A Consideration of Combinations of Drugs, Medical Devices and Body Parts with the Bio-networks Syste

A Consideration of Combinations of Drugs, Medical Devices and Body Parts with the Bio-networks System

     In general, combinations among various types of industry are useful approaches for innovation. Recently, millions of people worldwide have the opportunity to be involved in various fields such as informational technology, electrical appliances and mechanical engineering on the internet. However, it is very difficult to make adaptions in the field of medical treatments. Noteworthily, innovational approaches for the development of medical treatments would be slow because it should be carefully evaluated in the point of effectiveness, safety and quality for a long times under the jurisdiction of the authorities. Actually, there is a lot of room to open up innovational medical products, but the developments of drugs (including bio-materials), medical devices and biological products (including tissue engineering) are gradually developed as individual parts, not combinational approaches.

     Recently, some authorities are making guidelines of combinational products concerning its definition, quality controls and clinical trials. For example, the FDA introduced the definition of combination products1); “a combination product is a product composed of any combination of a drug and a devices; a biological product and a device; a drug and a biological product”. In addition, a product comprised of two or more regulated components. As a matter of fact, the concept to be applicable to a combinational product is hard to understand because the guidelines in a progress stage are still complicated to introduce and create a combinational product for nonprofessionals who are intend to enter into the medical market from outside of their area of expertise. From another point of view, in the case of Japan, there are ongoing debates between manufactures of drugs and medical devices over how to determine a combination or non combination product according to regulations. For example there is confusion over the process of categorizing a existing product as combinational or non combinational. In addition, they might confuse to make a product design to fall into several categories. Due to the ambiguous categorization process, many developers are unable to begin the design of combinational products.

     Now, I am considering the strategic transformational strategy in the medical field; “Bio-networks strategy2)” that is based on digital networks of the human body. The fundamental point is to use vital signs and digital signals on networks in medical treatment for creation of harmony among drugs, medical devices and “body parts”, that means tissue engineering. The strategy will lead the modern medical treatments to innovational approaches because a medical treatment of drugs, medical devices and body parts (tissue engineerings) must encourage combination approaches among them with digital signals. Thus, the establishment of the harmonious digital relationship among drugs and medical devices and body parts for future medicine is just around the corner.

     At present, there are already some innovational medical devices such as CT and MRI, however, their developments are still partially limited to imaging analysis. In the near future, the imaging medical technology will be the fusion of drug treatments and examinations of medical devices on digital signals upon demand, the bio-networks will promote the harmony of combinational treatments. In the end, the movement will bring a lot of benefits to innovational creators for innovational medical tools in the new era of medical digital standardization.

Reference

1) Combination products: http://www.fda.gov/CombinationProducts/

2) Bio-networks strategy: https://nmtbaron.amebaownd.com/