Medical Devices – Design Control, Verification & Validation

June 28, 2017 by · Leave a Comment
Filed under: Medical Devices 

Design to Value in Medical Devices – As price pressures increase, medical device makers need to rethink product development processes. Design to Value can help get costs under control—and deliver exactly what customers
value, says a McKinsey Report.

Medical Device manufacturers need to bring back the focus on “Design Thinking” in product development. Globally healthcare sector is moving towards creating affordable healthcare solutions and Design plays a crucial role in churning out value for money solutions.

Exclusive session for Product Development Teams in Medical Devices Manufacturing space in Chennai on July 14,2017 by Dr.G.S.Bhuvaneshwar at Hotel Savera, Mylapore, Chennai. Fee is Rs.6000 + tax per participant.

Please click here for Training Brochure
Please click here for Registration Form

 

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BIO ASIA 2017 @ HYDERABAD

January 13, 2017 by · Leave a Comment
Filed under: Healthcare, Medical Devices 

Dear AiMeD Members,

Greetings!!!

It is our pleasure to inform you regarding the 14th BioAsia being organized by the Government of Telangana in partnership with the Government of India and with support from AiMeD. This event will take place from February 6-8, 2017 at Hyderabad International Convention Center.

In light of the partnership with AiMeD, our Members will be entitled to a special discount of 50% on the registration fee (MOU enclosed).

The event will serve as a networking platform for about 1500 industry leaders, corporates, healthcare & medical professionals from over 50 countries. The event will feature about 50 start-ups with extraordinary promise to transform the life sciences and healthcare sectors.

BioAsia 2017 will feature a focused conference and CME on Automation in Diagnostics on February 7th and will bring together PoC users, regulators, diagnostic companies and suppliers to also discuss future of rapid testing, automation challenges, quality control, legislation, diagnostics, and the future of PoCT going forward. More information is available at www.2017.bioasia.in

The likes of Dr. Paul Stoffels (J&J Worldwide Chairman of Pharmaceuticals & CSO), Dr. Patrick Vallance (President Worldwide R&D, GSK), Mr. Narayan Murthy (Founder, Infosys), Nobel Laureate Prof. Kurt Wuthrich (Scripps Institute), among others have already confirmed their participation.

Given the participation of policy makers, R&D institutes and industry leaders, we would like to encourage our members to take part actively in the deliberations.

click here for the Catalouge / Brochure 
click here for the AiMed Mou
click here for the Bioasia 2017 Speakers list

Registration enquiries can be forwarded to Ms. Paridhi Gupta at paridhi@biofaba.org

Warm regards,

Rajiv Nath
Forum Coordinator
Association of Indian Medical Device Industry (AiMeD)
GL-3, Ashoka Estate,
24, Barakhamba Road,
New Delhi – 110 001
Ph. +91-129-4289000/4061151
Fax. +91-129-4061164 & 2233242
E-mail : forumcoordinator@aimedindia.com
Web : www.aimedindia.com

Medical Electronics Manufacturing in India – Seminar/Roadshow by #AMTZ – Andhra MedTech Zone @Chennai on January 6,2017- Hotel GRT Grand Days, T Nagar

According to an industry report, in India, the medical devices industry is small, with a disproportionate reliance on imports and a complex regulatory environment. The global medical devices and technology market is expected to grow to USD 520 billion by 2020 from an estimated USD 3.7 billion in 2014. The Indian market is among the top 20 in the world by market size, and fourth in Asia after Japan, China and South Korea. It is significantly behind developed economies like the United States (US) (USD 340). This current under penetration of Medical devices in India represents the sizeable growth opportunity.

Medical devices play a role not only in screening, diagnosing and treating patients, but also in restoring patients to normal lives and in regularly monitoring health indicators to prevent diseases.

The inflow of foreign direct investment (FDI) in medical devices was USD 90 million between December 2014 and August 2015; post the government permitting 100 per cent FDI under the automatic route. Several MNCs have been increasing their manufacturing footprint and locating research centres in India to serve both the Indian and global markets. Increased funding and investments have also reflected in other supply-side changes in healthcare delivery in India.

AMTZ (Andhra MedTech Zone) aims to make India a self-sufficient and in fact an exporter of good quality and cost-effective medical technology. The AMTZ would include the following facilities:

  • Plug-n- Play Infrastructure
  • Regulators’ office
  • Component testing centre
  • Electromagnetic interference laboratory
  • Medical-grade low vacuum molding, cabinet molding and injection molding centres
  • 3D designing and printing for medical grade products
  • Sterilisation & toxicity testing centre
  • Radiation testing centre
  • Warehousing
  • Other facilities commonly required in the manufacturing of medical devices

Against this backdrop PHD Chamber in association with AMTZ (Andhra MedTech Zone) is organizing the above captioned Seminar on ‘Medical Electronics International collaborations & Financing for Manufacturing’ in India on Friday, 6th January 2017, 10:0 am at Chennai.

Venue – Hotel GRT Grand Days, T Nagar – Marigold Hall in the convention center – Annex Building

image001

Registration form – 6th Jan 2017

The objective of the Seminar would be to familiarize the Industry on this opportunity which exists in fulfilling this gap which is likely to only widen as the healthcare services reach out to semi-urban and rural areas.

The seminar will also throw up opportunities for foreign collaborations for technology transfers and financing for setting up units.

We believe that for medical electronics to create a meaningful impact on the healthcare system, collaboration between key stakeholders including government, industry, healthcare providers, and health insurance companies will be important in order to come up with the right success strategy and improve overall health care access and delivery in the country.

This will also create an outlook towards the future and shaping the interventions required for a self-reliant and efficient healthcare system for India through technology solutions for the larger good.

We look forward to having you with us for the discussion on this important aspect of Medical Electronics.

Please note that there is no delegate registration fee. Since event participation is limited to few members, prior registration is a must.

Regards,

 

Vivek Seigell

Director

PHD House, 4/2 Siri Institutional Area

August Kranti Marg, New Delhi – 110016, India

Tel: +91.11.26863801-04

+91.11.49545451 Ext: 275

Fax:+91.11.26855450

+91.11.49545451

Bill separating medical electronics & devices from drugs soon

June 28, 2013 by · Leave a Comment
Filed under: Healthcare, Medical Devices 

The Ministry of Health & Family Welfare has proposed a new Bill bifurcating medical electronics & devices as separate entities from drugs. The Bill will be presented in Parliament soon and once enacted as law, it will give medical devices sector a new lease of life.

 

This was disclosed in New Delhi recently by Dr. A K Panda, Joint Secretary, Ministry of Health & Family Welfare, while addressing the global congress on ‘Investment Opportunities in Medical Electronics & Devices’ organized by FICCI in association with the Ministry of Health and Family Welfare on the theme ‘Harnessing Medical Technology for Inclusive Healthcare in India.’

Read more

Health Ministry revives steps to table pending bill on medical devices in monsoon session

June 27, 2012 by · Leave a Comment
Filed under: Medical Devices 

Health Ministry revives steps to table pending bill on medical devices in monsoon session

June 27, 2012, 0800 IST – Source : Pharmabiz News

 The Health Ministry has initiated steps to push the long pending bill on medical devices with the consent of the States and hopes to table it in the Parliament during the monsoon session. The Ministry held a meeting recently with stakeholder associations like FICCI and the Association of Indian Manufacturers of Medical Devices, apart from the senior officials from the Central Drugs Standard Control Organisation (CDSCO) to discuss the issue. In the face of continuing opposition from some States, the meeting decided to follow up the activities to secure the assent of all the States, sources said. Besides, the Ministry is also reportedly under pressure from Prime Minister’s Office to table the bill in the Parliament at the earliest so that the growing medical devices sector would get a much needed impetus in the form of regulatory mechanism. “The proposed amendment to the Drugs and Cosmetics Act (D&C Act) will lay down separate provisions for Medical Devices. The salient features of the bill would be to provide a separate definition of Medical Devices, their risk based classification for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions, etc.,” sources said. Currently, medical devices are treated as drugs. With only 14 notified devices regulated under the D&C Acts, thousands others remain unregulated in the country. The industry, which opposed the moves to increase the number of devices under regulation, wanted separate guidelines and definition for medical devices. Meanwhile, many States are still opposed to the bill but assent of all the States are required as health is under the concurrent list. The Ministry had circulated the draft among the States, after revising it on the basis of the recommendations by the Parliamentary Standing Committee attached to the Health Ministry. The bill has been pending now for over four years. Hoping that the bill will go to the Parliament during the monsoon session, the ministry had already sought Rs. 205 crore from the Planning Commission to set up regulatory mechanism for the sector during the next Five Year Plan period.

SEMINARS @ MEDICALL 2012

June 21, 2012 by · Leave a Comment
Filed under: Medical Devices 

SEMINARS @ MEDICALL 2012

Medicall Seminars are a big hit with the medical fraternity. The topics are chosen with great care for their relevance to stakeholders of the healthcare industry.

“Chain Reaction” is the theme for Medicall 2012.

Healthcare delivery chains in ophthalmology, dentistry & diagnostic path labs have carved a niche for themselves and are growing at a healthy clip. It’s time to take stock of this growth, discuss about the problems therein and identify opportunities for future.

Medicall 2012 has invited eminent speakers, who have walked the talk of promoting healthcare chains. Entrepreneurs, professional experts representing engineering, design, supply chains, turnkey consultants, medical administrators & top notch surgeons will not only be sharing their experiences of setting up similar chains but they will also be elucidating the value proposition.

Two days of immersion seminars focused on the whole gamut of a healthcare delivery chain are waiting for you. Any doubts or questions relating to the setting up of a new business, to the scaling up existing ones, any grey areas to be sorted out when you plan to expand or strategize an acquisition will be addressed by professionals, who have been there and done that.

Nominate your best minds viz., the Hospital Manager,CEOs, the Medical Administrators, the Physicians and / or Surgeons who are keen to wear a grey coat in preference to a white coat. 3rd to 6th AUGUST 2012 CHENNAI TRADE CENTER, CHENNAI INDIA

3RD AUGUST 2012 Topic Duration Mints Date Time
IT for Chains Health vault – Wealth in clinical data 45:00:00 Friday 3rd Aug 10:15 to 11:00
Supply Chain Management JIT supplies for Just care 45:00:00 Friday 3rd Aug 11:15 to 12:00
Branding Hospitals – A consumer brand? 45:00:00 Friday 3rd Aug 12:15 to 1 pm
Lunch
Remote Managing Practice Acquisition – Pitfalls & Potential 45:00:00 Friday 3rd Aug 2:15 pm to 3 pm
Eye care Eye 20-20, Secret formula of success/Wal-Mart of Eye care 45:00:00 Friday 3rd Aug 3:15 pm to 4 pm
Dental Care teething problems while setting up a dental chain 45:00:00 Friday 3rd Aug 4:15 pm to 5 pm
4TH AUGUST 2012
Chain Reaction
Oncology Care Emperor of all maladies- we need a cancerous growth of cancer centers 45:00:00 Saturday 4th Aug 10:15 to 11:00
Pharmacy How to maximize profits in a pharmacy 45:00:00 Saturday 4th Aug 11:15 to 12:00
Diagnostics What is the Business? Diagnostics or Logistics? 45:00:00 Saturday 4th Aug 12:15 to 1 pm
Lunch
Dialysis Do Nephrology Departments leak profits? 45:00:00 Saturday 4th Aug 2:15 pm to 3 pm
Finance for Chains Hospitals in ICU! Help! We need Funds! 45:00:00 Saturday 4th Aug 3:15 pm to 4 pm
Diabetes Life style diseases & Chronic Care 45:00:00 Saturday 4th Aug 4:15 pm to 5 pm
5TH AUGUST 2012
Hospital Infrastructure Sunday 5th Aug
Critical Care Sunday 5th Aug
Hospital Property Mela Healthcare real estate investment opportunity in India. Sunday 5th Aug 10:00 am to 5:00 pm
How to identify the right healthcare property.
 In- and Out-sourcing Real Estate Functions: Case Studies from Healthcare Systems
Medical mall – the need for hour
Recent trends in healthcare infrastructure
Technology Showcase Sunday 5th Aug
Technology Showcase for Dealers & Distrbutors

FOR MORE DETAILS VISIT http://medicall.in/medicall/Conferences-%20at-%20MEDICALL-2012.php

Govt mulls new norms, tax sops to revive SEZ boom

It could be a second innings for special economic zones, especially those held up for years, with the commerce department proposing fresh tax concessions and a cut in the minimum area requirement to a quarter of the present specifications.

The department has suggested that any zone that is not built around the identified 40 million-plus cities and state capitals would be eligible for duty benefits on capital investment for construction of hotels, hospitals, schools and colleges, residential and business complexes and training, leisure and entertainment facilities in what is billed as non-processing area (NPA) infrastructure. Sources said that the zones will be eligible for the tax concession if they are built 50-100 km from an urban conglomerate and facilities have to be for exclusive use of SEZ employees.

In case of SEZs constructed in 123 backward districts, this infrastructure can also be used by those who are not part of the zone, a 48-page note said. At present, the rules specify that NPA can’t exceed half the area of an SEZ.

In addition, the department wants to extend the benefits of export schemes to SEZ units, that are already available to entities outside the zone, to make up for the levy of minimum alternate tax and other tax concessions that were withdrawn by finance minister Pranab Mukherjee last year.

Further, nearly half the funding available under Aside, a scheme to build infrastructure for exports, may be allocated for building connectivity and infrastructure in SEZs.

Amid a flurry of SEZ development, which many had termed as real estate activity, the government decided to withdraw tax concessions and phase out several of them. According to the commerce department, since February 2006, 585 SEZs have been approved and 381 have been notified, with a majority of them related to information technology and IT-enabled services.

Exports from SEZs are in of Rs 3 lakh crore and account for over 28% of the shipments from the country. In all, over Rs 2 lakh crore has been invested in SEZs so far and over 7 lakh people are employed in development and running of the zones and companies located there.

The number could have been much more but several projects ran into land acquisition hurdles. To tide over the land problem, the commerce department has proposed not just cutting the minimum area requirement but also changing the rules for contiguity. If the department’s proposal goes through, a multi-product SEZ could be built over 250 hectares instead of the minimum floor area of 1,000 hectares at present (see table). In case the zones are planned in the special-category states, which include the North East and the hill states, the minimum area requirement is proposed to be cut from 200 hectares to 50 hectares.

Further, within the multi-product zones, more flexibility is proposed to be given in creating sector-specific areas if the land area is exceeded. For instance, if a multi-product developer has 270 hectares, it can have one multi-product zone and two others of 10 hectares each for, say, handicrafts and gems and jewellery. There will also be the option to build four sector-specific zones of 10 hectares each in case a developer has 40 hectares land.

There is concession planned for IT SEZs too with the commerce department suggesting that the minimum land requirement of 10 hectares be done away with. Also, the requirement of one lakh square metres of built-up area would be insisted upon only if the IT or ITES zone is in Delhi (NCR), Mumbai, Chennai, Hyderabad, Bangalore, Pune and Kolkata. In case of 15 category B towns, this requirement is proposed to be fixed at 50,000 square metres and 25,000 for all other cities.

There are other provisions too which are aimed at helping developers tide over the problem of land acquisition. For instance, the commerce ministry has suggested that continuity between the processing area, which houses the manufacturing units and related logistics, and NPA may not be instead upon. “You can have several gates which are manned by SEZ personnel to allay fears related to physical contiguity in case there are highways or water bodies,” said an official.

If the move goes through, developers can have over 50-60% of the processing area in one plot of land, while residential quarters, hospitals and schools can be built on another patch even if it is at a distance.

A commerce department official said the land norms were being changed as acquisition had become difficult and the government was trying to push for setting up of the zones in smaller towns and cities.

Source: The Times of India

ISO 10993-10:2010 Biological evaluation of Medical Devices – Part 10 Tests for irritation and skin sensitization

October 21, 2010 by · Leave a Comment
Filed under: Medical Devices, Uncategorized 

In order to ensure that medical devices do not irritate the skin or eyes, or cause other adverse reactions, ISO has published a testing standard for checking their safety prior to marketing and use.

ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization, describes procedures to assess medical devices and their constituent materials (including release of chemicals), so that they do not pose risks when in contact with human tissue.

Extra care has been taken to minimize the need for testing on animals, and ensure their well-being by encouraging the use of in vitro (not conducted in living beings) tests whenever possible. Project leader of the standard, Wim De Jong explains “Traditionally, small animal tests have been performed prior to testing on humans to help predict human response. More recently, in vitro tests as well as human tests have been added as adjuncts or alternatives.
“Despite progress and considerable effort in this direction, animal testing is still often required for reliable results and to ensure human safety. However, ISO 10993-10 now opens the possibility that in vitro tests take place prior to animal testing to identify risk. Furthermore, the standard aims to reduce the number of animals used, with a step-by-step approach, with review and analysis of test results at each stage.”

ISO 10993-10 requires that studies apply Good Laboratory Practice and comply with regulations related to animal welfare. The standard is intended for use by trained professionals.

This third edition replaces the previous version published in 2002, which has since been technically revised.
ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization, was developed by ISO/TC 194, Biological evaluation of medical devices, and is available from ISO national member institutes .

Medical devices sector seeks abolition of List 37 to help domestic units

July 20, 2009 by · Leave a Comment
Filed under: Medical Devices 

Medical devices sector seeks abolition of List 37 to help domestic units
July 04, 2009, 0800 IST – Source : Pharmabiz NewsWith the finance minister Pranab Mukherjee is all set to present his budget on July 6, the Association of Indian Medical Device Industry (AIMED) is hoping that some measures would come through to protect the interest of the hugely potential sector which has been ignored continuously in the previous budgets.

 

“The medical device market which is currently mainly import dependent needs a special focus and infrastructure development status at least for the next four years. In order to make the Indian industry globally competitive, there is a need for a holistic development and to regulate the industry for which Inter-ministerial coordination is required between the Ministries of health, finance and science and technology,” AIMED principal forum coordinator Rajiv Nath said.

In a recent representation, AIMED has pleaded with the government to consider creation of a new Medical Export Promotion Council to promote export and to check custom impasse on the border. It suggested that the name of Pharmaceuticals Export Promotion Council should be changed into Medical Export Promotion Council for enabling the inclusion of lab ware, diagnostics and medical tourism with medical devices. Medical devices are not medicines, so it should be treated as a separate industry.

AIMED had appealed to the ministry for the abolition of List 37 which consists 111 medical and surgical instruments and appliances. Abolition of List 37 will encourage development of domestic industry.

According to this List, duty on import of components is higher than imported finished devices. This marks a huge loss for the indigenous industry and inhibits growth of Indian manufacturers. Importation of Blood Collection Tube (BCT), used for collection of blood for testing, attracts a custom duty of 7.5 per cent while import of components i.e. glass tube and cap fall under custom duty at 10 per cent which is higher than the finished product. In order to develop the indigenous market, the rate of custom duty on BCT as finished product must be increased from 7.5 per cent to over 10 per cent and custom duty on imported components should be reduced from 10 per cent to 5 per cent, the association said.

AIMED is an apex umbrella association of 700 manufacturers producing a wide range of products like medical disposables, medical diagnostics, medical electronics and medical equipments and implants.

 

Medical devices industry needs to focus on alliance and R&D, NIPER study

June 22, 2009 by · Leave a Comment
Filed under: Medical Devices 

Medical devices industry needs to focus on alliance and R&D, NIPER study
June 4, 2009, 0800 IST

The fast growing Indian medical devices industry should increasingly focus on setting up alliances with multinational companies (MNCs) and add thrust to the research and development activities to provide modern equipments at low cost, in order to win the market and reduce dependence on imports, according to a latest analysis.

The Indian medical devices market is estimated at Rs 5750 crore with a growth rate of 23 per cent expected in the coming years. The market for medical supplies and disposables is dominated by the domestic manufacturers. The diagnostic equipment market is reported at Rs 2000 crore, surgical equipment supplies and imaging services at Rs 1300 crore each and electronic treatment devices at Rs 1000 crore, according to a latest sector analysis conducted by the National Institute of Pharmaceutical Education and Research (NIPER) – Ahmedabad. The total medical devices supplies and services market is estimated at Rs 7455 crore with a growth of more than four per cent from previous year, according to the analysis.

However, around 50 per cent of the market needs are satisfied with imports, mostly of specialised products, from countries like US, Japan, UK, France, Finland and Germany whereas the Indian companies are catering low cost common medical devices to the Indian healthcare market, comments the NIPER – Ahmedabad analysis submitted to the Department of Pharmaceuticals.

At present, high value medical devices products like cancer diagnostic, medical imaging, ultrasonic scanning, plastic surgery equipment and polymerase chain reaction (PCR) technologies are mostly imported in India. The analysis based on the level of technology involved in the manufacture of devices indicates that the import of high-end technology products have increased during 2001-06.

For instance, the import of LCDs, laser, other optical appliances and instruments has grown at 34.36 per cent, instruments and appliances used in medical, surgical, dental sciences including electro-medical apparatus and sight-testing instruments at 15.65 per cent, orthopaedic appliances and artificial parts of body at 23.23 per cent, radiotherapy instruments, X-ray generators and screens at 26.81 per cent, during the period.

“One possible reason for higher dependence on imports can be traced back to low level of R&D spending by Indian medical devices industry. Moreover, import duty exemption for devices and technologies that are not available in India in turn encourages the import rather than investing in domestic R&D and manufacturing; also, domestic manufacturers cannot offer their products at a competitive price against that of the imported products that have the benefit of tax exemption,” explains the study.

Having an alliance with overseas companies will give an edge to the Indian companies in terms of huge product basket, advanced products and technologies and technical expertise, which will help the domestic players in turn, to widen their business scope. Alliances like Wipro-GE and R&D alliances like Piramal Healthcare-Morvus Technology Ltd are some of the examples of successful partnership models for Indian medical devices companies.

Further, the level of R&D spending should also be addressed by the Indian firms. According to the study, the level of R&D spending in the medical device and diagnostics industry, as a percentage of its sales, has been consistently increasing from 5.4 per cent in 1990 to 12.9 per cent in post 2000. While western companies are ready to conduct their R&D in India in collaboration with local partners, the Indian industry is seldom investing in R&D, it shows.

The industry, which is focusing to bring in low cost products affordable to the end users, has to increase their R&D efforts for cost effective methods of developing products. Bringing down the cost of medical devices or manufacturing low cost devices can be achieved through intensive and continuous R&D efforts, high levels of process automation in the manufacturing facilities, striking manufacturing alliances with foreign companies to manufacture them locally so as to cut logistics and other import-related duties and taxes, lowering product registration fee and other documentation costs.

The low levels of health insurance coverage, recent stringent regulatory amendment in the country, high import duties which tends to escalate the cost of medical devices, poor medical infrastructure facilities and low level of awareness about the latest technologies in rural parts of the country are the challenges in the growth of medical devices segment, according to the study.

 

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