Max Neeman expands key-hole surgery devices trial services in India

Max Neeman International, a contract research organization (CRO), has formed a team of experts in minimally invasive surgery as part of its efforts to expand the service offering in medical devices trials in India.

Max Neeman International new team of physicians include some of the best minimal access surgeons in the country who have performed more than 25,000 procedures combined, the company said in a press release.

Max Neeman has already conducted multiple minimally invasive device trials for top device companies.

The new specialized team will add another level of expertise for conducting minimally invasive surgical studies across multiple therapeutic areas.

Patient numbers have been as high as 300 with major focus on peripheral vascular disease, gastric surgery and laparoscopy, recently.

Medical devices and supplies market in India is expected touch USD 1.7 billion in 2010, growing at the rate of 23% annually in the coming years from the current Rs. 5750 crores, according to a recent sector report by National Institute of Pharmaceutical Education and Research by (NIPER), Ahmedabad.

Among the segments in the medical devices market diagnostic equipment leads with Rs. 2000 crores, surgical equipment supplies worth Rs 1300 crores comes second and imaging and electronic treatment devices follow with Rs 1300 crores and  Rs. 1000 crores respectively.

India has also finalized the guidelines to the manufacture, import and sale of medical devices under Schedule M III.

The Drugs Technical Advisory Board (DTAB) which provides technical guidance to the Central Drugs Standard Control Organization – the apex body to regulate drugs and cosmetics – under the ministry of Health and Family Welfare has submitted the final draft of the guidelines on medical devices to the drug controller.

The medical devices and equipment are currently notified as drugs are regulated under the Drugs & Cosmetics Act and Rules. However, the guidelines will apply to inspections and other requirements Schedule M III.

The new guidelines Schedule M III which comes as extension to the Schedule M under India’s Drug and Cosmetics Act that stipulates norms for the manufacturing and sales of pharmaceutical products in the country.

Max Neeman International’s partner, Max Healthcare has over 800 beds and 12 hospitals throughout the country and is one of the leading hospital chains in India.Max Healthcare has 1500 physicians and over 225 ICU beds.

Max Neeman International offers services for the successful conduct of Phase II-IV clinical and device trials for small and mid-sized international and national pharmaceutical, biotechnology, medical device and nutraceutical companies in compliance with ICH GCP standards.

Max Neeman is an ISO 9001:2000 certified CRO for monitoring, site management and data management Services. The company is presently active in 22 cities with 5 regional offices.

In September 2009, Max Neeman announced a partnership with Max Healthcare to open a Phase I/IIa clinical trial unit at Max Super Speciality Hospital, New Delhi, India.

This proof of concept unit will offer services to pharmaceutical, biotech & device companies the option to complete a critical part of the development process across multiple therapeutic areas.

The new Phase I/IIa unit will evaluate compounds/devices developed both in India and in other countries. This unit will provide end-to-end services and will have approximately 24 beds, with plans to expand this number to 50 to meet predicted growth in demand.