A Five-Year Strategy for Product Innovation

As part of “Innovation 25,” the Ministry of Health, Labor & Welfare (MHLW); the Ministry of Economy, Trade & Industry (METI); the Ministry of Education, Culture, Sports, Science and Technology; and relevant representatives from the industry and academia developed a five-year strategy for the creation of innovative drugs and medical devices. This strategic plan is a package of potential future policies that are designed to support the development of innovative medical devices and drugs from the R&D stage to market launch, with a goal of making these industries a driver of national growth. The idea is to streamline the potential guidelines to ensure delivery of the most advanced drugs and medical devices to Japanese people more quickly and to aim toward Japan developing and bringing to market new products at similar—if not better—rates compared with other leading countries. The strategy includes:

• Concentration of resources

• Support of venture companies

• Development of a clinical trial infrastructure

• Partnership with Asian countries

• Faster evaluation and improvement of quality

• Adequate assessment of innovation

• Frequent dialogue between public and private sectors

Especially with respect to medical devices, the following subjects were featured in this plan:

• Promotion of strategic standardization of medical devices

• Consolidation of parts/module supply

• Support of entrepreneurs and networking of experienced retired people

• Promotion of international clinical trials

• Promotion of bioengineering/tissue engineering

• Centralization of investigators and IT support for clinical trials

• Education and training of support staff to clinical trials and regulatory affairs

• Dissolution of “device lag” (significant delays with introducing a device into the market in comparison with timelines seen in other leading countries)

• More reviewers for medical devices

• Reconsideration of user fees

• Concretization of reviewing methods and standardization

• Promotion of rationalization and simplification of document review

• Improvement of Good Clinical Practice management

• Joint consultation among the United States, Europe and Japan for international clinical trials

In addition, in order to motivate the incentives for development and commercialization of medical devices, the report promotes that medical devices be fairly and adequately assessed within a framework of a sustainable national health insurance system.

As a practical step, the MHLW and METI had a joint meeting to promote the faster development and quick evaluation of “next-generation medical devices” and exchanged views on five selected device categories including a DNA chip, an artificial heart support system, navigation surgery, implants made by biocompatible materials and tissue regeneration. The result of this discussion was a recommendation that guidance be drafted for development and evaluation (including engineering and clinical criteria) for ensuring smooth clinical trials and continued evaluation.

The MHLW also promotes the early introduction of devices in high demand. Armed with strong requests from medical academies, the MHLW prioritized 13 high-demand medical devices, such as an implantable artificial-heart support system, a vertical expandable prosthetic titanium rib (VEPTR), a thoracic aortic stent-graft, a carotid artery stent, an artificial vessel, an intravascular embolic material and so on. The agency called for Internet-based instruction for developers (or suppliers) of those devices regarding practical methods of conducting clinical trials and application for bringing devices to market quickly. Obviously many companies applied their devices, among which implantable heart support system and VEPTR were first evaluated by the special working groups and reported to the panel.

Yoshio Mitsumori is the president and CEO for Tokyo-based ADMIS, a consultant specializing in the medical device industry. He has more than 25 years of experience in the medical industry, including positions with the Itochu Corp., U.S. Surgical, National Medical Enterprises and Century Medical. A member of RAPS, he has spoken at many industry events and worked extensively in international trade of medical products and technologies. He can be reached at [email protected].