The Office of Reference Materials (ORM) manages business operations, administrative oversight, product sales, and technical support for the NIST Standard Reference Material (SRM) program. The MML produces about 90 percent of the total SRM NIST-wide.1 The office houses associated physical and cyber infrastructure to produce, package, store, and market SRM products and then sell them to customers worldwide. There were significant improvements to the ORM e-business platform that have increased productivity, efficiency, and customer relations. The ORM delivers its mission successfully with direct alignment of the NIST mission to support U.S. industry and commerce.
ASSESSMENT OF TECHNICAL PROGRAMS
In contrast to the MML divisions, ORM functions as a stand-alone e-commerce business operating within the constraints of a federal agency. This presents unique business, staffing, and technical challenges that are differentiated from other units within the MML. The assessment of ORM’s technical programs thus differs from that which applies to the divisions.
The ORM can list a number of accomplishments that are aligned with its mission and programmatic goals. The number of sales of SRM products totals approximately 32,000 units per year, resulting in roughly $21.5 million in income. The sales group of six people and one group leader fields more than 10,000 customer inquiries per year, including requests for quotes and technical information. More than 10,000 orders are shipped each year. The top 15 sales products for fiscal year 2019 are show in decreasing order of sales.
The customer base for ORM products consists of 52 percent, U.S. industry; 45 percent, international industry; 2 percent, U.S. federal government; 2 percent, foreign government; and 1 percent, state and local governments across all major industrial sectors. International sales have been increasing steadily and now account for nearly half of all sales.
Opportunities and Challenges
Packaging and storage concerns are a significant risk to the current operations and business model of ORM. The lack of sufficient facilities specifically related to bio-economy related SRMs limits ORM from moving into emerging markets that require good manufacturing practices (GMP) and other requirements. Product packaging and distribution is a significant fraction of ORM activities. Yet, ORM lacks expertise and partnerships for new packaging capabilities needed for anticipated products. Outreach
1 Steven Choquette, National Institute of Standards and Technology, 2020, “NIST/Office of Reference Materials Overview,” presentation to the panel, September 9.
TABLE 3.2 Top Selling Standard Reference Materials in Fiscal Year 2019
|2096||High-Energy Charpy V-Notch Specimens (NIST-Verification, 8-mm Striker)||1,632|
|2092||Low-Energy Charpy V-Notch Specimens (NIST-Verification, 8-mm Striker)||1,627|
|8671||NISTmAb, Humanized IgG1K Monoclonal Antibody||1,101|
|84l||Potassium Hydrogen Phthalate Acidimetric Primary Standard||712|
|1849a||Infant/Adult Nutritional Formula I (milk-based)||607|
|1640a||Trace Elements in Natural Water||551|
|114q||Portland Cement Fineness Standard||480|
|1921b||Infrared Transmission Wavelength/Wavenumber Standard||419|
|927e||Bovine Serum Albumin (7 % Solution) (Total Protein Standard)||362|
|1976c||Instrument Response Standard for X-Ray Powder Diffraction||353|
|17f||Sucrose (Optical Rotation)||325|
|46h||Portland Cement Fineness Standard||314|
|1976b||Instrument Response Standard for X-Ray Powder Diffraction||309|
|1950||Metabolites in Frozen Human Plasma||301|
|2709a||San Joaquin Soil Baseline Trace Element Concentrations||283|
NOTE: SRM is the inventory number (left-most column).
and partnerships with industry leaders may contribute to innovative solutions for ORM packaging and e-business platform modernization. Lastly, ORM briefed on storage infrastructure being at or close to capacity, particularly in the context of unstable products that require special handling, such as cold storage.
RECOMMENDATION 3-1: The Office of Reference Materials (ORM) should plan and host a series of topic-focused workshops with participation from industry, academia, and other government organizations to benchmark and identify state-of-the-art business practices, ecommerce tools/platforms, marketing and sales operations, packaging, and other areas critical to its operations. As part of such an undertaking, ORM should assess the appropriateness and feasibility of outsourcing portions of its operations or the expanded use of public-private partnerships to increase efficiency of its operations including standard reference material fabrication, storage (inventory control), packaging, and other critical operations.
PORTFOLIO OF SCIENTIFIC EXPERTISE
The portfolio of expertise of ORM is aligned with its mission as a stand-alone business unit and does not lend itself to direct comparison to other MML divisions. Of the 37 staff members, 32 percent are scientists, 24 percent are technicians, 35 percent provide administrative or other program support, and a further 8 percent are associates. This make-up is thus distinct from that of the divisions. The scientific and technical staff collaborate with peers in research divisions to produce and document existing SRMs and perform the necessary research and measurements to create new SRM products as they are needed by industrial customers.
ORM successfully manages the development, marketing, sales, and distribution of a vast inventory of SRMs to national and international customers. These SRMs are procured directly from ORM and utilized extensively by industry in broad sectors, including food and nutrition, manufacturing, biotechnology and pharmaceuticals, and chemicals. Many of the SRMs are long-standing offerings that are augmented by new SRMs developed in partnership with other units across the MML via a Working Capital Fund.
Opportunities and Challenges
International competitors are utilizing and leveraging the growth of SRM market to gain competitive advantage in emerging industry sectors, and ORM exists in an increasingly competitive market. ORM balances the market demand for recertifying existing products with the development of new SRMs in partnership with the MML research divisions. This tension stretches resources and may hinder ORM’s ability to anticipate and respond to industry needs for SRMs in time—particularly for emerging growth sectors. ORM recognizes the need for better strategic selection, focused investment, and shorter development times for new SRM products. Opportunities exist at the MML level to promote and incentivize the development of new SRMs through division(s)—ORM partnerships that align with the needs of industry.
RECOMMENDATION 3-2: The Office of Reference Materials should develop processes and procedures to strategically select and prioritize the use of working capital funds toward high-demand products, which can maximize the throughput and return value; and examine methods to accelerate and evaluate the development of these new standard reference material products. The evaluation can be used to further promote and/or incentivize the MML division-level SRM development.
ADEQUACY OF FACILITIES, EQUIPMENT AND HUMAN RESOURCES
ORM relies on the analytical and research facilities in 18 divisions across four NIST laboratories to make appropriate measurements in support of mission delivery. ORM has facilities and equipment that support SRM preparation, packaging, and shipping. The office is allocated a 20,000-square foot building for storage (approximately 800,000 units in bulk and packed), sample preparation, and shipping operations. Some products require controlled temperatures while stored, and ORM maintains close to sixty −80°C freezers, seven walk-in −20°C freezers and four walk-in 4°C refrigerators. In support of the growing need for biological SRMs, ORM has two 40-liter liquid N2 (nitrogen) freezers to store tissue samples from the Hollings Marine Laboratory.
DISSEMINATION OF OUTPUTS
ORM relies on marketing and dissemination of its product offerings, and the office has made great progress since 2017 in its e-commerce operations and platforms. Yet, opportunities exist to better communicate its products, engage the community for input on new products, outreach to broader future science, technology, engineering, and mathematics (STEM) generations, and advance its critical role in the nation’s competitive economic position. Internally, it appears that MML staff members have a varied understanding of SRM business operations. Incentives for greater participation in development of SRMs in MML division staff were not readily apparent. Externally, there are extensive partnerships and
engagement with industry and other SRM producers worldwide. These are important, yet largely transactional with limited specific strategic engagements. There are significant opportunities for MML and ORM to increase strategic engagements to improve marketing, especially on the e-commerce business context, of existing programs and garnering input for emerging product needs.
RECOMMENDATION 3-3: The Office of Reference Materials (ORM) should conduct informational symposia and workshops to better communicate the vital role that ORM plays in the mission of NIST and to highlight success stories. The office should also provide more systematic evaluation feedback and greater incentives for MML division staff to more effectively and efficiently develop new standard reference materials that are aligned with the needs of industry.