Since taking the CEO seat at Medtronic PLC last year, Omar Ishrak has set the multinational on two principal paths. The first path extends Medtronic’s reach into emerging markets, a popular destination for US and European health care companies seeking to tap into those countries’ surging economies to offset stagnant growth in their home markets. The second, less prominent, path is so-called reverse innovation, a philosophy Ishrak brought over from his time as CEO of GE Healthcare, the $12 billion subsidiary of General Electric. (See Also see "Reverse Innovation: Is The US Losing Its Edge In Innovation?" - In Vivo, 24 January, 2012..) Historically, the US medical device industry has been rewarded for innovation that provides better clinical outcomes. But competing in emerging markets – and ultimately in developed markets – also might require device makers to produce tools that provide good-to-adequate outcomes at lower prices.
Medical Device Market & Industry Briefs, October 2012
Brief summaries of recent medtech market and industry developments. This month we cover Medtronic’s acquisition of Kanghui, Greatbatch’s new R&D center in Singapore, the outlook for the ICD/CRT market, and Cook Medical’s newly launched ENT unit.
More from Asia
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.
Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
More from Geography
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.