive level of contact, do business, or even coordinate joint projects. For the first time, both specialist trade fairs will be taking place at completely the same time during the course of four days from 16 to 19 November. The market for medical technology and medical products is very dynamic. The innovation cycle is considerably shorter than is the case in other industries. The German medical technology manufacturers make about a third of their sales with products that haven’t even been introduced on the market for more than three years. In accordance with this, it is necessary for every specialist who deals with product development in the medical field to continually keep themselves up-to-date. The product range at the COMPAMED trade fair (in halls 8a and 8b) includes the following key branches: Components for medical technology (electronics, components, hoses, filters, pumps,
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In parallel with the world’s largest medical trade fair, MEDICA 2015, being held at a single time and a single location, it will cover the entire medical technology supply chain – from individual components to measuring techniques and quality testing through to sterile, packed end products. This coordinated tandem of trade fairs and topics is a one of its kind event and a significant success factor for both events. In 2014, MEDICA + COMPAMED welcomed a total of 130,000 specialist visitors, around 17,000 of whom were particularly interested in the topics covered by COMPAMED.
Events Calender • Medicall 2015 14th Edition Medicall 2015. Date : 9th - 11th October, 2015. Venue : Bombay Convention and Exhibition Center • COMPAMED 2015 High - Tech Solutions For Medical Technology Date : 16th - 19th November, 2015. Venue : Dusseldorf, Germany. • Plastivision Arabia 2016 Region’s Leading Plastics Event Date: 10-13 January, 2016 Venue: Expo Center, Sharjah. • 13th National Conference And Technology Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016. Date: 12-13 February, 2016 Venue: Ahmedabad Management Association, Ahmedaad. • Medical Fair India 2016 22st International Exhibition and Conference Date: 11-13 March, 2016 Venue: Bombay Convention & Exhibition Center, Mumai. July. - Aug. 2015
Operon
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July. - Aug. 2015
July. - Aug. 2015
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: Attention :
MEDICAL PRODUCTS MANUFACTURERS FOR
Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact :
Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com
Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products T-Oxygenator • Endotracheal Tube(Plain & Cuff) Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block Ventilator Circuit • Inflatable Anaesthesia Mask Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems Breathing Filters(HME & BVF) • Airovent T-Humidifier Resuscitator(Ambu Bag) • Dialflow Regulator Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer Stylet • 3 Ball Spirometer Guedel Airway • Three-way Stopcock Nasopharyngeal Airway • Extension Tubing for Infusion Laryngeal Mask Airway Systems Mallaeble gum Bougie • Pressure Monitoring Line
• • • • • • • • • • • • •
Contact : Anil Gupta +91-90999 15731 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com
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High Concentration Mask
Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber
Breathing Filters
Airovent T-Humidifier
Anaesthesia Circuits
Incentive Spirometer
ET Holder with Bite Block
Expandable Catheter Mount July. - Aug. 2015
GMP ISO - 9001-2008 Certified Company
S. Nath & Co.
MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
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I.V. Infusion Sets
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Blood Administration Sets
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Scalp Vein Set
Excellence in Quality
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Urine Collection Bags
Manufacturer & Exporter of Surgical Disposable Products since 1980
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Ryles / Feeding Tubes
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Catheters and Tubes
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Surgical Gloves.
IDEAL® • Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address
S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com
BASIL manufacturers PVC COMPOUNDS according to the customer requirements of strength, flexibility, x-ray traceability, transparency, colour and extraction resistance. BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Opaque Tubes • Flexible PVC Layflate Film For Medical PVC Bags • RF Welded Medical Bags for I.V. Fluid, Enema etc. • DEHP free Medical Grade PVC Compound • Injection Moulded Parts like PVC Chambers, Roller Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products.
BASIL POLYMERS 3-B, Verdan Exclusive, Near Stadium Petrol Pump, P. O. Navjivan, Navrangpura, Ahmedabad – 380014. Phone : 079-26565981 - 82 - 83 Mobile : 9909036411 / 9824045178 E-mail : basilpolymer@gmail.com www.basilpolymers.com July. - Aug. 2015
Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS
4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com
Venus manufacturers PVC COMPOUNDS according to the customer requirements of strength, flexibility, x-ray traceability, transparency, colour and extraction resistance. VENUS MEDICAL DISPOSABLE are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set, X-Ray Opaque Tubes • L. D. Tube For Carman Cannula • P. P. Stick For Urinbag. • Henging Tube For Urinebag
Venus
MEDICAL DISPOSABLE 15/a, Bhagirath Estate, Vibhag - 3, Jawaharnagar, B/h. Indiranagar, Amraiwadi, Ahmedabad–380026. Phone (F) : 079-22749329 (R) : 079-26621269 Mobile : 098240 32063 E-mail : vs.6163@rediffmail.com 40
Extrusion Molding Assembly
Your Single Source Provider
RAUMEDIC Components for Extra-CorporealCirculation (ECC)
RAUMEDIC – your partner for customized polymer solutions for medical and pharmaceutical industry applications.
Examples of RAUMEDIC extrusion and molding capabilities include components for Extra-Corporeal-Circulation. In this area we supply a complete range of semi-finished articles – all from one source.
RAUMEDIC’s expertise in material science, design, prototyping, tool making, engineering, R&D and Regulatory Affairs means successful development from customer concept to full CE marked products.
ÆÆ RAUMEDIC ECC PVC tubing ÆÆ RAUMEDIC ECC noDOP tubing ÆÆ RAUMEDIC ECC silicone tubing ÆÆ RAUMEDIC ECC connectors
RAUMEDIC is certified to ISO 13485 and manufactures under clean-room conditions ISO 14644, class 7 and according to GMP standards.
Additionally we offer silicone u-bends as well as accessories including silicone tubing for hypothermia circuits, multilumen tubing, spiralled tubing and funnels.
Please send your inquiries to: India@RAUMEDIC.com Contact: REHAU Polymers Pvt. Ltd. – Kamalnain Kurra – Mobile: 9850955508 – Fax: 02135-304800 www.RAUMEDIC.com
SMF0291 & SMM0291 Coupling Body & Coupling Insert, In-Line Hose Barb, Straight Thru Many CPC® Couplings Available
Non-Luer Shown Assembled
23202 Spike, Vented, Vented Cap FLS Connector
C1122 Medallion® COP Syringe MLL
97348 3 Part Torquer
80189 Needleless Injection Site, Swabbable, FLL, MLS, One Way Check Valve
20023 High Pressure FLL to Rotating MLL Connector
80185 Check Valve, FLL Inlet MLL Outlet
33043 3-Way Stopcock Tubing Port, FLL, ML with Spin Lock
80345 Tuohy Borst Adapter with Flat Cap, MLL Connector with Spin Lock
80326 Hemostasis Valve Y Connector Rotating MLL and FLL Sideport
80170 Needleless Injection Site, Swabbable with Break-Off Tip
28217 Hydrophilic Filter with FLL Inlet, MLS Outlet
80191
Swabbable Pre-Slit Transfer Valve
32302 Introducer Needle Super Sharp Tip with Protector Thin Wall
All trademarks and registered trademarks are the property of their respective owners
Qosina stocks thousands of OEM disposable components and offers excellent customer service including free samples, low minimums and immediate delivery. Visit Qosina.com to see over 5000 stock components, request samples and a catalog. +1 631-242-3000
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qosina.com
info@qosina.com
150-Q Executive Drive, Edgewood, NY 11717
8/13/2015 1:57:49 PM