Humbly report, All, regarding CMED, Description of Business:
From the last CMED Annual Report: edgar-online.com
ITEM 1. DESCRIPTION OF BUSINESS.
Colorado MEDtech, Inc. ("CMED") and its wholly-owned subsidiaries, RELA, Inc. ("RELA") and Novel Biomedical, Inc. ("Novel") (collectively, the "Company") are leading full-service providers of advanced medical products, technologies and services which increase the efficacy and lower the cost of health care. CMED was incorporated in 1977 as a Colorado corporation to develop, manufacture, market and service computerized diagnostic and testing instrumentation. RELA, a Colorado corporation, was incorporated in 1977. RELA is an integrated custom product development and manufacturing services company specializing in the design, development and manufacture of electronic and electro-mechanical medical products and software systems. Novel, a Minnesota corporation, was incorporated in 1986 and was acquired by CMED in February, 1997. Novel specializes in the custom design, development and manufacture of unique disposable medical devises, primarily catheters, used in angioplasty, minimally invasive surgery, electrophysiology and infertility treatment. In July 1997, CMED entered into an agreement to acquire the operating assets of Erbtec Engineering, Inc. ("Erbtec"). Erbtec, located in Boulder, Colorado, produces high power radio frequency ("RF") amplifiers and systems for Magnetic Resonance Imaging ("MRI") equipment and other medical imaging applications.
PRODUCTS AND SERVICES
The Company employs engineers, scientists, technicians, manufacturing specialists, and assembly workers. The Company believes its experience in applying its proven methodologies and advanced technologies to the development of innovative new products gives its clients an advantage in their marketplace by providing them with state-of-the-art, quality products in a timely and cost-effective manner. The Company designs, develops and manufactures healthcare products for a broad range of customers that include major pharmaceutical and medical instrumentation companies. In addition to development, the Company performs product definition services, conducts focus groups and performs software verification and validation ("V&V") activities necessary for Food and Drug Administration ("FDA") approval. CMED and RELA received ISO 9001 and EN 46001 certification during 1996. Novel is currently preparing to undergo an ISO 9001 and EN 46001 certification audit during fiscal year 1998. The Company is a Registered Device Manufacturer with the FDA and meets the agency's Quality Systems Regulation requirements.
Additional services include:
- Feasibility studies - Mechanical design and engineering - Market research - Machining and modeling services - Product modeling, graphic design - Disposables engineering and trade show support - Prototype development - Industrial design and human - Design for manufacturability factors engineering and reliability engineering - User interface design and - Pilot, short- and long-run usability testing production - Electronic design and development - Quality assurance and testing - Software development, verification - Product service and sustaining and validation engineering - Electronic packaging and printed- circuit design
Rapidly advancing technologies, heightened worldwide competition and the demands of an increasingly sophisticated marketplace have created pressures on companies, both domestic and international, to develop high quality, world-class products in time to meet the narrowing windows of opportunity in the marketplace. These conditions have produced opportunities for companies that can react to those market needs. Such companies need to have the technology, experience and ability to develop high quality, state-of-the-art products. The Company believes it is uniquely positioned to provide its clients, within a single integrated structure, the valuable product development and manufacturing resources they need to satisfy the requirements of a worldwide marketplace.
CMED was organized to develop, manufacture, market and service computerized diagnostic and testing instrumentation. The Company's respiratory product lines include respiratory filters, metabolic assessment instruments and computers and computer software for the measurement of metabolic parameters.
CMED is currently in the test phase of an oxygen regeneration system that is intended for use in long-term health care facilities. This system is expected to reduce the cost of oxygen to patients of these facilities due to the fact that they would be generating their own oxygen at their own facilities instead of purchasing it from third parties. The Company expects this product to be in commercial production during fiscal 1998.
The Company's MetaScope-TM- allows physicians to perform metabolic analysis in a noninvasive manner by means of the science of indirect calorimetry. The MetaScope-TM- provides physicians with precise nutritional information that assists in monitoring patient recovery. Cardiac output measurements based on oxygen consumption can also be computed with this instrument.
MARKETING
The Company markets its services through a direct sales program and nationwide network of independent manufacturers' representatives. The Company promotes its services through advertising, direct mail and attendance at industry trade shows.
The Company's respiratory products are sold primarily to Vencor, Inc. ("Vencor"), a related party that is a large hospital and nursing home organization and to other hospitals, clinics, and private physicians throughout the continental United States, and on a limited basis in Canada, Japan, Mexico and several other foreign countries. The Company distributes these products through its own support organization.
For the period ended June 30, 1997, three customers accounted for approximately 19%, 14% and 12%, respectively, of total revenues of the Company and foreign sales were less than 5% of the Company's total sales. The loss of a significant customer could have a material, detrimental impact on the Company's operations. Most sales are on net thirty-day credit terms. At June 30, 1997, the Company's backlog of orders for services or shipment of product in fiscal 1998 was approximately $21.7 million compared to approximately $16.0 million at June 30, 1996.
RESEARCH AND PRODUCT DEVELOPMENT
The Company intends to continue to improve current products and to develop new products and services. In addition to internal development efforts, the Company may acquire related technology and/or products from others.
In June of 1994, the Company signed a product development agreement with Vencor to develop mutually agreed upon products that Vencor would purchase exclusively from the Company, while the Company is unrestricted in its rights to sell the products. The Company has agreed to expend at least $800,000 toward development of products during the term of the agreement.
While the Company employs approximately 100 engineers, scientists and technicians in research and development activities, these employees' efforts are primarily devoted to contract work for customers. Research and development expenses historically were attributable to the metabolic and filter product lines. During fiscal year 1997 most of the research and development expenses are attributable to the oxygen regeneration system. No research and development expenditures are currently attributable to RELA or Novel. For fiscal years 1997 and 1996, the Company incurred approximately $304,000 and $97,000, respectively, for research and development activities.
Consistent with the Company's operating plans, the Company is continuously pursuing the acquisition and development of new or improved technology or products. Should the Company identify any opportunities that would be commercially viable, the amount of future research and development expenditures may increase.
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COMPETITION
The Company's present and future competition comes from a variety of sources. These sources include commercial product development and manufacturing companies. There are a number of firms that provide services similar to the Company's. These vary from small consulting operations offering a small subset of the Company's services to a few integrated service companies. Frequent RELA competitors include SeaMed Corporation and Kollsman Manufacturing Company. Frequent Novel competitors include ACT Medical, Incorporated and NuMED, Incorporated.
On a lesser scale, the Company also competes with commercial and university research laboratories. There are both for-profit and not-for-profit organizations nationwide that perform services similar to the product development aspect of the Company's business. These include Battelle, Inc., Stanford Research Institute, Arthur D. Little Center for Product Development, Southwest Research Institute and the research capabilities within the nation's leading universities.
CMED's MetaScope-TM- has three major competitors. Mallinckrodt Group, Incorporated has a unit dedicated for use with their line of hospital ventilators. Sensormedics Corporation and Medical Graphics Corporation both produce instruments that compete directly with the Company's product. Jaeger also produces a product that has not been released for sale in the United States.
As the Company develops and manufactures other proprietary products, such as the oxygen regeneration system, it can expect to encounter additional competitors, many of which may be larger and in a stronger financial position than the Company. As cost containment efforts continue in the healthcare marketplace, competition will continue to be intense in the future.
MANUFACTURING
The Company manufactures its products and customer products at three facilities in Boulder, Colorado, Longmont, Colorado and in Plymouth, Minnesota. Most products are fabricated as standard products, while others are built in response to specific customer purchase orders. The manufacturing process consists primarily of assembly, test and packaging of both custom and commercially available components from outside sources.
Most of the materials and components used in the Company's products are available from a number of different suppliers. The Company generally maintains multiple sources for most items, but some components are single source. The Company is dependent upon its suppliers for timely delivery of quality components.
PRODUCT WARRANTIES AND SERVICE
The Company generally warrants its products for 90 days, but in limited cases for up to one year against defects in materials and workmanship. The Company has established a provision for estimated expenses of providing service under these warranties. Nonwarranty service is billed to the customer as performed.
GOVERNMENT REGULATION
The Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act (the "Act") and regulations issued or proposed thereunder, including the Safe Medical Devices Act of 1990, provide for regulation by the U.S. Food and Drug Administration ("FDA") of the marketing, design, manufacturing, labeling, packaging and distribution of medical devices. These regulations apply to the Company's products and many of the Company's customers' products. The Act and the regulations include requirements that manufacturers of medical devices register with and furnish lists of devices manufactured by them to the FDA. Prior to marketing a medical device, FDA approval must be obtained. Tasks to be performed for approval range from bench-test data and engineering analysis to potentially expensive and time-consuming clinical trials. The types of tasks for a particular product submission are indicated by the classification of the device and previous approvals for similar devices. There are also certain requirements of other federal laws and of state, local, and foreign governments, which may apply to the manufacture and marketing of the Company's products. To date, the Company has not experienced significant difficulty in complying with the requirements imposed on it by the FDA or other governmental agencies.
The FDA's "Quality System Regulation for Medical Devices" ("QSR") sets forth standards for the Company's design and manufacturing processes that require the maintenance of certain records and provide for unscheduled inspections of the Company's facilities. The Company does not expect to make significant expenditures as a result of these requirements. The Company's procedures and records were reviewed in 1987, 1990, 1995, and 1997 by the FDA during routine general inspections. The inspections resulted in some procedural changes that are intended to assure continued compliance with current QSR.
CMED and RELA received ISO 9001 and EN 46001 certification in June of 1996. The ISO 9001 series of quality management and quality assurance standards has been adopted by 90 countries. ISO standards require that a quality system be used to guide work to assure quality and to produce quality products. ISO 9001, the most comprehensive of the standards, covers 20 elements. These elements include management responsibility, design control, training, process control and servicing. ISO 9001 is the quality systems standard used by companies providing design, development, manufacturing, installation, and servicing. Novel is currently preparing to apply for ISO 9001 and EN 46001 certification during fiscal year 1998.
There are no material costs or expenses associated with the Company's compliance with federal, state and local environmental laws.
PATENTS
The Company has no significant patents. The Company believes that the conduct of its business is not dependent upon its ability to obtain or defend patents.
EMPLOYEES
As of June 30, 1997, the Company had 245 employees, of which 189 are full-time. 85% of the Company's employees are employed at its operations in Boulder and Longmont, Colorado. The remaining 15% of employees are employed at Novel in Plymouth, Minnesota. No employees are represented by labor organizations and there are no collective bargaining agreements. Employee relations are believed to be good.
Form 10-Q for COLORADO MEDTECH INC filed on Feb 10 1998: edgar-online.com
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