With the increase of diabetes prevalence in Asia and the rise of Asia’s middle classes, the demand for newer and better treatments will provide opportunities for Western medtech companies.
There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.
There are usually only losers in patent litigation, so the best strategy is avoidance.
The doctor struggles to understand how the observation extracted from the warning letter referenced in this week’s guidance managed to rise to the level of a Form 483 Observation.
Global sports medicine is predicted to grow to around $35 billion by 2022, with the Asian market growing at a compound annual growth rate of nearly 7 percent.
The medical device industry has more than its share of challenges, from regulations and changing business environments to the need to drive down costs and compete on price, all the while accelerating their ability to accelerate the process from order entry to order fulfillment.
The removal of communication barriers and ambiguity allows technology providers to focus on their own inherent system benefits.
Technology should streamline the healthcare process for both patients and clinicians.
Increased prevalence and awareness of neurological disorders in Asia present market growth opportunities for neurology companies.
The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific status, raising questions regarding the regulations applicable to this medical innovation.