Category — Medical Technology

Owens & Minor Acquires Halyard’s India Surgical Business

Alpharetta, GA-based Halyard Health will divest its India subsidiary surgical business to Virginia-based Owens & Minor for $710 million — a transaction that confirms investor appetite and growing opportunities in India’s healthcare sector.

The sale gives Halyard a singular focus on its medical devices business. The company said it would benefit from “a more simplified structure, enhanced management focus and significant firepower to invest in growth” through research and development and M&A.

Doctors conducting surgery

Halyard will provide IT and other transition services to Owens & Minor for at least one year after closing the deal as they integrate the acquired Surgical and Infection Prevention business. Owens & Minor will also offer transition services to Halyard.

February 16, 2018   No Comments

India Simplifies Licensing for Medical Device Manufacturing

Per India’s Medical Device Rules, 2017 that came into effect in January this year, new licenses awarded for manufacturing and import of medical devices will not need periodical renewal and will remain valid until they are either suspended, cancelled, or surrendered. The licensee will need to pay a retention fee once every five years for the license to remain valid.

India’s federal regulator, the Central Drugs Standard Control Organization has launched Sugam, an online portal, to facilitate granting licenses for manufacturing, import, clinical investigation, sale and distribution of medical as well as in vitro diagnostics devices.

Authorities will inspect manufacturing sites  annually ensure compliance to the terms and conditions stipulated in the licenses. Manufacturers are required to follow a quality management system for manufacturing medical devices.

Blood pressure monitor

February 15, 2018   No Comments

India Regulator to Review Stent Price Controls

In July 2016, the Government of India decided to cap the prices of drug-eluting and bare-metal stents, and in February 2017, the ceiling price of bare metal stents was set at $108, while the price of drug-eluting stents was set at $442 before taxes, which for some products was a reduction in price of as much as  75%.

Some  U.S. companies, including Abbott and Medtronic, sought to stop selling some of their stents in India’s market, but were told that they must continue to sell.

India’s National Pharmaceutical Pricing Authority said it imposed the price controls after hearing from officials who claimed large multinational stent companies charge widely varying prices for devices that produce the same results. The authority said none of the importers could provide scientific evidence that their newer and more expensive stents work better than previous versions. Economic data gathered on stents in India showed the markups on imported stents “were exorbitant and irrational, indicating  ‘profiteering’ at every level and mostly at the level of hospitals,” the authority’s minutes. “

Howver, a study conducted for Washington-based med-tech trade group AdvaMed found that this price cut has not led to “significant increase in total number of angioplasties performed per month; across different hospital segments or the corresponding decrease in angioplasty costs for patients paying out of pocket expense.”

Abby Pratt, Advamed’s vice president of global strategy and analysis , said research shows that local hospitals and distributors are responsible for the high cost, not the stent importers. “The question is, what can the government do to step in and bring about greater transparency and greater efficiency in the supply chain, and tackle probably some of the corruption that exists in the supply chain? Singular focus on controlling price of devices without attempting to address the larger picture will not improve patient access. We need to consider alternatives to price control such as trade margin rationalization and more scientific approaches that facilitate differential pricing for innovative medical technologies.”

The stent price cut decision comes up for its annual review this month.

Sahajanand Medical Technologies Stent

Sahajanand Medical Technologies Stent

January 26, 2018   No Comments

Startups in India’s Defense Sector Forge Ahead

With the Government of India permitting 100 percent foreign direct investment in India’s defense industry, many startups in India’s private sector have started to design technologies that can be used in manufacturing defense equipment.

Bangalore-based Aadyah Aerospace builds electro-mechanical actuators, control actuation systems and electro-optics systems for missiles and launch vehicles.

Since military equipment can’t always be tested on the field, CM Envirosystems, another Bangalore-based startup designs and manufactures environmental test chambers which simulate real environmental conditions. The company provided these environmental test systems for Agni, India’s ballistic missiles program.

A smartphone with Start Up displayed on it

Samhams Technologies, ideaForge and Omnipresent Robotics are creating better quality drones that can be used in cloudy and foggy environs.

Entrepreneur says that biotech engineer Leo Mavely, founder of Axio realized the importance of the untapped healthcare market in the defense sector. His product Axiostat is a sterile, single-use haemostatic dressing intended to be used for temporary control of moderate to severe bleeding of wounds. Malvey added that the company has supplied these dressings to one hundred battalions in India, and have also shipped around 350,000 units worldwide.

Bangalore-based Tonbo Imaging makes digital imaging systems for equipment such as guns, unmanned aerial vehicles, and battle tanks. It earns nearly 80% of its revenues from the Indian defense services. This startup specializes in products such as advanced night-vision cameras, fire control systems, and advanced weaponry through “nature-inspired technology.”

December 29, 2017   No Comments

Indian Startup Uses Artificial Intelligence to Detect Breast Cancer

NIRAMAI, an acronym for Non-Invasive Risk Assessment with Machine Intelligence, uses thermography and machine learning to detect early signs of breast cancer. Founders of Bangalore-based startup Niramai Health Analytix, Dr. Geetha Manjunath, a PhD in computer science and Nidhi Mathur an MBA from the Indian Institute of Management, Bangalore, developed an AI-led diagnostic platform that uses patented thermal image processing and machine learning algorithms for reliable and accurate breast cancer screening.

Cancer Screening Images by Niramai

Cancer Screening Images by Niramai

This method of screening can detect tumors 5 years before mammography or a clinical exam can. The portable and  screening tool, called SMILE, has been tested on data from 300 patients, and results indicate an accuracy comparable to current diagnostics available. The AI and ML algorithms for the analysis of thermal images have resulted in 2 granted U.S. patents and many more patent applications.

“Our method of breast cancer screening can detect tumors 5 times smaller than what clinical exams can detect, is painless, non-contact and free of any radiation, apart from being low-cost, and universally accessible. With our solution, women of all age groups can undergo frequent screening without any side-effects. We are addressing a huge breast cancer screening market with the equipment market alone expected to reach $4.14 billion by 2021,” says Niramai.

December 18, 2017   No Comments