Mesa Laboratories, Inc. and its subsidiaries (Mesa) is a global leader in the design and manufacture of life sciences tools and critical quality control solutions for regulated applications in the pharmaceutical, healthcare, and medical device industries.
Mesa offers products and services to help the company’s customers ensure product integrity, increase patient and worker safety, and improve the quality of life throughout the world. The company has manufacturing operations in the United States...
Mesa Laboratories, Inc. and its subsidiaries (Mesa) is a global leader in the design and manufacture of life sciences tools and critical quality control solutions for regulated applications in the pharmaceutical, healthcare, and medical device industries.
Mesa offers products and services to help the company’s customers ensure product integrity, increase patient and worker safety, and improve the quality of life throughout the world. The company has manufacturing operations in the United States and Europe, and the company’s products are marketed by its sales personnel in North America, Europe, and the Asia Pacific; and by independent distributors in these areas, as well as throughout the rest of the world.
The company sells a significant number of products to distributors and other channel partners that have valuable relationships with customers and end-users.
Strategy
The company strives to create stakeholder value and further its purpose of Protecting the Vulnerable by growing its business both organically and through acquisitions. As a business, it commits to its purpose of Protecting the Vulnerable every day by taking a customer-focused approach to developing, building, and delivering its products and services. By delivering the highest quality products and services possible, the company is committed to protecting the communities it serves.
The company’s revenues come from product sales, which include consumables and hardware, and services, which include discrete and ongoing maintenance, calibration, and testing services. The company grows its revenues organically by expanding its customer base and the company’s product offerings, increasing sales volumes, and implementing price increases, as well as inorganically through acquisitions.
The company’s acquisition strategy is focused on businesses that complement its existing portfolio and those that expand the company’s global presence further into life sciences tools and critical quality control solutions markets for regulated applications.
The company focuses on improving its operating efficiency through the Mesa Way, which is its customer-centric, lean based system for sustainably improving and operating the manufacturing and administrative aspects of the company’s high-margin, niche businesses. The Mesa Way is based on four pillars:
Measure what matters: The company uses its customers’ perspectives to measure what matters most and to set high standards for performance. The company manages to leading indicators whenever possible, which drives the company to proactively avoid problems before they are apparent to the company’s customers.
Empower Teams: The company moves decision making as close to the customer as possible and provide real-time communication forums to align the whole organization toward surpassing customer expectations.
Sustainably Improve: The company leverages a common and proven set of lean-based tools to identify and prioritize opportunities and to enable change to be embraced and implemented.
Always Learn: The company ensures that improvements are maintained, enabling the company to raise performance expectations and repeat the cycle of improvement.
Segments
The company operates through four segments or divisions: (1) Sterilization and Disinfection Control, (2) Clinical Genomics, (3) Biopharmaceutical Development, and (4) Calibration Solutions.
Sterilization and Disinfection Control
The company’s Sterilization and Disinfection Control division manufactures and sells biological, chemical and cleaning indicators used to assess the effectiveness of sterilization, decontamination, disinfection and cleaning processes in the pharmaceutical, medical device, and healthcare industries. The division also provides testing and laboratory services, mainly to the dental and pharmaceutical industries.
Biological indicators contain spores of certain microorganisms that provide defined resistance to specified sterilization processes. In use, biological indicators are exposed to a sterilization process and then tested to determine the presence of surviving organisms. The company grows the microbiological spores used in its biological indicator products from raw materials and applies them to convenient carriers, such as small pieces of filter paper or stainless steel discs for sale. To ensure the company’s biological indicators accurately assess the effectiveness of sterilization, the company undertakes extensive quality control steps during manufacture to ensure the spores are well-characterized in terms of purity, the population of spores, and the spores’ resistance to sterilization following placement on or in the target carrier.
The company offers a variety of product formats, which allow its biological indicators to be used in many types of processes and environments. The company’s biological indicator products include inoculated carriers, such as spore strips or discs which require post-processing transfer to a growth media; self-contained indicators, which have the growth media already pre-packaged in crushable ampoules; process challenge devices (‘PCDs’), which increase the resistance of the biological indicators; and growth media. The company’s simple spore strips are used most often in small table-top steam sterilizers in dental offices, while the company’s more complex self-contained biological indicators, which may be used with or without PCDs, are frequently used by medical device manufacturers to assure sterility in complex ethylene oxide sterilization processes. The company also offers testing services in which customers return used dental sterilization spore strips to the company’s microbiological laboratory for testing.
Chemical indicators use a chemical reaction, generally evaluated by a color change, to assess sterilization conditions. Type 1 process indicators measure whether direct exposure to a sterilization process has occurred. Type 2 specific-use indicators test under a specific procedure, such as testing for air removal in a pre-vacuum steam sterilization cycle. Type 3 single-variable indicators test a single critical variable in a sterilization process, for example, whether a given temperature has been attained. Type 4 multivariable indicators measure two or more critical variables in a sterilization process and change color only, for example, when exposed to a given temperature for a specified period of time in a steam sterilization process. Type 5 integrating indicators respond to all critical process parameters. Type 6 emulating indicators respond to all critical process parameters for a specified sterilization cycle. Biological indicators and chemical indicators are often used together to monitor processes.
Cleaning indicators are used to assess the effectiveness of cleaning processes, including in washer-disinfectors and ultrasonic cleaners in healthcare settings. Cleaning is the critical first step performed prior to disinfection and sterilization. Debris left on an instrument may interfere with microbial inactivation and can compromise disinfection or sterilization processes. The company’s cleaning indicator products are manufactured either by inoculating a test soil onto a stainless-steel coupon or printing an ink, imitating a test soil, onto a plastic substrate. Test soils and inks are designed to mimic the challenge of removing blood and tissue from surgical instruments and evaluate the effectiveness of its customers' cleaning processes.
The company's facilities in Bozeman, Montana, and in Waldems, Germany, and Munich, Germany, manufacture its Sterilization and Disinfection Control division products, which include, among others, its GKE Clean-Record Indicators, Apex biological indicators, EZTest self-contained biological indicators, and PCDs. The company’s Sterilization and Disinfection Control division provides sterility assurance testing services to dental offices in the United States, Europe, and Canada. Sterilization and disinfection control products are disposable and are used on a routine basis, making product sales less sensitive to general economic conditions than certain other products and services the company offers. The company generates sales to end users through its direct sales personnel and independent distributors. Customers include industrial users involved in pharmaceutical and medical device manufacturing, hospitals, dental offices, and contract sterilization providers. The company's sterilization and disinfection control products are used in highly regulated industries.
Clinical Genomics
The company’s Clinical Genomics division develops, manufactures and sells highly sensitive, low-cost, high-throughput genetic analysis tools and related consumables and services that enable clinical research labs and contract research organizations to perform genomic testing for a broad range of research applications in several therapeutic areas.
Using Clinical Genomics’ MassARRAY system and the company’s proprietary consumables, including chips, panels, and chemical reagent solutions, its customers can analyze DNA samples for inherited genetic disease testing, pharmacogenetics, oncology testing, infectious disease testing, doping and toxicology testing, and other highly differentiated applications for use in research. The MassARRAY system couples mass spectrometry with end-point polymerase chain reaction (PCR) methods, enabling highly multiplexed reactions under universal cycling conditions to provide accurate, sensitive, rapid genetic analysis. The MassARRAY system is differentiated in the market by its ability to target up to 50 specific DNA variants in a single PCR reaction and run up to 384 samples on one SpectroCHIP array, multiple times a day, with the flexibility to process additional samples overnight.
In addition to the MassARRAY system and related consumable products, Clinical Genomics also sells services, including equipment maintenance contracts and custom laboratory services.
Approximately 75% of the company’s Clinical Genomics revenues are from consumables used on a routine basis; sales of these products are less sensitive to general economic conditions and typically have higher gross margins than hardware products. Approximately 15% of the company’s Clinical Genomics revenues are from hardware products that may be purchased by customers on a discretionary basis and are therefore more sensitive to general economic conditions. The remainder of Clinical Genomics revenues relate to services and support agreements.
Clinical Genomics sells its products and services predominantly to clinical research labs and contract research organizations, including large specialty, reference, and pathology labs, as well as to a variety of academic, hospital, and government facilities. The majority of revenues are derived from customers in the United States and China. The company’s Clinical Genomics products are manufactured in San Diego, California, primarily by assembling purchased subcomponents designed to the company’s specifications into finished goods, and by processing and mixing reagents. The company’s Clinical Genomics products generate revenues through direct sales, and also through independent distributors in certain regions.
Biopharmaceutical Development
The company’s Biopharmaceutical Development division develops, manufactures, sells and services automated systems for protein analysis (immunoassays) and peptide synthesis solutions. Immunoassays and peptide synthesis solutions accelerate the discovery, development, and manufacture of biologic therapies, among other applications. Customers include biopharmaceutical research, development, and manufacturing teams at biopharmaceutical companies and their contract research organization partners, as well as academic research and development laboratories.
The Biopharmaceutical Development division sells two major categories of instruments and consumables: (1) protein analysis solutions, which are used to test for the existence or concentration of specific proteins in a sample, and (2) peptide synthesis solutions, which automate the synthesis of peptides from amino acids; both are primarily used in biopharmaceutical research, discovery and development, and bioprocessing applications. The division also sells service agreements to maintain instruments sold by the division.
The company’s Biopharmaceutical Development division develops and manufactures Gyrolab xPand and Gyrolab xPlore hardware and software, as well as Gyrolab Bioaffy consumable microfluidic disks (‘CDs’) and Gyrolab kits and Rexxip buffers for protein analysis, in Uppsala, Sweden, while PurePep Symphony and Chorus instruments for peptide synthesis are developed and manufactured in Tucson, Arizona. The company’s PurePep EasyClean products, a green chemistry solution to purify peptides, is a consumables product line within its peptide synthesis business.
In the company’s fiscal year 2025, about 35% of its Biopharmaceutical Development revenues were from consumables used on a routine basis; sales of these products are less sensitive to general economic conditions. Approximately 40% of revenues were from more discretionary hardware purchases that are more sensitive to general economic conditions. The remainder of the division's sales relate to service and support agreements. Historically, hardware has comprised a smaller portion of the division's revenues; in fiscal year 2025, the division had higher hardware sales as it began recovering from the prior fiscal year's soft demand for capital equipment across the biopharmaceutical industry, resulting in a mix weighted more heavily toward its hardware during fiscal year 2025. The company generates sales to end users through direct sales, as well as through independent foreign distributors. Marketing activities include industry conferences, user meetings, educational webinars and all forms of digital marketing, in addition to market sensing and capturing user requirements for new product roadmaps.
The Biopharmaceutical Development division’s market success is primarily dependent upon creating high quality products that customers choose based on available features and performance.
Protein Analysis
The company develops, manufactures, and markets protein analysis equipment and consumable CDs, kits, and buffers that enable the detection and quantification of a target protein in a biological or bioprocess sample. Gyrolab technology is widely used across human and non-human applications, mainly for therapy development and bioprocess design. Customers, primarily pharmaceutical and biotech companies and their contract research organization partners developing protein-based therapies, use the company’s consumable CDs to deposit their samples for mixing with application specific reagents. The CDs and reagents are loaded into one of the company’s instruments for processing and analysis. The company’s proprietary software then facilitates the design of experiments, interprets results, provides useful data analysis for assay optimization and decision making, and supports end user regulatory compliance. The company’s protein analysis products accelerate the development and processing of assays to obtain accurate results for pre-clinical and clinical studies, as well as for upstream and downstream bioprocessing of biological therapies, thus enabling customers to meet critical data and time requirements. The company’s analytical protein technologies provide superior data consistency and accuracy while reducing labor and the attendant variability of more manual analysis methods.
Peptide Synthesis
The company’s peptide synthesis solutions enable customers to automate the chemical synthesis of peptides used in the creation of peptide therapies, biomaterials, cosmetics, and general research. The company’s peptide synthesizers and related consumables, including the company’s peptide purification consumables line, facilitate the ability to efficiently produce more complex and longer peptides with higher purity. The company’s synthesizers are designed to support regulatory compliance for end users. Customers of the company’s peptide synthesizers include commercial and academic biopharmaceutical laboratories, as well as contract manufacturers of peptides.
Calibration Solutions
The company's Calibration Solutions division develops, manufactures, sells, and services quality control products using principles of advanced metrology to enable customers to measure and calibrate critical parameters in applications, such as renal care, environmental and process monitoring, gas flow, air quality, and torque testing, primarily in medical device manufacturing, pharmaceutical manufacturing, laboratory, and hospital environments. Generally, the company’s Calibration Solutions products are used for quality control, safety validation, and regulatory compliance. The company's Lakewood, Colorado, and Hanover, Germany, facilities manufacture its Calibration Solutions products, which include continuous monitoring systems, dialysate meters and consumables, data loggers, gas flow calibration and air sampling equipment, and torque testing systems represented largely by the DialyGuard, ViewPoint, DataTrace, DryCal, and BGI brands.
The company's Calibration Solutions products are manufactured by assembling the products from purchased components and calibrating the final products. The company also installs certain of its products at customer sites. Service demand is driven by customers’ quality control and regulatory environments, which require products to be recalibrated or recertified periodically. The company generates sales through its direct sales personnel and independent distributors.
Renal Care Dialysate Meters and Consumables
The company's renal care medical meters are used to test various parameters of dialysis fluid (dialysate) and ensure the proper calibration and operation of dialysis machines. Each meter measures some combination of temperature, pressure, pH, conductivity, and flow to ensure that the dialysate has the proper composition to promote the transfer of waste products from the blood to the dialysate. The meters provide a digital readout verifying whether a dialysis machine is working within prescribed limits and delivering properly prepared dialysate. The company manufactures two styles of medical meters: those designed for use by dialysis machine manufacturers and biomedical technicians, and those used primarily by dialysis clinicians. The meters for technicians are characterized by exceptional accuracy, stability, and flexibility, and are used by the industry as the primary standard for the calibration of dialysis machines. The meters designed for use by dialysis clinicians are known primarily for their ease of use, and they incorporate a built-in syringe sampling system. These meters are used as the final quality control check on the dialysate just prior to starting treatment.
In addition to dialysate meters, the company markets a line of standard consumable solutions for use in dialysis clinics for the calibration of its meters. These standard solutions are regularly consumed by dialysis clinics, and thus, like the calibration services the company also provides, they are less impacted by general economic conditions than sales of meters. Customers that utilize the company's renal care products include dialysis facilities, medical device manufacturers, and biomedical service companies. With technological advancements in dialysis machines that include built-in calibrators, the company's meters designed for clinicians are subject to considerable competition in the market.
Continuous Monitoring
The company's continuous monitoring products are used to monitor various environmental parameters, such as temperature, humidity, and differential pressure to ensure that critical storage and processing conditions are maintained. Continuous monitoring systems are used in controlled environments, such as refrigerators, freezers, warehouses, laboratory incubators, clean rooms, and a number of other settings. Continuous monitoring systems consist of wireless sensors that are placed in controlled environments, which communicate with cloud and local servers to transmit and store data continuously. A critical function of its systems is the ability to provide local alarms and notifications via e-mail, text, or telephone if established environmental conditions are exceeded. Among the important competitive differentiators of the company's continuous monitoring systems are (1) their high degree of reliability and uptime; (2) a large variety of sensor types to meet the needs of most applications; (3) a skilled, distributed installation and service team; and (4) a full-featured and 21 CFR Part 11 (Electronic records; Electronic signatures) validated software program, providing extensive reporting and alarm capability. The company also offers support agreements and provides annual sensor recalibrations.
The company has a strong competitive position in North America but do not yet have a meaningful presence in markets outside of the U.S. and Canada. Key markets for its continuous monitoring systems are hospitals, pharmaceutical and medical device manufacturers, blood banks, pharmacies, and laboratory environments.
Data Loggers
The company’s data loggers are self-contained, wireless, high precision instruments used in critical manufacturing and quality control processes in the pharmaceutical, medical device, food, and tool industries. They are used to measure temperature, humidity and pressure inside a process or a product during manufacture. In addition, data loggers can be used to validate the proper operation of laboratory or manufacturing equipment, either during installation or for annual re-certifications. The products consist of individual data loggers, software, and various accessories. Customers typically purchase a large number of data loggers along with a single interface and software package. In practice, the user programs the loggers to collect environmental data at pre-determined time intervals, places the data loggers into the product or process to be tested, and then collects stored process data from the data logger. The user can then prepare tabular and graphical reports using the software. Unique aspects of the company’s data loggers are their ability to operate at elevated temperatures and in explosive environments, which are important differentiating factors in the marketplace.
Gas Flow Calibration and Air Sampling Equipment
The company manufactures a variety of instruments and equipment for gas flow calibration and environmental air sampling. The company’s gas flow calibration instruments provide the precise standards required by laboratories and industry for the design, development, manufacture, installation and calibration of various gas flow meters and air sampling devices. The company’s flow calibrators are used by professionals in many industries, including (1) industrial hygienists and environmental technicians, (2) calibration and research laboratories, (3) manufacturers who design, develop and manufacture gas flow metering devices, and (4) industrial engineering and manufacturing companies that utilize gas flow metering devices. The company sees expanded opportunities in gas flow calibration as markets that heavily use, and measure process gas are growing. There is competition in gas flow calibration; however, the company’s products are distinguished by their unique dry piston technology, accuracy and industry certifications.
In the air sampling area, the company’s technology is used primarily for the determination of particulate concentrations in air as a measure of urban or industrial air pollution, and for industrial hygiene assessments. The primary products include air samplers, particle separators and pumps. While both the public and private sector continue to focus on air quality and its impact on the environment and the health of populations, technological advances in real-time monitoring have made the traditional air sampling market more limited. In the environmental area, the company’s particle samplers were some of the first on the market and they were recognized early-on as ‘reference samplers’ by the U.S. Environmental Protection Agency. This product has a competitive advantage in the market because the company’s particle separation cyclones utilize the ‘federal reference method’ for the measurement of PM2.5 in ambient air and are sold to many manufacturers of ambient particulate measurement instrumentation.
Torque Testing Systems
The company’s automated torque testing systems are durable and reliable motorized cap torque analyzers that measure the amount of force required to open a container. The primary advantages of the company’s torque instruments are their high accuracy and long-term consistency of measurement. Industries utilizing these instruments include pharmaceutical and beverage and food processing companies. Given the niche nature of this product, there is a relatively low level of competition for this product line; however, the growth of this line is limited by the growth of new manufacturing facilities and packaging regulations in pharmaceutical manufacturing. Torque products are used by many of the same customers that purchase the company’s data loggers, offering channel synergy opportunities.
Regulatory Matters
The company is required to comply with certain International Standard Organization (ISO) standards, United States Pharmacopeia standards and Food and Drug Administration (FDA) requirements in order to sell some of its products. The company’s biological indicators are developed and manufactured according to ISO 11138 (Sterilization of healthcare products – Biological indicators) and its chemical indicators are developed and manufactured according to ISO 11140 (Sterilization of healthcare products – Chemical indicators), under a quality system that complies with ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes, and as applicable, 21 CFR 820 (Quality system regulation). Specific Calibration Solutions products are compliant under ISO 13485:2016, ISO 17025:2017, and certain 21 CFR 820 regulations. The company’s Biopharmaceutical Division’s Uppsala, Sweden and Tucson, Arizona facilities are ISO 9001:2015 certified. Clinical Genomics and GKE GmbH operate quality management systems which comply with the requirements of ISO 13485:2016. SAL GmbH operates a testing lab and quality management system in accordance with ISO 17025:2017 in Waldems, Germany.
Several products in the Sterilization and Disinfection Control, Calibration Solutions, and Clinical Genomics divisions are classified by the FDA as medical devices subject to the provisions of the Federal Food, Drug and Cosmetic Act, which requires any company proposing to market a medical device to notify the FDA of its intention at least 90 days before doing so. Some of the company’s facilities are subject to FDA regulations and inspections. This includes ongoing compliance with the FDA’s current Good Manufacturing Practices regulations that require, among other things, the systematic control of design, manufacture, packaging, storage and transportation of products. Failure to comply with these practices renders the product adulterated and could subject the company to an interruption of manufacturing and sales of these products, and possible regulatory action by the FDA.
The company is subject to data privacy and security laws, regulations, and customer-imposed controls in numerous jurisdictions as a result of having access to and processing confidential, personal or sensitive data in the course of its business, including the EU General Data Protection Regulation which imposes strict requirements on how the company collects, transmits, processes, and retains personal data.
History
Mesa Laboratories, Inc. was founded in 1982. The company was incorporated in 1982.
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