A recent decision by the Federal Circuit Court (the court of appeals that hears all patent appeals) may have just rung the bell commencing an "open season" on the infringement of medical device patents. 

The Vietnamese medical device market is estimated at US$400 million and is expected to grow at about 12 percent annually. Experts believe that the Vietnamese market will double over the next seven years, as the country further develops.

To grow in the new environment, device companies must deploy a new mix of sales resources, recognize the changing role of doctors, and shift focus from doctor to account, thus helping their hospital accounts manage through their own organizational upheavals and ongoing cost pressures.

For many mature and well-controlled processes, there would appear to be no value-add and no useful decrease in risk to be gained by arbitrarily imposing aseptic processing guidelines onto device manufacturing production lines.

Changes being made to the U.S. Patent system, will affect applications filed after March 16, 2013 and change the playing field for filing patents across the device sector – including large corporations, smaller companies and start-ups.

Many medical device companies are sourcing or manufacturing their products in Asia now and this trend will continue to grow in the future. While there are many benefits to sourcing in Asia, it is also important to remember potential problems that may arise. Picking the right Asian location and partner is the key to your success.

Thinking of marketing your product in China, India or Brazil? What do you need to know?

It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedicalDeviceSummit presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.