Standardization is an Important Strategy for Differentiation
Standardization refers to proposing new analytical techniques or other regulatory content to organizations that create regulations, such as the International Organization for Standardization (ISO), in an effort to have the proposals adopted as standardized rules. Competitors in Europe and the United States are actively engaged in creating regulatory rules. Laws and regulations do not mandate or recommend using products from a particular company, but sometimes they name the company that developed the default technique in the comment section of related documents. That makes it naturally easier to use the products or techniques of companies that were involved in creating rules. Furthermore, regulations often cite the analysis method or other standard technique for compliance with the regulation, making compliance with the standard a selling point for selling to users. That is why manufacturers in Europe and the United States invest so much effort on standardization as part of their differentiation strategies.
Shimadzu started focusing efforts on standardization strategies during the previous medium-term management plan and will accelerate those measures during the new medium-term management plan as well.
Specific Standardization Measures
Though standardization measures are being implemented in various fields, it takes 3 to 5 years for a proposed product or technique to be included in a regulation. That means activities started during the previous medium-term management plan might bear fruit this year or the next year at the earliest.
Though I cannot mention specifics here, one example in the environmental field is the efforts to unify and standardize the techniques used to pretreat microplastics. Microplastic analysis can result in completely different data depending on the pretreatment technique used. That prevents obtaining internationally comparable data about pollution circumstances using different pretreatment methods for analysis. Therefore, we are involved in internationally unifying analytical techniques, including pretreatment methods, and also developing products and application technologies useful for determining the actual status of microplastics. In addition, we are involved in standardizing the analytical conditions for analyzing PFAS* pollution in water and cooperating in establishing a variety of regulations for material informatics in material fields or for analyzing components with functional properties in food fields.
Nexis GC-2030 Gas Chromatograph Used to Analyze Impurities in Hydrogen and Ammonia Gases
In some cases, we have targeted global ISO regulations from the beginning, but obtaining acceptance as an ISO regulation involves a lot of work, because it requires approval by each applicable country and region throughout the world. Therefore, we used a variety of approaches for promoting standardization of various techniques, such as first achieving standardization in JIS or JAS regulations before achieving standardization in ISO regulations.
The new medium-term management plan also specifies implementing “green” transformations (GX). One such GX field is methanation technology for achieving the carbon neutrality of natural gas. Methanation essentially refers to technology for generating methane gas from CO2 and hydrogen and is being worked on by gas companies around the world. Conventional methane gas products are generated from liquid natural gas (LNG), but that process emits CO2. In fact, Japan will prohibit the sale of methane gas generated from LNG starting in 2050. Gas is analyzed using conventional gas chromatographs (GC), but analysis is difficult using existing systems. Consequently, the first company to develop the products, applications, and techniques for analyzing gas components will have a major advantage. Shimadzu currently has the second-largest market share of the global GC market, but developing such techniques before competitors would presumably be a game-changer.
However, considering that various countries and regions are investing the equivalent of trillions or tens of trillions of yen to promote GX technologies, it is unlikely that a single company will capture anything close to 100 % of the market. Despite the common misconception, ISO regulations do not specify just one standard. If other scientifically valid and equivalent technologies are available, ISO regulations can specify multiple standards. In the case of GX technologies, for example, I think ISO might end up specifying separate Japanese, European, and American methods. However, if Japan does not participate in the process of establishing international standards, then only the Japanese method will be missing from international standards.
In fields where standardization is difficult for Shimadzu, it is also difficult for competitors. Therefore, once a market is established, we need to promote standardizing techniques as soon as possible to ensure our market share keeps growing in that market.
- * Per- and polyfluoroalkyl substances (PFASs) are artificially synthesized organofluorine compounds.
Training Human Resources
Previously, standardization efforts at Shimadzu were mainly implemented by taskforce-like organizations. However, now standardization measures are strategically and systematically implemented by the International Standardization Group established in the Research & Development Management Department in April 2023.
Global deployment will first begin in North America. Actually, however, since there are already employees at our North American subsidiaries with experience working at U.S. government agencies, we will start standardization efforts in corresponding fields. That approach has already resulted in adoption in an ASTM standard. In addition, support for application development and other ASTM standardization activities is also being provided from Japan. Next, we intend to start deploying similar measures in Europe and Asian regions as well.
Expect Great Things from Shimadzu in the Future
For over 30 years I worked in a role of creating regulations and standards at the Japanese Ministry of Economy, Trade and Industry. Those that create regulations and standards create them in cooperation with partners and professionals they can trust. Rather than simply complying with rules, those involved in creating the rules can ensure ideal rules are created and can also enjoy business advantages. Many Japanese think of standards, regulations, and rules in the world only as something created by countries and that must be followed without question. Shimadzu used to share that view as well. Therefore, at first we were unsure whether Shimadzu could really achieve standardization. Creating new standards/regulations can take 3 to 5 years without enjoying any benefits and there is no guarantee cooperation with regulatory bodies will result in actually influencing a regulation or standard. Initially, the divisions would ask us how standardization would contribute to next year’s profit. However, after many small successes, standardization is now referred to within Shimadzu as a business strategy.
In the future as well, we intend to continue training standardization personnel and work to accelerate the process from initial development to looking ahead to standardization. Therefore, expect great things from Shimadzu in the future.
Biography of Fuminori Inagaki,
Senior Managing Executive Officer
In Charge of Standardization Strategy (CSO) and Medical Regulatory Policy
Deputy in Charge of Corporate Strategy Planning and Global Environmental Management (GX)
| Apr. 1982 | Joined Ministry of International Trade and Industry | |
| Nov. 2006 | Director, Trade Policy Division, Trade Policy Bureau, Ministry of Economy, Trade and Industry (METI) | |
| Jul. 2010 | Deputy Director General for Policy Evaluation, Minister’s Secretariat, METI | |
| Apr. 2011 | Director, Nippon Export and Investment Insurance (NEXI) | |
| Jun. 2015 | Joined Shimadzu Corporation, Managing Executive Officer deputy in Charge of Corporate Strategy Planning and Corporate Marketing | |
| Jun. 2017 | Managing Executive Officer in Charge of Global Environmental Management and Deputy in Charge of Corporate Strategy Planning and Corporate Marketing | |
| Apr. 2021 | Managing Executive Officer in Charge of Standardization Strategy (CSO), Global Environmental Management, and Medical Regulatory Policy, and Deputy in Charge of Corporate Strategy Planning | |
| Apr. 2023 | Senior Managing Executive Officer in Charge of Standardization Strategy (CSO) and Medical Regulatory Policy, and Deputy in Charge of Corporate Strategy Planning and Global Environmental Management (GX) (current) |
