The new medical ecosystems of the open innovation.

The report of "United States-Japan Economic Harmonization Initiative" made a suggestion that the progress of IT creates innovational change for the medical industry in Japan ( 2-1 ). In general, the principle of open source strategy will promote a business opportunity. There are some benefits to adopt the open-source approach to the medical industry. For this purpose, "open source activity" is one of the innovational methods to create new values in especially medical fields.

On the contrary, there are some rules and regulations in the medical field because they have an obligation to protect human life. They might sometimes have obstacles that prevent medical innovation on the basis of the open source strategy. One of the obstacles in the medical field is regulations of the telecommunications law for the patient's safety and QOL, it might occasionally prevent technological innovations. Recently, it is good news for developers making mobile platforms in both the drug and medical device areas that FDA released its final guidance on Mobile Medical Application in September 25, 2013 ( 2-2 ). The guidance defines mobile applications and mobile platforms, and explains what is subject to agency oversight. Therefore, it is very important for the new medical market to consider a blueprint of the open source movement because there are some useful approaches to create new values of open digital networks. For example, the concept of General Public License (GPL) that is based on the open source is the most famous license to distribute products and works. Equally important is FRAND Licensing which will be worthy of note for R&D process of new drugs (2-3). These announcements will lead user community and provide the reliable and robust systems. The strategy can also support these systems in a broad application range to promote commerce and business. Moreover, it is important to consider these new trends in making decision for R&D cost with the cooperative open source because the cooperative relationship will change the traditional R&D process ( 2-4 ). In other word, the open-source announcement of shorter length of patent and smaller cost of imitation will change the attitudes of inventors who will choose not to patent and keep the innovation secret. Therefore, there are other options such as GLP and FRAND licensing if the inventor will not want to hold the patent for a long time. The choice will provide a new strategy for open-innovation whether inventors and developers will take a process with collaboration or an unaided operation, considering patent length and imitation cost (2-5). The imitational method with cooperative license will promote open-innovational movements that are a powerful method for creating new medical products.

Under the circumstances of the new medical ecosystems, the new relationship between patients with developers are able to get informational common property each other from new medical technologies such as clinical digital databases, imaging, and treatment analyzing by artificial intelligence (2-6). The approach concurrently allows medical developers, researchers and patients to run multiple operations on the same physical and material factors for useful medical treatments, and promotes enhanced medical solutions support for new drugs and medical devices. Using the new corroboratory networks, pharmaceutical companies can access closely with patients to choose of their treatment, drugs, and the design of medical examinations. In short, it can provide patients various medical options for their medical treatment.

Reference

2-1) UNITED STATES-JAPAN ECONOMIC HARMONIZATION INITIATIVE. (FEBRUARY 2001).

2-2) Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (September 25, 2013.)., Strategic Plan for Risk Communication at the FDA. (April 15, 2009).

2-3) The Evolving IP marketplace (Federal Trade Commission., March 2001.)., Policy Statement on Remedies for Standards - Essential Patents Subject to Voluntary F/RAND Commitments. (January 8, 2013).

2-4) PATENT ASSERTION AND U.S. INNOVATION (June 2013)., Universities seek to boost industry partnerships. (Nature., 2014, 509, 146.)

2-5) Patent-free pact pushes the boundaries of precompetitive research., (Nature Medicine., 2014, 20, 564)., Imitation Is More Valuable Than Innovation. (Harvard Business Review, April 2010)., Innovation, imitation, and new product performance: The case of China. (Industrial Marketing Management., 2006, 35, 394-402)., Innovation, imitation, and growth with cumulative technology. (Journal of Monetary Economics., 2003, 50, 361-380., Real options valuation of pharmaceutical patents. A case study. ( http://ssrn.com/abstract=1547185)

2-6) New platforms aim to obliterate silos of participatory science. (Nature Medicine., 2014, 20, 565-566)., Systematic review: Effects, design choices, and context of pay-for-performance in health care. (BMC Health Services Research., 2010, 10, 247.)